<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/NCT01723384</url>
  </required_header>
  <id_info>
    <org_study_id>12-09809</org_study_id>
    <secondary_id>R36DA035109-01</secondary_id>
    <nct_id>NCT01723384</nct_id>
  </id_info>
  <brief_title>Intermittent Naltrexone Among Polysubstance Users</brief_title>
  <acronym>Project iN</acronym>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Francisco</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>University of California, San Francisco</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Naltrexone, a µ-opioid receptor antagonist, is a promising agent for methamphetamine-using&#xD;
      and binge-drinking men who have sex with men (MSM). Naltrexone has shown efficacy in reducing&#xD;
      relapse to amphetamines and is FDA-approved for alcohol dependence. Oral naltrexone is&#xD;
      inexpensive and has few toxicities but the standard daily regimen for naltrexone is&#xD;
      problematic as patients forget to take the medication. Given the challenges in daily dosing,&#xD;
      alternate regimen schedules have been proposed to increase efficacy and expand the population&#xD;
      that may benefit from this pharmacologic agent. One approach is intermittent targeted&#xD;
      administration of naltrexone, whereby individuals take the medication as-needed in&#xD;
      anticipation of substance use or during periods of craving. Administration of naltrexone&#xD;
      prior to exposure to amphetamines significantly attenuates craving and targeted naltrexone&#xD;
      has shown efficacy in reducing heavy alcohol use. However, there have been no studies&#xD;
      assessing intermittent targeted dosing of naltrexone among methamphetamine-using and&#xD;
      binge-drinking MSM. Polysubstance use patterns are common among MSM, and studies among those&#xD;
      who abuse more than one substance are urgently needed. The aims of this study are to&#xD;
      determine whether targeted dosing of naltrexone is feasible, tolerable and acceptable among&#xD;
      non-dependent methamphetamine-using and binge-drinking MSM.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2013</start_date>
  <completion_date type="Actual">November 2014</completion_date>
  <primary_completion_date type="Actual">October 2014</primary_completion_date>
  <phase>Phase 2</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>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility of Retaining Participants in Trial</measure>
    <time_frame>proportions eligible and enrolled assessed on ongoing basis throughout the study, proportion of visits completed assessed bi-weekly for each participant; overall retention assessed over 2 month follow-up for each participant</time_frame>
    <description>Proportion of persons retained by study arm.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Acceptability to Taking Medication</measure>
    <time_frame>2 month follow-up</time_frame>
    <description>Mean number of pills taken weekly, as determined by recorded openings from an electronic monitoring device for study medication pill dispensers</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tolerability to Study Drug, as Measured by Adverse Events</measure>
    <time_frame>2 months</time_frame>
    <description>Frequency of Adverse Events, by arm</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Methamphetamine</condition>
  <condition>Alcohol</condition>
  <arm_group>
    <arm_group_label>Naltrexone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intermittent oral naltrexone to be taken on an as-needed basis for 8 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Intermittent oral placebo to be taken on an as-needed basis for 8 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Intermittent Oral Naltrexone</intervention_name>
    <arm_group_label>Naltrexone</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. male gender or transgender male-to-female&#xD;
&#xD;
          2. self-reported anal sex with men in the prior six months while under the influence of&#xD;
             meth and/or alcohol&#xD;
&#xD;
          3. self-reported meth use at least bi-weekly in the prior three months&#xD;
&#xD;
          4. at least weekly binge drinking (five or more drinks on a single drinking session) in&#xD;
             the prior three months&#xD;
&#xD;
        4) interested in reducing meth use and/or binge drinking 5) HIV-negative by rapid test or&#xD;
        medical record of HIV infection 6) no current acute illnesses requiring prolonged medical&#xD;
        care 7) no chronic illnesses that are likely to progress clinically during trial&#xD;
        participation 8) able and willing to provide informed consent and adhere to visit schedule&#xD;
        9) age 18-70 years 10) baseline complete blood count (CBC), total protein, albumin,&#xD;
        glucose, alkaline phosphatase, creatinine, blood urea nitrogen (BUN), and electrolytes&#xD;
        without clinically significant abnormalities as determined by study clinician in&#xD;
        conjunction with symptoms, physical exam, and medical history&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. any psychiatric (e.g., depression with suicidal ideation) or medical condition that&#xD;
             would preclude safe participation in the protocol&#xD;
&#xD;
          2. known allergy or previous adverse reaction to naltrexone&#xD;
&#xD;
          3. current use of or dependence on any opioids or a known medical condition which&#xD;
             currently requires or may likely require opioid analgesics&#xD;
&#xD;
          4. opioid-positive urine test at enrollment&#xD;
&#xD;
          5. current cluster of differentiation 4 (CD4) count &lt; 200 cells/mm3&#xD;
&#xD;
          6. moderate or severe liver disease (aspartate aminotransferase, alanine&#xD;
             aminotransferase, or total bilirubin &gt; 3 times upper limit of normal)&#xD;
&#xD;
          7. impaired renal function (creatinine clearance &lt; 60 ml/min)&#xD;
&#xD;
          8. currently participating in another research study&#xD;
&#xD;
          9. meth or alcohol dependence as determined by Structured Clinical Interview for&#xD;
             Diagnostic and Statistical Manual of Mental Disorders (SCID) criteria&#xD;
&#xD;
         10. any condition that, in the principal investigator and/or study clinician's judgment&#xD;
             interferes with safe participation or adherence to study procedures.&#xD;
&#xD;
         11. unwillingness to provide minimum locator for information&#xD;
&#xD;
         12. not having a cellular phone that can send or receive a text message&#xD;
&#xD;
         13. plans to leave the Bay Area during study follow-up&#xD;
&#xD;
         14. not comfortable speaking and reading English, enough to participate in a program in&#xD;
             English&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Glenn-Milo Santos, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, San Francisco</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jason Euren, MA</last_name>
    <role>Study Director</role>
    <affiliation>San Francisco Department of Public Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>San Francisco Department of Public Health, Substance Use Research Unit</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>November 2, 2012</study_first_submitted>
  <study_first_submitted_qc>November 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 7, 2012</study_first_posted>
  <results_first_submitted>December 7, 2018</results_first_submitted>
  <results_first_submitted_qc>January 25, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">February 12, 2019</results_first_posted>
  <last_update_submitted>April 15, 2019</last_update_submitted>
  <last_update_submitted_qc>April 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 23, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, San Francisco</investigator_affiliation>
    <investigator_full_name>Glenn-Milo Santos</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>methamphetamine</keyword>
  <keyword>alcohol</keyword>
  <keyword>HIV</keyword>
  <keyword>sexual behavior</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Naltrexone</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Naltrexone</title>
          <description>Intermittent oral naltrexone to be taken on an as-needed basis for 8 weeks.&#xD;
Intermittent Oral Naltrexone</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Intermittent oral placebo to be taken on an as-needed basis for 8 weeks&#xD;
Placebo</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Naltrexone</title>
          <description>Intermittent oral naltrexone to be taken on an as-needed basis for 8 weeks.&#xD;
Intermittent Oral Naltrexone</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Intermittent oral placebo to be taken on an as-needed basis for 8 weeks&#xD;
Placebo</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="15"/>
            <count group_id="B2" value="15"/>
            <count group_id="B3" value="30"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="30"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="43.7" spread="10"/>
                    <measurement group_id="B2" value="42.3" spread="10"/>
                    <measurement group_id="B3" value="43" spread="9.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="30"/>
                  </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>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Feasibility of Retaining Participants in Trial</title>
        <description>Proportion of persons retained by study arm.</description>
        <time_frame>proportions eligible and enrolled assessed on ongoing basis throughout the study, proportion of visits completed assessed bi-weekly for each participant; overall retention assessed over 2 month follow-up for each participant</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Naltrexone</title>
            <description>Naltrexone</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Feasibility of Retaining Participants in Trial</title>
          <description>Proportion of persons retained by study arm.</description>
          <units>percentage that completed study</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="86.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Acceptability to Taking Medication</title>
        <description>Mean number of pills taken weekly, as determined by recorded openings from an electronic monitoring device for study medication pill dispensers</description>
        <time_frame>2 month follow-up</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Naltrexone</title>
            <description>Naltrexone</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Acceptability to Taking Medication</title>
          <description>Mean number of pills taken weekly, as determined by recorded openings from an electronic monitoring device for study medication pill dispensers</description>
          <units>number of wisepill openings by week</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.2" spread="1"/>
                    <measurement group_id="O2" value="1.9" spread="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Tolerability to Study Drug, as Measured by Adverse Events</title>
        <description>Frequency of Adverse Events, by arm</description>
        <time_frame>2 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Naltrexone</title>
            <description>Naltrexone</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Tolerability to Study Drug, as Measured by Adverse Events</title>
          <description>Frequency of Adverse Events, by arm</description>
          <units>Count</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Nausea</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Headaches</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Upper respiratory tract infection</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Naltrexone</title>
          <description>Naltrexone</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Placebo</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="15"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Headaches</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Glenn-Milo Santos</name_or_title>
      <organization>San Francisco Department of Public Healt</organization>
      <phone>415-437-6231</phone>
      <email>glenn-milo.santos@ucsf.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/NCT01723384
org study id: 12-09809
secondary id: R36DA035109-01
nct id: NCT01723384
lead sponsor: 
collaborator: 
has dmc: Yes
Naltrexone, a µ-opioid receptor antagonist, is a promising agent for methamphetamine-using
      and binge-drinking men who have sex with men (MSM). Naltrexone has shown efficacy in reducing
      relapse to amphetamines and is FDA-approved for alcohol dependence. Oral naltrexone is
      inexpensive and has few toxicities but the standard daily regimen for naltrexone is
      problematic as patients forget to take the medication. Given the challenges in daily dosing,
      alternate regimen schedules have been proposed to increase efficacy and expand the population
      that may benefit from this pharmacologic agent. One approach is intermittent targeted
      administration of naltrexone, whereby individuals take the medication as-needed in
      anticipation of substance use or during periods of craving. Administration of naltrexone
      prior to exposure to amphetamines significantly attenuates craving and targeted naltrexone
      has shown efficacy in reducing heavy alcohol use. However, there have been no studies
      assessing intermittent targeted dosing of naltrexone among methamphetamine-using and
      binge-drinking MSM. Polysubstance use patterns are common among MSM, and studies among those
      who abuse more than one substance are urgently needed. The aims of this study are to
      determine whether targeted dosing of naltrexone is feasible, tolerable and acceptable among
      non-dependent methamphetamine-using and binge-drinking MSM.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Feasibility of Retaining Participants in Trial
time frame: proportions eligible and enrolled assessed on ongoing basis throughout the study, proportion of visits completed assessed bi-weekly for each participant; overall retention assessed over 2 month follow-up for each participant
description: Proportion of persons retained by study arm.
measure: Acceptability to Taking Medication
time frame: 2 month follow-up
description: Mean number of pills taken weekly, as determined by recorded openings from an electronic monitoring device for study medication pill dispensers
measure: Tolerability to Study Drug, as Measured by Adverse Events
time frame: 2 months
description: Frequency of Adverse Events, by arm
arm group label: Naltrexone
arm group type: Active Comparator
description: Intermittent oral naltrexone to be taken on an as-needed basis for 8 weeks.
arm group label: Placebo
arm group type: Placebo Comparator
description: Intermittent oral placebo to be taken on an as-needed basis for 8 weeks
intervention type: Drug
intervention name: Intermittent Oral Naltrexone
arm group label: Naltrexone
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Glenn-Milo Santos, PhD
role: Principal Investigator
affiliation: University of California, San Francisco
last name: Jason Euren, MA
role: Study Director
affiliation: San Francisco Department of Public Health
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of California, San Francisco
investigator full name: Glenn-Milo Santos
investigator title: Assistant Professor
mesh term: Naltrexone
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 