Evaluating Naltrexone for Use in Conjunction With Buprenorphine in Adults With Opioid Use Disorder Transitioning From Buprenorphine Maintenance Prior to First Dose of VIVITROL

Alkermes

Status and phase: Completed; Phase 3

Conditions: Opioid Use Disorder

Treatments: Drug: Buprenorphine; Drug: Naltrexone; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02696434

ALK6428-A302

Details and patient eligibility

About

This study will evaluate the efficacy, safety, and tolerability of oral naltrexone used in conjunction with buprenorphine in adults with Opioid Use Disorder transitioning from buprenorphine maintenance prior to the first dose of VIVITROL.

Enrollment: 101 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Willing and able to provide informed consent
• Willing and able to provide government-issued identification
• Has a Body Mass Index (BMI) of 18.0-40.0 kg/m^2
• Has a history of opioid use disorder diagnosis for at least 6 months
• Has a history of prescribed buprenorphine (or buprenorphine/naloxone) maintenance for the prior 3 or more consecutive months and is currently buprenorphine-maintained
• Must be voluntarily seeking treatment for opioid use disorder and be motivated to receive antagonist therapy
• Willing to abide by the contraception requirements for the duration of the study
• Additional criteria may apply

Exclusion criteria

• Is pregnant, planning to become pregnant or breastfeeding during the study
• Has a positive urine drug screen for opiates or oxycodone at screening
• Has used methadone within 30 days prior to study Day -5
• Has used naltrexone (oral or VIVITROL) within the 90 days prior to Day -5
• Has a history of seizures or has received anticonvulsant therapy within the past 5 years for treatment of seizures (use of anticonvulsant during the past detoxification is not exclusionary)
• Has a condition, disease state, or previous medical history that would preclude safe participation in the study or affect the ability to adhere to the protocol visit schedule, requirements, or assessments
• Has a current diagnosis of schizoaffective disorder, bipolar disorder, or untreated and unstable major depressive disorder
• Is currently physiologically dependent on any psychoactive substance (except opioids, caffeine, or nicotine) requiring medical intervention for detoxification
• Has a history of hypersensitivity or adverse reaction to buprenorphine, naltrexone, VIVITROL, or naloxone
• Additional criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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101 participants in 2 patient groups

PBO NTX + BUP

Active Comparator group

Description:

Placebo naltrexone + buprenorphine

Treatment:

Drug: Buprenorphine

Drug: Placebo

NTX + BUP

Experimental group

Description:

Naltrexone + buprenorphine

Treatment:

Drug: Buprenorphine

Drug: Naltrexone