NCT02696096

Neuroimaging Predictors of Relapse During Treatment for Opiate Dependence

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Butler Hospital · Academic / Other
• Sex: All
• Age: 21 Years – 50 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Opioid Addiction

Interventions

Type	Name	Description
OTHER	FMRI	all participants will complete 2 FMRIs
DRUG	Suboxone	all participants will be prescribed Suboxone for 4 months during their study participation

Timeline

• Start date: 2016-08-01
• Primary completion: 2020-02-01
• Completion: 2020-02-01
• First posted: 2016-03-02
• Last updated: 2022-08-17
• Results posted: 2022-08-17

Locations

1 site across 1 country: United States