Clinical trial Recruiting at 2 sites Observational Ages 18 to 50

Examining brain activity patterns related to opioid relapse during treatment

Official title: Functional Connectivity Mechanisms of Opioid Abstinence

Run by Yale University · NCT06651333 · Data updated 2026-11-12

This study is testing how brain activity patterns might predict the risk of relapse to opioid use in people who have just started treatment with methadone or buprenorphine.

Quick facts

Study typeObservational
Ages18 Years to 50 Years
SexAll
Enrollment240 (estimated)
SponsorYale University
Academic / other
Locations2 sites (Hartford, Connecticut and 1 other locations)
StatusRecruiting
StartedDecember 12, 2024
Main results expectedNovember 2029
Study endsNovember 2029
Registry record updatedAugust 7, 2026
Trial IDNCT06651333 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are individuals who have recently initiated treatment for opioid use disorder with methadone or buprenorphine and are eligible for MRI scanning.

Probably not a fit

Patients with acute psychosis, severe cognitive impairment, or other significant medical conditions may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study investigates the functional connectivity patterns in the brain using fMRI to understand the risk of relapse to illicit opioids among individuals undergoing treatment for opioid use disorder. Participants will be those who have recently started treatment with methadone or buprenorphine at the APT Foundation. The study aims to identify brain activity that correlates with relapse risk during this critical period of treatment. By analyzing these patterns, researchers hope to gain insights that could inform future interventions and support strategies for individuals in recovery.

Why it matters

Potential benefit: If successful, this study could lead to improved strategies for preventing relapse in individuals undergoing treatment for opioid dependence.

How similar studies have gone: Other studies have explored brain activity in relation to substance use disorders, suggesting that this approach has potential but may still be considered novel in the specific context of opioid relapse.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* recent initiation of methadone or buprenorphine at a clinic, program, or doctor 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.

Where it's running

  • Hartford Healthcare
    Hartford, Connecticut, United States
    Recruiting
  • The APT Foundation
    New Haven, Connecticut, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.