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fMRI and Opioid Abstinence

Functional Connectivity Mechanisms of Opioid Abstinence

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06651333
Enrollment
240
Registered
2024-10-21
Start date
2024-12-12
Completion date
2029-11-01
Last updated
2026-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Drug Use Disorder, Opioid Abuse, Opioid Dependence, Opioid-Related Disorders, Opioid Use

Keywords

Relapse

Brief summary

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

Interventions

DIAGNOSTIC_TESTfMRI

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.

Sponsors

Yale University
Lead SponsorOTHER
National Institute on Drug Abuse (NIDA)
CollaboratorNIH

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Illicit opioid-useAt monthly visits for 6 months following neuroimagingDefined 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).

Secondary

MeasureTime frameDescription
MOUD retentionup to 9 monthsPercentage of visits attended out of visits expected based on electronic health record data and time line follow back.

Countries

United States

Contacts

CONTACTMonica Holler
monica.holler@yale.edu203-278-1107
PRINCIPAL_INVESTIGATORSarah Yip, PhD, MSc

Yale University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 8, 2026