Clinical trial NCT02537574: Naltrexone for Use in Conjunction With Buprenorphine in Adults With Opioid Use Disorder Prior to First Dose of VIVITROL® (Naltrexone for Extended-Release Injectable Suspension)
Official title: A Phase 3 Study to Evaluate the Safety, Tolerability, and Efficacy of Naltrexone for Use in Conjunction With Buprenorphine in Adults With Opioid Use Disorder Prior to First Dose of VIVITROL®
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Opioid Use Disorder
Keywords: Alkermes
Buprenorphine
Naltrexone
Vivitrol
Opioid Use
Opiates
Dependence
Abuse
Heroin
Painkillers
Substance Abuse
Lead sponsor: Alkermes, Inc.
Sponsor class: INDUSTRY
First posted: 2015-09-01
Enrollment: 380
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 safety, effectiveness and tolerance of low doses of oral naltrexone along with buprenorphine to treat opioid use disorder prior to the first injection of VIVITROL.


Eligibility criteria: Inclusion Criteria:

* Willing and able to provide informed consent
* Willing and able to provide government-issued identification
* Has a BMI of 18.0-40.0 kg/m\^2
* Has a physiologic dependence on opioids
* Is voluntarily seeking treatment for opioid use disorder and willing to completely withdraw from his/her opioid use throughout the study with desire for or motivation for antagonist therapy
* Wiling 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 used Buprenorphine within 7 days prior to randomization
* Has used Methadone within 14 days prior to randomization
* Has a history of VIVITROL use within 90 days prior to screening or has used oral naltrexone within 14 days prior to randomization
* 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
* Has a history of more than 3 unsuccessful inpatient or medically assisted outpatient opioid detoxifications during his/her lifetime
* Has significant suicidal ideation or behavior within the past year
* Is currently participating, or has participated, in a clinical trial of an investigational drug, device, or biologics within 3 months prior to screening
* Has a history of accidental opioid drug overdose in the past 3 years whether or not medical treatment was sought or received
* Is court mandated to receive treatment for opioid use disorder
* Additional criteria may apply

Primary outcomes:
measure: Proportion of Subjects Who Receive and Tolerate a VIVITROL Injection
timeFrame: 1 week
Secondary outcomes:
measure: Proportion of Days With COWS Peak Score of Less Than or Equal to 12 During the Treatment Period Prior to the VIVITROL Injection
timeFrame: 1 week
measure: Mean Peak COWS Score During Treatment Period Prior to VIVITROL Injection
timeFrame: 1 week
measure: Area Under the Curve (AUC) COWS Score During the Treatment Period Prior to VIVITROL Injection
timeFrame: The COWS was administered 4-6 times per day during the Treatment Period (Days 1-7)
measure: Mean Score for Desire of Opioids During Treatment Period Prior to VIVITROL Injection
timeFrame: 1 week
measure: Incidence of Adverse Effects
timeFrame: Up to 92 days
measure: Area Under the Curve SOWS Score During the Treatment Period Prior to the VIVITROL Injection
timeFrame: The SOWS was administered 4-6 times per day during the Treatment Period
Other outcomes:
Locations:
city: Oceanside
country: United States
facility: North Country Clinical Research
state: California
city: Orange
country: United States
facility: NRC Research Institute
state: California
city: Lauderhill
country: United States
facility: Atlantic Shores Hospital
state: Florida
city: Maitland
country: United States
facility: TRY Research
state: Florida
city: Oakland Park
country: United States
facility: Research Centers of America
state: Florida
city: Orlando
country: United States
facility: CNS Healthcare
state: Florida
city: Winfield
country: United States
facility: Neuroscience Research Institute
state: Illinois
city: Baltimore
country: United States
facility: John Hopkins University School of Medicine
state: Maryland
city: Berlin
country: United States
facility: Comprehensive Clinical Research
state: New Jersey
city: Marlton
country: United States
facility: PRA Health Sciences
state: New Jersey
city: New York
country: United States
facility: New York State Psychiatric Institute/ Columbia University
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Canton
country: United States
facility: Neuro-Behavioral Clinical Research, Inc.
state: Ohio
city: Dayton
country: United States
facility: Midwest Clinical Research Center, LLC
state: Ohio
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 UPMC
state: Pennsylvania
city: Austin
country: United States
facility: Community Clinical Research, Inc.
state: Texas
city: DeSoto
country: United States
facility: Insite Clinical Research
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Salt Lake City
country: United States
facility: Pharmaceutical Research Associates Inc.
state: Utah
Study officials:
affiliation: Alkermes, Inc.
name: Maria A. Sullivan, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Bisaga A, Mannelli P, Yu M, Nangia N, Graham CE, Tompkins DA, Kosten TR, Akerman SC, Silverman BL, Sullivan MA. Outpatient transition to extended-release injectable naltrexone for patients with opioid use disorder: A phase 3 randomized trial. Drug Alcohol Depend. 2018 Jun 1;187:171-178. doi: 10.1016/j.drugalcdep.2018.02.023. Epub 2018 Apr 10.
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.