Extended-Release Naltrexone vs. Buprenorphine for Opioid Treatment

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:
• 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;
• Severe, untreated or inadequately treated mental disorder (e.g., active psychosis, uncontrolled manic-depressive illness) as assessed by history and/or clinical interview;
• 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)