fMRI and Opioid Abstinence

NCT ID: NCT06651333

Last Updated: 2025-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

240 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-12

Study Completion Date

2029-11-30

Brief Summary

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

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Methadone

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

fMRI

Intervention Type DIAGNOSTIC_TEST

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.

Buprenorphrine

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

fMRI

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sarah Yip, PhD, MSc

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

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The APT Foundation

New Haven, Connecticut, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Monica Holler, BS

Role: CONTACT

203 737 3531

Other Identifiers

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1R01DA060631-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2000038046

Identifier Type: -

Identifier Source: org_study_id

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