Neuroimaging Predictors of Relapse During Treatment for Opiate Dependence

NCT ID: NCT02696096

Last Updated: 2022-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2020-02-29

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

All Participants

FMRI Suboxone

Group Type: OTHER

FMRI

Intervention Type: OTHER

all participants will complete 2 FMRIs

Suboxone

Intervention Type: DRUG

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

Interventions

FMRI

all participants will complete 2 FMRIs

Intervention Type: OTHER

Suboxone

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

Intervention Type: DRUG

Other Intervention Names

functional magnetic resonance imaging; buprenorphine

Eligibility Criteria

Inclusion Criteria

• opiate dependent persons
• 21-50 years old
• interested in initiating outpatient buprenorphine treatment

Exclusion Criteria

• current methadone maintenance treatment program participation
• medically necessary prescription opiate treatment (e.g., for chronic pain)
• current criteria for a DSM-V diagnosis of substance dependence for sedative or hypnotic drugs, alcohol, stimulants, cocaine, inhalants, hallucinogens
• diagnosis of organic brain disorder, bipolar disorder, schizophrenia, schizo-affective, schizophreniform or paranoid disorder
• current suicidality on the Modified Scale for Suicidal Ideation
• evidence of neuropsychological dysfunction as assessed by the study physician with confirmation with the Folstein Mini-Mental Status Examination•
• anticipated major painful event (significant surgical procedure) in the coming 4 months
• probation or parole requirements or an upcoming move that might interfere with protocol participation
• history of allergic reaction to buprenorphine or naloxone
• currently pregnant or planning to become pregnant in the next 4 months
• history of neurological disorder (e.g., epilepsy, stroke, brain injury)
• impaired uncorrected vision
• FMRI contraindications (e.g., claustrophobia, specific metallic implants and injuries)

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Butler Hospital

OTHER

Sponsor Role: lead

Responsible Party

Michael Stein, MD

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Butler Hospital

Providence, Rhode Island, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

793387

Identifier Type: -

Identifier Source: org_study_id