fMRI and Opioid Abstinence
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-50
SponsorYale University
About this trial
This project examines functional connectivity patterns associated with subsequent relapse to illicit opioids during treatment for OUD.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial population
Participants will be individuals with primary opioid use disorder who are at least 18 years old and enrolled in formal MOUD treatment (either methadone or buprenorphine) for less than 6 months. Investigators will recruit a sample that is 50% female and 50% male.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
fMRI
Diagnostic testParticipants 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.
Treatment groups
240 Participants
are divided into 2 treatment groupsGroup A: Methadone1 intervention
Group B: Buprenorphrine1 intervention
Trial outcomes
Primary outcomes
1
Illicit opioid-use
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).
Time frame
At monthly visits for 6 months following neuroimagingSecondary outcomes
1
MOUD retention
Percentage of visits attended out of visits expected based on electronic health record data and time line follow back.
Time frame
up to 9 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Yale University
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
Source ClinicalTrials.gov