<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/NCT03232346</url>
  </required_header>
  <id_info>
    <org_study_id>7522</org_study_id>
    <secondary_id>1R21DA042243</secondary_id>
    <nct_id>NCT03232346</nct_id>
  </id_info>
  <brief_title>A Strategy to Improve Success of Treatment Discontinuation in Buprenorphine Responders</brief_title>
  <official_title>A Strategy to Improve Success of Treatment Discontinuation in Buprenorphine Responders</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>New York State Psychiatric Institute</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>New York State Psychiatric Institute</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>
      This study is an open--label randomized outpatient trial to evaluate feasibility and efficacy&#xD;
      of rapid buprenorphine (BUP) discontinuation followed by brief course of treatment with&#xD;
      long--acting naltrexone (XR--NTX) and to compare it to the standard method of gradual BUP&#xD;
      taper.Individuals with opioid use disorder (OUD) (N=60) who have successfully completed at&#xD;
      least 6 months of buprenorphine treatment and do not wish to remain in a long--term&#xD;
      buprenorphine maintenance program will be recruited. The first phase includes a 4--week&#xD;
      period of stabilization on buprenorphine 4--8 mg at the research clinic to assure that&#xD;
      patients are stable, compliant, and free from illicit opioids. Participants that meet the&#xD;
      above criteria will be randomized 1:1 to: 1) buprenorphine discontinuation and outpatient&#xD;
      transition to XR--NTX with 3 monthly injections, or 2) buprenorphine discontinuation using a&#xD;
      gradual 5-week long taper. In both groups participants will receive weekly relapse prevention&#xD;
      therapy and will be monitored for the duration of the trial, which is 25 weeks post&#xD;
      randomization.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Actual">June 30, 2021</completion_date>
  <primary_completion_date type="Actual">June 30, 2021</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>Percent of Patients Successfully Transitioned Off Buprenorphine</measure>
    <time_frame>Week 25</time_frame>
    <description>Percent of patients retained in treatment and abstinent from opioids at the end of the trial</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">11</enrollment>
  <condition>Opioid-use Disorder</condition>
  <arm_group>
    <arm_group_label>Regimen 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Rapid Monday to Friday oral naltrexone-induction procedure</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Regimen 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>5-week buprenorphine taper from maintenance dose of 8, 6, or 4mg</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vivitrol</intervention_name>
    <description>Oral naltrexone induction procedure followed by Vivitrol</description>
    <arm_group_label>Regimen 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Buprenorphine</intervention_name>
    <description>5-week buprenorphine taper</description>
    <arm_group_label>Regimen 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. A documented history of treatment with buprenorphine or buprenorphine/naloxone for at&#xD;
             least 6 months with sustained abstinence from illicit opioids for at least 3 months.&#xD;
             Participants must be maintained on daily dose of buprenorphine in the 4--8 mg&#xD;
             range.(MINI interview by therapist, Clinical interview by psychiatrist, consultation&#xD;
             with previous prescriber or the verification patients's self-report with the&#xD;
             prescribing records (PMP) with patient's permission).&#xD;
&#xD;
          2. Aged 18 to 60 years (Clinical interview).&#xD;
&#xD;
          3. In otherwise good health based on complete medical history, physical examination,&#xD;
             vital signs measurement, ECG, and laboratory tests (hematology, blood chemistry,&#xD;
             urinalysis) within normal ranges (Medical history and physical examination by&#xD;
             psychiatrist or NP, laboratory tests (serum Chem-20 and CBC, urinalysis), ECG).&#xD;
&#xD;
          4. Seeking buprenorphine discontinuation and willing to accept randomization to either&#xD;
             taper from buprenorphine or injection naltrexone (clinical interview).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Lifetime history of DSM-5 diagnosis of schizophrenia, schizoaffective disorder, or&#xD;
             bipolar disorder (MINI interview by therapist, Clinical interview by psychiatrist).&#xD;
&#xD;
          2. Current DSM-5 criteria for any other psychiatric disorder that in the investigator's&#xD;
             judgment is unstable, would be disrupted by the study medication, or is likely to&#xD;
             require pharmacotherapy or psychotherapy during the study period. Concurrent treatment&#xD;
             with other psychotropic medication is exclusionary. ( MINI interview by therapist,&#xD;
             Clinical interview and mental status exam by psychiatrist, contact with collateral&#xD;
             information as needed and available).&#xD;
&#xD;
          3. Individuals who meet DSM-5 criteria for any substance use disorders - severe, other&#xD;
             than opioid and nicotine use disorder. Physiological dependence on alcohol or&#xD;
             sedative-hypnotics is exclusionary. (MINI interview by therapist, Clinical interview&#xD;
             by psychiatrist).&#xD;
&#xD;
          4. A recent history of binge-use of alcohol or sedative-hypnotics (using large amounts in&#xD;
             a short time to severe intoxication or blackouts). (Clinical interview by&#xD;
             psychiatrist).&#xD;
&#xD;
          5. Pregnancy, lactation, or failure to use adequate contraceptive method in female&#xD;
             patients who are currently engaging in sexual activity with men. ( Clinical interview&#xD;
             by psychiatrist, physical examination and medical history by psychiatrist or NP, urine&#xD;
             pregnancy test, serum HCG).&#xD;
&#xD;
          6. Unstable medical conditions, such as AIDS, cancer, uncontrolled hypertension (blood&#xD;
             pressure &gt; 140/90), uncontrolled diabetes, pulmonary hypertension or heart disease.&#xD;
             (Medical history and physical examination by psychiatrist or NP, laboratory tests&#xD;
             (serum Chem-20 and CBC, urinalysis), ECG).&#xD;
&#xD;
          7. Legally mandated to participate in a substance use disorder treatment program (&#xD;
             Participant self-report, Clinical interview by psychiatrist).&#xD;
&#xD;
          8. Current or recent history of significant violent or suicidal behavior, risk for&#xD;
             suicide or homicide (MINI interview by therapist, Clinical interview by psychiatrist).&#xD;
&#xD;
          9. History of accidental opioid overdose in the last three years or any other significant&#xD;
             history of overdose following detoxification within past 10 years defined as an&#xD;
             episode of opioid-induced unconsciousness, whether or not medical treatment was sought&#xD;
             or received. ( MINI interview by therapist, Clinical interview by psychiatrist).&#xD;
&#xD;
         10. Elevated liver function tests (AST and ALT &gt; 3 times the upper limit of normal) (&#xD;
             Laboratory tests -serum Chem-20).&#xD;
&#xD;
         11. Known history of allergy, intolerance, or hypersensitivity to naltrexone or any other&#xD;
             study medications( Participant self-report, Clinical interview by psychiatrist).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>New York State Psychiatric Institute</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>July 25, 2017</study_first_submitted>
  <study_first_submitted_qc>July 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2017</study_first_posted>
  <results_first_submitted>May 25, 2022</results_first_submitted>
  <results_first_submitted_qc>May 25, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">June 21, 2022</results_first_posted>
  <last_update_submitted>November 3, 2022</last_update_submitted>
  <last_update_submitted_qc>November 3, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 7, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>New York State Psychiatric Institute</investigator_affiliation>
    <investigator_full_name>Adam Bisaga</investigator_full_name>
    <investigator_title>Research Psychiatrist</investigator_title>
  </responsible_party>
  <keyword>buprenorphine</keyword>
  <keyword>naltrexone</keyword>
  <keyword>Vivitrol</keyword>
  <keyword>opioid dependence</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>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Informed Consent Form</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>April 2, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/46/NCT03232346/Prot_ICF_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 15, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/46/NCT03232346/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Regimen 1</title>
          <description>Rapid Monday to Friday oral naltrexone-induction procedure&#xD;
Vivitrol: Oral naltrexone induction procedure followed by Vivitrol</description>
        </group>
        <group group_id="P2">
          <title>Regimen 2</title>
          <description>5-week buprenorphine taper from maintenance dose of 8, 6, or 4mg&#xD;
Buprenorphine: 5-week buprenorphine taper</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Regimen 1</title>
          <description>Rapid Monday to Friday oral naltrexone-induction procedure&#xD;
Vivitrol: Oral naltrexone induction procedure followed by Vivitrol</description>
        </group>
        <group group_id="B2">
          <title>Regimen 2</title>
          <description>5-week buprenorphine taper from maintenance dose of 8, 6, or 4mg&#xD;
Buprenorphine: 5-week buprenorphine taper</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="6"/>
            <count group_id="B2" value="5"/>
            <count group_id="B3" value="11"/>
          </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="6"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="11"/>
                  </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>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="41.7" lower_limit="29" upper_limit="52"/>
                    <measurement group_id="B2" value="49.6" lower_limit="35" upper_limit="60"/>
                    <measurement group_id="B3" value="45.3" lower_limit="29" upper_limit="60"/>
                  </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="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</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>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>
          <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="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</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>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>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percent of Patients Successfully Transitioned Off Buprenorphine</title>
        <description>Percent of patients retained in treatment and abstinent from opioids at the end of the trial</description>
        <time_frame>Week 25</time_frame>
        <population>Participants who were randomized to one of the two study regimens</population>
        <group_list>
          <group group_id="O1">
            <title>Regimen 1</title>
            <description>Rapid Monday to Friday oral naltrexone-induction procedure&#xD;
Vivitrol: Oral naltrexone induction procedure followed by Vivitrol</description>
          </group>
          <group group_id="O2">
            <title>Regimen 2</title>
            <description>5-week buprenorphine taper from maintenance dose of 8, 6, or 4mg&#xD;
Buprenorphine: 5-week buprenorphine taper</description>
          </group>
        </group_list>
        <measure>
          <title>Percent of Patients Successfully Transitioned Off Buprenorphine</title>
          <description>Percent of patients retained in treatment and abstinent from opioids at the end of the trial</description>
          <population>Participants who were randomized to one of the two study regimens</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>7 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Regimen 1</title>
          <description>Rapid Monday to Friday oral naltrexone-induction procedure&#xD;
Vivitrol: Oral naltrexone induction procedure followed by Vivitrol</description>
        </group>
        <group group_id="E2">
          <title>Regimen 2</title>
          <description>5-week buprenorphine taper from maintenance dose of 8, 6, or 4mg&#xD;
Buprenorphine: 5-week buprenorphine taper</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>hospitalization for pneumonia</sub_title>
                <description>Participant had difficulty breathing, chest congestion, runny nose, and decreased energy. The participant was admitted to the hospital, and he was diagnosed with pneumonia. Participant was treated with IV antibiotics and fully recovered.</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</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="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
              </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. Adam Bisaga</name_or_title>
      <organization>NYS Psychiatric Institute</organization>
      <phone>646-774-6155</phone>
      <email>adam.bisaga@nyspi.columbia.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/NCT03232346
org study id: 7522
secondary id: 1R21DA042243
nct id: NCT03232346
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
This study is an open--label randomized outpatient trial to evaluate feasibility and efficacy
      of rapid buprenorphine (BUP) discontinuation followed by brief course of treatment with
      long--acting naltrexone (XR--NTX) and to compare it to the standard method of gradual BUP
      taper.Individuals with opioid use disorder (OUD) (N=60) who have successfully completed at
      least 6 months of buprenorphine treatment and do not wish to remain in a long--term
      buprenorphine maintenance program will be recruited. The first phase includes a 4--week
      period of stabilization on buprenorphine 4--8 mg at the research clinic to assure that
      patients are stable, compliant, and free from illicit opioids. Participants that meet the
      above criteria will be randomized 1:1 to: 1) buprenorphine discontinuation and outpatient
      transition to XR--NTX with 3 monthly injections, or 2) buprenorphine discontinuation using a
      gradual 5-week long taper. In both groups participants will receive weekly relapse prevention
      therapy and will be monitored for the duration of the trial, which is 25 weeks post
      randomization.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percent of Patients Successfully Transitioned Off Buprenorphine
time frame: Week 25
description: Percent of patients retained in treatment and abstinent from opioids at the end of the trial
arm group label: Regimen 1
arm group type: Experimental
description: Rapid Monday to Friday oral naltrexone-induction procedure
arm group label: Regimen 2
arm group type: Experimental
description: 5-week buprenorphine taper from maintenance dose of 8, 6, or 4mg
intervention type: Drug
intervention name: Vivitrol
description: Oral naltrexone induction procedure followed by Vivitrol
arm group label: Regimen 1
intervention type: Drug
intervention name: Buprenorphine
description: 5-week buprenorphine taper
arm group label: Regimen 2
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: New York State Psychiatric Institute
investigator full name: Adam Bisaga
investigator title: Research Psychiatrist
mesh term: Opioid-Related Disorders
mesh term: Buprenorphine
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 