<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/NCT03012815</url>
  </required_header>
  <id_info>
    <org_study_id>16-008712</org_study_id>
    <nct_id>NCT03012815</nct_id>
  </id_info>
  <brief_title>Gabapentin for Alcohol Withdrawal Syndrome</brief_title>
  <official_title>A Prospective Randomized Controlled Open Label Trial of Symptom-triggered Benzodiazepine Versus Fixed-dose Gabapentin for Alcohol Withdrawal Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The current &quot;gold-standard&quot; for the management of alcohol withdrawal syndrome (AWS) is&#xD;
      symptom-triggered administration of benzodiazepines. This method of treatment has several&#xD;
      drawbacks that have been described in the literature. Thus benzodiazepine sparing agents have&#xD;
      been evaluated for use in AWS. One of these agents that has not only shown benefit for AWS&#xD;
      but also benefits on complete abstinence, reducing a return to heavy drinking, and cravings&#xD;
      is gabapentin. In clinical practice at Mayo Clinic gabapentin is used for this purpose. Due&#xD;
      to the limited reports of the safety and efficacy of a protocol involving gabapentin for AWS,&#xD;
      a study to compare gabapentin to symptom-triggered lorazepam will be completed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The current &quot;gold-standard&quot; for the management of alcohol withdrawal syndrome is&#xD;
      symptom-triggered administration of benzodiazepines. Benzodiazepines and use of a&#xD;
      symptom-triggered approach has several drawbacks such as over administration of medication&#xD;
      due to many subjective patient reported symptoms. Benzodiazepines may contribute to a&#xD;
      drug-induced delirium or high dosage may necessitate transfer to an ICU setting. Abrupt&#xD;
      withdrawal of benzodiazepines also contribute to cravings, rebound insomnia, and anxiety that&#xD;
      have been shown to increase the risk of a return drinking.&#xD;
&#xD;
      Clinical use of gabapentin for alcohol withdrawal has been presented by Maldonado at Stanford&#xD;
      University Hospitals. (Academy of Psychosomatic Medicine Annual Meeting, 2013-2015) At Mayo&#xD;
      Clinic, the Psychiatry Consultation-Liaison hospital service has been recommending the use of&#xD;
      a modified gabapentin protocol since January 2015, which has been clinically accepted on&#xD;
      medical, surgical, and psychiatric hospital services. The purpose of this research is to&#xD;
      investigate the reactive benzodiazepine versus proactive gabapentin approaches to AWS in a&#xD;
      prospective, randomized, open-label study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2017</start_date>
  <completion_date type="Actual">March 1, 2021</completion_date>
  <primary_completion_date type="Actual">March 1, 2021</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean Length of Hospital Stay</measure>
    <time_frame>Time to discharge or time to CIWA-Ar score &lt; 10 for 36 hours (whichever came first) up to 240 hrs.</time_frame>
    <description>The length of hospital stay for Alcohol withdrawal syndrome. The time interval between admission and either discharge or the time at which Clinical Institute Withdrawal Assessment - Alcohol revised (CIWA-Ar) scores are &lt;10 for 36 hours (up to 240 hours). Measured in hours. CIWA-Ar measures severity of 10 observed or measured alcohol withdrawal signs or symptoms. Zero to 7 points are assigned to each item, except for the last item, which is assigned 0-4 points, with a total possible score of 67. Total score ranges from 0 (best possible outcome)-67 (worst possible outcome). Lower scores (0-8) represent fewer withdrawal symptoms and less severity, scores &gt; 8 represent more withdrawal symptoms and greater severity</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Delirium Tremens (DT)</measure>
    <time_frame>During hospitalization (up to 240 hours)</time_frame>
    <description>The number of participants experiencing delirium tremens during their hospitalization (between admission and discharge).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximun Alcohol Withdrawal Severity Per CIWA-Ar Scale</measure>
    <time_frame>4 days</time_frame>
    <description>CIWA-Ar measures severity of 10 observed or measured alcohol withdrawal signs or symptoms. Zero to 7 points are assigned to each item, except for the last item, which is assigned 0-4 points, with a total possible score of 67. Total score ranges from 0 (best possible outcome)-67 (worst possible outcome). Lower scores (0-8) represent fewer withdrawal symptoms and less severity, scores &gt; 8 represent more withdrawal symptoms and greater severity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Sleepiness as Assessed by the Epworth Sleepiness Scale</measure>
    <time_frame>Baseline and 2 days</time_frame>
    <description>The ESS is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3), their usual chances of dozing off or falling asleep while engaged in eight different activities. Most people engage in those activities at least occasionally, although not necessarily every day. The ESS score (the sum of 8 item scores, 0-3) can range from 0 to 24. The higher the ESS score, the higher that person's average sleep propensity in daily life (ASP), or their daytime sleepiness.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Total Benzodiazepine Use</measure>
    <time_frame>Time to discharge or time to CIWA-Ar score &lt; 10 for 36 hours (whichever came first) up to 240 hrs.</time_frame>
    <description>The total amount of benzodiazepines administered. Measured by lorazepam equivalent, mg.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Experiencing Seizure</measure>
    <time_frame>During hospitalization (up to 240 hours).</time_frame>
    <description>The number of subjects who developed seizure during their hospitalization.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Cravings as Assessed by the Penn Alcohol Craving (PACS) Scale</measure>
    <time_frame>Baseline and 2 days</time_frame>
    <description>PACS is a 5 item self-rated scale of alcohol craving (0 = none to 6 = strong urge). Total scores range from 0 (little craving for alcohol) to 30 (irresistible urge to drink alcohol)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Anxiety Symptoms as Measured by the Generalized Anxiety Disorder-7 (GAD-7) Scale</measure>
    <time_frame>Baseline and 2 days</time_frame>
    <description>GAD-7 is GAD-7 is a 7-item self-administered scale of Generalized Anxiety Disorder symptoms (0 = not at all to 3 = nearly every day). Total scores range from 0 to 21. Total scores of 0-4 = minimal anxiety, Total scores of 5-9 = mild anxiety, total scores of 10-14 = moderate anxiety and total scores of 15-21 = severe anxiety.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">88</enrollment>
  <condition>Alcohol Withdrawal Syndrome</condition>
  <arm_group>
    <arm_group_label>Gabapentin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive gabapentin taper over 9 days with the option to add divalproex for patients who have a history of seizures or severe withdrawal. Will still undergo CIWA-Ar scoring but will not be administered a benzodiazepine.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Benzodiazepine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will receive a benzodiazepine if scoring greater than 9 on the CIWA-Ar scale.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Gabapentin</intervention_name>
    <description>Gabapentin administered as a taper</description>
    <arm_group_label>Gabapentin</arm_group_label>
    <other_name>Neurontin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Benzodiazepines</intervention_name>
    <description>Benzodiazepines administered using a symptoms triggered protocol</description>
    <arm_group_label>Benzodiazepine</arm_group_label>
    <other_name>lorazepam</other_name>
    <other_name>chlordiazepoxide</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Divalproex Sodium</intervention_name>
    <description>Given in addition to gabapentin in high risk patients (i.e. seizures, TBI history, DT history)</description>
    <arm_group_label>Gabapentin</arm_group_label>
    <other_name>Depakote</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria&#xD;
&#xD;
          1. Prediction of Alcohol Withdrawal Severity Scale (PAWSS) score &gt;4.&#xD;
&#xD;
          2. Adults age 18 or older.&#xD;
&#xD;
          3. Sufficient understanding of English.&#xD;
&#xD;
          4. Hospitalized on Hospital Internal Medicine or Generose.&#xD;
&#xD;
        Exclusion criteria&#xD;
&#xD;
          1. Severe renal impairment (estimated CrCl &lt; 30).&#xD;
&#xD;
          2. Intensive Care Unit (ICU) level of care.&#xD;
&#xD;
          3. Not responsive due to alcohol intoxication or withdrawal.&#xD;
&#xD;
          4. Already taking gabapentin more than 300 mg three times a day.&#xD;
&#xD;
          5. Prescribed pregabalin.&#xD;
&#xD;
          6. Primary seizure disorder.&#xD;
&#xD;
          7. Acute benzodiazepine withdrawal.&#xD;
&#xD;
          8. Concurrent substance use disorders (such as opioid use disorder, stimulant use&#xD;
             disorder) if the disorder is assessed to be clinically significant. Cannabis use&#xD;
             disorder will be allowed.&#xD;
&#xD;
          9. Concurrent anticonvulsant medications for psychiatric indications (e.g. bipolar&#xD;
             disorder) will be allowed.&#xD;
&#xD;
         10. Pregnancy.&#xD;
&#xD;
         11. Involuntary legal status (e.g., on court commitment).&#xD;
&#xD;
         12. Patients admitted greater than 12 hours prior to potential enrollment.&#xD;
&#xD;
         13. Patients receiving therapeutic dose of gabapentin (rather than continuation of home&#xD;
             dose) prior to enrollment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ruth E Bates, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic in Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.mayo.edu/research/clinical-trials</url>
    <description>Mayo Clinic Clinical Trials</description>
  </link>
  <reference>
    <citation>Furieri FA, Nakamura-Palacios EM. Gabapentin reduces alcohol consumption and craving: a randomized, double-blind, placebo-controlled trial. J Clin Psychiatry. 2007 Nov;68(11):1691-700. doi: 10.4088/jcp.v68n1108.</citation>
    <PMID>18052562</PMID>
  </reference>
  <reference>
    <citation>Leung JG, Hall-Flavin D, Nelson S, Schmidt KA, Schak KM. The role of gabapentin in the management of alcohol withdrawal and dependence. Ann Pharmacother. 2015 Aug;49(8):897-906. doi: 10.1177/1060028015585849. Epub 2015 May 12.</citation>
    <PMID>25969570</PMID>
  </reference>
  <reference>
    <citation>Maldonado JR, Sher Y, Das S, Hills-Evans K, Frenklach A, Lolak S, Talley R, Neri E. Prospective Validation Study of the Prediction of Alcohol Withdrawal Severity Scale (PAWSS) in Medically Ill Inpatients: A New Scale for the Prediction of Complicated Alcohol Withdrawal Syndrome. Alcohol Alcohol. 2015 Sep;50(5):509-18. doi: 10.1093/alcalc/agv043. Epub 2015 May 21.</citation>
    <PMID>25999438</PMID>
  </reference>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>December 27, 2016</study_first_submitted>
  <study_first_submitted_qc>January 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 6, 2017</study_first_posted>
  <results_first_submitted>February 9, 2022</results_first_submitted>
  <results_first_submitted_qc>March 1, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">March 24, 2022</results_first_posted>
  <last_update_submitted>March 1, 2022</last_update_submitted>
  <last_update_submitted_qc>March 1, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 24, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Ruth E Bates</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>gabapentin</keyword>
  <keyword>Alcohol Withdrawal Syndrome</keyword>
  <keyword>benzodiazepine</keyword>
  <keyword>symptom-triggered</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Syndrome</mesh_term>
    <mesh_term>Substance Withdrawal Syndrome</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chlordiazepoxide</mesh_term>
    <mesh_term>Gabapentin</mesh_term>
    <mesh_term>Lorazepam</mesh_term>
    <mesh_term>Valproic Acid</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>November 14, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/15/NCT03012815/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Gabapentin</title>
          <description>Patients received gabapentin taper over 9 days with the option to add divalproex for patients who have a history of seizures or severe withdrawal. Still underwent CIWA-Ar scoring but did not receive a benzodiazepine.&#xD;
Gabapentin: Gabapentin administered as a taper&#xD;
Divalproex Sodium: Given in addition to gabapentin in high risk patients (i.e. seizures, TBI history, DT history)</description>
        </group>
        <group group_id="P2">
          <title>Benzodiazepine</title>
          <description>Patients received a benzodiazepine if scoring greater than 9 on the CIWA-Ar scale.&#xD;
Benzodiazepines: Benzodiazepines administered using a symptoms triggered protocol</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="46"/>
                <participants group_id="P2" count="42"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="41"/>
                <participants group_id="P2" count="40"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="2"/>
              </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>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <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_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Gabapentin</title>
          <description>Patients received gabapentin taper over 9 days with the option to add divalproex for patients who have a history of seizures or severe withdrawal. Still underwent CIWA-Ar scoring but did not receive a benzodiazepine.&#xD;
Gabapentin: Gabapentin administered as a taper&#xD;
Divalproex Sodium: Given in addition to gabapentin in high risk patients (i.e. seizures, TBI history, DT history)</description>
        </group>
        <group group_id="B2">
          <title>Benzodiazepine</title>
          <description>Patients received a benzodiazepine if scoring greater than 9 on the CIWA-Ar scale.&#xD;
Benzodiazepines: Benzodiazepines administered using a symptoms triggered protocol</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="46"/>
            <count group_id="B2" value="42"/>
            <count group_id="B3" value="88"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="46"/>
                    <count group_id="B2" value="42"/>
                    <count group_id="B3" value="88"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="48.4" spread="13.51"/>
                    <measurement group_id="B2" value="46.7" spread="11.88"/>
                    <measurement group_id="B3" value="47.6" spread="12.72"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="46"/>
                    <count group_id="B2" value="42"/>
                    <count group_id="B3" value="88"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="23"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="46"/>
                    <count group_id="B2" value="42"/>
                    <count group_id="B3" value="88"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="46"/>
                    <measurement group_id="B2" value="42"/>
                    <measurement group_id="B3" value="88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Mean Length of Hospital Stay</title>
        <description>The length of hospital stay for Alcohol withdrawal syndrome. The time interval between admission and either discharge or the time at which Clinical Institute Withdrawal Assessment - Alcohol revised (CIWA-Ar) scores are &lt;10 for 36 hours (up to 240 hours). Measured in hours. CIWA-Ar measures severity of 10 observed or measured alcohol withdrawal signs or symptoms. Zero to 7 points are assigned to each item, except for the last item, which is assigned 0-4 points, with a total possible score of 67. Total score ranges from 0 (best possible outcome)-67 (worst possible outcome). Lower scores (0-8) represent fewer withdrawal symptoms and less severity, scores &gt; 8 represent more withdrawal symptoms and greater severity</description>
        <time_frame>Time to discharge or time to CIWA-Ar score &lt; 10 for 36 hours (whichever came first) up to 240 hrs.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Gabapentin</title>
            <description>Patients received gabapentin taper over 9 days with the option to add divalproex for patients who have a history of seizures or severe withdrawal. Still underwent CIWA-Ar scoring but did not receive a benzodiazepine.&#xD;
Gabapentin: Gabapentin administered as a taper&#xD;
Divalproex Sodium: Given in addition to gabapentin in high risk patients (i.e. seizures, TBI history, DT history)</description>
          </group>
          <group group_id="O2">
            <title>Benzodiazepine</title>
            <description>Patients received a benzodiazepine if scoring greater than 9 on the CIWA-Ar scale.&#xD;
Benzodiazepines: Benzodiazepines administered using a symptoms triggered protocol</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Length of Hospital Stay</title>
          <description>The length of hospital stay for Alcohol withdrawal syndrome. The time interval between admission and either discharge or the time at which Clinical Institute Withdrawal Assessment - Alcohol revised (CIWA-Ar) scores are &lt;10 for 36 hours (up to 240 hours). Measured in hours. CIWA-Ar measures severity of 10 observed or measured alcohol withdrawal signs or symptoms. Zero to 7 points are assigned to each item, except for the last item, which is assigned 0-4 points, with a total possible score of 67. Total score ranges from 0 (best possible outcome)-67 (worst possible outcome). Lower scores (0-8) represent fewer withdrawal symptoms and less severity, scores &gt; 8 represent more withdrawal symptoms and greater severity</description>
          <units>hours</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
                <count group_id="O2" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.91" spread="12.17"/>
                    <measurement group_id="O2" value="50.50" spread="25.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Delirium Tremens (DT)</title>
        <description>The number of participants experiencing delirium tremens during their hospitalization (between admission and discharge).</description>
        <time_frame>During hospitalization (up to 240 hours)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Gabapentin</title>
            <description>Patients received gabapentin taper over 9 days with the option to add divalproex for patients who have a history of seizures or severe withdrawal. Still underwent CIWA-Ar scoring but did not receive a benzodiazepine.&#xD;
Gabapentin: Gabapentin administered as a taper&#xD;
Divalproex Sodium: Given in addition to gabapentin in high risk patients (i.e. seizures, TBI history, DT history)</description>
          </group>
          <group group_id="O2">
            <title>Benzodiazepine</title>
            <description>Patients received a benzodiazepine if scoring greater than 9 on the CIWA-Ar scale.&#xD;
Benzodiazepines: Benzodiazepines administered using a symptoms triggered protocol</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Delirium Tremens (DT)</title>
          <description>The number of participants experiencing delirium tremens during their hospitalization (between admission and discharge).</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
                <count group_id="O2" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Maximun Alcohol Withdrawal Severity Per CIWA-Ar Scale</title>
        <description>CIWA-Ar measures severity of 10 observed or measured alcohol withdrawal signs or symptoms. Zero to 7 points are assigned to each item, except for the last item, which is assigned 0-4 points, with a total possible score of 67. Total score ranges from 0 (best possible outcome)-67 (worst possible outcome). Lower scores (0-8) represent fewer withdrawal symptoms and less severity, scores &gt; 8 represent more withdrawal symptoms and greater severity</description>
        <time_frame>4 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Gabapentin</title>
            <description>Patients received gabapentin taper over 9 days with the option to add divalproex for patients who have a history of seizures or severe withdrawal. Still underwent CIWA-Ar scoring but did not receive a benzodiazepine.&#xD;
Gabapentin: Gabapentin administered as a taper&#xD;
Divalproex Sodium: Given in addition to gabapentin in high risk patients (i.e. seizures, TBI history, DT history)</description>
          </group>
          <group group_id="O2">
            <title>Benzodiazepine</title>
            <description>Patients received a benzodiazepine if scoring greater than 9 on the CIWA-Ar scale.&#xD;
Benzodiazepines: Benzodiazepines administered using a symptoms triggered protocol</description>
          </group>
        </group_list>
        <measure>
          <title>Maximun Alcohol Withdrawal Severity Per CIWA-Ar Scale</title>
          <description>CIWA-Ar measures severity of 10 observed or measured alcohol withdrawal signs or symptoms. Zero to 7 points are assigned to each item, except for the last item, which is assigned 0-4 points, with a total possible score of 67. Total score ranges from 0 (best possible outcome)-67 (worst possible outcome). Lower scores (0-8) represent fewer withdrawal symptoms and less severity, scores &gt; 8 represent more withdrawal symptoms and greater severity</description>
          <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="46"/>
                <count group_id="O2" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.15" spread="5.70"/>
                    <measurement group_id="O2" value="12.81" spread="6.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Sleepiness as Assessed by the Epworth Sleepiness Scale</title>
        <description>The ESS is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3), their usual chances of dozing off or falling asleep while engaged in eight different activities. Most people engage in those activities at least occasionally, although not necessarily every day. The ESS score (the sum of 8 item scores, 0-3) can range from 0 to 24. The higher the ESS score, the higher that person's average sleep propensity in daily life (ASP), or their daytime sleepiness.</description>
        <time_frame>Baseline and 2 days</time_frame>
        <population>Those patients who completed baseline questionnaire and follow-up questionnaire 48 hours later</population>
        <group_list>
          <group group_id="O1">
            <title>Gabapentin</title>
            <description>Patients received gabapentin taper over 9 days with the option to add divalproex for patients who have a history of seizures or severe withdrawal. Still underwent CIWA-Ar scoring but did not receive a benzodiazepine.&#xD;
Gabapentin: Gabapentin administered as a taper&#xD;
Divalproex Sodium: Given in addition to gabapentin in high risk patients (i.e. seizures, TBI history, DT history)</description>
          </group>
          <group group_id="O2">
            <title>Benzodiazepine</title>
            <description>Patients received a benzodiazepine if scoring greater than 9 on the CIWA-Ar scale.&#xD;
Benzodiazepines: Benzodiazepines administered using a symptoms triggered protocol</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Sleepiness as Assessed by the Epworth Sleepiness Scale</title>
          <description>The ESS is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3), their usual chances of dozing off or falling asleep while engaged in eight different activities. Most people engage in those activities at least occasionally, although not necessarily every day. The ESS score (the sum of 8 item scores, 0-3) can range from 0 to 24. The higher the ESS score, the higher that person's average sleep propensity in daily life (ASP), or their daytime sleepiness.</description>
          <population>Those patients who completed baseline questionnaire and follow-up questionnaire 48 hours later</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="19"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.03" spread="4.02"/>
                    <measurement group_id="O2" value="0.07" spread="5.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Total Benzodiazepine Use</title>
        <description>The total amount of benzodiazepines administered. Measured by lorazepam equivalent, mg.</description>
        <time_frame>Time to discharge or time to CIWA-Ar score &lt; 10 for 36 hours (whichever came first) up to 240 hrs.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Gabapentin</title>
            <description>Patients received gabapentin taper over 9 days with the option to add divalproex for patients who have a history of seizures or severe withdrawal.&#xD;
Gabapentin: Gabapentin administered as a taper&#xD;
Divalproex Sodium: Given in addition to gabapentin in high risk patients (i.e. seizures, TBI history, DT history)</description>
          </group>
          <group group_id="O2">
            <title>Benzodiazepine</title>
            <description>Patients received a benzodiazepine if scoring greater than 9 on the CIWA-Ar scale.&#xD;
Benzodiazepines: Benzodiazepines administered using a symptoms triggered protocol</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Total Benzodiazepine Use</title>
          <description>The total amount of benzodiazepines administered. Measured by lorazepam equivalent, mg.</description>
          <units>milligrams</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
                <count group_id="O2" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.2" spread="6.8"/>
                    <measurement group_id="O2" value="10.8" spread="14.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Experiencing Seizure</title>
        <description>The number of subjects who developed seizure during their hospitalization.</description>
        <time_frame>During hospitalization (up to 240 hours).</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Gabapentin</title>
            <description>Patients received gabapentin taper over 9 days with the option to add divalproex for patients who have a history of seizures or severe withdrawal. Still underwent CIWA-Ar scoring but did not receive a benzodiazepine.&#xD;
Gabapentin: Gabapentin administered as a taper&#xD;
Divalproex Sodium: Given in addition to gabapentin in high risk patients (i.e. seizures, TBI history, DT history)</description>
          </group>
          <group group_id="O2">
            <title>Benzodiazepine</title>
            <description>Patients received a benzodiazepine if scoring greater than 9 on the CIWA-Ar scale.&#xD;
Benzodiazepines: Benzodiazepines administered using a symptoms triggered protocol</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Experiencing Seizure</title>
          <description>The number of subjects who developed seizure during their hospitalization.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
                <count group_id="O2" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Cravings as Assessed by the Penn Alcohol Craving (PACS) Scale</title>
        <description>PACS is a 5 item self-rated scale of alcohol craving (0 = none to 6 = strong urge). Total scores range from 0 (little craving for alcohol) to 30 (irresistible urge to drink alcohol)</description>
        <time_frame>Baseline and 2 days</time_frame>
        <population>Those patients who completed baseline questionnaire and follow-up questionnaire 48 hours later</population>
        <group_list>
          <group group_id="O1">
            <title>Gabapentin</title>
            <description>Patients received gabapentin taper over 9 days with the option to add divalproex for patients who have a history of seizures or severe withdrawal. Still underwent CIWA-Ar scoring but did not receive a benzodiazepine.&#xD;
Gabapentin: Gabapentin administered as a taper&#xD;
Divalproex Sodium: Given in addition to gabapentin in high risk patients (i.e. seizures, TBI history, DT history)</description>
          </group>
          <group group_id="O2">
            <title>Benzodiazepine</title>
            <description>Patients received a benzodiazepine if scoring greater than 9 on the CIWA-Ar scale.&#xD;
Benzodiazepines: Benzodiazepines administered using a symptoms triggered protocol</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Cravings as Assessed by the Penn Alcohol Craving (PACS) Scale</title>
          <description>PACS is a 5 item self-rated scale of alcohol craving (0 = none to 6 = strong urge). Total scores range from 0 (little craving for alcohol) to 30 (irresistible urge to drink alcohol)</description>
          <population>Those patients who completed baseline questionnaire and follow-up questionnaire 48 hours later</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="19"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.12" spread="9.15"/>
                    <measurement group_id="O2" value="-8.45" spread="7.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Anxiety Symptoms as Measured by the Generalized Anxiety Disorder-7 (GAD-7) Scale</title>
        <description>GAD-7 is GAD-7 is a 7-item self-administered scale of Generalized Anxiety Disorder symptoms (0 = not at all to 3 = nearly every day). Total scores range from 0 to 21. Total scores of 0-4 = minimal anxiety, Total scores of 5-9 = mild anxiety, total scores of 10-14 = moderate anxiety and total scores of 15-21 = severe anxiety.</description>
        <time_frame>Baseline and 2 days</time_frame>
        <population>Those patients who completed baseline questionnaire and follow-up questionnaire 48 hours later</population>
        <group_list>
          <group group_id="O1">
            <title>Gabapentin</title>
            <description>Patients received gabapentin taper over 9 days with the option to add divalproex for patients who have a history of seizures or severe withdrawal. Still underwent CIWA-Ar scoring but did not receive a benzodiazepine.&#xD;
Gabapentin: Gabapentin administered as a taper&#xD;
Divalproex Sodium: Given in addition to gabapentin in high risk patients (i.e. seizures, TBI history, DT history)</description>
          </group>
          <group group_id="O2">
            <title>Benzodiazepine</title>
            <description>Patients received a benzodiazepine if scoring greater than 9 on the CIWA-Ar scale.&#xD;
Benzodiazepines: Benzodiazepines administered using a symptoms triggered protocol</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Anxiety Symptoms as Measured by the Generalized Anxiety Disorder-7 (GAD-7) Scale</title>
          <description>GAD-7 is GAD-7 is a 7-item self-administered scale of Generalized Anxiety Disorder symptoms (0 = not at all to 3 = nearly every day). Total scores range from 0 to 21. Total scores of 0-4 = minimal anxiety, Total scores of 5-9 = mild anxiety, total scores of 10-14 = moderate anxiety and total scores of 15-21 = severe anxiety.</description>
          <population>Those patients who completed baseline questionnaire and follow-up questionnaire 48 hours later</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="19"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.07" spread="4.80"/>
                    <measurement group_id="O2" value="-3.79" spread="6.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were collected during the patient's hospitalization (from admission to discharge, up to 240 hours).</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Gabapentin</title>
          <description>Patients received gabapentin taper over 9 days with the option to add divalproex for patients who have a history of seizures or severe withdrawal. Still underwent CIWA-Ar scoring but did not receive a benzodiazepine.&#xD;
Gabapentin: Gabapentin administered as a taper&#xD;
Divalproex Sodium: Given in addition to gabapentin in high risk patients (i.e. seizures, TBI history, DT history)</description>
        </group>
        <group group_id="E2">
          <title>Benzodiazepine</title>
          <description>Patients received a benzodiazepine if scoring greater than 9 on the CIWA-Ar scale.&#xD;
Benzodiazepines: Benzodiazepines administered using a symptoms triggered protocol</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <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="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Allergic reaction</sub_title>
                <description>Angioedema attributed to allergic reaction to gabapentin</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>
    <point_of_contact>
      <name_or_title>Ruth Bates</name_or_title>
      <organization>Mayo Clinic</organization>
      <phone>507-255-8716</phone>
      <email>Bates.Ruth@mayo.edu</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/NCT03012815
org study id: 16-008712
nct id: NCT03012815
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The current "gold-standard" for the management of alcohol withdrawal syndrome (AWS) is
      symptom-triggered administration of benzodiazepines. This method of treatment has several
      drawbacks that have been described in the literature. Thus benzodiazepine sparing agents have
      been evaluated for use in AWS. One of these agents that has not only shown benefit for AWS
      but also benefits on complete abstinence, reducing a return to heavy drinking, and cravings
      is gabapentin. In clinical practice at Mayo Clinic gabapentin is used for this purpose. Due
      to the limited reports of the safety and efficacy of a protocol involving gabapentin for AWS,
      a study to compare gabapentin to symptom-triggered lorazepam will be completed.
The current "gold-standard" for the management of alcohol withdrawal syndrome is
      symptom-triggered administration of benzodiazepines. Benzodiazepines and use of a
      symptom-triggered approach has several drawbacks such as over administration of medication
      due to many subjective patient reported symptoms. Benzodiazepines may contribute to a
      drug-induced delirium or high dosage may necessitate transfer to an ICU setting. Abrupt
      withdrawal of benzodiazepines also contribute to cravings, rebound insomnia, and anxiety that
      have been shown to increase the risk of a return drinking.

      Clinical use of gabapentin for alcohol withdrawal has been presented by Maldonado at Stanford
      University Hospitals. (Academy of Psychosomatic Medicine Annual Meeting, 2013-2015) At Mayo
      Clinic, the Psychiatry Consultation-Liaison hospital service has been recommending the use of
      a modified gabapentin protocol since January 2015, which has been clinically accepted on
      medical, surgical, and psychiatric hospital services. The purpose of this research is to
      investigate the reactive benzodiazepine versus proactive gabapentin approaches to AWS in a
      prospective, randomized, open-label study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Mean Length of Hospital Stay
time frame: Time to discharge or time to CIWA-Ar score < 10 for 36 hours (whichever came first) up to 240 hrs.
description: The length of hospital stay for Alcohol withdrawal syndrome. The time interval between admission and either discharge or the time at which Clinical Institute Withdrawal Assessment - Alcohol revised (CIWA-Ar) scores are <10 for 36 hours (up to 240 hours). Measured in hours. CIWA-Ar measures severity of 10 observed or measured alcohol withdrawal signs or symptoms. Zero to 7 points are assigned to each item, except for the last item, which is assigned 0-4 points, with a total possible score of 67. Total score ranges from 0 (best possible outcome)-67 (worst possible outcome). Lower scores (0-8) represent fewer withdrawal symptoms and less severity, scores > 8 represent more withdrawal symptoms and greater severity
measure: Number of Participants With Delirium Tremens (DT)
time frame: During hospitalization (up to 240 hours)
description: The number of participants experiencing delirium tremens during their hospitalization (between admission and discharge).
measure: Maximun Alcohol Withdrawal Severity Per CIWA-Ar Scale
time frame: 4 days
description: CIWA-Ar measures severity of 10 observed or measured alcohol withdrawal signs or symptoms. Zero to 7 points are assigned to each item, except for the last item, which is assigned 0-4 points, with a total possible score of 67. Total score ranges from 0 (best possible outcome)-67 (worst possible outcome). Lower scores (0-8) represent fewer withdrawal symptoms and less severity, scores > 8 represent more withdrawal symptoms and greater severity
measure: Change in Sleepiness as Assessed by the Epworth Sleepiness Scale
time frame: Baseline and 2 days
description: The ESS is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3), their usual chances of dozing off or falling asleep while engaged in eight different activities. Most people engage in those activities at least occasionally, although not necessarily every day. The ESS score (the sum of 8 item scores, 0-3) can range from 0 to 24. The higher the ESS score, the higher that person's average sleep propensity in daily life (ASP), or their daytime sleepiness.
measure: Mean Total Benzodiazepine Use
time frame: Time to discharge or time to CIWA-Ar score < 10 for 36 hours (whichever came first) up to 240 hrs.
description: The total amount of benzodiazepines administered. Measured by lorazepam equivalent, mg.
measure: Number of Participants Experiencing Seizure
time frame: During hospitalization (up to 240 hours).
description: The number of subjects who developed seizure during their hospitalization.
measure: Change in Cravings as Assessed by the Penn Alcohol Craving (PACS) Scale
time frame: Baseline and 2 days
description: PACS is a 5 item self-rated scale of alcohol craving (0 = none to 6 = strong urge). Total scores range from 0 (little craving for alcohol) to 30 (irresistible urge to drink alcohol)
measure: Change in Anxiety Symptoms as Measured by the Generalized Anxiety Disorder-7 (GAD-7) Scale
time frame: Baseline and 2 days
description: GAD-7 is GAD-7 is a 7-item self-administered scale of Generalized Anxiety Disorder symptoms (0 = not at all to 3 = nearly every day). Total scores range from 0 to 21. Total scores of 0-4 = minimal anxiety, Total scores of 5-9 = mild anxiety, total scores of 10-14 = moderate anxiety and total scores of 15-21 = severe anxiety.
arm group label: Gabapentin
arm group type: Experimental
description: Patients will receive gabapentin taper over 9 days with the option to add divalproex for patients who have a history of seizures or severe withdrawal. Will still undergo CIWA-Ar scoring but will not be administered a benzodiazepine.
arm group label: Benzodiazepine
arm group type: Active Comparator
description: Patients will receive a benzodiazepine if scoring greater than 9 on the CIWA-Ar scale.
intervention type: Drug
intervention name: Gabapentin
description: Gabapentin administered as a taper
arm group label: Gabapentin
other name: Neurontin
intervention type: Drug
intervention name: Benzodiazepines
description: Benzodiazepines administered using a symptoms triggered protocol
arm group label: Benzodiazepine
other name: lorazepam
other name: chlordiazepoxide
intervention type: Drug
intervention name: Divalproex Sodium
description: Given in addition to gabapentin in high risk patients (i.e. seizures, TBI history, DT history)
arm group label: Gabapentin
other name: Depakote
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ruth E Bates, MD
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
url: https://www.mayo.edu/research/clinical-trials
description: Mayo Clinic Clinical Trials
citation: Furieri FA, Nakamura-Palacios EM. Gabapentin reduces alcohol consumption and craving: a randomized, double-blind, placebo-controlled trial. J Clin Psychiatry. 2007 Nov;68(11):1691-700. doi: 10.4088/jcp.v68n1108.
PMID: 18052562
citation: Leung JG, Hall-Flavin D, Nelson S, Schmidt KA, Schak KM. The role of gabapentin in the management of alcohol withdrawal and dependence. Ann Pharmacother. 2015 Aug;49(8):897-906. doi: 10.1177/1060028015585849. Epub 2015 May 12.
PMID: 25969570
citation: Maldonado JR, Sher Y, Das S, Hills-Evans K, Frenklach A, Lolak S, Talley R, Neri E. Prospective Validation Study of the Prediction of Alcohol Withdrawal Severity Scale (PAWSS) in Medically Ill Inpatients: A New Scale for the Prediction of Complicated Alcohol Withdrawal Syndrome. Alcohol Alcohol. 2015 Sep;50(5):509-18. doi: 10.1093/alcalc/agv043. Epub 2015 May 21.
PMID: 25999438
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Ruth E Bates
investigator title: MD
mesh term: Syndrome
mesh term: Substance Withdrawal Syndrome
mesh term: Chlordiazepoxide
mesh term: Gabapentin
mesh term: Lorazepam
mesh term: Valproic Acid
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 