Recruiting NCT06651333

fMRI and Opioid Abstinence

— Observational Drug Use Disorder Opioid Dependence Opioid-Related Disorders Opioid Use

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: fMRI.
Who it may be relevant to: Registry conditions: Drug Use Disorder, Opioid Dependence, Opioid-Related Disorders, Opioid Use. Basic parameters: 18 years — 50 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Official title

Functional Connectivity Mechanisms of Opioid Abstinence

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

Diagnostic test 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.

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

Secondary outcome measures (1)

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.

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

United States · 2 centers

NCT: NCT06651333 · 2000038046 · 1R01DA060631-01