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)
NCT ID: NCT02537574
Last Updated: 2019-03-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
380 participants
INTERVENTIONAL
2015-08-31
2017-01-09
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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NTX/BUP
Oral naltrexone + sublingual buprenorphine
NTX/BUP
Daily doses
NTX/PBO-B
Oral naltrexone + sublingual placebo
NTX/PBO-B
Daily doses
PBO-N/PBO-B
Oral placebo naltrexone + sublingual placebo buprenorphine
PBO-N/PBO-B
Daily doses
Interventions
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NTX/BUP
Daily doses
NTX/PBO-B
Daily doses
PBO-N/PBO-B
Daily doses
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
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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North Country Clinical Research
Oceanside, California, United States
NRC Research Institute
Orange, California, United States
Atlantic Shores Hospital
Lauderhill, Florida, United States
TRY Research
Maitland, Florida, United States
Research Centers of America
Oakland Park, Florida, United States
CNS Healthcare
Orlando, Florida, United States
Neuroscience Research Institute
Winfield, Illinois, United States
John Hopkins University School of Medicine
Baltimore, Maryland, United States
Comprehensive Clinical Research
Berlin, New Jersey, United States
PRA Health Sciences
Marlton, New Jersey, United States
New York State Psychiatric Institute/ Columbia University
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Neuro-Behavioral Clinical Research, Inc.
Canton, Ohio, United States
Midwest Clinical Research Center, LLC
Dayton, Ohio, United States
University Of Pennsylvania - Treatment Research Center
Philadelphia, Pennsylvania, United States
Western Psychiatric Institute and Clinic of UPMC
Pittsburgh, Pennsylvania, United States
Community Clinical Research, Inc.
Austin, Texas, United States
Insite Clinical Research
DeSoto, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Pharmaceutical Research Associates Inc.
Salt Lake City, Utah, United States
Countries
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References
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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.
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.
Other Identifiers
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ALK6428-A301
Identifier Type: -
Identifier Source: org_study_id
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