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NCT02696434 · ClinicalTrials.gov registry record · Phase 3
Evaluating Naltrexone for Use in Conjunction With Buprenorphine in Adults With Opioid Use Disorder Transitioning From Buprenorphine Maintenance Prior to First Dose of VIVITROL
A Phase 3 study, sponsored by Alkermes.
- Completed
- Registry status
- Phase 3
- Development phase
- 101
- Enrollment target
NCT02696434: Completed Phase 3 study, sponsored by Alkermes.
NCT02696434 is a Phase 3 study that has completed, run by Alkermes. The registered enrollment target is 101 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02696434, a Phase 3 study, has completed, sponsored by Alkermes.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 101 participants
- Enrollment target
Study Summary
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.
Primary Outcome
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); 25-36 (moderately severe); and
Interventions
- DRUG Placebo
- DRUG Buprenorphine
- DRUG Naltrexone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 101 participants |
| Start Date | 2016-04 |
| Est. Completion | 2017-11-30 |
| Phase | Phase 3 |
What the finished NCT02696434 record still lists
NCT02696434 is an interventional study that assigns participants to a tested intervention. The registered 101 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02696434 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02696434 about?
NCT02696434 is a clinical study titled "Evaluating Naltrexone for Use in Conjunction With Buprenorphine in Adults With Opioid Use Disorder Transitioning From Buprenorphine Maintenance Prior to First Dose of VIVITROL". 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.
What is the current status of trial NCT02696434?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 101 participants. The study started on 2016-04. Estimated completion is 2017-11-30.
What interventions are being tested in trial NCT02696434?
The interventions under investigation include: Placebo (DRUG), Buprenorphine (DRUG), Naltrexone (DRUG).
Who is sponsoring clinical trial NCT02696434?
This trial is sponsored by Alkermes, which has 66 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02696434's enrollment target sits among peer trials
101 1680th of 2000 higher than 320 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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