Extended-Release Naltrexone vs. Buprenorphine for Opioid Treatment
Condition: Opioid Use Disorder
MeSH terms: Opioid-Related Disorders
Intervention: Extended-Release Naltrexone; Buprenorphine-Naloxone
Intervention description: Extended-Release Naltrexone (Vivitrol®); Buprenorphine-Naloxone (Suboxone®)
Intervention MeSH terms: Naltrexone; Buprenorphine; Buprenorphine, Naloxone Drug Combination; Naloxone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 570.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: extended-release naltrexone (Vivitrol); buprenorphine-naloxone (Suboxone); comparative effective; relapse prevention

Summary:

      CTN-0051 assesses the comparative effectiveness of extended release injectable naltrexone
      (XR-NTX, Vivitrol®), an opioid antagonist recently approved and indicated for the prevention
      of relapse to opioid dependence, versus buprenorphine-naloxone (BUP-NX, Suboxone®), a high
      affinity partial agonist indicated for maintenance treatment of opioid dependence, as
      pharmacotherapeutic aids to recovery.

      The study is conducted in 8 NIDA Clinical Trials Network affiliated community based treatment
      programs. Up to 600 eligible participants will be randomized to treatment with XR-NTX or
      BUP-NX for 24 weeks (sufficient to include 350 participants who are randomized more than 72
      hours after their last opioid).

      The primary goal of the study is to estimate the difference, if one exists, between XR-NTX
      and BUP-NX in the distribution of the time to relapse (i.e.., loss of persistent abstinence)
      during the 6-month trial. Secondary objectives are to: (1) compare outcome on XR-NTX versus
      BUP-NX across a range of clinical safety and secondary efficacy domains, and (2) explore
      demographic and, clinical, and genetic predictors of successful treatment and moderators of
      differential effectiveness (i.e., what variables may help clinicians choose which of these
      treatments is best for a given patient).), and (3) collect a limited dataset to permit
      analyses of economic costs and benefits of the two treatments.
    

Eligibility criteria:

        Inclusion Criteria

          -  Male or female

          -  18 years of age and older

          -  Meet DSM-5 criteria for opioid-use disorder (heroin and/or prescription opioids)

          -  Have used opioids other than as specifically prescribed within thirty days prior to
             consent

          -  Seeking treatment for opioid dependence and willing to accept "agonist-based" or
             "antagonist-based" therapy

          -  In good-enough general health, as determined by the study physician on the basis of
             medical history, review of systems, physical exam and laboratory assessments, to
             permit treatment with XR-NTX or BUP-NX

          -  Able to provide written informed consent

          -  Able to speak English sufficiently to understand the study procedures and provide
             written informed consent to participate in the study

          -  If female of childbearing potential, be willing to practice an effective method of
             birth control for the duration of participation in the study

        Exclusion Criteria

          -  Serious medical, psychiatric or substance use disorder that, in the opinion of the
             study physician, would make study participation hazardous to the participant, or
             compromise study findings or would prevent the participant from completing the study.
             Examples include:

               1. Disabling or terminal medical illness (e.g., uncompensated heart failure,
                  cirrhosis or end-stage liver disease) as assessed by medical history, review of
                  systems, physical exam and/or laboratory assessments;

               2. Severe, untreated or inadequately treated mental disorder (e.g., active
                  psychosis, uncontrolled manic-depressive illness) as assessed by history and/or
                  clinical interview;

               3. Current severe alcohol, benzodiazepine, or other depressant or sedative hypnotic
                  use likely to require a complicated medical detoxification (routine alcohol and
                  sedative detoxifications may be included)

          -  LFTs (ALT, AST) greater than 5 times upper limit of normal

          -  Suicidal or homicidal ideation that requires immediate attention

          -  Known allergy or sensitivity to buprenorphine, naloxone, naltrexone,
             polylactide-co-glycolide, carboxymethylcellulose, or other components of the Vivitrol®
             diluent

          -  Maintenance on methadone at doses of 30mg or greater at the time of signing consent

          -  Presence of pain of sufficient severity as to require ongoing pain management with
             opioids

          -  Pending legal action or other reasons that might prevent an individual from completing
             the study

          -  If female, currently pregnant or breastfeeding, or planning on conception

          -  Body habitus that, in the judgment of the study physician, precludes safe
             intramuscular injection of XR-NTX (e.g., BMI>40, excess fat tissue over the buttocks,
             emaciation)