fMRI and Opioid Abstinence

Yale University

Status: Enrolling

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

Treatments: Diagnostic Test: fMRI

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT06651333

1R01DA060631-01 (U.S. NIH Grant/Contract)

2000038046

Details and patient eligibility

About

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

Enrollment: 240 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

240 participants in 2 patient groups

Methadone

Description:

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

Treatment:

Diagnostic Test: fMRI

Buprenorphrine

Description:

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

Treatment:

Diagnostic Test: fMRI