fMRI and Opioid Abstinence

Recruiting

• Conditions: Opioid-Related Disorders; Opioid Use; Opioid Abuse; Drug Use Disorder; Opioid Dependence

• Registration Number: NCT06651333
• Lead Sponsor: Yale University

Brief Summary

This project examines functional connectivity patterns associated with subsequent relapse to illicit opioids during treatment for OUD.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-18
• Study First Submitted QC: 2024-10-18
• Study First Posted: 2024-10-21
• Study Start: 2024-12-12
• Status Verified: 2025-01
• Last Update Submitted: 2025-04-11
• Last Update Posted: 2025-04-15
• Primary Completion: 2029-11
• Study Completion: 2029-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

• recent initiation of methadone or buprenorphine at APT Foundation within the last year (i.e., period of time during which treatment drop-out and risk for relapse is highest);
• eligibility for MRI scanning;
• ability to commit to study visits.

Exclusion Criteria

• current acute psychosis, mania, or suicidal ideation with intent, as assessed during screening with the SCID-5;
• current intoxication or acute withdrawal at time of study visit sufficient to prevent participation based on: behavioral observation, breathalyzer, and SOWS assessment;
• severe cognitive impairment as determined via trained clinical research staff through consent process and during consent quiz or as indicated by a PROMIS Cognitive Function tscore <30 (i.e., severe impairment)
• past or present history of intellectual disability, developmental disorder, or neurological disease;
• head trauma with loss of consciousness >30 min;
• organ dysfunction or any unstable or untreated medical conditions that may interfere with study participation.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Illicit opioid-use	At monthly visits for 6 months following neuroimaging	Defined as the percent days of self-reported use of illicit opioids (assessed at monthly visits for 6-months following neuroimaging), with the exception of primary type of MOUD (i.e., methadone for methadone treated individuals, buprenorphine for buprenorphine treated individuals).

Secondary Outcome Measures

Name	Time	Method
MOUD retention	up to 9 months	Percentage of visits attended out of visits expected based on electronic health record data and time line follow back.

Trial Locations

Locations (1)

The APT Foundation; 🇺🇸 New Haven, Connecticut, United States