Overview

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

Summary

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.

Recruiting in the following locations…

United States Florida and New Jersey
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
Arm
(Active Comparator)
Placebo naltrexone + buprenorphine
placebo
daily dosing
buprenorphine
daily dosing
(Experimental)
Naltrexone + buprenorphine
naltrexone
daily dosing
buprenorphine
daily dosing

Primary Outcomes

Measure
Proportion of subjects who receive and tolerate a VIVITROL injection on Day 8
time frame: 8 days

Secondary Outcomes

Measure
Proportion of days with COWS peak score </=12 during the treatment period prior to the VIVITROL injection
time frame: 1 week
Proportion of post-VIVITROL days (Days 9-11) in which subjects in each group demonstrate mild opioid withdrawal
time frame: Up to 11 days
Mean peak COWS scores during the Treatment Period and VIVITROL Induction and Post-VIVITROL Observation Period
time frame: Up to 11 days
Area under the curve (AUC) for COWS scores during the Treatment Period and VIVITROL Induction and Post-VIVITROL Observation Period
time frame: up to 11 days
Mean score for "desire for opioids" Visual Analog Scale (VAS) during the Treatment Period and VIVITROL Induction and Post-VIVITROL Observation Period
time frame: Up to 11 days
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 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 morphine 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

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 December 2016.
Information provided to ClinicalTrials.gov by Alkermes, Inc..