RecruitingNot Applicable

fMRI and Opioid Abstinence

United States240 participantsStarted 2024-12-12

Plain-language summary

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

Who can participate

Age range

18 Years – 50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Illicit opioid-use

Timeframe: At monthly visits for 6 months following neuroimaging

Trial details

NCT IDNCT06651333

SponsorYale University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2029-11

Contact for this trial

Monica Holler

203-278-1107 monica.holler@yale.edu

View on ClinicalTrials.gov More Drug Use Disorder trials

Who can participate

Age range

18 Years – 50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.