fMRI and Opioid Abstinence

Functional Connectivity Mechanisms of Opioid Abstinence

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

Study Overview

• Status: Recruiting
• Conditions: Opioid-Related Disorders; Opioid Dependence; Opioid Use; Opioid Abuse; Drug Use Disorder
• Intervention / Treatment: Diagnostic test: fMRI

• Study Type: Observational
• Enrollment (Estimated): 240

Contacts and Locations

• Study Contact: Name: Monica Holler, BS; Phone Number: 203 737 3531; Email: monica.holler@yale.edu

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Recruiting
      • The APT Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

• 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.

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Methadone; Participants initiated into methadone within the past 6 months will receive fMRI and cognitive assessment battery.	Diagnostic test: fMRI; 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; Participants initiated into buprenorphine within the past 6 months will receive fMRI and cognitive assessment battery.	Diagnostic test: fMRI; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Sarah Yip, PhD, MSc, Yale University

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2024
• Primary Completion (Estimated): November 1, 2029
• Study Completion (Estimated): November 1, 2029

Study Registration Dates

• First Submitted: October 18, 2024
• First Submitted That Met QC Criteria: October 18, 2024
• First Posted (Actual): October 21, 2024

Study Record Updates

• Last Update Posted (Estimated): October 20, 2025
• Last Update Submitted That Met QC Criteria: October 16, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Relapse
• Additional Relevant MeSH Terms: Narcotic-Related Disorders; Mental Disorders; Pathologic Processes; Disease Attributes; Chemically-Induced Disorders; Pathological Conditions, Signs and Symptoms; Recurrence; Opioid-Related Disorders; Substance-Related Disorders; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Diagnostic Imaging; Magnetic Resonance Imaging
• Other Study ID Numbers: 2000038046; 1R01DA060631-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: This study will submit and share data with OpenNeuro. This will include de-identified demographic data, neuropsychological assessment data, clinical assessment data, and fMRI data (raw).
• IPD Sharing 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.
• IPD Sharing 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No