CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 21 enrolled
Drug / intervention
Suboxone +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02696096
NCT02696096Phase 3Completed

Neuroimaging Predictors of Relapse During Treatment for Opiate Dependence

Butler Hospital·interventional·Posted Mar 2, 2016·Updated Aug 17, 2022

In Brief

A Phase 3 clinical trial evaluating FMRI and Suboxone for Opioid Addiction. Completed, enrolled 21 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 2, 2016
Enrollment StartAug 1, 2016
Primary CompletionFeb 1, 2020
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 10.3 years ago

Interventions

FMRIother

all participants will complete 2 FMRIs

Suboxonedrug

all participants will be prescribed Suboxone for 4 months during their study participation