<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/NCT02187198</url>
  </required_header>
  <id_info>
    <org_study_id>IP0040</org_study_id>
    <nct_id>NCT02187198</nct_id>
  </id_info>
  <brief_title>Buprenorphine Treatment for Opioid Dependence</brief_title>
  <official_title>Buprenorphine Treatment for Prescription Opioid Dependence</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>United States Department of Defense</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>Yale University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Buprenorphine/naloxone (BUP/NLX) treatment is effective for the treatment of prescription&#xD;
      opioid dependence, previous studies have not determined the optimum dose of BUP/NLX for this&#xD;
      patient population. The goal of this study is to determine if there are differences in&#xD;
      clinical efficacy of BUP/NLX tablet in low dose range (less than or equal to 8/2mg) vs. high&#xD;
      dose range (greater than or equal to 16, range 16-24mg). The main outcomes of interest will&#xD;
      be treatment retention, use of opioids, and the use of other drugs of abuse.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized, open-label clinical trial with approximately 9 Veteran opioid dependent&#xD;
      men and women. Veterans were randomized to one of two treatment groups: low dose range of&#xD;
      buprenorphine (&lt;8mg) vs. high dose range of buprenorphine/naloxone (BUP/NLX (&lt;16mg). During&#xD;
      induction into buprenorphine, all participants will be started at a dose of 2mg, and this&#xD;
      dose will be increased as needed for stabilization of opioid withdrawal symptoms, up to 8mg&#xD;
      for the low dose group, and up to 16mg for the high dose group, within a 5 day period.&#xD;
      Participants will be seen on a daily basis (excluding weekends) for the initial 5 day&#xD;
      induction. At the end of the 12-week study, participants will either be referred to a&#xD;
      buprenorphine clinic if they wish to continue this medication, or if they wish to be drug&#xD;
      free, will undergo detoxification from buprenorphine for up to a 4-week period. Follow-up&#xD;
      visits, scheduled at 1, 3, and 6 months after study completion.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2015</start_date>
  <completion_date type="Actual">January 1, 2023</completion_date>
  <primary_completion_date type="Actual">February 1, 2022</primary_completion_date>
  <phase>Phase 3</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>Urine Toxicology for Opiate Use</measure>
    <time_frame>Weeks 1-12</time_frame>
    <description>Will be used to document opioid use, a urine toxicology screening will be completed weekly during study participation (12 week study)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Urine Toxicology</measure>
    <time_frame>Weeks 1-12</time_frame>
    <description>Will be used to document cannabinoid use, a urine toxicology screening will be completed weekly during study participation (12 week study)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">9</enrollment>
  <condition>Opioid Dependence</condition>
  <arm_group>
    <arm_group_label>Buprenorphine low dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this arm will receive a low dose (less than or equal to 8/2mg) of buprenorphine for 12 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Buprenorphine high dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this arm will receive a high dose (16-24mg) of buprenorphine for 12 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Buprenorphine</intervention_name>
    <arm_group_label>Buprenorphine high dose</arm_group_label>
    <arm_group_label>Buprenorphine low dose</arm_group_label>
    <other_name>Naloxone</other_name>
    <other_name>Suboxone</other_name>
    <other_name>Buprenex</other_name>
    <other_name>Subutex</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Males and females between the ages of 18 to 65, current dependence on prescription&#xD;
             opioids as evidenced by documented prior treatment for opioid dependence, signs of&#xD;
             opiate withdrawal as evidenced by a Clinical Opiate Withdrawal Scale score of 7 or&#xD;
             greater, self-reported history of opioid dependence, and a positive urine toxicology&#xD;
             for opiates;&#xD;
&#xD;
          2. willingness to be detoxified from opioids for buprenorphine maintenance ;&#xD;
&#xD;
          3. for women of childbearing age, a negative pregnancy test at screening with agreement&#xD;
             to use adequate contraception to prevent pregnancy, with monthly pregnancy tests&#xD;
             obtained during study participation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. use of heroin for more than 4 days in the past month;&#xD;
&#xD;
          2. lifetime history of opioid dependence due to heroin alone;&#xD;
&#xD;
          3. ever used heroin intravenously;&#xD;
&#xD;
          4. requirement for current ongoing opioid treatment for adequate pain management;&#xD;
&#xD;
          5. current alcohol, benzodiazepine, barbiturate use with physiologic dependence as&#xD;
             determined during screening history and physical,&#xD;
&#xD;
          6. serious unstable medical illness including bradycardia or other arrhythmias, major&#xD;
             cardiovascular, renal, endocrine, or hepatic disorders for which buprenorphine&#xD;
             treatment is contraindicated or which at the determination of the MD is medically&#xD;
             dangerous;&#xD;
&#xD;
          7. serious psychiatric illness including psychosis, bipolar disorder with psychosis:&#xD;
&#xD;
          8. or significant current suicidal or homicidal thoughts necessitating a higher level or&#xD;
             care;&#xD;
&#xD;
          9. known allergy or intolerance to buprenorphine.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Elizabeth Ralevski, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yale University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>VA Connecticut Healthcare System - West Haven Campus</name>
      <address>
        <city>West Haven</city>
        <state>Connecticut</state>
        <zip>06516</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>July 8, 2014</study_first_submitted>
  <study_first_submitted_qc>July 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 10, 2014</study_first_posted>
  <results_first_submitted>January 27, 2023</results_first_submitted>
  <results_first_submitted_qc>March 8, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">March 10, 2023</results_first_posted>
  <last_update_submitted>March 8, 2023</last_update_submitted>
  <last_update_submitted_qc>March 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 10, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Opioid Dependence</keyword>
  <keyword>Buprenorphine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Opioid-Related Disorders</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Buprenorphine</mesh_term>
    <mesh_term>Naloxone</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 23, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/98/NCT02187198/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Buprenorphine Low Dose</title>
          <description>Participants in this arm will receive a low dose (less than or equal to 8/2mg) of buprenorphine for 12 weeks.&#xD;
Buprenorphine</description>
        </group>
        <group group_id="P2">
          <title>Buprenorphine High Dose</title>
          <description>Participants in this arm will receive a high dose (16-24mg) of buprenorphine for 12 weeks.&#xD;
Buprenorphine</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>did not show up for appointment and did not return calls after week 9</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>did not show up for appointment and did not return calls after week 11</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Buprenorphine Low Dose</title>
          <description>Participants in this arm will receive a low dose (less than or equal to 8/2mg) of buprenorphine for 12 weeks.&#xD;
Buprenorphine</description>
        </group>
        <group group_id="B2">
          <title>Buprenorphine High Dose</title>
          <description>Participants in this arm will receive a high dose (16-24mg) of buprenorphine for 12 weeks.&#xD;
Buprenorphine</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="5"/>
            <count group_id="B2" value="4"/>
            <count group_id="B3" value="9"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <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="38.60" spread="13.07"/>
                    <measurement group_id="B2" value="43.25" spread="16.72"/>
                    <measurement group_id="B3" value="40.67" spread="14.01"/>
                  </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="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</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>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Urine Toxicology for Opiate Use</title>
        <description>Will be used to document opioid use, a urine toxicology screening will be completed weekly during study participation (12 week study)</description>
        <time_frame>Weeks 1-12</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Buprenorphine Low Dose</title>
            <description>Participants in this arm will receive a low dose (less than or equal to 8/2mg) of buprenorphine for 12 weeks.&#xD;
Buprenorphine</description>
          </group>
          <group group_id="O2">
            <title>Buprenorphine High Dose</title>
            <description>Participants in this arm will receive a high dose (16-24mg) of buprenorphine for 12 weeks.&#xD;
Buprenorphine</description>
          </group>
        </group_list>
        <measure>
          <title>Urine Toxicology for Opiate Use</title>
          <description>Will be used to document opioid use, a urine toxicology screening will be completed weekly during study participation (12 week study)</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="5"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Negative urine toxicology for opiates</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>
              <title>One positive urine toxicology for opiates during 12 week study</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Two positive urine toxicology for opiates during 12 week study</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Urine Toxicology</title>
        <description>Will be used to document cannabinoid use, a urine toxicology screening will be completed weekly during study participation (12 week study)</description>
        <time_frame>Weeks 1-12</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Buprenorphine Low Dose</title>
            <description>Participants in this arm will receive a low dose (less than or equal to 8/2mg) of buprenorphine for 12 weeks.&#xD;
Buprenorphine</description>
          </group>
          <group group_id="O2">
            <title>Buprenorphine High Dose</title>
            <description>Participants in this arm will receive a high dose (16-24mg) of buprenorphine for 12 weeks.&#xD;
Buprenorphine</description>
          </group>
        </group_list>
        <measure>
          <title>Urine Toxicology</title>
          <description>Will be used to document cannabinoid use, a urine toxicology screening will be completed weekly during study participation (12 week study)</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="5"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Negative urine toxicology for cannabinoids</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Less than 6 positive urine toxicology for cannabinoids during 12 week study</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>More than 6 positive urine toxicology for cannabinoids during 12 week study</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>12 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Buprenorphine Low Dose</title>
          <description>Participants in this arm will receive a low dose (less than or equal to 8/2mg) of buprenorphine for 12 weeks.&#xD;
Buprenorphine</description>
        </group>
        <group group_id="E2">
          <title>Buprenorphine High Dose</title>
          <description>Participants in this arm will receive a high dose (16-24mg) of buprenorphine for 12 weeks.&#xD;
Buprenorphine</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
              </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="5"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
              </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>Elizabeth Ralevski, PhD</name_or_title>
      <organization>Yale University School of Medicine, Department of Psychiatry</organization>
      <phone>203-932-5711 ext 4282</phone>
      <email>elizabeth.ralevski@yale.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/NCT02187198
org study id: IP0040
nct id: NCT02187198
lead sponsor: 
collaborator: 
has dmc: Yes
Buprenorphine/naloxone (BUP/NLX) treatment is effective for the treatment of prescription
      opioid dependence, previous studies have not determined the optimum dose of BUP/NLX for this
      patient population. The goal of this study is to determine if there are differences in
      clinical efficacy of BUP/NLX tablet in low dose range (less than or equal to 8/2mg) vs. high
      dose range (greater than or equal to 16, range 16-24mg). The main outcomes of interest will
      be treatment retention, use of opioids, and the use of other drugs of abuse.
This is a randomized, open-label clinical trial with approximately 9 Veteran opioid dependent
      men and women. Veterans were randomized to one of two treatment groups: low dose range of
      buprenorphine (<8mg) vs. high dose range of buprenorphine/naloxone (BUP/NLX (<16mg). During
      induction into buprenorphine, all participants will be started at a dose of 2mg, and this
      dose will be increased as needed for stabilization of opioid withdrawal symptoms, up to 8mg
      for the low dose group, and up to 16mg for the high dose group, within a 5 day period.
      Participants will be seen on a daily basis (excluding weekends) for the initial 5 day
      induction. At the end of the 12-week study, participants will either be referred to a
      buprenorphine clinic if they wish to continue this medication, or if they wish to be drug
      free, will undergo detoxification from buprenorphine for up to a 4-week period. Follow-up
      visits, scheduled at 1, 3, and 6 months after study completion.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Urine Toxicology for Opiate Use
time frame: Weeks 1-12
description: Will be used to document opioid use, a urine toxicology screening will be completed weekly during study participation (12 week study)
measure: Urine Toxicology
time frame: Weeks 1-12
description: Will be used to document cannabinoid use, a urine toxicology screening will be completed weekly during study participation (12 week study)
arm group label: Buprenorphine low dose
arm group type: Experimental
description: Participants in this arm will receive a low dose (less than or equal to 8/2mg) of buprenorphine for 12 weeks.
arm group label: Buprenorphine high dose
arm group type: Experimental
description: Participants in this arm will receive a high dose (16-24mg) of buprenorphine for 12 weeks.
intervention type: Drug
intervention name: Buprenorphine
arm group label: Buprenorphine high dose
arm group label: Buprenorphine low dose
other name: Naloxone
other name: Suboxone
other name: Buprenex
other name: Subutex
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Elizabeth Ralevski, Ph.D.
role: Principal Investigator
affiliation: Yale University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Opioid-Related Disorders
mesh term: Buprenorphine
mesh term: Naloxone
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 