xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06023459</url>
    </required_header>
    <id_info>
      <org_study_id>CTN-0102-XR</org_study_id>
      <secondary_id>UG1DA049435</secondary_id>
      <nct_id>NCT06023459</nct_id>
    </id_info>
    <brief_title>Extended-release Buprenorphine Compared to Sublingual Buprenorphine in Rural Settings (RXR)</brief_title>
    <acronym>RXR</acronym>
    <official_title>Randomized Controlled Pilot Trial of Extended-released Buprenorphine vs. Sublingual Buprenorphine-naloxone in Rural Settings</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Yih-Ing Hser</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Institute on Drug Abuse (NIDA)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
      <collaborator>
        <agency>National Institutes of Health (NIH)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
      <collaborator>
        <agency>The Emmes Company, LLC</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of California, Los Angeles</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>RAND</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Cornell University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Oregon Health and Science University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of Illinois at Chicago</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of Washington</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>West Virginia University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of California, Los Angeles</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 pilot trial will explore the feasibility, acceptability, and effectiveness of the most&#xD;
        recently approved formulation of injectable extended-release buprenorphine (XR-BUP) for&#xD;
        treatment of opioid use disorder (OUD) in rural settings. We will randomize 144 eligible&#xD;
        individuals with moderate to severe OUD in a 2:1 ratio to one of two medication conditions:&#xD;
        (1) XR-BUP (128mg target), administered every 4 weeks or (2) SL-BUP (16mg-24 mg/day&#xD;
        target).Participants will receive study medication treatment for the 14 week-intervention&#xD;
        period, including an initial ~2-week period of induction/stabilization. The study will use a&#xD;
        mixed-methods approach (participant assessments, study medication records, qualitative&#xD;
        interviews) for assessing feasibility and acceptability, and results will include patient&#xD;
        outcome data on the comparative effectiveness of XR-BUP versus SL-BUP for patients with OUD&#xD;
        in rural settings.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This 24-month randomized controlled open-label pilot study will be conducted in approximately&#xD;
        6 clinics in rural settings. The study objectives are to describe the feasibility of&#xD;
        implementing the study in rural settings, document the acceptability of the XR-BUP condition,&#xD;
        and assess the comparative effectiveness of XR-BUP compared with SL-BUP. Participants will be&#xD;
        randomized within each clinic to XR-BUP or SL-BUP in a ratio of 2:1 (overall approximately 96&#xD;
        in the XR-BUP condition, 48 in the SL-BUP condition). They will receive study medication for&#xD;
        approximately 14 weeks following randomization, including an initial ~2-week period of&#xD;
        induction/stabilization. The XR-BUP condition will use Brixadi®/CAM2038 injectable,&#xD;
        extended-release buprenorphine. The measure for the main comparative effectiveness outcome is&#xD;
        number of urine drug screen (UDS) results negative for opioids at scheduled assessments&#xD;
        during Week 2 through Week 14 of the trial. Missing or positive UDS for any non-prescribed&#xD;
        opioid is considered UDS positive.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">January 1, 2024</start_date>
    <completion_date type="Anticipated">December 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">November 30, 2024</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>
      <intervention_model_description>A 24-month randomized controlled open-label pilot study will be conducted in approximately 6 clinics in rural settings. Participants will be randomized within each clinic to XR-BUP or SL-BUP in a ratio of 2:1 (overall approximately 96 in the XR-BUP condition, 48 in the SL-BUP condition). They will receive study medication for approximately 14 weeks following randomization, including an initial ~2-week period of induction/stabilization.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Comparative effectiveness</measure>
      <time_frame>Week 2 through Week 14 of the trial</time_frame>
      <description>Number or percentage of urine drug screen (UDS) results negative for opioids</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Feasibility of study implementation</measure>
      <time_frame>through study completion, an average of 1 year</time_frame>
      <description>Overall recruitment, study completion, study dropout during the 14-week intervention period, and qualitative feedback from clinic personnel and patients.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Acceptability of XR-BUP</measure>
      <time_frame>through study completion, an average of 1 year</time_frame>
      <description>Initial patient medication preference prior to randomization, percentage of participants randomized to the XR-BUP condition who receive the first monthly injection, percentage of XR-BUP participants who receive at least the first two monthly injections, and qualitative feedback from clinic personnel and patients.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">144</enrollment>
    <condition>Opioid-Related Disorders</condition>
    <condition>Substance-Related Disorders</condition>
    <condition>Narcotic-Related Disorders</condition>
    <arm_group>
      <arm_group_label>Injectable extended-release buprenorphine (XR-BUP)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will be randomly assigned to XR-BUP, with approximately 96 in the XR-BUP condition. The XR-BUP condition will use Brixadi/CAM2038 injectable, extended-release buprenorphine (Braeburn Pharmaceuticals, Inc.). After titrating to a stable dosage in approximately two weeks using weekly injection dosages as clinically indicated to relieve cravings and withdrawal symptoms, the target monthly dosage (128mg) of XR-BUP will be administered by injection at approximately Day 14 and approximately four weeks later in Week 6, with a third injection in Week 10. Dosage adjustments will be made as indicated for tolerability.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Sublingual buprenorphine-naloxone (SL-BUP)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Participants will be randomly assigned to SL-BUP with approximately 48 in the SL-BUP condition. The SL-BUP condition will use sublingual buprenorphine-naloxone, with a target maintenance daily dose range of 16-24mg as recommended for clinical practice. Titration to maintenance dosage will be attempted within the first two weeks of the SL-BUP condition. During the initial stabilization weeks, SL-BUP will be flexibly dosed as clinically indicated to relieve cravings and withdrawal symptoms, after which dosage adjustments will be based on clinical decisions by the site clinicians. The maintenance dosage of SL-BUP will be dispensed on a schedule similar to the XR-BUP injections (i.e., at approximately Day 14, Week 6, and Week 10).</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Injectable extended-release buprenorphine</intervention_name>
      <description>Participants randomized to the XR-BUP condition will receive XR-BUP study medication for approximately 14 weeks following randomization, including an initial ~2-week period of induction/stabilization.</description>
      <arm_group_label>Injectable extended-release buprenorphine (XR-BUP)</arm_group_label>
      <other_name>XR-BUP (Brixadi)</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Sublingual buprenorphine-naloxone</intervention_name>
      <description>Participants randomized to the SL-BUP condition will receive SL-BUP study medication for approximately 14 weeks following randomization, including an initial ~2-week period of induction/stabilization.</description>
      <arm_group_label>Sublingual buprenorphine-naloxone (SL-BUP)</arm_group_label>
      <other_name>SL-BUP</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Be ≥18 years of age&#xD;
  &#xD;
            2. Meet DSM-5 criteria for moderate to severe OUD or be on buprenorphine medication for&#xD;
               OUD&#xD;
  &#xD;
            3. Be interested in receiving buprenorphine treatment for OUD&#xD;
  &#xD;
            4. Be willing to be randomized to either SL-BUP or XR-BUP&#xD;
  &#xD;
            5. Be willing to comply with all study procedures&#xD;
  &#xD;
            6. Be in good general health, as determined by the study Medical Clinician based on&#xD;
               medical/psychiatric histories and physical exam, to permit treatment in an outpatient&#xD;
               setting&#xD;
  &#xD;
            7. If female of childbearing potential, be willing to practice an effective method of&#xD;
               birth control for the duration of participation in the study intervention and agree to&#xD;
               study-administered pregnancy testing during their participation in the study&#xD;
  &#xD;
            8. Be able to speak English sufficiently to understand the study procedures&#xD;
  &#xD;
            9. Be willing and able to provide written informed consent to participate in the study&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Have evidence of a serious psychiatric disorder as assessed by the study Medical&#xD;
               Clinician that would make participation difficult or unsafe (e.g., active psychosis,&#xD;
               severe depression, or mania)&#xD;
  &#xD;
            2. Have suicidal or homicidal ideation or behavior that requires immediate attention&#xD;
  &#xD;
            3. Have a medical condition or serious medical illness that, in the opinion of the study&#xD;
               Medical Clinician, would make study participation medically unsafe&#xD;
  &#xD;
            4. Have been in treatment with naltrexone within 28 days of consent&#xD;
  &#xD;
            5. Have been in methadone maintenance treatment within 28 days of consent&#xD;
  &#xD;
            6. Be taking medication or require any medication that, in the judgment of the study&#xD;
               Medical Clinician, could interact adversely with study medication&#xD;
  &#xD;
            7. Have known allergy or sensitivity to SL-BUP or XR-BUP formulations or their components&#xD;
  &#xD;
            8. Be currently incarcerated or have pending legal action that could preclude&#xD;
               participation in study activities&#xD;
  &#xD;
            9. Have other situation that might prevent the participant from remaining in the area for&#xD;
               the duration of the study (e.g., planned move)&#xD;
  &#xD;
           10. Have a current pattern of alcohol, benzodiazepine, or other sedative hypnotic use, as&#xD;
               determined by the study Medical Clinician, that would require a different level of&#xD;
               care and preclude safe participation in the study&#xD;
  &#xD;
           11. Be currently pregnant or breastfeeding or planning on conception&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Yih-Ing Hser, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of California, Los Angeles</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Larissa Mooney, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of California, Los Angeles</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Megan Black, MPH</last_name>
      <phone>310-985-3696</phone>
      <email>MBlack@mednet.ucla.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Cynthia Boubion, BA</last_name>
      <email>CBoubion@mednet.ucla.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Southern Humboldt Community Healthcare District - Jerold Phelps Community Hospital</name>
        <address>
          <city>Garberville</city>
          <state>California</state>
          <zip>95542</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Gibson Area Hospital and Health Services - Gibson Recovery Optimizing Wellness</name>
        <address>
          <city>Gibson City</city>
          <state>Illinois</state>
          <zip>60936</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Oregon Health &amp; Science University Primary Care Clinic, Scappoose</name>
        <address>
          <city>Scappoose</city>
          <state>Oregon</state>
          <zip>97056</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Harbor Regional Health - HarborCrest Behavioral Health</name>
        <address>
          <city>Aberdeen</city>
          <state>Washington</state>
          <zip>98550</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Providence Northeast Washington Medical Group</name>
        <address>
          <city>Colville</city>
          <state>Washington</state>
          <zip>99114</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>New Beginnings Recovery Clinic &amp; Behavioral Health Center</name>
        <address>
          <city>New Martinsville</city>
          <state>West Virginia</state>
          <zip>26155</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 8, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 5, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>University of California, Los Angeles</investigator_affiliation>
      <investigator_full_name>Yih-Ing Hser</investigator_full_name>
      <investigator_title>Distinguished Research Professor, Department of Psychiatry and Behavioral Sciences, Geffen School of Medicine</investigator_title>
    </responsible_party>
    <keyword>Opioid Use Disorder</keyword>
    <keyword>Opioid Medication Assisted Treatment</keyword>
    <keyword>Buprenorphine</keyword>
    <keyword>Comparative Effectiveness Research</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Substance-Related Disorders</mesh_term>
      <mesh_term>Opioid-Related Disorders</mesh_term>
      <mesh_term>Narcotic-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>Buprenorphine, Naloxone Drug Combination</mesh_term>
      <mesh_term>Naloxone</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>This study will comply with the NIH Data Sharing Policy and Implementation Guidance and the HEAL Public Access and Data Sharing Policy. Primary data for this study will be available to the public in the NIDA Data Share repository, per NIDA CTN policy. For more details on data sharing please visit https://datashare.nida.nih.gov/.The main outcome(s) publication will be included along with study underlying primary data in the data share repository, and it will also be deposited in PubMed Central http://www.pubmedcentral.nih.gov/ per NIH Policy (http://publicaccess.nih.gov/).</ipd_description>
      <ipd_time_frame>After the main outcome(s) paper(s) have been published or 18 months after data lock, whichever comes first.</ipd_time_frame>
      <ipd_access_criteria>For more details on data sharing please visit https://datashare.nida.nih.gov</ipd_access_criteria>
      <ipd_url>https://datashare.nida.nih.gov</ipd_url>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06023459
  org study id: CTN-0102-XR
  secondary id: UG1DA049435
  nct id: NCT06023459
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: No
  This pilot trial will explore the feasibility, acceptability, and effectiveness of the most
        recently approved formulation of injectable extended-release buprenorphine (XR-BUP) for
        treatment of opioid use disorder (OUD) in rural settings. We will randomize 144 eligible
        individuals with moderate to severe OUD in a 2:1 ratio to one of two medication conditions:
        (1) XR-BUP (128mg target), administered every 4 weeks or (2) SL-BUP (16mg-24 mg/day
        target).Participants will receive study medication treatment for the 14 week-intervention
        period, including an initial ~2-week period of induction/stabilization. The study will use a
        mixed-methods approach (participant assessments, study medication records, qualitative
        interviews) for assessing feasibility and acceptability, and results will include patient
        outcome data on the comparative effectiveness of XR-BUP versus SL-BUP for patients with OUD
        in rural settings.
  This 24-month randomized controlled open-label pilot study will be conducted in approximately
        6 clinics in rural settings. The study objectives are to describe the feasibility of
        implementing the study in rural settings, document the acceptability of the XR-BUP condition,
        and assess the comparative effectiveness of XR-BUP compared with SL-BUP. Participants will be
        randomized within each clinic to XR-BUP or SL-BUP in a ratio of 2:1 (overall approximately 96
        in the XR-BUP condition, 48 in the SL-BUP condition). They will receive study medication for
        approximately 14 weeks following randomization, including an initial ~2-week period of
        induction/stabilization. The XR-BUP condition will use Brixadi®/CAM2038 injectable,
        extended-release buprenorphine. The measure for the main comparative effectiveness outcome is
        number of urine drug screen (UDS) results negative for opioids at scheduled assessments
        during Week 2 through Week 14 of the trial. Missing or positive UDS for any non-prescribed
        opioid is considered UDS positive.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: A 24-month randomized controlled open-label pilot study will be conducted in approximately 6 clinics in rural settings. Participants will be randomized within each clinic to XR-BUP or SL-BUP in a ratio of 2:1 (overall approximately 96 in the XR-BUP condition, 48 in the SL-BUP condition). They will receive study medication for approximately 14 weeks following randomization, including an initial ~2-week period of induction/stabilization.
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Comparative effectiveness
  time frame: Week 2 through Week 14 of the trial
  description: Number or percentage of urine drug screen (UDS) results negative for opioids
  measure: Feasibility of study implementation
  time frame: through study completion, an average of 1 year
  description: Overall recruitment, study completion, study dropout during the 14-week intervention period, and qualitative feedback from clinic personnel and patients.
  measure: Acceptability of XR-BUP
  time frame: through study completion, an average of 1 year
  description: Initial patient medication preference prior to randomization, percentage of participants randomized to the XR-BUP condition who receive the first monthly injection, percentage of XR-BUP participants who receive at least the first two monthly injections, and qualitative feedback from clinic personnel and patients.
  arm group label: Injectable extended-release buprenorphine (XR-BUP)
  arm group type: Experimental
  description: Participants will be randomly assigned to XR-BUP, with approximately 96 in the XR-BUP condition. The XR-BUP condition will use Brixadi/CAM2038 injectable, extended-release buprenorphine (Braeburn Pharmaceuticals, Inc.). After titrating to a stable dosage in approximately two weeks using weekly injection dosages as clinically indicated to relieve cravings and withdrawal symptoms, the target monthly dosage (128mg) of XR-BUP will be administered by injection at approximately Day 14 and approximately four weeks later in Week 6, with a third injection in Week 10. Dosage adjustments will be made as indicated for tolerability.
  arm group label: Sublingual buprenorphine-naloxone (SL-BUP)
  arm group type: Active Comparator
  description: Participants will be randomly assigned to SL-BUP with approximately 48 in the SL-BUP condition. The SL-BUP condition will use sublingual buprenorphine-naloxone, with a target maintenance daily dose range of 16-24mg as recommended for clinical practice. Titration to maintenance dosage will be attempted within the first two weeks of the SL-BUP condition. During the initial stabilization weeks, SL-BUP will be flexibly dosed as clinically indicated to relieve cravings and withdrawal symptoms, after which dosage adjustments will be based on clinical decisions by the site clinicians. The maintenance dosage of SL-BUP will be dispensed on a schedule similar to the XR-BUP injections (i.e., at approximately Day 14, Week 6, and Week 10).
  intervention type: Drug
  intervention name: Injectable extended-release buprenorphine
  description: Participants randomized to the XR-BUP condition will receive XR-BUP study medication for approximately 14 weeks following randomization, including an initial ~2-week period of induction/stabilization.
  arm group label: Injectable extended-release buprenorphine (XR-BUP)
  other name: XR-BUP (Brixadi)
  intervention type: Drug
  intervention name: Sublingual buprenorphine-naloxone
  description: Participants randomized to the SL-BUP condition will receive SL-BUP study medication for approximately 14 weeks following randomization, including an initial ~2-week period of induction/stabilization.
  arm group label: Sublingual buprenorphine-naloxone (SL-BUP)
  other name: SL-BUP
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Yih-Ing Hser, PhD
  role: Principal Investigator
  affiliation: University of California, Los Angeles
  last name: Larissa Mooney, MD
  role: Principal Investigator
  affiliation: University of California, Los Angeles
  last name: Megan Black, MPH
  phone: 310-985-3696
  email: MBlack@mednet.ucla.edu
  last name: Cynthia Boubion, BA
  email: CBoubion@mednet.ucla.edu
  facility: 
  facility: 
  facility: 
  facility: 
  facility: 
  facility: 
  country: United States
  responsible party type: Sponsor-Investigator
  investigator affiliation: University of California, Los Angeles
  investigator full name: Yih-Ing Hser
  investigator title: Distinguished Research Professor, Department of Psychiatry and Behavioral Sciences, Geffen School of Medicine
  mesh term: Substance-Related Disorders
  mesh term: Opioid-Related Disorders
  mesh term: Narcotic-Related Disorders
  mesh term: Buprenorphine
  mesh term: Buprenorphine, Naloxone Drug Combination
  mesh term: Naloxone
  sharing ipd: Yes
  ipd description: This study will comply with the NIH Data Sharing Policy and Implementation Guidance and the HEAL Public Access and Data Sharing Policy. Primary data for this study will be available to the public in the NIDA Data Share repository, per NIDA CTN policy. For more details on data sharing please visit https://datashare.nida.nih.gov/.The main outcome(s) publication will be included along with study underlying primary data in the data share repository, and it will also be deposited in PubMed Central http://www.pubmedcentral.nih.gov/ per NIH Policy (http://publicaccess.nih.gov/).
  ipd time frame: After the main outcome(s) paper(s) have been published or 18 months after data lock, whichever comes first.
  ipd access criteria: For more details on data sharing please visit https://datashare.nida.nih.gov
  ipd url: https://datashare.nida.nih.gov