Extended-Release Naltrexone vs. Buprenorphine for Opioid Treatment

• Status: Completed
• Trial end date: 2017-01-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York University School of Medicine; NYU Langone Health
• Collaborators: National Institute on Drug Abuse (NIDA); The Emmes Company, LLC; The EMMES Corporation
• Treatments: Buprenorphine; Buprenorphine, Naloxone Drug Combination; Naloxone; Naltrexone

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)