Evaluating Naltrexone for Use in Conjunction With Buprenorphine in Adults With Opioid Use Disorder Transitioning From Buprenorphine Maintenance Prior to First Dose of VIVITROL
Completed · Phase 3 · Has a placebo group
Conditions studied: Opioid Use Disorder
In brief
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.
Key facts
- Study ID
- NCT02696434
- Run by
- Alkermes, Inc.
- People needed
- 101
- Starts
- 2016-04-01
- Expected to finish
- 2017-11-30
- Last updated by the study team
- 2019-02-12
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 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
You may not qualify if…
- 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
Where it is running
- 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
Full record on ClinicalTrials.gov
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