Neuroimaging Predictors of Relapse During Treatment for Opiate Dependence

NCT02696096 | Completed Phase 3 Results

• 1 other identifier: 793387
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• Changes in Resting State Disorganization Between Baseline and One Week by Person by Lapsed Category

  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 associations. Attributing the qualitative labels better or worse to these values depend upon the brain network and context. In many networks (eg, task-positive cognitive control network), a stronger positive correlation is thought to reflect better network organization. In the task-negative default mode network a stronger positive relationship is considered by some as worse. For this study, these are not yet used as clinical measures and there are not known cutoffs.

  Baseline and 1 week

• Working Memory - Between Groups at Baseline by Lapsed Category

  fMRI working memory differences between participants who lapse back to opioid use and those who don't

  Baseline

• Changes in Working Memory - Within Groups During Satiation and Withdrawal

  fMRI working memory differences under satiation vs withdrawal from opioids

  Baseline and 1 week

Study Arms (1)

All Participants

OTHER

FMRI Suboxone

Other: FMRI; Drug: Suboxone

Interventions

FMRI OTHER

all participants will complete 2 FMRIs

Also known as: functional magnetic resonance imaging

All Participants

Suboxone DRUG

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

Also known as: buprenorphine

All Participants

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Butler Hospital: lead

Study Sites (1)

Butler Hospital

Providence, Rhode Island, 02906, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Buprenorphine, Naloxone Drug Combination; Buprenorphine

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Naloxone; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr. Michael Stein
• Organization: Butler Hospital

michael_stein@brown.edu

401-455-6652

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: February 9, 2016
• First Posted: March 2, 2016
• Study Start: August 1, 2016
• Primary Completion: February 1, 2020
• Study Completion: February 1, 2020
• Last Updated: August 17, 2022
• Results First Posted: August 17, 2022

Record last verified: 2022-07

Locations

US (1)