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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 is a Phase 3 study that has completed, run by Butler Hospital. The registered enrollment target is 21 participants.
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).
Interventions
- DRUG Suboxone
- OTHER FMRI
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2016-08 |
| Est. Completion | 2020-02 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02696096
The ClinicalTrials.gov registry entry for NCT02696096 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Butler Hospital, which has 103 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Suboxone is the first listed.
NCT02696096 reports 0 study locations.
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.
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