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NCT02537574 · ClinicalTrials.gov registry record · Phase 3
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)
A Phase 3 study of Opioid Use Disorder, sponsored by Alkermes.
- Completed
- Registry status
- Phase 3
- Development phase
- 380
- Enrollment target
- 20
- Study locations
NCT02537574: Completed Phase 3 study of Opioid Use Disorder, sponsored by Alkermes.
NCT02537574 is a Phase 3 study of Opioid Use Disorder that has completed, run by Alkermes. The registered enrollment target is 380 participants, below the 4,655-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (92% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02537574, a Phase 3 study of Opioid Use Disorder, has completed, sponsored by Alkermes.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 380 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Toleration to the injection was demonstrated by mild opioid withdrawal symptoms (Clinical Opiate Withdrawal Scale \[COWS\] \</=12 or Subjective Opiate Withdrawal Scale \[SOWS\] \</=10) following VIVITROL administration. The COWS is a clinician-rated questionnaire designed to measure 11 common opioid withdrawal signs or symptoms. The summed score provides information about the level of physical dependence on opioids. The range of COWS scores is 0-4 (none to minimal); 5-12 (mild); 13-24 (moderate)
Conditions Studied
Interventions
- DRUG NTX/BUP
- DRUG NTX/PBO-B
- DRUG PBO-N/PBO-B
Study Locations (20)
Florida
- Atlantic Shores Hospital - Lauderhill
- TRY Research - Maitland
- Research Centers of America - Oakland Park
- CNS Healthcare - Orlando
Texas
- Community Clinical Research, Inc. - Austin
- Insite Clinical Research - DeSoto
- Baylor College of Medicine - Houston
California
- North Country Clinical Research - Oceanside
- NRC Research Institute - Orange
New Jersey
- Comprehensive Clinical Research - Berlin
- PRA Health Sciences - Marlton
Ohio
- Neuro-Behavioral Clinical Research, Inc. - Canton
- Midwest Clinical Research Center, LLC - Dayton
Pennsylvania
- University Of Pennsylvania - Treatment Research Center - Philadelphia
- Western Psychiatric Institute and Clinic of UPMC - Pittsburgh
Illinois
- Neuroscience Research Institute - Winfield
Maryland
- John Hopkins University School of Medicine - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 380 participants |
| Start Date | 2015-08 |
| Est. Completion | 2017-01-09 |
| Phase | Phase 3 |
What the finished NCT02537574 record still lists
NCT02537574 is an interventional study that assigns participants to a tested intervention. The registered 380 participants enrollment target is mid-sized for trials with a published cap, below the 4,655-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (92% lower).
The record links to 1 condition, with Opioid Use Disorder appearing as the primary indexed condition, and to 3 interventions - of which NTX/BUP is the first listed.
NCT02537574 names 20 study sites across 11 states, led by Florida, Texas, California.
Frequently Asked Questions
What is clinical trial NCT02537574 about?
NCT02537574 is a clinical study titled "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)". 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.
What is the current status of trial NCT02537574?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 380 participants. The study started on 2015-08. Estimated completion is 2017-01-09.
What conditions does trial NCT02537574 study?
This clinical trial studies the following conditions: Opioid Use Disorder.
What interventions are being tested in trial NCT02537574?
The interventions under investigation include: NTX/BUP (DRUG), NTX/PBO-B (DRUG), PBO-N/PBO-B (DRUG).
Who is sponsoring clinical trial NCT02537574?
This trial is sponsored by Alkermes, which has 66 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02537574 being conducted?
This trial has 20 study locations across California, Florida, Illinois, Maryland, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Opioid Use Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02537574's enrollment target sits among peer trials
380 48th of 257 higher than 210 of 257 other Opioid Use Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Opioid Use Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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