<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/NCT02218021</url>
  </required_header>
  <id_info>
    <org_study_id>ALK33-012</org_study_id>
    <nct_id>NCT02218021</nct_id>
  </id_info>
  <brief_title>A Study of the Abuse Liability Potential of Samidorphan in Healthy, Non-Dependent, Recreational Opioid Users</brief_title>
  <official_title>A Randomized, Double-Blind, Placebo- and Positive-Controlled, Crossover Study to Evaluate the Abuse Potential and Safety of Orally Administered Samidorphan in Non-Dependent Recreational Opioid Users</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Alkermes, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Alkermes, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the abuse potential and safety of samidorphan in&#xD;
      healthy, non-dependent, adult, recreational opioid users.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">November 2014</completion_date>
  <primary_completion_date type="Actual">November 2014</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pharmacodynamics: Abuse potential measured by visual analog scales (VAS)</measure>
    <time_frame>Approximately 4 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety: Incidence of adverse events (AEs)</measure>
    <time_frame>Approximately 5.5 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics: Plasma concentrations of samidorphan and metabolite</measure>
    <time_frame>Approximately 4 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">59</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>Samidorphan Dose 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Samidorphan Dose 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Samidorphan Dose 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Oxycodone Dose 1</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Oxycodone Dose 2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Samidorphan</intervention_name>
    <arm_group_label>Samidorphan Dose 1</arm_group_label>
    <arm_group_label>Samidorphan Dose 2</arm_group_label>
    <arm_group_label>Samidorphan Dose 3</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxycodone</intervention_name>
    <arm_group_label>Oxycodone Dose 1</arm_group_label>
    <arm_group_label>Oxycodone Dose 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Be in good general physical health&#xD;
&#xD;
          -  Body mass index of 18-34 kg/m2, inclusive with minimum weight of 50 kg&#xD;
&#xD;
          -  Recreational opioid use experience for non-therapeutic purposes (at &gt;/= 10 times in&#xD;
             lifetime and &gt;/= 1 in previous 3 months&#xD;
&#xD;
          -  Agree to use an approved method of birth control for the duration of the study&#xD;
&#xD;
          -  Additional criteria may apply&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Currently pregnant or breastfeeding&#xD;
&#xD;
          -  History of or current infection with hepatitis B virus, hepatitis C virus or HIV&#xD;
&#xD;
          -  Current or history of any clinically significant medical or psychiatric condition&#xD;
&#xD;
          -  Current or history of in the last 2 years of dependence on alcohol or any illicit&#xD;
             drugs&#xD;
&#xD;
          -  Have used any prescription or over-the-counter medication, including natural health&#xD;
             products (with the exception of prescription birth control or hormonal replacements,&#xD;
             acetaminophen, ibuprofen, or multivitamins) within 14 days&#xD;
&#xD;
          -  Have a history of intolerance or hypersensitivity to opioid antagonists, opioid&#xD;
             agonists or related drugs (eg, naltrexone, naloxone, oxycodone, morphine)&#xD;
&#xD;
          -  Additional criteria may apply&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sanjeev Pathak, MD</last_name>
    <role>Study Director</role>
    <affiliation>Alkermes, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Alkermes Investigational Site</name>
      <address>
        <city>Overland Park</city>
        <state>Kansas</state>
        <zip>66212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2014</verification_date>
  <study_first_submitted>August 14, 2014</study_first_submitted>
  <study_first_submitted_qc>August 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2014</study_first_posted>
  <last_update_submitted>December 1, 2014</last_update_submitted>
  <last_update_submitted_qc>December 1, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 2, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Alkermes</keyword>
  <keyword>ALKS 33</keyword>
  <keyword>ALKS 5461</keyword>
  <keyword>Samidorphan</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Oxycodone</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT02218021
org study id: ALK33-012
nct id: NCT02218021
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate the abuse potential and safety of samidorphan in
      healthy, non-dependent, adult, recreational opioid users.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Pharmacodynamics: Abuse potential measured by visual analog scales (VAS)
time frame: Approximately 4 weeks
measure: Safety: Incidence of adverse events (AEs)
time frame: Approximately 5.5 weeks
measure: Pharmacokinetics: Plasma concentrations of samidorphan and metabolite
time frame: Approximately 4 weeks
arm group label: Samidorphan Dose 1
arm group type: Experimental
arm group label: Samidorphan Dose 2
arm group type: Experimental
arm group label: Samidorphan Dose 3
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
arm group label: Oxycodone Dose 1
arm group type: Active Comparator
arm group label: Oxycodone Dose 2
arm group type: Active Comparator
intervention type: Drug
intervention name: Samidorphan
arm group label: Samidorphan Dose 1
arm group label: Samidorphan Dose 2
arm group label: Samidorphan Dose 3
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
intervention type: Drug
intervention name: Oxycodone
arm group label: Oxycodone Dose 1
arm group label: Oxycodone Dose 2
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sanjeev Pathak, MD
role: Study Director
affiliation: Alkermes, Inc.
facility: 
country: United States
responsible party type: Sponsor
mesh term: Oxycodone