<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03271528</url>
  </required_header>
  <id_info>
    <org_study_id>H-36766</org_study_id>
    <secondary_id>1R21AA026389-01</secondary_id>
    <nct_id>NCT03271528</nct_id>
  </id_info>
  <brief_title>Lacosamide Effects on Alcohol Self Administration and Craving in Heavy Drinkers</brief_title>
  <official_title>Lacosamide Effects on Alcohol Self Administration and Craving in Heavy Drinkers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Alcohol Abuse and Alcoholism (NIAAA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Boston Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a double-blind, randomized, placebo-controlled, crossover design trial tested the&#xD;
      effect of lacosamide on alcohol self-administration and craving following a priming dose of&#xD;
      alcohol. The specific objective of this study was to determine whether lacosamide, a novel&#xD;
      anticonvulsant that is FDA-approved for treating partial seizures, has effects on alcohol&#xD;
      craving and consumption.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The present proposal was intended to answer the call for accelerating drug development by&#xD;
      exploring the potential of a novel anticonvulsant, lacosamide, as a candidate medication for&#xD;
      the treatment of alcohol use disorder (AUD). This drug, which is approved for the treatment&#xD;
      of seizure disorders, has unique pharmacological actions that include enhancement of slow&#xD;
      sodium channel inactivation and inhibition of collapsin response mediator protein-2 (CRMP-2).&#xD;
      Alcohol consumption in mice that had knockdown of CRMP-2 within the nucleus accumbens was&#xD;
      decreased from levels seen in control animals. In rodent studies, lacosamide administration&#xD;
      has produced reductions in 'excessive' drinking and has experimentally-induced decreased&#xD;
      expression of the CRMP-2 protein. These findings implicate CRMP-2 as playing a role in the&#xD;
      regulation of alcohol consumption. None of the FDA-approved AUD medications or medications&#xD;
      commonly used off-label to treat AUD target this CRMP-2 pathway, making lacosamide a&#xD;
      promising compound for AUD drug development. The aims of this study were to: 1) test the&#xD;
      effects of lacosamide on alcohol self-administration and craving, 2) test the effects of 7&#xD;
      days of lacosamide administration on cognitive function, and 3) test the effects of&#xD;
      lacosamide on alcohol consumption and craving during a 7-day period of exposure. The effects&#xD;
      of 7 days of lacosamide (300mg) or placebo were evaluated in a human laboratory using an&#xD;
      alcohol self-administration methodology. In this within-subjects crossover design, heavy&#xD;
      drinkers (N=27) were randomized to the order of exposure (lacosamide or placebo) prior to&#xD;
      completing two alcohol self-administration trials. Subjects received a priming drink of&#xD;
      alcohol and had access to 8 alcoholic drinks over a 2-hour period. The investigators&#xD;
      anticipated that subjects would consume less alcohol during an alcohol self-administration&#xD;
      trial when receiving lacosamide compared to when they are receiving placebo. Significant&#xD;
      lacosamide-induced reductions in the quantity of alcohol self-administered are considered to&#xD;
      be an indication that this drug may have value as an AUD medication. This study may provide a&#xD;
      rationale for phase II clinical studies testing lacosamide with a treatment-seeking AUD&#xD;
      population. These results should also help to spur further pre-clinical investigation into&#xD;
      the role play by CRMP-2 in regulating both alcohol consumption and alcohol seeking behaviors.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 15, 2018</start_date>
  <completion_date type="Actual">August 31, 2020</completion_date>
  <primary_completion_date type="Actual">August 31, 2020</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <intervention_model_description>This is a double-blind, randomized, placebo-controlled, crossover design trial to test the effect of lacosamide on alcohol self-administration and craving following a priming dose of alcohol.This study is a within subjects design in which each subject receives both study drug (lacosamide) and placebo during participation.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>This study is double-blind. Medications are over-encapsulated.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Alcohol Consumption in Alcohol Self-Administration Trials</measure>
    <time_frame>2 hours</time_frame>
    <description>Alcohol consumption will be measured by using a graduated cylinder to determine the amount of alcohol given to the subject that was consumed. This outcome will be measured as standard drink units. A standard drink contains approximately 0.6 fluid ounces of pure alcohol.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Verbal Fluency: Controlled Word Association (COWAT)</measure>
    <time_frame>3 minutes</time_frame>
    <description>The Controlled Word Association (COWAT) is a verbal fluency test that measures the spontaneous production of words beginning with some designated letter. The participant is asked to name words beginning with a given letter, excluding proper nouns, for one minute and this procedure is repeated three times with a different letter each time. A different set of letters was used in each of the two alcohol self-administration trials: C-F-L and P-R-W. The examiner writes down the words provided by the participant on a piece of paper. This test is scored by counting the number of words generated by the subject for each letter, then adding the scores for each of the three letters to calculate a total test score. The lowest possible score is 0 and there is no upper limit to the score range. A higher score is indicative of better outcomes (I.e. better verbal fluency).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive Function: Spatial Span Forward</measure>
    <time_frame>10 minutes</time_frame>
    <description>The Wechsler Memory Scale (WMS-III) Spatial Span test will be used to assess subjects' working memory. Subjects will be shown a sequence of block tapping and asked to repeat back an increasing number of tapped blocks in the same order. Each of the 16 items on this test is scored 0 (incorrect answer) or 1 (correct answer). The total score is calculated by adding the scores for each of the 16 items. The total score range is 0-16. Higher scores are indicative of higher levels of working memory (better outcome) and lower scores are indicative of lesser working memory function (worse outcome).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive Function: Spatial Span Backward</measure>
    <time_frame>10 minutes</time_frame>
    <description>The Wechsler Memory Scale (WMS-III) Spatial Span test will be used to assess subjects' working memory. Subjects will be shown a sequence of block tapping and asked to repeat back an increasing number of tapped blocks in the opposite order. Each of the 16 items on this test is scored 0 (incorrect answer) or 1 (correct answer). The total score is calculated by adding the scores for each of the 16 items. The total score range is 0-16. Higher scores are indicative of higher levels of working memory (better outcome) and lower scores are indicative of lesser working memory function (worse outcome).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive Function: Digit Span Forward</measure>
    <time_frame>10 minutes</time_frame>
    <description>The Wechsler Adult Intelligence Scale (WAIS-IV) Digit Span test will be used to assess subjects' working memory. Subjects will be read and asked to repeat back an increasing number of digits in the same order. Each of the 16 items on this test is scored 0 (incorrect answer) or 1 (correct answer). The total score is calculated by adding the scores for each of the 16 items. The total score range is 0-16. Higher scores are indicative of higher levels of working memory (better outcome) and lower scores are indicative of lesser working memory function (worse outcome).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive Function: Digit Span Backward</measure>
    <time_frame>10 minutes</time_frame>
    <description>The Wechsler Adult Intelligence Scale (WAIS-IV) Digit Span test will be used to assess subjects' working memory. Subjects will be read and asked to repeat back an increasing number of digits in the opposite order. Each of the 16 items on this test is scored 0 (incorrect answer) or 1 (correct answer). The total score is calculated by adding the scores for each of the 16 items. The total score range is 0-16. Higher scores are indicative of higher levels of working memory (better outcome) and lower scores are indicative of lesser working memory function (worse outcome).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive Function: Digit Span Sequencing</measure>
    <time_frame>10 minutes</time_frame>
    <description>The Wechsler Adult Intelligence Scale (WAIS-IV) Digit Span test will be used to assess subjects' working memory. Subjects will be read and asked to repeat back an increasing number of digits in ascending order. Each of the 16 items on this test is scored 0 (incorrect answer) or 1 (correct answer). The total score is calculated by adding the scores for each of the 16 items. The total score range is 0-16. Higher scores are indicative of higher levels of working memory (better outcome) and lower scores are indicative of lesser working memory function (worse outcome).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alcohol Craving: Obsessive-Compulsive Drinking Scale (OCDS) Pretrial</measure>
    <time_frame>5 minutes</time_frame>
    <description>The Obsessive-Compulsive Drinking Scale (OCDS) is a quick and reliable 14-item self-rating instrument that provides a total score that measures some cognitive aspects of alcohol craving (obsessive and compulsive drinking). Each of the 14 items is scored from 0 to 4. The total score is calculated by adding the scores for each of the 14 items. The total score range is 0-56. Higher scores are indicative of more obsessive or compulsive drinking and lower scores are indicative of less obsessive or compulsive drinking.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alcohol Craving: Visual Analog Scale (VAS) Pretrial</measure>
    <time_frame>1 minute</time_frame>
    <description>Alcohol craving was measured by self report with the Visual Analog Scale (VAS). The VAS is a straight horizontal line with one end indicating no alcohol craving and the other end indicating intense alcohol craving. The participant marks a point on the line that matches their present amount of alcohol craving. Location of the point on the line is measured for a score range of 0-100. A lower score indicates less craving for alcohol and a higher score indicated more craving for alcohol.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alcohol Craving: Visual Analog Scale (VAS) Observation Period, Minute 10</measure>
    <time_frame>1 minute</time_frame>
    <description>Alcohol craving was measured by self report with the Visual Analog Scale (VAS). The VAS is a straight horizontal line with one end indicating no alcohol craving and the other end indicating intense alcohol craving. The participant marks a point on the line that matches their present amount of alcohol craving. Location of the point on the line is measured for a score range of 0-100. A lower score indicates less craving for alcohol and a higher score indicated more craving for alcohol.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alcohol Craving: Visual Analog Scale (VAS) Observation Period, Minute 20</measure>
    <time_frame>1 minute</time_frame>
    <description>Alcohol craving was measured by self report with the Visual Analog Scale (VAS). The VAS is a straight horizontal line with one end indicating no alcohol craving and the other end indicating intense alcohol craving. The participant marks a point on the line that matches their present amount of alcohol craving. Location of the point on the line is measured for a score range of 0-100. A lower score indicates less craving for alcohol and a higher score indicated more craving for alcohol.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alcohol Craving: Visual Analog Scale (VAS) Observation Period, Minute 30</measure>
    <time_frame>1 minute</time_frame>
    <description>Alcohol craving was measured by self report with the Visual Analog Scale (VAS). The VAS is a straight horizontal line with one end indicating no alcohol craving and the other end indicating intense alcohol craving. The participant marks a point on the line that matches their present amount of alcohol craving. Location of the point on the line is measured for a score range of 0-100. A lower score indicates less craving for alcohol and a higher score indicated more craving for alcohol.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alcohol Craving: Visual Analog Scale (VAS) Observation Period, Minute 40</measure>
    <time_frame>1 minute</time_frame>
    <description>Alcohol craving was measured by self report with the Visual Analog Scale (VAS). The VAS is a straight horizontal line with one end indicating no alcohol craving and the other end indicating intense alcohol craving. The participant marks a point on the line that matches their present amount of alcohol craving. Location of the point on the line is measured for a score range of 0-100. A lower score indicates less craving for alcohol and a higher score indicated more craving for alcohol.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alcohol Craving: Visual Analog Scale (VAS) Self-Administration Blocks 1 and 2, Minute 30</measure>
    <time_frame>1 minute</time_frame>
    <description>Alcohol craving was measured by self report with the Visual Analog Scale (VAS). The VAS is a straight horizontal line with one end indicating no alcohol craving and the other end indicating intense alcohol craving. The participant marks a point on the line that matches their present amount of alcohol craving. Location of the point on the line is measured for a score range of 0-100. A lower score indicates less craving for alcohol and a higher score indicated more craving for alcohol.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alcohol Craving: Visual Analog Scale (VAS) Self-Administration Blocks 1 and 2, Minute 60</measure>
    <time_frame>1 minute</time_frame>
    <description>Alcohol craving was measured by self report with the Visual Analog Scale (VAS). The VAS is a straight horizontal line with one end indicating no alcohol craving and the other end indicating intense alcohol craving. The participant marks a point on the line that matches their present amount of alcohol craving. Location of the point on the line is measured for a score range of 0-100. A lower score indicates less craving for alcohol and a higher score indicated more craving for alcohol.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alcohol Craving: Visual Analog Scale (VAS) Self-Administration Blocks 1 and 2, Minute 90</measure>
    <time_frame>1 minute</time_frame>
    <description>Alcohol craving was measured by self report with the Visual Analog Scale (VAS). The VAS is a straight horizontal line with one end indicating no alcohol craving and the other end indicating intense alcohol craving. The participant marks a point on the line that matches their present amount of alcohol craving. Location of the point on the line is measured for a score range of 0-100. A lower score indicates less craving for alcohol and a higher score indicated more craving for alcohol.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alcohol Craving: Visual Analog Scale (VAS) Self-Administration Blocks 1 and 2, Minute 120</measure>
    <time_frame>1 minute</time_frame>
    <description>Alcohol craving was measured by self report with the Visual Analog Scale (VAS). The VAS is a straight horizontal line with one end indicating no alcohol craving and the other end indicating intense alcohol craving. The participant marks a point on the line that matches their present amount of alcohol craving. Location of the point on the line is measured for a score range of 0-100. A lower score indicates less craving for alcohol and a higher score indicated more craving for alcohol.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alcohol Craving: Alcohol Urge Questionnaire (AUQ) Self-Administration Blocks 1 and 2, Minute 30</measure>
    <time_frame>1 minute</time_frame>
    <description>The Alcohol Urge Questionnaire (AUQ) is an 8-item self report that measures the participant's urge for an alcoholic drink at the time the questionnaire is completed. Questions are in the form of a 7-point Likert scale (from strongly disagree to strongly agree) and the participant selects the extent to which they disagree or agree with the 8 statements relating to desire to drink, expectation of a desired outcome from drinking, and inability to avoid drinking if alcohol was available. Each of the 8 items is scored 1-7. The total score is calculated by adding the scores for each of the items. The total score range is 8-56. Lower scores indicate less urge for alcohol and higher scores indicate more urge for alcohol.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alcohol Craving: Alcohol Urge Questionnaire (AUQ) Self-Administration Blocks 1 and 2, Minute 60</measure>
    <time_frame>1 minute</time_frame>
    <description>The Alcohol Urge Questionnaire (AUQ) is an 8-item self report that measures the participant's urge for an alcoholic drink at the time the questionnaire is completed. Questions are in the form of a 7-point Likert scale (from strongly disagree to strongly agree) and the participant selects the extent to which they disagree or agree with the 8 statements relating to desire to drink, expectation of a desired outcome from drinking, and inability to avoid drinking if alcohol was available. Each of the 8 items is scored 1-7. The total score is calculated by adding the scores for each of the items. The total score range is 8-56. Lower scores indicate less urge for alcohol and higher scores indicate more urge for alcohol.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alcohol Craving: Alcohol Urge Questionnaire (AUQ) Self-Administration Blocks 1 and 2, Minute 90</measure>
    <time_frame>1 minute</time_frame>
    <description>The Alcohol Urge Questionnaire (AUQ) is an 8-item self report that measures the participant's urge for an alcoholic drink at the time the questionnaire is completed. Questions are in the form of a 7-point Likert scale (from strongly disagree to strongly agree) and the participant selects the extent to which they disagree or agree with the 8 statements relating to desire to drink, expectation of a desired outcome from drinking, and inability to avoid drinking if alcohol was available. Each of the 8 items is scored 1-7. The total score is calculated by adding the scores for each of the items. The total score range is 8-56. Lower scores indicate less urge for alcohol and higher scores indicate more urge for alcohol.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alcohol Craving: Alcohol Urge Questionnaire (AUQ) Self-Administration Blocks 1 and 2, Minute 120</measure>
    <time_frame>1 minute</time_frame>
    <description>The Alcohol Urge Questionnaire (AUQ) is an 8-item self report that measures the participant's urge for an alcoholic drink at the time the questionnaire is completed. Questions are in the form of a 7-point Likert scale (from strongly disagree to strongly agree) and the participant selects the extent to which they disagree or agree with the 8 statements relating to desire to drink, expectation of a desired outcome from drinking, and inability to avoid drinking if alcohol was available. Each of the 8 items is scored 1-7. The total score is calculated by adding the scores for each of the items. The total score range is 8-56. Lower scores indicate less urge for alcohol and higher scores indicate more urge for alcohol.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">66</enrollment>
  <condition>Alcohol Use Disorder</condition>
  <arm_group>
    <arm_group_label>Lacosamide</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Lacosamide titration was done to a target dose of 300mg. Participants took 100 mg of lacosamide once on day 1, 100 mg twice per day from day 2 through day 6 (200 mg daily total), on day 7 the lacosamide dose was increased to 150 mg twice daily (300 mg daily total), and on day 8 the participant took one dose of 150 mg.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo oral capsule</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants took a placebo oral capsule once on day 1, twice per day from day 2 to day 7, and once on day 8.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lacosamide</intervention_name>
    <description>Lacosamide titration was done to a target dose of 300mg. Participants took 100 mg of lacosamide once on day 1, 100 mg twice per day from day 2 through day 6 (200 mg daily total), on day 7 the lacosamide dose was increased to 150 mg twice daily (300 mg daily total), and on day 8 the participant took one dose of 150 mg.</description>
    <arm_group_label>Lacosamide</arm_group_label>
    <other_name>Vimpat</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo oral capsule</intervention_name>
    <description>Participants took a placebo oral capsule once on day 1, twice per day from day 2 to day 7, and once on day 8.</description>
    <arm_group_label>Placebo oral capsule</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Subject Inclusion Criteria&#xD;
&#xD;
          1. 21-55 years of age&#xD;
&#xD;
          2. Can provide proof of age with state-issued or federal picture ID&#xD;
&#xD;
          3. Exceeds safe weekly drinking limits (≥14 drinks for women or ≥21 drinks for men per&#xD;
             week)&#xD;
&#xD;
          4. Reports at least an average of one episode per week of binge drinking (&gt;3 for women,&#xD;
             &gt;4 for men) in the four weeks prior to baseline screening&#xD;
&#xD;
          5. Meets DSM-5 criteria for mild alcohol use disorder or greater severity.&#xD;
&#xD;
          6. Has a smartphone to complete some of the study assessments.&#xD;
&#xD;
        Subject Exclusion Criteria&#xD;
&#xD;
          1. Currently seeking treatment for alcohol problems&#xD;
&#xD;
          2. Clinical Institute Withdrawal Assessment at &gt;10&#xD;
&#xD;
          3. DSM-5 diagnosis of current major depression, bipolar disorder, schizophrenia,&#xD;
             bulimia/anorexia, dementia, or a substance use disorder other than alcohol, nicotine,&#xD;
             marijuana or caffeine&#xD;
&#xD;
          4. If female, pregnant, nursing, or have plans to become pregnant&#xD;
&#xD;
          5. If female, does not agree to use an accepted form of birth control&#xD;
&#xD;
          6. Is currently using medications for which alcohol is a contraindication&#xD;
&#xD;
          7. Has a medical or mental health condition for which further alcohol exposure at the&#xD;
             planned dose range would be contraindicated.&#xD;
&#xD;
          8. Current risk of suicidality (MINI suicidality score greater than 8 (low risk) or Yes&#xD;
             to the ideation question #4 of the C-SSRS)&#xD;
&#xD;
          9. Has a history of myocardial infarction, congestive heart failure, has a risk for the&#xD;
             development of heart block, or are taking medications that can decrease conduction&#xD;
             through the atrial ventricular node.&#xD;
&#xD;
         10. Has previous exposure to lacosamide&#xD;
&#xD;
         11. Has received any form of counseling, self-help, pharmacotherapy, or other intervention&#xD;
             to treat AUD in the past 90 days.&#xD;
&#xD;
         12. Is unwilling to suspend use of multivitamins that contain riboflavin during study&#xD;
             participation&#xD;
&#xD;
         13. Has urine toxicology results positive for cocaine, opioids, amphetamines,&#xD;
             buprenorphine, methadone, or methamphetamines&#xD;
&#xD;
         14. Liver function values AST or ALT are twice the normal limit&#xD;
&#xD;
         15. GFR &lt;80 mL/min&#xD;
&#xD;
         16. Unable to comfortably abstain from nicotine for a period of 8 hours.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eric Devine, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistant Professor</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Boston University Psychiatry Research Center, Clinical Studies Unit</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>August 31, 2017</study_first_submitted>
  <study_first_submitted_qc>August 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 5, 2017</study_first_posted>
  <results_first_submitted>April 9, 2021</results_first_submitted>
  <results_first_submitted_qc>May 7, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">June 3, 2021</results_first_posted>
  <last_update_submitted>May 7, 2021</last_update_submitted>
  <last_update_submitted_qc>May 7, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 3, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Lacosamide</keyword>
  <keyword>Alcohol craving</keyword>
  <keyword>Alcohol Urge Questionnaire</keyword>
  <keyword>Obsessive-Compulsive Drinking Scale</keyword>
  <keyword>Visual Analog Scale</keyword>
  <keyword>Alcohol consumption</keyword>
  <keyword>Alcohol use disorder</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alcoholism</mesh_term>
    <mesh_term>Alcoholic Intoxication</mesh_term>
    <mesh_term>Alcohol Drinking</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lacosamide</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 11, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/28/NCT03271528/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>December 5, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/28/NCT03271528/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>66 subjects were consented but 39 dropped out prior to randomization in the study (ineligible after screening or lost to follow-up). A total of 27 subjects were randomized.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Lacosamide Then Placebo</title>
          <description>This is a within subjects design study in which each subject receives both study drug and placebo. Subjects in this group received 7 days of lacosamide before the first alcohol self-administration trial and 7 days of placebo before the second alcohol self-administration trial.</description>
        </group>
        <group group_id="P2">
          <title>Placebo Then Lacosamide</title>
          <description>This is a within subjects design study in which each subject receives both study drug and placebo. Subjects in this group received 7 days of placebo before the first alcohol self-administration trial and 7 days of lacosamide before the second alcohol self-administration trial.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Medication Dispense/Exposure Period 1</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="14"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Participation discontinued due to COVID-19 research pause</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Alcohol Trial 1, Washout Period 1</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Failed urine drug screen at time of Alcohol Trial 1</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Medication Dispense/Exposure Period 2</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Alcohol Self-Administration Trial 2</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>66 subjects were consented, 27 subjects were randomized, and 19 subjects completed the study. Three subjects that completed the study were omitted from statistical analysis due to not consuming any alcohol during either alcohol self-administration session.</population>
      <group_list>
        <group group_id="B1">
          <title>Lacosamide Then Placebo</title>
          <description>This is a within subjects design study in which each subject receives both study drug and placebo. Subjects in this group received 7 days of lacosamide before the first alcohol self-administration trial and 7 days of placebo before the second alcohol self-administration trial.</description>
        </group>
        <group group_id="B2">
          <title>Placebo Then Lacosamide</title>
          <description>This is a within subjects design study in which each subject receives both study drug and placebo. Subjects in this group received 7 days of placebo before the first alcohol self-administration trial and 7 days of lacosamide before the second alcohol self-administration trial.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="7"/>
            <count group_id="B2" value="9"/>
            <count group_id="B3" value="16"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="34.5" spread="9.4"/>
                    <measurement group_id="B2" value="37.8" spread="8.2"/>
                    <measurement group_id="B3" value="36.4" spread="9.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Alcohol Consumption in Alcohol Self-Administration Trials</title>
        <description>Alcohol consumption will be measured by using a graduated cylinder to determine the amount of alcohol given to the subject that was consumed. This outcome will be measured as standard drink units. A standard drink contains approximately 0.6 fluid ounces of pure alcohol.</description>
        <time_frame>2 hours</time_frame>
        <population>66 subjects were consented, 27 subjects were randomized, and 19 subjects completed the study. Three subjects that completed the study were omitted from statistical analysis due to not consuming any alcohol during either alcohol self-administration session.</population>
        <group_list>
          <group group_id="O1">
            <title>Lacosamide</title>
            <description>Lacosamide titration was done to a target dose of 300mg. Participants took 100 mg of lacosamide once on day 1, 100 mg twice per day from day 2 through day 6 (200 mg daily total), on day 7 the lacosamide dose was increased to 150 mg twice daily (300 mg daily total), and on day 8 the participant took one dose of 150 mg.</description>
          </group>
          <group group_id="O2">
            <title>Placebo Oral Capsule</title>
            <description>Participants took a placebo oral capsule once on day 1, twice per day from day 2 to day 7, and once on day 8.</description>
          </group>
        </group_list>
        <measure>
          <title>Alcohol Consumption in Alcohol Self-Administration Trials</title>
          <description>Alcohol consumption will be measured by using a graduated cylinder to determine the amount of alcohol given to the subject that was consumed. This outcome will be measured as standard drink units. A standard drink contains approximately 0.6 fluid ounces of pure alcohol.</description>
          <population>66 subjects were consented, 27 subjects were randomized, and 19 subjects completed the study. Three subjects that completed the study were omitted from statistical analysis due to not consuming any alcohol during either alcohol self-administration session.</population>
          <units>Standard Drink Units (SDU)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.02" spread="3.00"/>
                    <measurement group_id="O2" value="2.35" spread="2.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Verbal Fluency: Controlled Word Association (COWAT)</title>
        <description>The Controlled Word Association (COWAT) is a verbal fluency test that measures the spontaneous production of words beginning with some designated letter. The participant is asked to name words beginning with a given letter, excluding proper nouns, for one minute and this procedure is repeated three times with a different letter each time. A different set of letters was used in each of the two alcohol self-administration trials: C-F-L and P-R-W. The examiner writes down the words provided by the participant on a piece of paper. This test is scored by counting the number of words generated by the subject for each letter, then adding the scores for each of the three letters to calculate a total test score. The lowest possible score is 0 and there is no upper limit to the score range. A higher score is indicative of better outcomes (I.e. better verbal fluency).</description>
        <time_frame>3 minutes</time_frame>
        <population>66 subjects were consented, 27 subjects were randomized, and 19 subjects completed the study. Three subjects that completed the study were omitted from statistical analysis due to not consuming any alcohol during either alcohol self-administration session.</population>
        <group_list>
          <group group_id="O1">
            <title>Lacosamide</title>
            <description>Lacosamide titration was done to a target dose of 300mg. Participants took 100 mg of lacosamide once on day 1, 100 mg twice per day from day 2 through day 6 (200 mg daily total), on day 7 the lacosamide dose was increased to 150 mg twice daily (300 mg daily total), and on day 8 the participant took one dose of 150 mg.</description>
          </group>
          <group group_id="O2">
            <title>Placebo Oral Capsule</title>
            <description>Participants took a placebo oral capsule once on day 1, twice per day from day 2 to day 7, and once on day 8.</description>
          </group>
        </group_list>
        <measure>
          <title>Verbal Fluency: Controlled Word Association (COWAT)</title>
          <description>The Controlled Word Association (COWAT) is a verbal fluency test that measures the spontaneous production of words beginning with some designated letter. The participant is asked to name words beginning with a given letter, excluding proper nouns, for one minute and this procedure is repeated three times with a different letter each time. A different set of letters was used in each of the two alcohol self-administration trials: C-F-L and P-R-W. The examiner writes down the words provided by the participant on a piece of paper. This test is scored by counting the number of words generated by the subject for each letter, then adding the scores for each of the three letters to calculate a total test score. The lowest possible score is 0 and there is no upper limit to the score range. A higher score is indicative of better outcomes (I.e. better verbal fluency).</description>
          <population>66 subjects were consented, 27 subjects were randomized, and 19 subjects completed the study. Three subjects that completed the study were omitted from statistical analysis due to not consuming any alcohol during either alcohol self-administration session.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.19" spread="8.26"/>
                    <measurement group_id="O2" value="42.25" spread="9.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cognitive Function: Spatial Span Forward</title>
        <description>The Wechsler Memory Scale (WMS-III) Spatial Span test will be used to assess subjects' working memory. Subjects will be shown a sequence of block tapping and asked to repeat back an increasing number of tapped blocks in the same order. Each of the 16 items on this test is scored 0 (incorrect answer) or 1 (correct answer). The total score is calculated by adding the scores for each of the 16 items. The total score range is 0-16. Higher scores are indicative of higher levels of working memory (better outcome) and lower scores are indicative of lesser working memory function (worse outcome).</description>
        <time_frame>10 minutes</time_frame>
        <population>66 subjects were consented, 27 subjects were randomized, and 19 subjects completed the study. Three subjects that completed the study were omitted from statistical analysis due to not consuming any alcohol during either alcohol self-administration session.</population>
        <group_list>
          <group group_id="O1">
            <title>Lacosamide</title>
            <description>Lacosamide titration was done to a target dose of 300mg. Participants took 100 mg of lacosamide once on day 1, 100 mg twice per day from day 2 through day 6 (200 mg daily total), on day 7 the lacosamide dose was increased to 150 mg twice daily (300 mg daily total), and on day 8 the participant took one dose of 150 mg.</description>
          </group>
          <group group_id="O2">
            <title>Placebo Oral Capsule</title>
            <description>Participants took a placebo oral capsule once on day 1, twice per day from day 2 to day 7, and once on day 8.</description>
          </group>
        </group_list>
        <measure>
          <title>Cognitive Function: Spatial Span Forward</title>
          <description>The Wechsler Memory Scale (WMS-III) Spatial Span test will be used to assess subjects' working memory. Subjects will be shown a sequence of block tapping and asked to repeat back an increasing number of tapped blocks in the same order. Each of the 16 items on this test is scored 0 (incorrect answer) or 1 (correct answer). The total score is calculated by adding the scores for each of the 16 items. The total score range is 0-16. Higher scores are indicative of higher levels of working memory (better outcome) and lower scores are indicative of lesser working memory function (worse outcome).</description>
          <population>66 subjects were consented, 27 subjects were randomized, and 19 subjects completed the study. Three subjects that completed the study were omitted from statistical analysis due to not consuming any alcohol during either alcohol self-administration session.</population>
          <units>correct items</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.44" spread="2.53"/>
                    <measurement group_id="O2" value="7.75" spread="3.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cognitive Function: Spatial Span Backward</title>
        <description>The Wechsler Memory Scale (WMS-III) Spatial Span test will be used to assess subjects' working memory. Subjects will be shown a sequence of block tapping and asked to repeat back an increasing number of tapped blocks in the opposite order. Each of the 16 items on this test is scored 0 (incorrect answer) or 1 (correct answer). The total score is calculated by adding the scores for each of the 16 items. The total score range is 0-16. Higher scores are indicative of higher levels of working memory (better outcome) and lower scores are indicative of lesser working memory function (worse outcome).</description>
        <time_frame>10 minutes</time_frame>
        <population>66 subjects were consented, 27 subjects were randomized, and 19 subjects completed the study. Three subjects that completed the study were omitted from statistical analysis due to not consuming any alcohol during either alcohol self-administration session.</population>
        <group_list>
          <group group_id="O1">
            <title>Lacosamide</title>
            <description>Lacosamide titration was done to a target dose of 300mg. Participants took 100 mg of lacosamide once on day 1, 100 mg twice per day from day 2 through day 6 (200 mg daily total), on day 7 the lacosamide dose was increased to 150 mg twice daily (300 mg daily total), and on day 8 the participant took one dose of 150 mg.</description>
          </group>
          <group group_id="O2">
            <title>Placebo Oral Capsule</title>
            <description>Participants took a placebo oral capsule once on day 1, twice per day from day 2 to day 7, and once on day 8.</description>
          </group>
        </group_list>
        <measure>
          <title>Cognitive Function: Spatial Span Backward</title>
          <description>The Wechsler Memory Scale (WMS-III) Spatial Span test will be used to assess subjects' working memory. Subjects will be shown a sequence of block tapping and asked to repeat back an increasing number of tapped blocks in the opposite order. Each of the 16 items on this test is scored 0 (incorrect answer) or 1 (correct answer). The total score is calculated by adding the scores for each of the 16 items. The total score range is 0-16. Higher scores are indicative of higher levels of working memory (better outcome) and lower scores are indicative of lesser working memory function (worse outcome).</description>
          <population>66 subjects were consented, 27 subjects were randomized, and 19 subjects completed the study. Three subjects that completed the study were omitted from statistical analysis due to not consuming any alcohol during either alcohol self-administration session.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.19" spread="2.49"/>
                    <measurement group_id="O2" value="7.62" spread="3.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cognitive Function: Digit Span Forward</title>
        <description>The Wechsler Adult Intelligence Scale (WAIS-IV) Digit Span test will be used to assess subjects' working memory. Subjects will be read and asked to repeat back an increasing number of digits in the same order. Each of the 16 items on this test is scored 0 (incorrect answer) or 1 (correct answer). The total score is calculated by adding the scores for each of the 16 items. The total score range is 0-16. Higher scores are indicative of higher levels of working memory (better outcome) and lower scores are indicative of lesser working memory function (worse outcome).</description>
        <time_frame>10 minutes</time_frame>
        <population>66 subjects were consented, 27 subjects were randomized, and 19 subjects completed the study. Three subjects that completed the study were omitted from statistical analysis due to not consuming any alcohol during either alcohol self-administration session.</population>
        <group_list>
          <group group_id="O1">
            <title>Lacosamide</title>
            <description>Lacosamide titration was done to a target dose of 300mg. Participants took 100 mg of lacosamide once on day 1, 100 mg twice per day from day 2 through day 6 (200 mg daily total), on day 7 the lacosamide dose was increased to 150 mg twice daily (300 mg daily total), and on day 8 the participant took one dose of 150 mg.</description>
          </group>
          <group group_id="O2">
            <title>Placebo Oral Capsule</title>
            <description>Participants took a placebo oral capsule once on day 1, twice per day from day 2 to day 7, and once on day 8.</description>
          </group>
        </group_list>
        <measure>
          <title>Cognitive Function: Digit Span Forward</title>
          <description>The Wechsler Adult Intelligence Scale (WAIS-IV) Digit Span test will be used to assess subjects' working memory. Subjects will be read and asked to repeat back an increasing number of digits in the same order. Each of the 16 items on this test is scored 0 (incorrect answer) or 1 (correct answer). The total score is calculated by adding the scores for each of the 16 items. The total score range is 0-16. Higher scores are indicative of higher levels of working memory (better outcome) and lower scores are indicative of lesser working memory function (worse outcome).</description>
          <population>66 subjects were consented, 27 subjects were randomized, and 19 subjects completed the study. Three subjects that completed the study were omitted from statistical analysis due to not consuming any alcohol during either alcohol self-administration session.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.81" spread="1.97"/>
                    <measurement group_id="O2" value="10.81" spread="2.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cognitive Function: Digit Span Backward</title>
        <description>The Wechsler Adult Intelligence Scale (WAIS-IV) Digit Span test will be used to assess subjects' working memory. Subjects will be read and asked to repeat back an increasing number of digits in the opposite order. Each of the 16 items on this test is scored 0 (incorrect answer) or 1 (correct answer). The total score is calculated by adding the scores for each of the 16 items. The total score range is 0-16. Higher scores are indicative of higher levels of working memory (better outcome) and lower scores are indicative of lesser working memory function (worse outcome).</description>
        <time_frame>10 minutes</time_frame>
        <population>66 subjects were consented, 27 subjects were randomized, and 19 subjects completed the study. Three subjects that completed the study were omitted from statistical analysis due to not consuming any alcohol during either alcohol self-administration session.</population>
        <group_list>
          <group group_id="O1">
            <title>Lacosamide</title>
            <description>Lacosamide titration was done to a target dose of 300mg. Participants took 100 mg of lacosamide once on day 1, 100 mg twice per day from day 2 through day 6 (200 mg daily total), on day 7 the lacosamide dose was increased to 150 mg twice daily (300 mg daily total), and on day 8 the participant took one dose of 150 mg.</description>
          </group>
          <group group_id="O2">
            <title>Placebo Oral Capsule</title>
            <description>Participants took a placebo oral capsule once on day 1, twice per day from day 2 to day 7, and once on day 8.</description>
          </group>
        </group_list>
        <measure>
          <title>Cognitive Function: Digit Span Backward</title>
          <description>The Wechsler Adult Intelligence Scale (WAIS-IV) Digit Span test will be used to assess subjects' working memory. Subjects will be read and asked to repeat back an increasing number of digits in the opposite order. Each of the 16 items on this test is scored 0 (incorrect answer) or 1 (correct answer). The total score is calculated by adding the scores for each of the 16 items. The total score range is 0-16. Higher scores are indicative of higher levels of working memory (better outcome) and lower scores are indicative of lesser working memory function (worse outcome).</description>
          <population>66 subjects were consented, 27 subjects were randomized, and 19 subjects completed the study. Three subjects that completed the study were omitted from statistical analysis due to not consuming any alcohol during either alcohol self-administration session.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.06" spread="1.48"/>
                    <measurement group_id="O2" value="7.62" spread="2.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cognitive Function: Digit Span Sequencing</title>
        <description>The Wechsler Adult Intelligence Scale (WAIS-IV) Digit Span test will be used to assess subjects' working memory. Subjects will be read and asked to repeat back an increasing number of digits in ascending order. Each of the 16 items on this test is scored 0 (incorrect answer) or 1 (correct answer). The total score is calculated by adding the scores for each of the 16 items. The total score range is 0-16. Higher scores are indicative of higher levels of working memory (better outcome) and lower scores are indicative of lesser working memory function (worse outcome).</description>
        <time_frame>10 minutes</time_frame>
        <population>66 subjects were consented, 27 subjects were randomized, and 19 subjects completed the study. Three subjects that completed the study were omitted from statistical analysis due to not consuming any alcohol during either alcohol self-administration session.</population>
        <group_list>
          <group group_id="O1">
            <title>Lacosamide</title>
            <description>Lacosamide titration was done to a target dose of 300mg. Participants took 100 mg of lacosamide once on day 1, 100 mg twice per day from day 2 through day 6 (200 mg daily total), on day 7 the lacosamide dose was increased to 150 mg twice daily (300 mg daily total), and on day 8 the participant took one dose of 150 mg.</description>
          </group>
          <group group_id="O2">
            <title>Placebo Oral Capsule</title>
            <description>Participants took a placebo oral capsule once on day 1, twice per day from day 2 to day 7, and once on day 8.</description>
          </group>
        </group_list>
        <measure>
          <title>Cognitive Function: Digit Span Sequencing</title>
          <description>The Wechsler Adult Intelligence Scale (WAIS-IV) Digit Span test will be used to assess subjects' working memory. Subjects will be read and asked to repeat back an increasing number of digits in ascending order. Each of the 16 items on this test is scored 0 (incorrect answer) or 1 (correct answer). The total score is calculated by adding the scores for each of the 16 items. The total score range is 0-16. Higher scores are indicative of higher levels of working memory (better outcome) and lower scores are indicative of lesser working memory function (worse outcome).</description>
          <population>66 subjects were consented, 27 subjects were randomized, and 19 subjects completed the study. Three subjects that completed the study were omitted from statistical analysis due to not consuming any alcohol during either alcohol self-administration session.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.12" spread="2.33"/>
                    <measurement group_id="O2" value="7.62" spread="2.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Alcohol Craving: Obsessive-Compulsive Drinking Scale (OCDS) Pretrial</title>
        <description>The Obsessive-Compulsive Drinking Scale (OCDS) is a quick and reliable 14-item self-rating instrument that provides a total score that measures some cognitive aspects of alcohol craving (obsessive and compulsive drinking). Each of the 14 items is scored from 0 to 4. The total score is calculated by adding the scores for each of the 14 items. The total score range is 0-56. Higher scores are indicative of more obsessive or compulsive drinking and lower scores are indicative of less obsessive or compulsive drinking.</description>
        <time_frame>5 minutes</time_frame>
        <population>66 subjects were consented, 27 subjects were randomized, and 19 subjects completed the study. Three subjects that completed the study were omitted from statistical analysis due to not consuming any alcohol during either alcohol self-administration session.</population>
        <group_list>
          <group group_id="O1">
            <title>Lacosamide</title>
            <description>Lacosamide titration was done to a target dose of 300mg. Participants took 100 mg of lacosamide once on day 1, 100 mg twice per day from day 2 through day 6 (200 mg daily total), on day 7 the lacosamide dose was increased to 150 mg twice daily (300 mg daily total), and on day 8 the participant took one dose of 150 mg.</description>
          </group>
          <group group_id="O2">
            <title>Placebo Oral Capsule</title>
            <description>Participants took a placebo oral capsule once on day 1, twice per day from day 2 to day 7, and once on day 8.</description>
          </group>
        </group_list>
        <measure>
          <title>Alcohol Craving: Obsessive-Compulsive Drinking Scale (OCDS) Pretrial</title>
          <description>The Obsessive-Compulsive Drinking Scale (OCDS) is a quick and reliable 14-item self-rating instrument that provides a total score that measures some cognitive aspects of alcohol craving (obsessive and compulsive drinking). Each of the 14 items is scored from 0 to 4. The total score is calculated by adding the scores for each of the 14 items. The total score range is 0-56. Higher scores are indicative of more obsessive or compulsive drinking and lower scores are indicative of less obsessive or compulsive drinking.</description>
          <population>66 subjects were consented, 27 subjects were randomized, and 19 subjects completed the study. Three subjects that completed the study were omitted from statistical analysis due to not consuming any alcohol during either alcohol self-administration session.</population>
          <units>scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.19" spread="4.79"/>
                    <measurement group_id="O2" value="12.25" spread="5.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Alcohol Craving: Visual Analog Scale (VAS) Pretrial</title>
        <description>Alcohol craving was measured by self report with the Visual Analog Scale (VAS). The VAS is a straight horizontal line with one end indicating no alcohol craving and the other end indicating intense alcohol craving. The participant marks a point on the line that matches their present amount of alcohol craving. Location of the point on the line is measured for a score range of 0-100. A lower score indicates less craving for alcohol and a higher score indicated more craving for alcohol.</description>
        <time_frame>1 minute</time_frame>
        <population>66 subjects were consented, 27 subjects were randomized, and 19 subjects completed the study. Three subjects that completed the study were omitted from statistical analysis due to not consuming any alcohol during either alcohol self-administration session.</population>
        <group_list>
          <group group_id="O1">
            <title>Lacosamide</title>
            <description>Lacosamide titration was done to a target dose of 300mg. Participants took 100 mg of lacosamide once on day 1, 100 mg twice per day from day 2 through day 6 (200 mg daily total), on day 7 the lacosamide dose was increased to 150 mg twice daily (300 mg daily total), and on day 8 the participant took one dose of 150 mg.</description>
          </group>
          <group group_id="O2">
            <title>Placebo Oral Capsule</title>
            <description>Participants took a placebo oral capsule once on day 1, twice per day from day 2 to day 7, and once on day 8.</description>
          </group>
        </group_list>
        <measure>
          <title>Alcohol Craving: Visual Analog Scale (VAS) Pretrial</title>
          <description>Alcohol craving was measured by self report with the Visual Analog Scale (VAS). The VAS is a straight horizontal line with one end indicating no alcohol craving and the other end indicating intense alcohol craving. The participant marks a point on the line that matches their present amount of alcohol craving. Location of the point on the line is measured for a score range of 0-100. A lower score indicates less craving for alcohol and a higher score indicated more craving for alcohol.</description>
          <population>66 subjects were consented, 27 subjects were randomized, and 19 subjects completed the study. Three subjects that completed the study were omitted from statistical analysis due to not consuming any alcohol during either alcohol self-administration session.</population>
          <units>scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.25" spread="31.00"/>
                    <measurement group_id="O2" value="31.60" spread="35.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Alcohol Craving: Visual Analog Scale (VAS) Observation Period, Minute 10</title>
        <description>Alcohol craving was measured by self report with the Visual Analog Scale (VAS). The VAS is a straight horizontal line with one end indicating no alcohol craving and the other end indicating intense alcohol craving. The participant marks a point on the line that matches their present amount of alcohol craving. Location of the point on the line is measured for a score range of 0-100. A lower score indicates less craving for alcohol and a higher score indicated more craving for alcohol.</description>
        <time_frame>1 minute</time_frame>
        <population>66 subjects were consented, 27 subjects were randomized, and 19 subjects completed the study. Three subjects that completed the study were omitted from statistical analysis due to not consuming any alcohol during either alcohol self-administration session.</population>
        <group_list>
          <group group_id="O1">
            <title>Lacosamide</title>
            <description>Lacosamide titration was done to a target dose of 300mg. Participants took 100 mg of lacosamide once on day 1, 100 mg twice per day from day 2 through day 6 (200 mg daily total), on day 7 the lacosamide dose was increased to 150 mg twice daily (300 mg daily total), and on day 8 the participant took one dose of 150 mg.</description>
          </group>
          <group group_id="O2">
            <title>Placebo Oral Capsule</title>
            <description>Participants took a placebo oral capsule once on day 1, twice per day from day 2 to day 7, and once on day 8.</description>
          </group>
        </group_list>
        <measure>
          <title>Alcohol Craving: Visual Analog Scale (VAS) Observation Period, Minute 10</title>
          <description>Alcohol craving was measured by self report with the Visual Analog Scale (VAS). The VAS is a straight horizontal line with one end indicating no alcohol craving and the other end indicating intense alcohol craving. The participant marks a point on the line that matches their present amount of alcohol craving. Location of the point on the line is measured for a score range of 0-100. A lower score indicates less craving for alcohol and a higher score indicated more craving for alcohol.</description>
          <population>66 subjects were consented, 27 subjects were randomized, and 19 subjects completed the study. Three subjects that completed the study were omitted from statistical analysis due to not consuming any alcohol during either alcohol self-administration session.</population>
          <units>scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.75" spread="20.07"/>
                    <measurement group_id="O2" value="41.87" spread="33.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Alcohol Craving: Visual Analog Scale (VAS) Observation Period, Minute 20</title>
        <description>Alcohol craving was measured by self report with the Visual Analog Scale (VAS). The VAS is a straight horizontal line with one end indicating no alcohol craving and the other end indicating intense alcohol craving. The participant marks a point on the line that matches their present amount of alcohol craving. Location of the point on the line is measured for a score range of 0-100. A lower score indicates less craving for alcohol and a higher score indicated more craving for alcohol.</description>
        <time_frame>1 minute</time_frame>
        <population>66 subjects were consented, 27 subjects were randomized, and 19 subjects completed the study. Three subjects that completed the study were omitted from statistical analysis due to not consuming any alcohol during either alcohol self-administration session.</population>
        <group_list>
          <group group_id="O1">
            <title>Lacosamide</title>
            <description>Lacosamide titration was done to a target dose of 300mg. Participants took 100 mg of lacosamide once on day 1, 100 mg twice per day from day 2 through day 6 (200 mg daily total), on day 7 the lacosamide dose was increased to 150 mg twice daily (300 mg daily total), and on day 8 the participant took one dose of 150 mg.</description>
          </group>
          <group group_id="O2">
            <title>Placebo Oral Capsule</title>
            <description>Participants took a placebo oral capsule once on day 1, twice per day from day 2 to day 7, and once on day 8.</description>
          </group>
        </group_list>
        <measure>
          <title>Alcohol Craving: Visual Analog Scale (VAS) Observation Period, Minute 20</title>
          <description>Alcohol craving was measured by self report with the Visual Analog Scale (VAS). The VAS is a straight horizontal line with one end indicating no alcohol craving and the other end indicating intense alcohol craving. The participant marks a point on the line that matches their present amount of alcohol craving. Location of the point on the line is measured for a score range of 0-100. A lower score indicates less craving for alcohol and a higher score indicated more craving for alcohol.</description>
          <population>66 subjects were consented, 27 subjects were randomized, and 19 subjects completed the study. Three subjects that completed the study were omitted from statistical analysis due to not consuming any alcohol during either alcohol self-administration session.</population>
          <units>scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.31" spread="28.33"/>
                    <measurement group_id="O2" value="39.75" spread="34.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Alcohol Craving: Visual Analog Scale (VAS) Observation Period, Minute 30</title>
        <description>Alcohol craving was measured by self report with the Visual Analog Scale (VAS). The VAS is a straight horizontal line with one end indicating no alcohol craving and the other end indicating intense alcohol craving. The participant marks a point on the line that matches their present amount of alcohol craving. Location of the point on the line is measured for a score range of 0-100. A lower score indicates less craving for alcohol and a higher score indicated more craving for alcohol.</description>
        <time_frame>1 minute</time_frame>
        <population>66 subjects were consented, 27 subjects were randomized, and 19 subjects completed the study. Three subjects that completed the study were omitted from statistical analysis due to not consuming any alcohol during either alcohol self-administration session.</population>
        <group_list>
          <group group_id="O1">
            <title>Lacosamide</title>
            <description>Lacosamide titration was done to a target dose of 300mg. Participants took 100 mg of lacosamide once on day 1, 100 mg twice per day from day 2 through day 6 (200 mg daily total), on day 7 the lacosamide dose was increased to 150 mg twice daily (300 mg daily total), and on day 8 the participant took one dose of 150 mg.</description>
          </group>
          <group group_id="O2">
            <title>Placebo Oral Capsule</title>
            <description>Participants took a placebo oral capsule once on day 1, twice per day from day 2 to day 7, and once on day 8.</description>
          </group>
        </group_list>
        <measure>
          <title>Alcohol Craving: Visual Analog Scale (VAS) Observation Period, Minute 30</title>
          <description>Alcohol craving was measured by self report with the Visual Analog Scale (VAS). The VAS is a straight horizontal line with one end indicating no alcohol craving and the other end indicating intense alcohol craving. The participant marks a point on the line that matches their present amount of alcohol craving. Location of the point on the line is measured for a score range of 0-100. A lower score indicates less craving for alcohol and a higher score indicated more craving for alcohol.</description>
          <population>66 subjects were consented, 27 subjects were randomized, and 19 subjects completed the study. Three subjects that completed the study were omitted from statistical analysis due to not consuming any alcohol during either alcohol self-administration session.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.19" spread="28.85"/>
                    <measurement group_id="O2" value="37.81" spread="36.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Alcohol Craving: Visual Analog Scale (VAS) Observation Period, Minute 40</title>
        <description>Alcohol craving was measured by self report with the Visual Analog Scale (VAS). The VAS is a straight horizontal line with one end indicating no alcohol craving and the other end indicating intense alcohol craving. The participant marks a point on the line that matches their present amount of alcohol craving. Location of the point on the line is measured for a score range of 0-100. A lower score indicates less craving for alcohol and a higher score indicated more craving for alcohol.</description>
        <time_frame>1 minute</time_frame>
        <population>66 subjects were consented, 27 subjects were randomized, and 19 subjects completed the study. Three subjects that completed the study were omitted from statistical analysis due to not consuming any alcohol during either alcohol self-administration session.</population>
        <group_list>
          <group group_id="O1">
            <title>Lacosamide</title>
            <description>Lacosamide titration was done to a target dose of 300mg. Participants took 100 mg of lacosamide once on day 1, 100 mg twice per day from day 2 through day 6 (200 mg daily total), on day 7 the lacosamide dose was increased to 150 mg twice daily (300 mg daily total), and on day 8 the participant took one dose of 150 mg.</description>
          </group>
          <group group_id="O2">
            <title>Placebo Oral Capsule</title>
            <description>Participants took a placebo oral capsule once on day 1, twice per day from day 2 to day 7, and once on day 8.</description>
          </group>
        </group_list>
        <measure>
          <title>Alcohol Craving: Visual Analog Scale (VAS) Observation Period, Minute 40</title>
          <description>Alcohol craving was measured by self report with the Visual Analog Scale (VAS). The VAS is a straight horizontal line with one end indicating no alcohol craving and the other end indicating intense alcohol craving. The participant marks a point on the line that matches their present amount of alcohol craving. Location of the point on the line is measured for a score range of 0-100. A lower score indicates less craving for alcohol and a higher score indicated more craving for alcohol.</description>
          <population>66 subjects were consented, 27 subjects were randomized, and 19 subjects completed the study. Three subjects that completed the study were omitted from statistical analysis due to not consuming any alcohol during either alcohol self-administration session.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.87" spread="26.71"/>
                    <measurement group_id="O2" value="36.69" spread="34.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Alcohol Craving: Visual Analog Scale (VAS) Self-Administration Blocks 1 and 2, Minute 30</title>
        <description>Alcohol craving was measured by self report with the Visual Analog Scale (VAS). The VAS is a straight horizontal line with one end indicating no alcohol craving and the other end indicating intense alcohol craving. The participant marks a point on the line that matches their present amount of alcohol craving. Location of the point on the line is measured for a score range of 0-100. A lower score indicates less craving for alcohol and a higher score indicated more craving for alcohol.</description>
        <time_frame>1 minute</time_frame>
        <population>66 subjects were consented, 27 subjects were randomized, and 19 subjects completed the study. Three subjects that completed the study were omitted from statistical analysis due to not consuming any alcohol during either alcohol self-administration session.</population>
        <group_list>
          <group group_id="O1">
            <title>Lacosamide</title>
            <description>Lacosamide titration was done to a target dose of 300mg. Participants took 100 mg of lacosamide once on day 1, 100 mg twice per day from day 2 through day 6 (200 mg daily total), on day 7 the lacosamide dose was increased to 150 mg twice daily (300 mg daily total), and on day 8 the participant took one dose of 150 mg.</description>
          </group>
          <group group_id="O2">
            <title>Placebo Oral Capsule</title>
            <description>Participants took a placebo oral capsule once on day 1, twice per day from day 2 to day 7, and once on day 8.</description>
          </group>
        </group_list>
        <measure>
          <title>Alcohol Craving: Visual Analog Scale (VAS) Self-Administration Blocks 1 and 2, Minute 30</title>
          <description>Alcohol craving was measured by self report with the Visual Analog Scale (VAS). The VAS is a straight horizontal line with one end indicating no alcohol craving and the other end indicating intense alcohol craving. The participant marks a point on the line that matches their present amount of alcohol craving. Location of the point on the line is measured for a score range of 0-100. A lower score indicates less craving for alcohol and a higher score indicated more craving for alcohol.</description>
          <population>66 subjects were consented, 27 subjects were randomized, and 19 subjects completed the study. Three subjects that completed the study were omitted from statistical analysis due to not consuming any alcohol during either alcohol self-administration session.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.00" spread="19.73"/>
                    <measurement group_id="O2" value="31.87" spread="30.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Alcohol Craving: Visual Analog Scale (VAS) Self-Administration Blocks 1 and 2, Minute 60</title>
        <description>Alcohol craving was measured by self report with the Visual Analog Scale (VAS). The VAS is a straight horizontal line with one end indicating no alcohol craving and the other end indicating intense alcohol craving. The participant marks a point on the line that matches their present amount of alcohol craving. Location of the point on the line is measured for a score range of 0-100. A lower score indicates less craving for alcohol and a higher score indicated more craving for alcohol.</description>
        <time_frame>1 minute</time_frame>
        <population>66 subjects were consented, 27 subjects were randomized, and 19 subjects completed the study. Three subjects that completed the study were omitted from statistical analysis due to not consuming any alcohol during either alcohol self-administration session.</population>
        <group_list>
          <group group_id="O1">
            <title>Lacosamide</title>
            <description>Lacosamide titration was done to a target dose of 300mg. Participants took 100 mg of lacosamide once on day 1, 100 mg twice per day from day 2 through day 6 (200 mg daily total), on day 7 the lacosamide dose was increased to 150 mg twice daily (300 mg daily total), and on day 8 the participant took one dose of 150 mg.</description>
          </group>
          <group group_id="O2">
            <title>Placebo Oral Capsule</title>
            <description>Participants took a placebo oral capsule once on day 1, twice per day from day 2 to day 7, and once on day 8.</description>
          </group>
        </group_list>
        <measure>
          <title>Alcohol Craving: Visual Analog Scale (VAS) Self-Administration Blocks 1 and 2, Minute 60</title>
          <description>Alcohol craving was measured by self report with the Visual Analog Scale (VAS). The VAS is a straight horizontal line with one end indicating no alcohol craving and the other end indicating intense alcohol craving. The participant marks a point on the line that matches their present amount of alcohol craving. Location of the point on the line is measured for a score range of 0-100. A lower score indicates less craving for alcohol and a higher score indicated more craving for alcohol.</description>
          <population>66 subjects were consented, 27 subjects were randomized, and 19 subjects completed the study. Three subjects that completed the study were omitted from statistical analysis due to not consuming any alcohol during either alcohol self-administration session.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.94" spread="20.78"/>
                    <measurement group_id="O2" value="30.37" spread="30.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Alcohol Craving: Visual Analog Scale (VAS) Self-Administration Blocks 1 and 2, Minute 90</title>
        <description>Alcohol craving was measured by self report with the Visual Analog Scale (VAS). The VAS is a straight horizontal line with one end indicating no alcohol craving and the other end indicating intense alcohol craving. The participant marks a point on the line that matches their present amount of alcohol craving. Location of the point on the line is measured for a score range of 0-100. A lower score indicates less craving for alcohol and a higher score indicated more craving for alcohol.</description>
        <time_frame>1 minute</time_frame>
        <population>66 subjects were consented, 27 subjects were randomized, and 19 subjects completed the study. Three subjects that completed the study were omitted from statistical analysis due to not consuming any alcohol during either alcohol self-administration session.</population>
        <group_list>
          <group group_id="O1">
            <title>Lacosamide</title>
            <description>Lacosamide titration was done to a target dose of 300mg. Participants took 100 mg of lacosamide once on day 1, 100 mg twice per day from day 2 through day 6 (200 mg daily total), on day 7 the lacosamide dose was increased to 150 mg twice daily (300 mg daily total), and on day 8 the participant took one dose of 150 mg.</description>
          </group>
          <group group_id="O2">
            <title>Placebo Oral Capsule</title>
            <description>Participants took a placebo oral capsule once on day 1, twice per day from day 2 to day 7, and once on day 8.</description>
          </group>
        </group_list>
        <measure>
          <title>Alcohol Craving: Visual Analog Scale (VAS) Self-Administration Blocks 1 and 2, Minute 90</title>
          <description>Alcohol craving was measured by self report with the Visual Analog Scale (VAS). The VAS is a straight horizontal line with one end indicating no alcohol craving and the other end indicating intense alcohol craving. The participant marks a point on the line that matches their present amount of alcohol craving. Location of the point on the line is measured for a score range of 0-100. A lower score indicates less craving for alcohol and a higher score indicated more craving for alcohol.</description>
          <population>66 subjects were consented, 27 subjects were randomized, and 19 subjects completed the study. Three subjects that completed the study were omitted from statistical analysis due to not consuming any alcohol during either alcohol self-administration session.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.62" spread="21.60"/>
                    <measurement group_id="O2" value="27.81" spread="29.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Alcohol Craving: Visual Analog Scale (VAS) Self-Administration Blocks 1 and 2, Minute 120</title>
        <description>Alcohol craving was measured by self report with the Visual Analog Scale (VAS). The VAS is a straight horizontal line with one end indicating no alcohol craving and the other end indicating intense alcohol craving. The participant marks a point on the line that matches their present amount of alcohol craving. Location of the point on the line is measured for a score range of 0-100. A lower score indicates less craving for alcohol and a higher score indicated more craving for alcohol.</description>
        <time_frame>1 minute</time_frame>
        <population>66 subjects were consented, 27 subjects were randomized, and 19 subjects completed the study. Three subjects that completed the study were omitted from statistical analysis due to not consuming any alcohol during either alcohol self-administration session.</population>
        <group_list>
          <group group_id="O1">
            <title>Lacosamide</title>
            <description>Lacosamide titration was done to a target dose of 300mg. Participants took 100 mg of lacosamide once on day 1, 100 mg twice per day from day 2 through day 6 (200 mg daily total), on day 7 the lacosamide dose was increased to 150 mg twice daily (300 mg daily total), and on day 8 the participant took one dose of 150 mg.</description>
          </group>
          <group group_id="O2">
            <title>Placebo Oral Capsule</title>
            <description>Participants took a placebo oral capsule once on day 1, twice per day from day 2 to day 7, and once on day 8.</description>
          </group>
        </group_list>
        <measure>
          <title>Alcohol Craving: Visual Analog Scale (VAS) Self-Administration Blocks 1 and 2, Minute 120</title>
          <description>Alcohol craving was measured by self report with the Visual Analog Scale (VAS). The VAS is a straight horizontal line with one end indicating no alcohol craving and the other end indicating intense alcohol craving. The participant marks a point on the line that matches their present amount of alcohol craving. Location of the point on the line is measured for a score range of 0-100. A lower score indicates less craving for alcohol and a higher score indicated more craving for alcohol.</description>
          <population>66 subjects were consented, 27 subjects were randomized, and 19 subjects completed the study. Three subjects that completed the study were omitted from statistical analysis due to not consuming any alcohol during either alcohol self-administration session.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.62" spread="28.78"/>
                    <measurement group_id="O2" value="29.00" spread="32.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Alcohol Craving: Alcohol Urge Questionnaire (AUQ) Self-Administration Blocks 1 and 2, Minute 30</title>
        <description>The Alcohol Urge Questionnaire (AUQ) is an 8-item self report that measures the participant's urge for an alcoholic drink at the time the questionnaire is completed. Questions are in the form of a 7-point Likert scale (from strongly disagree to strongly agree) and the participant selects the extent to which they disagree or agree with the 8 statements relating to desire to drink, expectation of a desired outcome from drinking, and inability to avoid drinking if alcohol was available. Each of the 8 items is scored 1-7. The total score is calculated by adding the scores for each of the items. The total score range is 8-56. Lower scores indicate less urge for alcohol and higher scores indicate more urge for alcohol.</description>
        <time_frame>1 minute</time_frame>
        <population>66 subjects were consented, 27 subjects were randomized, and 19 subjects completed the study. Three subjects that completed the study were omitted from statistical analysis due to not consuming any alcohol during either alcohol self-administration session.</population>
        <group_list>
          <group group_id="O1">
            <title>Lacosamide</title>
            <description>Lacosamide titration was done to a target dose of 300mg. Participants took 100 mg of lacosamide once on day 1, 100 mg twice per day from day 2 through day 6 (200 mg daily total), on day 7 the lacosamide dose was increased to 150 mg twice daily (300 mg daily total), and on day 8 the participant took one dose of 150 mg.</description>
          </group>
          <group group_id="O2">
            <title>Placebo Oral Capsule</title>
            <description>Participants took a placebo oral capsule once on day 1, twice per day from day 2 to day 7, and once on day 8.</description>
          </group>
        </group_list>
        <measure>
          <title>Alcohol Craving: Alcohol Urge Questionnaire (AUQ) Self-Administration Blocks 1 and 2, Minute 30</title>
          <description>The Alcohol Urge Questionnaire (AUQ) is an 8-item self report that measures the participant's urge for an alcoholic drink at the time the questionnaire is completed. Questions are in the form of a 7-point Likert scale (from strongly disagree to strongly agree) and the participant selects the extent to which they disagree or agree with the 8 statements relating to desire to drink, expectation of a desired outcome from drinking, and inability to avoid drinking if alcohol was available. Each of the 8 items is scored 1-7. The total score is calculated by adding the scores for each of the items. The total score range is 8-56. Lower scores indicate less urge for alcohol and higher scores indicate more urge for alcohol.</description>
          <population>66 subjects were consented, 27 subjects were randomized, and 19 subjects completed the study. Three subjects that completed the study were omitted from statistical analysis due to not consuming any alcohol during either alcohol self-administration session.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.00" spread="7.54"/>
                    <measurement group_id="O2" value="23.94" spread="8.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Alcohol Craving: Alcohol Urge Questionnaire (AUQ) Self-Administration Blocks 1 and 2, Minute 60</title>
        <description>The Alcohol Urge Questionnaire (AUQ) is an 8-item self report that measures the participant's urge for an alcoholic drink at the time the questionnaire is completed. Questions are in the form of a 7-point Likert scale (from strongly disagree to strongly agree) and the participant selects the extent to which they disagree or agree with the 8 statements relating to desire to drink, expectation of a desired outcome from drinking, and inability to avoid drinking if alcohol was available. Each of the 8 items is scored 1-7. The total score is calculated by adding the scores for each of the items. The total score range is 8-56. Lower scores indicate less urge for alcohol and higher scores indicate more urge for alcohol.</description>
        <time_frame>1 minute</time_frame>
        <population>66 subjects were consented, 27 subjects were randomized, and 19 subjects completed the study. Three subjects that completed the study were omitted from statistical analysis due to not consuming any alcohol during either alcohol self-administration session.</population>
        <group_list>
          <group group_id="O1">
            <title>Lacosamide</title>
            <description>Lacosamide titration was done to a target dose of 300mg. Participants took 100 mg of lacosamide once on day 1, 100 mg twice per day from day 2 through day 6 (200 mg daily total), on day 7 the lacosamide dose was increased to 150 mg twice daily (300 mg daily total), and on day 8 the participant took one dose of 150 mg.</description>
          </group>
          <group group_id="O2">
            <title>Placebo Oral Capsule</title>
            <description>Participants took a placebo oral capsule once on day 1, twice per day from day 2 to day 7, and once on day 8.</description>
          </group>
        </group_list>
        <measure>
          <title>Alcohol Craving: Alcohol Urge Questionnaire (AUQ) Self-Administration Blocks 1 and 2, Minute 60</title>
          <description>The Alcohol Urge Questionnaire (AUQ) is an 8-item self report that measures the participant's urge for an alcoholic drink at the time the questionnaire is completed. Questions are in the form of a 7-point Likert scale (from strongly disagree to strongly agree) and the participant selects the extent to which they disagree or agree with the 8 statements relating to desire to drink, expectation of a desired outcome from drinking, and inability to avoid drinking if alcohol was available. Each of the 8 items is scored 1-7. The total score is calculated by adding the scores for each of the items. The total score range is 8-56. Lower scores indicate less urge for alcohol and higher scores indicate more urge for alcohol.</description>
          <population>66 subjects were consented, 27 subjects were randomized, and 19 subjects completed the study. Three subjects that completed the study were omitted from statistical analysis due to not consuming any alcohol during either alcohol self-administration session.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.88" spread="7.49"/>
                    <measurement group_id="O2" value="26.25" spread="6.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Alcohol Craving: Alcohol Urge Questionnaire (AUQ) Self-Administration Blocks 1 and 2, Minute 90</title>
        <description>The Alcohol Urge Questionnaire (AUQ) is an 8-item self report that measures the participant's urge for an alcoholic drink at the time the questionnaire is completed. Questions are in the form of a 7-point Likert scale (from strongly disagree to strongly agree) and the participant selects the extent to which they disagree or agree with the 8 statements relating to desire to drink, expectation of a desired outcome from drinking, and inability to avoid drinking if alcohol was available. Each of the 8 items is scored 1-7. The total score is calculated by adding the scores for each of the items. The total score range is 8-56. Lower scores indicate less urge for alcohol and higher scores indicate more urge for alcohol.</description>
        <time_frame>1 minute</time_frame>
        <population>66 subjects were consented, 27 subjects were randomized, and 19 subjects completed the study. Three subjects that completed the study were omitted from statistical analysis due to not consuming any alcohol during either alcohol self-administration session.</population>
        <group_list>
          <group group_id="O1">
            <title>Lacosamide</title>
            <description>Lacosamide titration was done to a target dose of 300mg. Participants took 100 mg of lacosamide once on day 1, 100 mg twice per day from day 2 through day 6 (200 mg daily total), on day 7 the lacosamide dose was increased to 150 mg twice daily (300 mg daily total), and on day 8 the participant took one dose of 150 mg.</description>
          </group>
          <group group_id="O2">
            <title>Placebo Oral Capsule</title>
            <description>Participants took a placebo oral capsule once on day 1, twice per day from day 2 to day 7, and once on day 8.</description>
          </group>
        </group_list>
        <measure>
          <title>Alcohol Craving: Alcohol Urge Questionnaire (AUQ) Self-Administration Blocks 1 and 2, Minute 90</title>
          <description>The Alcohol Urge Questionnaire (AUQ) is an 8-item self report that measures the participant's urge for an alcoholic drink at the time the questionnaire is completed. Questions are in the form of a 7-point Likert scale (from strongly disagree to strongly agree) and the participant selects the extent to which they disagree or agree with the 8 statements relating to desire to drink, expectation of a desired outcome from drinking, and inability to avoid drinking if alcohol was available. Each of the 8 items is scored 1-7. The total score is calculated by adding the scores for each of the items. The total score range is 8-56. Lower scores indicate less urge for alcohol and higher scores indicate more urge for alcohol.</description>
          <population>66 subjects were consented, 27 subjects were randomized, and 19 subjects completed the study. Three subjects that completed the study were omitted from statistical analysis due to not consuming any alcohol during either alcohol self-administration session.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.94" spread="7.46"/>
                    <measurement group_id="O2" value="22.00" spread="4.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Alcohol Craving: Alcohol Urge Questionnaire (AUQ) Self-Administration Blocks 1 and 2, Minute 120</title>
        <description>The Alcohol Urge Questionnaire (AUQ) is an 8-item self report that measures the participant's urge for an alcoholic drink at the time the questionnaire is completed. Questions are in the form of a 7-point Likert scale (from strongly disagree to strongly agree) and the participant selects the extent to which they disagree or agree with the 8 statements relating to desire to drink, expectation of a desired outcome from drinking, and inability to avoid drinking if alcohol was available. Each of the 8 items is scored 1-7. The total score is calculated by adding the scores for each of the items. The total score range is 8-56. Lower scores indicate less urge for alcohol and higher scores indicate more urge for alcohol.</description>
        <time_frame>1 minute</time_frame>
        <population>66 subjects were consented, 27 subjects were randomized, and 19 subjects completed the study. Three subjects that completed the study were omitted from statistical analysis due to not consuming any alcohol during either alcohol self-administration session.</population>
        <group_list>
          <group group_id="O1">
            <title>Lacosamide</title>
            <description>Lacosamide titration was done to a target dose of 300mg. Participants took 100 mg of lacosamide once on day 1, 100 mg twice per day from day 2 through day 6 (200 mg daily total), on day 7 the lacosamide dose was increased to 150 mg twice daily (300 mg daily total), and on day 8 the participant took one dose of 150 mg.</description>
          </group>
          <group group_id="O2">
            <title>Placebo Oral Capsule</title>
            <description>Participants took a placebo oral capsule once on day 1, twice per day from day 2 to day 7, and once on day 8.</description>
          </group>
        </group_list>
        <measure>
          <title>Alcohol Craving: Alcohol Urge Questionnaire (AUQ) Self-Administration Blocks 1 and 2, Minute 120</title>
          <description>The Alcohol Urge Questionnaire (AUQ) is an 8-item self report that measures the participant's urge for an alcoholic drink at the time the questionnaire is completed. Questions are in the form of a 7-point Likert scale (from strongly disagree to strongly agree) and the participant selects the extent to which they disagree or agree with the 8 statements relating to desire to drink, expectation of a desired outcome from drinking, and inability to avoid drinking if alcohol was available. Each of the 8 items is scored 1-7. The total score is calculated by adding the scores for each of the items. The total score range is 8-56. Lower scores indicate less urge for alcohol and higher scores indicate more urge for alcohol.</description>
          <population>66 subjects were consented, 27 subjects were randomized, and 19 subjects completed the study. Three subjects that completed the study were omitted from statistical analysis due to not consuming any alcohol during either alcohol self-administration session.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.94" spread="9.45"/>
                    <measurement group_id="O2" value="25.44" spread="8.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 44 days</time_frame>
      <desc>The primary risks of this study were risks related to taking study medication, loss of confidentiality, discomfort with study procedures, overconsumption of alcohol, and interference with efforts for recovery from alcohol use disorder. These risks were adequately minimized by study design and adherence to the study protocol.</desc>
      <group_list>
        <group group_id="E1">
          <title>Lacosamide</title>
          <description>Subjects received 7 days of lacosamide before the alcohol self-administration trial.</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Subjects received 7 days of placebo before the alcohol self-administration trial.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Indigestion</sub_title>
                <description>General indigestion and upset stomach, bloating, gassiness</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Drowsiness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Unpleasant taste in mouth</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Mental foginess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Bright yellow urine</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Mosquito bites</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>This study was terminated early at the discretion of the Principal Investigator due to COVID-19 restrictions on human subject research recruitment, leading to a smaller number of subjects analyzed than planned. At the time of termination, 19 subjects had completed the study compared to the target sample size of 28. Three subjects that completed the study were omitted from statistical analysis due to not consuming any alcohol during either alcohol self-administration session.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Eric Devine</name_or_title>
      <organization>Boston Medical Center</organization>
      <phone>617-638-7888</phone>
      <email>eric.devine@bmc.org</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03271528
org study id: H-36766
secondary id: 1R21AA026389-01
nct id: NCT03271528
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
This is a double-blind, randomized, placebo-controlled, crossover design trial tested the
      effect of lacosamide on alcohol self-administration and craving following a priming dose of
      alcohol. The specific objective of this study was to determine whether lacosamide, a novel
      anticonvulsant that is FDA-approved for treating partial seizures, has effects on alcohol
      craving and consumption.
The present proposal was intended to answer the call for accelerating drug development by
      exploring the potential of a novel anticonvulsant, lacosamide, as a candidate medication for
      the treatment of alcohol use disorder (AUD). This drug, which is approved for the treatment
      of seizure disorders, has unique pharmacological actions that include enhancement of slow
      sodium channel inactivation and inhibition of collapsin response mediator protein-2 (CRMP-2).
      Alcohol consumption in mice that had knockdown of CRMP-2 within the nucleus accumbens was
      decreased from levels seen in control animals. In rodent studies, lacosamide administration
      has produced reductions in 'excessive' drinking and has experimentally-induced decreased
      expression of the CRMP-2 protein. These findings implicate CRMP-2 as playing a role in the
      regulation of alcohol consumption. None of the FDA-approved AUD medications or medications
      commonly used off-label to treat AUD target this CRMP-2 pathway, making lacosamide a
      promising compound for AUD drug development. The aims of this study were to: 1) test the
      effects of lacosamide on alcohol self-administration and craving, 2) test the effects of 7
      days of lacosamide administration on cognitive function, and 3) test the effects of
      lacosamide on alcohol consumption and craving during a 7-day period of exposure. The effects
      of 7 days of lacosamide (300mg) or placebo were evaluated in a human laboratory using an
      alcohol self-administration methodology. In this within-subjects crossover design, heavy
      drinkers (N=27) were randomized to the order of exposure (lacosamide or placebo) prior to
      completing two alcohol self-administration trials. Subjects received a priming drink of
      alcohol and had access to 8 alcoholic drinks over a 2-hour period. The investigators
      anticipated that subjects would consume less alcohol during an alcohol self-administration
      trial when receiving lacosamide compared to when they are receiving placebo. Significant
      lacosamide-induced reductions in the quantity of alcohol self-administered are considered to
      be an indication that this drug may have value as an AUD medication. This study may provide a
      rationale for phase II clinical studies testing lacosamide with a treatment-seeking AUD
      population. These results should also help to spur further pre-clinical investigation into
      the role play by CRMP-2 in regulating both alcohol consumption and alcohol seeking behaviors.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: This is a double-blind, randomized, placebo-controlled, crossover design trial to test the effect of lacosamide on alcohol self-administration and craving following a priming dose of alcohol.This study is a within subjects design in which each subject receives both study drug (lacosamide) and placebo during participation.
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: This study is double-blind. Medications are over-encapsulated.
measure: Alcohol Consumption in Alcohol Self-Administration Trials
time frame: 2 hours
description: Alcohol consumption will be measured by using a graduated cylinder to determine the amount of alcohol given to the subject that was consumed. This outcome will be measured as standard drink units. A standard drink contains approximately 0.6 fluid ounces of pure alcohol.
measure: Verbal Fluency: Controlled Word Association (COWAT)
time frame: 3 minutes
description: The Controlled Word Association (COWAT) is a verbal fluency test that measures the spontaneous production of words beginning with some designated letter. The participant is asked to name words beginning with a given letter, excluding proper nouns, for one minute and this procedure is repeated three times with a different letter each time. A different set of letters was used in each of the two alcohol self-administration trials: C-F-L and P-R-W. The examiner writes down the words provided by the participant on a piece of paper. This test is scored by counting the number of words generated by the subject for each letter, then adding the scores for each of the three letters to calculate a total test score. The lowest possible score is 0 and there is no upper limit to the score range. A higher score is indicative of better outcomes (I.e. better verbal fluency).
measure: Cognitive Function: Spatial Span Forward
time frame: 10 minutes
description: The Wechsler Memory Scale (WMS-III) Spatial Span test will be used to assess subjects' working memory. Subjects will be shown a sequence of block tapping and asked to repeat back an increasing number of tapped blocks in the same order. Each of the 16 items on this test is scored 0 (incorrect answer) or 1 (correct answer). The total score is calculated by adding the scores for each of the 16 items. The total score range is 0-16. Higher scores are indicative of higher levels of working memory (better outcome) and lower scores are indicative of lesser working memory function (worse outcome).
measure: Cognitive Function: Spatial Span Backward
time frame: 10 minutes
description: The Wechsler Memory Scale (WMS-III) Spatial Span test will be used to assess subjects' working memory. Subjects will be shown a sequence of block tapping and asked to repeat back an increasing number of tapped blocks in the opposite order. Each of the 16 items on this test is scored 0 (incorrect answer) or 1 (correct answer). The total score is calculated by adding the scores for each of the 16 items. The total score range is 0-16. Higher scores are indicative of higher levels of working memory (better outcome) and lower scores are indicative of lesser working memory function (worse outcome).
measure: Cognitive Function: Digit Span Forward
time frame: 10 minutes
description: The Wechsler Adult Intelligence Scale (WAIS-IV) Digit Span test will be used to assess subjects' working memory. Subjects will be read and asked to repeat back an increasing number of digits in the same order. Each of the 16 items on this test is scored 0 (incorrect answer) or 1 (correct answer). The total score is calculated by adding the scores for each of the 16 items. The total score range is 0-16. Higher scores are indicative of higher levels of working memory (better outcome) and lower scores are indicative of lesser working memory function (worse outcome).
measure: Cognitive Function: Digit Span Backward
time frame: 10 minutes
description: The Wechsler Adult Intelligence Scale (WAIS-IV) Digit Span test will be used to assess subjects' working memory. Subjects will be read and asked to repeat back an increasing number of digits in the opposite order. Each of the 16 items on this test is scored 0 (incorrect answer) or 1 (correct answer). The total score is calculated by adding the scores for each of the 16 items. The total score range is 0-16. Higher scores are indicative of higher levels of working memory (better outcome) and lower scores are indicative of lesser working memory function (worse outcome).
measure: Cognitive Function: Digit Span Sequencing
time frame: 10 minutes
description: The Wechsler Adult Intelligence Scale (WAIS-IV) Digit Span test will be used to assess subjects' working memory. Subjects will be read and asked to repeat back an increasing number of digits in ascending order. Each of the 16 items on this test is scored 0 (incorrect answer) or 1 (correct answer). The total score is calculated by adding the scores for each of the 16 items. The total score range is 0-16. Higher scores are indicative of higher levels of working memory (better outcome) and lower scores are indicative of lesser working memory function (worse outcome).
measure: Alcohol Craving: Obsessive-Compulsive Drinking Scale (OCDS) Pretrial
time frame: 5 minutes
description: The Obsessive-Compulsive Drinking Scale (OCDS) is a quick and reliable 14-item self-rating instrument that provides a total score that measures some cognitive aspects of alcohol craving (obsessive and compulsive drinking). Each of the 14 items is scored from 0 to 4. The total score is calculated by adding the scores for each of the 14 items. The total score range is 0-56. Higher scores are indicative of more obsessive or compulsive drinking and lower scores are indicative of less obsessive or compulsive drinking.
measure: Alcohol Craving: Visual Analog Scale (VAS) Pretrial
time frame: 1 minute
description: Alcohol craving was measured by self report with the Visual Analog Scale (VAS). The VAS is a straight horizontal line with one end indicating no alcohol craving and the other end indicating intense alcohol craving. The participant marks a point on the line that matches their present amount of alcohol craving. Location of the point on the line is measured for a score range of 0-100. A lower score indicates less craving for alcohol and a higher score indicated more craving for alcohol.
measure: Alcohol Craving: Visual Analog Scale (VAS) Observation Period, Minute 10
time frame: 1 minute
description: Alcohol craving was measured by self report with the Visual Analog Scale (VAS). The VAS is a straight horizontal line with one end indicating no alcohol craving and the other end indicating intense alcohol craving. The participant marks a point on the line that matches their present amount of alcohol craving. Location of the point on the line is measured for a score range of 0-100. A lower score indicates less craving for alcohol and a higher score indicated more craving for alcohol.
measure: Alcohol Craving: Visual Analog Scale (VAS) Observation Period, Minute 20
time frame: 1 minute
description: Alcohol craving was measured by self report with the Visual Analog Scale (VAS). The VAS is a straight horizontal line with one end indicating no alcohol craving and the other end indicating intense alcohol craving. The participant marks a point on the line that matches their present amount of alcohol craving. Location of the point on the line is measured for a score range of 0-100. A lower score indicates less craving for alcohol and a higher score indicated more craving for alcohol.
measure: Alcohol Craving: Visual Analog Scale (VAS) Observation Period, Minute 30
time frame: 1 minute
description: Alcohol craving was measured by self report with the Visual Analog Scale (VAS). The VAS is a straight horizontal line with one end indicating no alcohol craving and the other end indicating intense alcohol craving. The participant marks a point on the line that matches their present amount of alcohol craving. Location of the point on the line is measured for a score range of 0-100. A lower score indicates less craving for alcohol and a higher score indicated more craving for alcohol.
measure: Alcohol Craving: Visual Analog Scale (VAS) Observation Period, Minute 40
time frame: 1 minute
description: Alcohol craving was measured by self report with the Visual Analog Scale (VAS). The VAS is a straight horizontal line with one end indicating no alcohol craving and the other end indicating intense alcohol craving. The participant marks a point on the line that matches their present amount of alcohol craving. Location of the point on the line is measured for a score range of 0-100. A lower score indicates less craving for alcohol and a higher score indicated more craving for alcohol.
measure: Alcohol Craving: Visual Analog Scale (VAS) Self-Administration Blocks 1 and 2, Minute 30
time frame: 1 minute
description: Alcohol craving was measured by self report with the Visual Analog Scale (VAS). The VAS is a straight horizontal line with one end indicating no alcohol craving and the other end indicating intense alcohol craving. The participant marks a point on the line that matches their present amount of alcohol craving. Location of the point on the line is measured for a score range of 0-100. A lower score indicates less craving for alcohol and a higher score indicated more craving for alcohol.
measure: Alcohol Craving: Visual Analog Scale (VAS) Self-Administration Blocks 1 and 2, Minute 60
time frame: 1 minute
description: Alcohol craving was measured by self report with the Visual Analog Scale (VAS). The VAS is a straight horizontal line with one end indicating no alcohol craving and the other end indicating intense alcohol craving. The participant marks a point on the line that matches their present amount of alcohol craving. Location of the point on the line is measured for a score range of 0-100. A lower score indicates less craving for alcohol and a higher score indicated more craving for alcohol.
measure: Alcohol Craving: Visual Analog Scale (VAS) Self-Administration Blocks 1 and 2, Minute 90
time frame: 1 minute
description: Alcohol craving was measured by self report with the Visual Analog Scale (VAS). The VAS is a straight horizontal line with one end indicating no alcohol craving and the other end indicating intense alcohol craving. The participant marks a point on the line that matches their present amount of alcohol craving. Location of the point on the line is measured for a score range of 0-100. A lower score indicates less craving for alcohol and a higher score indicated more craving for alcohol.
measure: Alcohol Craving: Visual Analog Scale (VAS) Self-Administration Blocks 1 and 2, Minute 120
time frame: 1 minute
description: Alcohol craving was measured by self report with the Visual Analog Scale (VAS). The VAS is a straight horizontal line with one end indicating no alcohol craving and the other end indicating intense alcohol craving. The participant marks a point on the line that matches their present amount of alcohol craving. Location of the point on the line is measured for a score range of 0-100. A lower score indicates less craving for alcohol and a higher score indicated more craving for alcohol.
measure: Alcohol Craving: Alcohol Urge Questionnaire (AUQ) Self-Administration Blocks 1 and 2, Minute 30
time frame: 1 minute
description: The Alcohol Urge Questionnaire (AUQ) is an 8-item self report that measures the participant's urge for an alcoholic drink at the time the questionnaire is completed. Questions are in the form of a 7-point Likert scale (from strongly disagree to strongly agree) and the participant selects the extent to which they disagree or agree with the 8 statements relating to desire to drink, expectation of a desired outcome from drinking, and inability to avoid drinking if alcohol was available. Each of the 8 items is scored 1-7. The total score is calculated by adding the scores for each of the items. The total score range is 8-56. Lower scores indicate less urge for alcohol and higher scores indicate more urge for alcohol.
measure: Alcohol Craving: Alcohol Urge Questionnaire (AUQ) Self-Administration Blocks 1 and 2, Minute 60
time frame: 1 minute
description: The Alcohol Urge Questionnaire (AUQ) is an 8-item self report that measures the participant's urge for an alcoholic drink at the time the questionnaire is completed. Questions are in the form of a 7-point Likert scale (from strongly disagree to strongly agree) and the participant selects the extent to which they disagree or agree with the 8 statements relating to desire to drink, expectation of a desired outcome from drinking, and inability to avoid drinking if alcohol was available. Each of the 8 items is scored 1-7. The total score is calculated by adding the scores for each of the items. The total score range is 8-56. Lower scores indicate less urge for alcohol and higher scores indicate more urge for alcohol.
measure: Alcohol Craving: Alcohol Urge Questionnaire (AUQ) Self-Administration Blocks 1 and 2, Minute 90
time frame: 1 minute
description: The Alcohol Urge Questionnaire (AUQ) is an 8-item self report that measures the participant's urge for an alcoholic drink at the time the questionnaire is completed. Questions are in the form of a 7-point Likert scale (from strongly disagree to strongly agree) and the participant selects the extent to which they disagree or agree with the 8 statements relating to desire to drink, expectation of a desired outcome from drinking, and inability to avoid drinking if alcohol was available. Each of the 8 items is scored 1-7. The total score is calculated by adding the scores for each of the items. The total score range is 8-56. Lower scores indicate less urge for alcohol and higher scores indicate more urge for alcohol.
measure: Alcohol Craving: Alcohol Urge Questionnaire (AUQ) Self-Administration Blocks 1 and 2, Minute 120
time frame: 1 minute
description: The Alcohol Urge Questionnaire (AUQ) is an 8-item self report that measures the participant's urge for an alcoholic drink at the time the questionnaire is completed. Questions are in the form of a 7-point Likert scale (from strongly disagree to strongly agree) and the participant selects the extent to which they disagree or agree with the 8 statements relating to desire to drink, expectation of a desired outcome from drinking, and inability to avoid drinking if alcohol was available. Each of the 8 items is scored 1-7. The total score is calculated by adding the scores for each of the items. The total score range is 8-56. Lower scores indicate less urge for alcohol and higher scores indicate more urge for alcohol.
arm group label: Lacosamide
arm group type: Experimental
description: Lacosamide titration was done to a target dose of 300mg. Participants took 100 mg of lacosamide once on day 1, 100 mg twice per day from day 2 through day 6 (200 mg daily total), on day 7 the lacosamide dose was increased to 150 mg twice daily (300 mg daily total), and on day 8 the participant took one dose of 150 mg.
arm group label: Placebo oral capsule
arm group type: Placebo Comparator
description: Participants took a placebo oral capsule once on day 1, twice per day from day 2 to day 7, and once on day 8.
intervention type: Drug
intervention name: Lacosamide
description: Lacosamide titration was done to a target dose of 300mg. Participants took 100 mg of lacosamide once on day 1, 100 mg twice per day from day 2 through day 6 (200 mg daily total), on day 7 the lacosamide dose was increased to 150 mg twice daily (300 mg daily total), and on day 8 the participant took one dose of 150 mg.
arm group label: Lacosamide
other name: Vimpat
intervention type: Drug
intervention name: Placebo oral capsule
description: Participants took a placebo oral capsule once on day 1, twice per day from day 2 to day 7, and once on day 8.
arm group label: Placebo oral capsule
criteria: 
gender: All
minimum age: 21 Years
maximum age: 55 Years
healthy volunteers: No
last name: Eric Devine, PhD
role: Principal Investigator
affiliation: Assistant Professor
facility: 
country: United States
responsible party type: Sponsor
mesh term: Alcoholism
mesh term: Alcoholic Intoxication
mesh term: Alcohol Drinking
mesh term: Lacosamide
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: This study was terminated early at the discretion of the Principal Investigator due to COVID-19 restrictions on human subject research recruitment, leading to a smaller number of subjects analyzed than planned. At the time of termination, 19 subjects had completed the study compared to the target sample size of 28. Three subjects that completed the study were omitted from statistical analysis due to not consuming any alcohol during either alcohol self-administration session.
point of contact: 