Clinical trial NCT02696434: Evaluating Naltrexone for Use in Conjunction With Buprenorphine in Adults With Opioid Use Disorder Transitioning From Buprenorphine Maintenance Prior to First Dose of VIVITROL
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Opioid Use Disorder
Keywords: naltrexone
VIVITROL
buprenorphine
opioid
addiction
Lead sponsor: Alkermes, Inc.
Sponsor class: INDUSTRY
First posted: 2016-03-02
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of Subjects Who Receive and Tolerate a VIVITROL Injection on Day 8
timeFrame: 8 days
Secondary outcomes:
measure: Proportion of Days With COWS Peak Score </=12 During the Treatment Period Prior to the VIVITROL Injection
timeFrame: 1 week
measure: Proportion of Post-VIVITROL Days (Days 9-11) in Which Subjects in Each Group Demonstrate Mild Opioid Withdrawal
timeFrame: Days 9-11
measure: Mean Peak COWS Scores During the Treatment Period (Days 1/1a-7)
timeFrame: Up to 7 days
measure: Area Under the Curve (AUC) for COWS Scores During the Treatment Period and VIVITROL Induction and Post-VIVITROL Observation Period
timeFrame: The COWS was administered 4-6 times per day during the Treatment Period
measure: Mean Score for "Desire for Opioids" Visual Analog Scale (VAS) During the Treatment Period and VIVITROL Induction and Post-VIVITROL Observation Period
timeFrame: Up to 11 days
measure: Incidence of Adverse Events (AEs)
timeFrame: Up to 42 days
Other outcomes:
Locations:
city: Lauderhill
country: United States
facility: Segal Institute for Clinical Research
state: Florida
city: Oakland Park
country: United States
facility: Research Centers of America, LLC
state: Florida
city: Winfield
country: United States
facility: Neuroscience Research Institute, Inc.
state: Illinois
city: Baltimore
country: United States
facility: John Hopkins School of Medicine
state: Maryland
city: Berlin
country: United States
facility: Hassman Research Institute
state: New Jersey
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Philadelphia
country: United States
facility: University of Pennsylvania Treatment Research Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Western Psychiatric Institute and Clinic of University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: Alkermes, Inc.
name: Maria A. Sullivan, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Mannelli P, Douaihy AB, Akerman SC, Legedza A, Fratantonio J, Zavod A, Sullivan MA. Characteristics and treatment preferences of individuals with opioid use disorder seeking to transition from buprenorphine to extended-release naltrexone in a residential setting. Am J Addict. 2022 Mar;31(2):142-147. doi: 10.1111/ajad.13264. Epub 2022 Feb 9.
citation: Mannelli P, Douaihy AB, Zavod A, Legedza A, Akerman SC, Sullivan MA. Patterns of withdrawal in patients with opioid use disorder (OUD) transitioning from untreated OUD or buprenorphine treatment to extended-release naltrexone. Am J Drug Alcohol Abuse. 2021 Nov 2;47(6):753-759. doi: 10.1080/00952990.2021.1969659. Epub 2021 Nov 9.
citation: Kosten T, Aharonovich E, Nangia N, Zavod A, Akerman SC, Lopez-Bresnahan M, Sullivan MA. Cognitive performance of patients with opioid use disorder transitioned to extended-release injectable naltrexone from buprenorphine: Post hoc analysis of exploratory results of a phase 3 randomized controlled trial. Addict Behav. 2020 Dec;111:106538. doi: 10.1016/j.addbeh.2020.106538. Epub 2020 Jul 3.