Recruiting

fMRI & Opioid

Sponsor:

Yale University

Code:

NCT06651333

Conditions

Drug Use Disorder

Opioid Dependence

Opioid-Related Disorders

Opioid Use

Opioid Abuse

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Not accepted

Interventions

fMRI

Study Details

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

Study ID

NCT06651333

Start date

Dec 12, 2024

Status verified date

Aug, 2026

Completion date

Nov, 2029

Anticipated

Primary completion date

Nov, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

240 participants

Anticipated

Interventions and Outcome Measures

Arms

Methadone

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

Buprenorphrine

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

Interventions

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.

Primary outcome measure

  • Illicit opioid-use [ Time Frame: At monthly visits for 6 months following neuroimaging ]

Central Contacts and Locations

Central contacts

Monica Holler

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

Locations

Hartford Healthcare

Recruiting

Hartford, Connecticut, United States, 06102

Contacts

Monica Holler

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

Principal Investigator:

Vaughn Steele

The APT Foundation

Recruiting

New Haven, Connecticut, United States, 06520

More Information

Sponsor

Yale University

Last update posted

Aug 7, 2026

Last verified

Aug, 2026

Keywords

  • Relapse

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Yale University on 2026-08-07.