Evaluating Naltrexone for Use in Conjunction With Buprenorphine in Adults With Opioid Use Disorder Transitioning From Buprenorphine Maintenance Prior to First Dose of VIVITROL
NCT ID: NCT02696434
Last Updated: 2019-02-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
101 participants
INTERVENTIONAL
2016-04-30
2017-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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PBO NTX + BUP
Placebo naltrexone + buprenorphine
Placebo
daily dosing
Buprenorphine
daily dosing
NTX + BUP
Naltrexone + buprenorphine
Naltrexone
daily dosing
Buprenorphine
daily dosing
Interventions
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Naltrexone
daily dosing
Placebo
daily dosing
Buprenorphine
daily dosing
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
60 Years
ALL
No
Sponsors
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Alkermes, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Maria A. Sullivan, MD, PhD
Role: STUDY_DIRECTOR
Alkermes, Inc.
Locations
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Segal Institute for Clinical Research
Lauderhill, Florida, United States
Research Centers of America, LLC
Oakland Park, Florida, United States
Neuroscience Research Institute, Inc.
Winfield, Illinois, United States
John Hopkins School of Medicine
Baltimore, Maryland, United States
Hassman Research Institute
Berlin, New Jersey, United States
New York State Psychiatric Institute
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
University of Pennsylvania Treatment Research Center
Philadelphia, Pennsylvania, United States
Western Psychiatric Institute and Clinic of University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Countries
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References
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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.
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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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ALK6428-A302
Identifier Type: -
Identifier Source: org_study_id
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