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NCT02696096 · ClinicalTrials.gov registry record · Phase 3
Neuroimaging Predictors of Relapse During Treatment for Opiate Dependence
A Phase 3 study, sponsored by Butler Hospital.
- Completed
- Registry status
- Phase 3
- Development phase
- 21
- Enrollment target
NCT02696096: Completed Phase 3 study, sponsored by Butler Hospital.
NCT02696096 is a Phase 3 study that has completed, run by Butler Hospital. The registered enrollment target is 21 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02696096, a Phase 3 study, has completed, sponsored by Butler Hospital.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 21 participants
- Enrollment target
Study Summary
This study proposes to use functional magnetic resonance imaging (FMRI) to observe brain activity and behavior associated with decision-making about rewards (DD task), working memory and working memory cognitive persistence (WM task), and craving (CR task) in 72 opiate dependent participants initiating buprenorphine. While stably using opiates (initial study appointment) and again during withdrawal (approximately 3 days later), participants will receive an FMRI scan with behavioral challenges; immediately after the second FMRI, they will receive their first dose of buprenorphine. Buprenorphine treatment will continue for twelve weeks, followed by a four week taper. Urine toxicological analysis will be performed prior to the first scanning session, weekly for two weeks and biweekly thereafter. Participation for all individuals will last 4 months. Assessments will occur at baseline, and weeks 1, 2, 4, 8, and 12. Buprenorphine induction will begin at the completion of the second scan; follow-up medical visits will align with study assessments on weeks 1, 2, 4, 8 and 12. All participants will receive 16 weeks of buprenorphine (the final 4 of these 16 weeks will include a taper).
Primary Outcome
The measure of resting state organization is a z-value derived from Pearson's r-values. They represent the effect of the association between the brain activity of the seed region and each brain voxel over time during the resting state FMRI scan. A central z-value of 0 means that there is no association between the seed region and the voxel. Positive and negative z-values approaching 0 reflect increasingly weaker associations, and more extreme positive and negative values reflect stronger associ
Interventions
- DRUG Suboxone
- OTHER FMRI
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2016-08 |
| Est. Completion | 2020-02 |
| Phase | Phase 3 |
What the finished NCT02696096 record still lists
NCT02696096 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Suboxone is the first listed.
NCT02696096 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02696096 about?
NCT02696096 is a clinical study titled "Neuroimaging Predictors of Relapse During Treatment for Opiate Dependence". This study proposes to use functional magnetic resonance imaging (FMRI) to observe brain activity and behavior associated with decision-making about rewards (DD task), working memory and working memory cognitive persistence (WM task), and craving (CR task) in 72 opiate dependent participants initiat...
What is the current status of trial NCT02696096?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 21 participants. The study started on 2016-08. Estimated completion is 2020-02.
What interventions are being tested in trial NCT02696096?
The interventions under investigation include: Suboxone (DRUG), FMRI (OTHER).
Who is sponsoring clinical trial NCT02696096?
This trial is sponsored by Butler Hospital, which has 103 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02696096's enrollment target sits among peer trials
21 1953rd of 2000 higher than 45 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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