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NCT02357901 · ClinicalTrials.gov registry record · Phase 3
Treatment Seeking Participants With Opioid Use Disorders Assessing Tolerability of Depot Injections of Buprenorphine
A Phase 3 study of Opioid-Related Disorders and Opioid Dependence, sponsored by Indivior.
- Completed
- Registry status
- Phase 3
- Development phase
- 665
- Enrollment target
- 20
- Study locations
NCT02357901: Completed Phase 3 study of Opioid-Related Disorders and Opioid Dependence, sponsored by Indivior.
NCT02357901 is a Phase 3 study of Opioid-Related Disorders and Opioid Dependence that has completed, run by Indivior. The registered enrollment target is 665 participants, above the 333-participant average among 47 other Opioid-Related Disorders trials with a reported enrollment target (100% higher). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02357901, a Phase 3 study of Opioid-Related Disorders and Opioid Dependence, has completed, sponsored by Indivior.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 665 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a randomized, double-blind, placebo controlled, multicenter study in male and female participants who are seeking treatment for opioid use disorder.
Primary Outcome
Data represent the count of participants at various percentage abstinence levels. Abstinence was defined as urine samples being negative for opioids AND negative self-reports (obtained from Timeline Followback (TLFB) interviews) for illicit opioid use. The primary endpoint was based on visits in which paired urine samples and self-reports were expected for each subject as specified in the schedule of events. Missing urine drug screen(s) (UDS) samples and/or self-reports were considered as non-ne
Conditions Studied
Interventions
- DRUG Placebo
- DRUG RBP-6000
- DRUG SUBOXONE
Study Locations (20)
California
- Collaborative Neuroscience Network - Garden Grove
- Behavioral Research Specialists - Glendale
- Synergy Clinical Research Center - National City
- North County Clinical Research - Oceanside
- Artemis Institute for Clinical Research - San Diego
- Care Practice - San Francisco
- Southern California Research - Thousand Oaks
Florida
- Amit Vijapura - Jacksonville
- Meridien Research - Lakeland
- Innovative Clinical Research - Lauderhill
- Florida Clinical Research Center - Maitland
- Try Research - Maitland
- Scientific Clinical Research - North Miami
- Research Centers of America - Oakland Park
Alabama
- Haleyville Clinical Research - Haleyville
- Boyett Health Services - Hamilton
Arkansas
- Woodland International Research Group - Little Rock
Illinois
- Behavioral Health Care Associates - Schaumburg
Kansas
- Phoenix Medical Research - Prairie Village
Louisiana
- Louisiana Research Associates - New Orleans
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 665 participants |
| Start Date | 2015-01-28 |
| Est. Completion | 2016-04-29 |
| Phase | Phase 3 |
What the finished NCT02357901 record still lists
NCT02357901 is an interventional study that assigns participants to a tested intervention. The registered 665 participants enrollment target is mid-sized for trials with a published cap, above the 333-participant average among 47 other Opioid-Related Disorders trials with a reported enrollment target (100% higher).
The record links to 2 conditions, with Opioid-Related Disorders appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT02357901 names 20 study sites across 7 states, led by California, Florida, Alabama.
Frequently Asked Questions
What is clinical trial NCT02357901 about?
NCT02357901 is a clinical study titled "Treatment Seeking Participants With Opioid Use Disorders Assessing Tolerability of Depot Injections of Buprenorphine". This is a randomized, double-blind, placebo controlled, multicenter study in male and female participants who are seeking treatment for opioid use disorder.
What is the current status of trial NCT02357901?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 665 participants. The study started on 2015-01-28. Estimated completion is 2016-04-29.
What conditions does trial NCT02357901 study?
This clinical trial studies the following conditions: Opioid-Related Disorders, Opioid Dependence.
What interventions are being tested in trial NCT02357901?
The interventions under investigation include: Placebo (DRUG), RBP-6000 (DRUG), SUBOXONE (DRUG).
Who is sponsoring clinical trial NCT02357901?
This trial is sponsored by Indivior, which has 37 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02357901 being conducted?
This trial has 20 study locations across Alabama, Arkansas, California, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02357901's enrollment target sits among peer trials
665 6th of 47 higher than 42 of 47 other Opioid-Related Disorders trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Opioid-Related Disorders 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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