xml: <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/NCT05988710</url>
    </required_header>
    <id_info>
      <org_study_id>222204</org_study_id>
      <secondary_id>1K23DA057387</secondary_id>
      <nct_id>NCT05988710</nct_id>
    </id_info>
    <brief_title>Low-dose Buccal Buprenorphine: Relative Abuse Potential and Analgesia</brief_title>
    <official_title>Low-dose Buccal Buprenorphine: Relative Abuse Potential and Analgesia</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Vanderbilt University Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Institute on Drug Abuse (NIDA)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>Vanderbilt University Medical Center</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this study is to compare the abuse potential of low-dose equianalgesic buccal&#xD;
        buprenorphine to a commonly used full mu opioid receptor (MOR) agonist in a highly controlled&#xD;
        experimental setting. This is a translational study in which healthy participants are&#xD;
        phenotyped for psychosocial and Opioid-Use-Disorder-risk-related metrics. In a&#xD;
        within-subjects crossover design, 60 participants will receive a standard postoperative oral&#xD;
        oxycodone dose (10 mg), placebo, and 3 different doses of buccal buprenorphine across 5&#xD;
        separate sessions. Quantitative Sensory Testing (QST) will be used to evaluate alterations in&#xD;
        pain responsiveness relative to placebo across buprenorphine doses and oxycodone, and will&#xD;
        compare abuse potential (indexed by the standard FDA drug liking metric) following&#xD;
        equianalgesic doses of the two drugs.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">September 2026</completion_date>
    <primary_completion_date type="Anticipated">September 2026</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>Crossover Assignment</intervention_model>
      <intervention_model_description>randomized, double blind, double-dummy, placebo-controlled, crossover</intervention_model_description>
      <primary_purpose>Other</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Difference in mean maximum effect score (Emax) of the drug liking visual analog scale (VAS) between oxycodone 10 mg and an equianalgesic dose of buprenorphine</measure>
      <time_frame>Baseline through 3.5 hours after study drug administration on each medication condition</time_frame>
      <description>Difference in mean Emax of the drug liking VAS between oxycodone 10 mg and an equianalgesic dose of buprenorphine conditions. Drug liking VAS is a bipolar scale designed to assess a participant's liking for a given study intervention at the time the question is being asked (that is, at this moment). It is scored as an integer ranging from 0 (strong disliking) to 100 (strong liking).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Quantitative sensory testing (QST) thermal pain tolerance in seconds</measure>
      <time_frame>Baseline through 3.5 hours after study drug administration on each medication condition</time_frame>
      <description>Mean time in seconds elapsed from onset of the heat pain stimulus to participants withdrawal from the stimulus. Heat pain tolerance is an indicator of pain sensitivity. This will determine the equianalgesic dose of buccal buprenorphine compared to oxycodone 10 mg. Equivalence to oxycodone will be defined as the buprenorphine does that produces a mean thermal pain tolerance increase within 0.5 standard deviation of the oxycodone. response.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Difference in mean maximum effect score (Emax) of the drug liking visual analog scale between equianalgesic dose of buprenorphine and placebo conditions</measure>
      <time_frame>Baseline through 3.5 hours after study drug administration on each medication condition</time_frame>
      <description>Difference in mean maximum effect score (Emax) of the drug liking visual analog scale between equianalgesic dose of buprenorphine and placebo conditions. Drug liking VAS is a bipolar scale designed to assess a participant's liking for a given study intervention at the time the question is being asked (that is, at this moment). It is scored as an integer ranging from 0 (strong disliking) to 100 (strong liking).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Difference in mean maximum effect score (Emax) of the drug liking visual analog scale between oxycodone 10 mg and placebo conditions</measure>
      <time_frame>Baseline through 3.5 hours after study drug administration on each medication condition</time_frame>
      <description>Difference in mean maximum effect score (Emax) of the drug liking visual analog scale between oxycodone 10 mg and placebo conditions. Drug liking VAS is a bipolar scale designed to assess a participant's liking for a given study intervention at the time the question is being asked (that is, at this moment). It is scored as an integer ranging from 0 (strong disliking) to 100 (strong liking).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>QST heat pain threshold</measure>
      <time_frame>Baseline through 3.5 hours after study drug administration on each medication condition</time_frame>
      <description>Mean time in seconds elapsed from onset of the thermal stimulus to the point at which heat stimulus is first experienced as painful. Thermal pain threshold is an indicator of pain sensitivity.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Visual Analog Scale (VAS) pain intensity</measure>
      <time_frame>Baseline through 3.5 hours after study drug administration on each medication condition</time_frame>
      <description>Difference in mean Emax of the pain intensity VAS between oxycodone 10 mg, equianalgesic dose of buprenorphine and placebo. The VAS pain intensity is a measure of experienced pain intensity on 0 to 100 scale when 0 is no pain and 100 is worst pain imaginable.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>VAS pain unpleasantness</measure>
      <time_frame>Baseline through 3.5 hours after study drug administration on each medication condition</time_frame>
      <description>Difference in mean Emax of the pain unpleasantness VAS between oxycodone 10 mg, equianalgesic dose of buprenorphine and placebo. The VAS pain unpleasantness is a measure of experienced pain unpleasantness on 0 to 100 scale, when 0 is no unpleasantness and 100 is most unpleasant imaginable.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>McGill Pain Questionnaire - Short Form</measure>
      <time_frame>Baseline through 3.5 hours after study drug administration on each medication condition</time_frame>
      <description>Mean of maximum McGill Pain Questionnaire - Short Form score between oxycodone 10mg, equianalgesic dose of buprenorphine and placebo. The score ranges from 0-33 where 0 represents no pain and 33 represents most intense pain. Positive change values indicate decreased pain responsiveness.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>VAS alertness/drowsiness</measure>
      <time_frame>Baseline through 3.5 hours after study drug administration on each medication condition</time_frame>
      <description>Difference in mean Emax of the VAS alertness/drowsiness between oxycodone 10 mg, equianalgesic dose of buprenorphine and placebo. The VAS alertness/drowsiness assesses alertness and drowsiness following drug administration on 0 to 100 sale, when 0 is extreme drowsiness, 50 is neutral, and 100 is extreme alertness.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>VAS any drug effects</measure>
      <time_frame>Baseline through 3.5 hours after study drug administration on each medication condition</time_frame>
      <description>Difference in mean Emax of the VAS any drug effects between oxycodone 10 mg, equianalgesic dose of buprenorphine and placebo. VAS any drug effects assesses presence of any drug effects felt by participant on 0 to 100 scale, when 0 is no drug effects and 100 is extreme drug effects.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>VAS good effects</measure>
      <time_frame>Baseline through 3.5 hours after study drug administration on each medication condition</time_frame>
      <description>Difference in mean Emax of the VAS good effects between oxycodone 10 mg, equianalgesic dose of buprenorphine and placebo. VAS good effects assesses presence of drug effects characterized as good felt by participant on scale 0 to 100 when 0 is no good drug effects and 100 is extreme good drug effects.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>VAS feeling high</measure>
      <time_frame>Baseline through 3.5 hours after study drug administration on each medication condition</time_frame>
      <description>Difference in mean Emax of the VAS feeling high between oxycodone 10 mg, equianalgesic dose of buprenorphine and placebo. VAS feeling high assesses presence of &quot;feeling high&quot; by participant on 0 to 100 scale when o is not feeling high at all and 100 is feeling extremely high.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>VAS bad effects</measure>
      <time_frame>Baseline through 3.5 hours after study drug administration on each medication condition</time_frame>
      <description>Difference in mean Emax of the VAS bad effects between oxycodone 10 mg, equianalgesic dose of buprenorphine and placebo. VAS bad effects assesses presence of drug effects characterized as bad felt by participant on 0 to 100 scale when 0 is no bad drug effects and 100 is extreme bad drug effects.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>VAS desire to use opioids</measure>
      <time_frame>Baseline through 3.5 hours after study drug administration on each medication condition</time_frame>
      <description>Difference in mean Emax of the VAS desire to use opioids between oxycodone 10 mg, equianalgesic dose of buprenorphine and placebo. VAS desire to use opioids assesses participant's desire to use opioids on a 0-100 scale when 0 is no desire to use opioids and 100 is extreme desire to use opioids.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Opioid Adjective Rating Scale</measure>
      <time_frame>Baseline through 3.5 hours after study drug administration on each medication condition</time_frame>
      <description>Difference in mean Emax of the VAS Opioid Adjective Rating Scale between oxycodone 10 mg, equianalgesic dose of buprenorphine and placebo. VAS Opioid Adjective Rating Scale is a 12 item questionnaire which evaluates common sensory and somatic effects of opioid (e.g., itching, vomiting, sweating, nausea, dry mouth). Each effect is rated on 0 to 4 scale when 0 is not at all and 4 is extremely.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Temporal summation of pain (TSP)</measure>
      <time_frame>Baseline through 3.5 hours after study drug administration on each medication condition</time_frame>
      <description>Change in pain intensity between first and most painful TSP stimuli (mean of two TSP trials) compared between oxycodone 10 mg, equianalgesic dose of buprenorphine and placebo conditions. Pain intensity will be measured on a 0-10 Numeric Rating Scale when when 0 is no pain and 100 is worst pain imaginable.</description>
    </secondary_outcome>
    <number_of_arms>5</number_of_arms>
    <enrollment type="Anticipated">72</enrollment>
    <condition>Analgesia</condition>
    <condition>Abuse Opioids</condition>
    <condition>Pain</condition>
    <arm_group>
      <arm_group_label>Buccal Buprenorphine 300mcg and oral Placebo</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>In randomized order (crossover) across 5 laboratory sessions approximately 5 days apart, participants will receive: 1) Buccal buprenorphine 300 mcg and oral placebo, 2) Buccal buprenorphine 600 mcg and oral placebo, 3) Buccal buprenorphine 900 mg and oral placebo, 4) oral immediate-release oxycodone 10mg and oral placebo, or 5) buccal placebo and oral placebo.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Buccal Buprenorphine 600mcg and oral Placebo</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>In randomized order (crossover) across 5 laboratory sessions approximately 5 days apart, participants will receive: 1) Buccal buprenorphine 300 mcg and oral placebo, 2) Buccal buprenorphine 600 mcg and oral placebo, 3) Buccal buprenorphine 900 mg and oral placebo, 4) oral immediate-release oxycodone 10mg and oral placebo, or 5) buccal placebo and oral placebo.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Buccal Buprenorphine 900mcg and oral Placebo</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>In randomized order (crossover) across 5 laboratory sessions approximately 5 days apart, participants will receive: 1) Buccal buprenorphine 300 mcg and oral placebo, 2) Buccal buprenorphine 600 mcg and oral placebo, 3) Buccal buprenorphine 900 mg and oral placebo, 4) oral immediate-release oxycodone 10mg and oral placebo, or 5) buccal placebo and oral placebo.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Oral immediate release oxycodone 10mg and buccal placebo</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>In randomized order (crossover) across 5 laboratory sessions approximately 5 days apart, participants will receive: 1) Buccal buprenorphine 300 mcg and oral placebo, 2) Buccal buprenorphine 600 mcg and oral placebo, 3) Buccal buprenorphine 900 mg and oral placebo, 4) oral immediate-release oxycodone 10mg and oral placebo, or 5) buccal placebo and oral placebo.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Oral placebo and buccal placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>In randomized order (crossover) across 5 laboratory sessions approximately 5 days apart, participants will receive: 1) Buccal buprenorphine 300 mcg and oral placebo, 2) Buccal buprenorphine 600 mcg and oral placebo, 3) Buccal buprenorphine 900 mg and oral placebo, 4) oral immediate-release oxycodone 10mg and oral placebo, or 5) buccal placebo and oral placebo.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Buccal Buprenorphine 300 mcg</intervention_name>
      <description>buprenorphine for 300mcg buccal administration</description>
      <arm_group_label>Buccal Buprenorphine 300mcg and oral Placebo</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Buccal Buprenorphine 600 mcg</intervention_name>
      <description>buprenorphine for 600mcg buccal administration</description>
      <arm_group_label>Buccal Buprenorphine 600mcg and oral Placebo</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Buccal Buprenorphine 900 mcg</intervention_name>
      <description>buprenorphine for 900mcg buccal administration</description>
      <arm_group_label>Buccal Buprenorphine 900mcg and oral Placebo</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Buccal Placebo</intervention_name>
      <description>Placebo for buccal administration</description>
      <arm_group_label>Oral immediate release oxycodone 10mg and buccal placebo</arm_group_label>
      <arm_group_label>Oral placebo and buccal placebo</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Oral Placebo</intervention_name>
      <description>Placebo for oral administration</description>
      <arm_group_label>Buccal Buprenorphine 300mcg and oral Placebo</arm_group_label>
      <arm_group_label>Buccal Buprenorphine 600mcg and oral Placebo</arm_group_label>
      <arm_group_label>Buccal Buprenorphine 900mcg and oral Placebo</arm_group_label>
      <arm_group_label>Oral placebo and buccal placebo</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Oral immediate-release oxycodone 10mg</intervention_name>
      <description>Immediate-release oxycodone for 10 mg oral administration</description>
      <arm_group_label>Oral immediate release oxycodone 10mg and buccal placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Intact cognitive status and ability to provide informed consent&#xD;
  &#xD;
            -  Ability to read and write in English sufficiently to understand and complete study&#xD;
               questionnaires&#xD;
  &#xD;
            -  Age 18-65&#xD;
  &#xD;
            -  Opioid-naive status (defined as no use of full mu-opioid receptor (MOR) agonist,&#xD;
               partial MOR agonist, or mixed agonist/antagonist medications for the prior 3 months by&#xD;
               patient report&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Liver/kidney disease&#xD;
  &#xD;
            -  Chronic pain&#xD;
  &#xD;
            -  Current/prior substance use disorder&#xD;
  &#xD;
            -  Pregnancy (to avoid fetal drug exposure, with pregnancy tests conducted to confirm&#xD;
               eligibility)&#xD;
  &#xD;
            -  Seizure disorder&#xD;
  &#xD;
            -  Certain psychiatric conditions (severe depression, bipolar disorder, psychotic&#xD;
               disorders)&#xD;
  &#xD;
            -  Recent use of medications that may interfere with study drug metabolism&#xD;
  &#xD;
            -  Recent benzodiazepine or opioid use (confirmed via rapid urine screening prior to each&#xD;
               lab session)&#xD;
  &#xD;
            -  The presence of any medical conditions felt by the study physician to render&#xD;
               participant unsafe&#xD;
  &#xD;
            -  Prior allergic reaction or intolerance to oxycodone, buprenorphine, or their analogs&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Daniel Larach, MD, MSTR, MA</last_name>
      <role>Principal Investigator</role>
      <affiliation>Vanderbilt University Medical Center</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Daniel Larach, MD, MSTR, MA</last_name>
      <phone>615-322-6033</phone>
      <email>daniel.larach@vumc.org</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Gail Mayo</last_name>
      <phone>6159361705</phone>
      <email>gail.mayo@vumc.org</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Vanderbilt University Medical Center</name>
        <address>
          <city>Nashville</city>
          <state>Tennessee</state>
          <zip>37069</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Daniel Larach Larach, MD, MSTR, MA</last_name>
        <phone>615-322-6033</phone>
        <email>daniel.larach@vumc.org</email>
      </contact>
      <contact_backup>
        <last_name>Gail Mayo</last_name>
        <phone>6159361705</phone>
        <email>gail.mayo@vumc.org</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 1, 2023</study_first_submitted>
    <study_first_submitted_qc>August 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 8, 2023</last_update_submitted>
    <last_update_submitted_qc>August 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Vanderbilt University Medical Center</investigator_affiliation>
      <investigator_full_name>Daniel Larach</investigator_full_name>
      <investigator_title>Asst Professor of Anesthesiology</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Agnosia</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Oxycodone</mesh_term>
      <mesh_term>Buprenorphine</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05988710
  org study id: 222204
  secondary id: 1K23DA057387
  nct id: NCT05988710
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: No
  The goal of this study is to compare the abuse potential of low-dose equianalgesic buccal
        buprenorphine to a commonly used full mu opioid receptor (MOR) agonist in a highly controlled
        experimental setting. This is a translational study in which healthy participants are
        phenotyped for psychosocial and Opioid-Use-Disorder-risk-related metrics. In a
        within-subjects crossover design, 60 participants will receive a standard postoperative oral
        oxycodone dose (10 mg), placebo, and 3 different doses of buccal buprenorphine across 5
        separate sessions. Quantitative Sensory Testing (QST) will be used to evaluate alterations in
        pain responsiveness relative to placebo across buprenorphine doses and oxycodone, and will
        compare abuse potential (indexed by the standard FDA drug liking metric) following
        equianalgesic doses of the two drugs.
  allocation: Randomized
  intervention model: Crossover Assignment
  intervention model description: randomized, double blind, double-dummy, placebo-controlled, crossover
  primary purpose: Other
  masking: Double (Participant, Investigator)
  measure: Difference in mean maximum effect score (Emax) of the drug liking visual analog scale (VAS) between oxycodone 10 mg and an equianalgesic dose of buprenorphine
  time frame: Baseline through 3.5 hours after study drug administration on each medication condition
  description: Difference in mean Emax of the drug liking VAS between oxycodone 10 mg and an equianalgesic dose of buprenorphine conditions. Drug liking VAS is a bipolar scale designed to assess a participant's liking for a given study intervention at the time the question is being asked (that is, at this moment). It is scored as an integer ranging from 0 (strong disliking) to 100 (strong liking).
  measure: Quantitative sensory testing (QST) thermal pain tolerance in seconds
  time frame: Baseline through 3.5 hours after study drug administration on each medication condition
  description: Mean time in seconds elapsed from onset of the heat pain stimulus to participants withdrawal from the stimulus. Heat pain tolerance is an indicator of pain sensitivity. This will determine the equianalgesic dose of buccal buprenorphine compared to oxycodone 10 mg. Equivalence to oxycodone will be defined as the buprenorphine does that produces a mean thermal pain tolerance increase within 0.5 standard deviation of the oxycodone. response.
  measure: Difference in mean maximum effect score (Emax) of the drug liking visual analog scale between equianalgesic dose of buprenorphine and placebo conditions
  time frame: Baseline through 3.5 hours after study drug administration on each medication condition
  description: Difference in mean maximum effect score (Emax) of the drug liking visual analog scale between equianalgesic dose of buprenorphine and placebo conditions. Drug liking VAS is a bipolar scale designed to assess a participant's liking for a given study intervention at the time the question is being asked (that is, at this moment). It is scored as an integer ranging from 0 (strong disliking) to 100 (strong liking).
  measure: Difference in mean maximum effect score (Emax) of the drug liking visual analog scale between oxycodone 10 mg and placebo conditions
  time frame: Baseline through 3.5 hours after study drug administration on each medication condition
  description: Difference in mean maximum effect score (Emax) of the drug liking visual analog scale between oxycodone 10 mg and placebo conditions. Drug liking VAS is a bipolar scale designed to assess a participant's liking for a given study intervention at the time the question is being asked (that is, at this moment). It is scored as an integer ranging from 0 (strong disliking) to 100 (strong liking).
  measure: QST heat pain threshold
  time frame: Baseline through 3.5 hours after study drug administration on each medication condition
  description: Mean time in seconds elapsed from onset of the thermal stimulus to the point at which heat stimulus is first experienced as painful. Thermal pain threshold is an indicator of pain sensitivity.
  measure: Visual Analog Scale (VAS) pain intensity
  time frame: Baseline through 3.5 hours after study drug administration on each medication condition
  description: Difference in mean Emax of the pain intensity VAS between oxycodone 10 mg, equianalgesic dose of buprenorphine and placebo. The VAS pain intensity is a measure of experienced pain intensity on 0 to 100 scale when 0 is no pain and 100 is worst pain imaginable.
  measure: VAS pain unpleasantness
  time frame: Baseline through 3.5 hours after study drug administration on each medication condition
  description: Difference in mean Emax of the pain unpleasantness VAS between oxycodone 10 mg, equianalgesic dose of buprenorphine and placebo. The VAS pain unpleasantness is a measure of experienced pain unpleasantness on 0 to 100 scale, when 0 is no unpleasantness and 100 is most unpleasant imaginable.
  measure: McGill Pain Questionnaire - Short Form
  time frame: Baseline through 3.5 hours after study drug administration on each medication condition
  description: Mean of maximum McGill Pain Questionnaire - Short Form score between oxycodone 10mg, equianalgesic dose of buprenorphine and placebo. The score ranges from 0-33 where 0 represents no pain and 33 represents most intense pain. Positive change values indicate decreased pain responsiveness.
  measure: VAS alertness/drowsiness
  time frame: Baseline through 3.5 hours after study drug administration on each medication condition
  description: Difference in mean Emax of the VAS alertness/drowsiness between oxycodone 10 mg, equianalgesic dose of buprenorphine and placebo. The VAS alertness/drowsiness assesses alertness and drowsiness following drug administration on 0 to 100 sale, when 0 is extreme drowsiness, 50 is neutral, and 100 is extreme alertness.
  measure: VAS any drug effects
  time frame: Baseline through 3.5 hours after study drug administration on each medication condition
  description: Difference in mean Emax of the VAS any drug effects between oxycodone 10 mg, equianalgesic dose of buprenorphine and placebo. VAS any drug effects assesses presence of any drug effects felt by participant on 0 to 100 scale, when 0 is no drug effects and 100 is extreme drug effects.
  measure: VAS good effects
  time frame: Baseline through 3.5 hours after study drug administration on each medication condition
  description: Difference in mean Emax of the VAS good effects between oxycodone 10 mg, equianalgesic dose of buprenorphine and placebo. VAS good effects assesses presence of drug effects characterized as good felt by participant on scale 0 to 100 when 0 is no good drug effects and 100 is extreme good drug effects.
  measure: VAS feeling high
  time frame: Baseline through 3.5 hours after study drug administration on each medication condition
  description: Difference in mean Emax of the VAS feeling high between oxycodone 10 mg, equianalgesic dose of buprenorphine and placebo. VAS feeling high assesses presence of "feeling high" by participant on 0 to 100 scale when o is not feeling high at all and 100 is feeling extremely high.
  measure: VAS bad effects
  time frame: Baseline through 3.5 hours after study drug administration on each medication condition
  description: Difference in mean Emax of the VAS bad effects between oxycodone 10 mg, equianalgesic dose of buprenorphine and placebo. VAS bad effects assesses presence of drug effects characterized as bad felt by participant on 0 to 100 scale when 0 is no bad drug effects and 100 is extreme bad drug effects.
  measure: VAS desire to use opioids
  time frame: Baseline through 3.5 hours after study drug administration on each medication condition
  description: Difference in mean Emax of the VAS desire to use opioids between oxycodone 10 mg, equianalgesic dose of buprenorphine and placebo. VAS desire to use opioids assesses participant's desire to use opioids on a 0-100 scale when 0 is no desire to use opioids and 100 is extreme desire to use opioids.
  measure: Opioid Adjective Rating Scale
  time frame: Baseline through 3.5 hours after study drug administration on each medication condition
  description: Difference in mean Emax of the VAS Opioid Adjective Rating Scale between oxycodone 10 mg, equianalgesic dose of buprenorphine and placebo. VAS Opioid Adjective Rating Scale is a 12 item questionnaire which evaluates common sensory and somatic effects of opioid (e.g., itching, vomiting, sweating, nausea, dry mouth). Each effect is rated on 0 to 4 scale when 0 is not at all and 4 is extremely.
  measure: Temporal summation of pain (TSP)
  time frame: Baseline through 3.5 hours after study drug administration on each medication condition
  description: Change in pain intensity between first and most painful TSP stimuli (mean of two TSP trials) compared between oxycodone 10 mg, equianalgesic dose of buprenorphine and placebo conditions. Pain intensity will be measured on a 0-10 Numeric Rating Scale when when 0 is no pain and 100 is worst pain imaginable.
  arm group label: Buccal Buprenorphine 300mcg and oral Placebo
  arm group type: Experimental
  description: In randomized order (crossover) across 5 laboratory sessions approximately 5 days apart, participants will receive: 1) Buccal buprenorphine 300 mcg and oral placebo, 2) Buccal buprenorphine 600 mcg and oral placebo, 3) Buccal buprenorphine 900 mg and oral placebo, 4) oral immediate-release oxycodone 10mg and oral placebo, or 5) buccal placebo and oral placebo.
  arm group label: Buccal Buprenorphine 600mcg and oral Placebo
  arm group type: Experimental
  description: In randomized order (crossover) across 5 laboratory sessions approximately 5 days apart, participants will receive: 1) Buccal buprenorphine 300 mcg and oral placebo, 2) Buccal buprenorphine 600 mcg and oral placebo, 3) Buccal buprenorphine 900 mg and oral placebo, 4) oral immediate-release oxycodone 10mg and oral placebo, or 5) buccal placebo and oral placebo.
  arm group label: Buccal Buprenorphine 900mcg and oral Placebo
  arm group type: Experimental
  description: In randomized order (crossover) across 5 laboratory sessions approximately 5 days apart, participants will receive: 1) Buccal buprenorphine 300 mcg and oral placebo, 2) Buccal buprenorphine 600 mcg and oral placebo, 3) Buccal buprenorphine 900 mg and oral placebo, 4) oral immediate-release oxycodone 10mg and oral placebo, or 5) buccal placebo and oral placebo.
  arm group label: Oral immediate release oxycodone 10mg and buccal placebo
  arm group type: Active Comparator
  description: In randomized order (crossover) across 5 laboratory sessions approximately 5 days apart, participants will receive: 1) Buccal buprenorphine 300 mcg and oral placebo, 2) Buccal buprenorphine 600 mcg and oral placebo, 3) Buccal buprenorphine 900 mg and oral placebo, 4) oral immediate-release oxycodone 10mg and oral placebo, or 5) buccal placebo and oral placebo.
  arm group label: Oral placebo and buccal placebo
  arm group type: Placebo Comparator
  description: In randomized order (crossover) across 5 laboratory sessions approximately 5 days apart, participants will receive: 1) Buccal buprenorphine 300 mcg and oral placebo, 2) Buccal buprenorphine 600 mcg and oral placebo, 3) Buccal buprenorphine 900 mg and oral placebo, 4) oral immediate-release oxycodone 10mg and oral placebo, or 5) buccal placebo and oral placebo.
  intervention type: Drug
  intervention name: Buccal Buprenorphine 300 mcg
  description: buprenorphine for 300mcg buccal administration
  arm group label: Buccal Buprenorphine 300mcg and oral Placebo
  intervention type: Drug
  intervention name: Buccal Buprenorphine 600 mcg
  description: buprenorphine for 600mcg buccal administration
  arm group label: Buccal Buprenorphine 600mcg and oral Placebo
  intervention type: Drug
  intervention name: Buccal Buprenorphine 900 mcg
  description: buprenorphine for 900mcg buccal administration
  arm group label: Buccal Buprenorphine 900mcg and oral Placebo
  intervention type: Drug
  intervention name: Buccal Placebo
  description: Placebo for buccal administration
  arm group label: Oral immediate release oxycodone 10mg and buccal placebo
  arm group label: Oral placebo and buccal placebo
  intervention type: Drug
  intervention name: Oral Placebo
  description: Placebo for oral administration
  arm group label: Buccal Buprenorphine 300mcg and oral Placebo
  arm group label: Buccal Buprenorphine 600mcg and oral Placebo
  arm group label: Buccal Buprenorphine 900mcg and oral Placebo
  arm group label: Oral placebo and buccal placebo
  intervention type: Drug
  intervention name: Oral immediate-release oxycodone 10mg
  description: Immediate-release oxycodone for 10 mg oral administration
  arm group label: Oral immediate release oxycodone 10mg and buccal placebo
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Daniel Larach, MD, MSTR, MA
  role: Principal Investigator
  affiliation: Vanderbilt University Medical Center
  last name: Daniel Larach, MD, MSTR, MA
  phone: 615-322-6033
  email: daniel.larach@vumc.org
  last name: Gail Mayo
  phone: 6159361705
  email: gail.mayo@vumc.org
  facility: 
  contact: 
  contact backup: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Vanderbilt University Medical Center
  investigator full name: Daniel Larach
  investigator title: Asst Professor of Anesthesiology
  mesh term: Agnosia
  mesh term: Oxycodone
  mesh term: Buprenorphine
  sharing ipd: No