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)
Completed · Phase 3
Conditions studied: Opioid Use Disorder
In brief
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.
Key facts
- Study ID
- NCT02537574
- Run by
- Alkermes, Inc.
- People needed
- 380
- Starts
- 2015-08-01
- Expected to finish
- 2017-01-09
- Last updated by the study team
- 2019-03-06
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- 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
Full record on ClinicalTrials.gov
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