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Recruiting

NCT Number: NCT06651333

fMRI and Opioid Abstinence

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

Recruiting

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The APT Foundation

New Haven, Connecticut, 06520, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

fMRI

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.

Primary outcomes

  1. Illicit opioid-use

    Time frame: At monthly visits for 6 months following neuroimaging

    Defined 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 outcomes

  1. MOUD retention

    Time frame: up to 9 months

    Percentage of visits attended out of visits expected based on electronic health record data and time line follow back.

Study contacts

Contact information is provided by the study sponsor or research team.

Monica Holler, BS

CONTACT

[email protected]

203 737 3531

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Functional Connectivity Mechanisms of Opioid Abstinence

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Oct 21, 2024
Registry last updated
Oct 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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