This trial is active, not recruiting.

Condition opioid use disorder
Treatments naltrexone, placebo, buprenorphine
Phase phase 3
Sponsor Alkermes, Inc.
Start date April 2016
End date May 2017
Trial size 92 participants
Trial identifier NCT02696434, ALK6428-A302


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
(Active Comparator)
Placebo naltrexone + buprenorphine
daily dosing
daily dosing
Naltrexone + buprenorphine
daily dosing
daily dosing

Primary Outcomes

Proportion of subjects who receive and tolerate a VIVITROL injection on Day 14
time frame: 2 weeks

Secondary Outcomes

Proportion of days with COWS peak score </=12 during the treatment period prior to the VIVITROL injection
time frame: 2 weeks
Mean peak COWS scores during the inpatient period
time frame: 2 weeks
Area under the curve (AUC) for COWS scores during the inpatient period
time frame: 2 weeks
Mean score for "desire for opioids" Visual Analog Scale (VAS) during the inpatient period
time frame: 2 weeks
Incidence of adverse events
time frame: Up to 42 days

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

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 at least 3 months of supervised buprenorphine maintenance and must be currently buprenorphine-maintained by prescription - 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 - Urine test is positive for oxycodone or morphine, and/or negative for buprenorphine at screening - Has used methadone within 30 days prior to inpatient admission - Has used naltrexone (oral or VIVITROL) within the 90 days prior to inpatient admission - Has a history of seizures or has received anticonvulsant therapy within the past 5 years - 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, or naloxone - Additional criteria may apply

Additional Information

Official title A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Safety, Tolerability, and Efficacy of Naltrexone for Use in Conjunction With Buprenorphine in Adults With Opioid Use Disorder Transitioning From Buprenorphine Maintenance Prior to First Dose of VIVITROL
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Alkermes, Inc..