fMRI and Opioid Abstinence

NCT06651333 | Recruiting FDA Device

• 2 other identifiers: 20000380461R01DA060631-01
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Drug Use Disorder; Opioid Dependence; Opioid-Related Disorders; Opioid Use; Opioid Abuse

Keywords

Relapse

Outcome Measures

Primary Outcomes (1)

• Illicit opioid-use

  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).

  At monthly visits for 6 months following neuroimaging

Secondary Outcomes (1)

• MOUD retention

  up to 9 months

Study Arms (2)

Methadone

Participants initiated into methadone within the past 6 months will receive fMRI and cognitive assessment battery.

Diagnostic Test: fMRI

Buprenorphrine

Participants initiated into buprenorphine within the past 6 months will receive fMRI and cognitive assessment battery.

Diagnostic Test: fMRI

Interventions

fMRI DIAGNOSTIC_TEST

Participants will be performing tasks while undergoing fMRI. Tasks include Stroop task, Emotion-regulation task and an Ambiguity reward task, Drug cue task, and Cognitive behavioral therapy task. Participants are not presented with any specific stimulus.

Buprenorphrine; Methadone

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be individuals with primary opioid use disorder who are at least 18 years old and enrolled in formal MOUD treatment (either methadone or buprenorphine) for less than 6 months. Investigators will recruit a sample that is 50% female and 50% male.

You may qualify if:

• recent initiation of methadone or buprenorphine at a clinic or program within the past 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

The APT Foundation

New Haven, Connecticut, 06520, United States

RECRUITING

MeSH Terms

Conditions

Substance-Related Disorders; Opioid-Related Disorders; Recurrence

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Narcotic-Related Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Sarah Yip, PhD, MSc

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Monica Holler, BS

CONTACT

203 737 3531; monica.holler@yale.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2024
• First Posted: October 21, 2024
• Study Start: December 12, 2024
• Primary Completion (Estimated): November 1, 2029
• Study Completion (Estimated): November 1, 2029
• Last Updated: October 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Time Frame: All data will be deposited to OpenNeuro starting 24 months after data collection begins and will be deposited every six months thereafter. OpenNeuro policy states that any data uploaded to their repository becomes publicly available under a Creative Commons CC0 license after a 36-month period beginning from first successful version of the dataset.
• Access Criteria: OpenNeuro policy states that any data uploaded to their repository becomes publicly available under a Creative Commons (CC) license after a 36-month period beginning from first successful version of the dataset. Users create an account with OpenNeuro account in order to download BIDS formatted files and any associated metadata.

Locations

US (1)