What this study is
This project aims to collect a densely sampled neuroimaging dataset among individuals receiving medications for opioid use disorder (MOUD). MOUD is multiphasic, comprised of medication induction, stabilization, ongoing treatment, and eventual dis-continuation phases. However, with a few small exceptions, existing neuroimaging efforts are almost exclusively single time-point assessments which, by definition, fail to capture these clinically relevant transitions and thus also do not capture individual risk and resilience trajectories. The investigators innovation, the characterization of neurocomputational trajectories during clinically relevant phases of MOUD treatment, will provide unprecedented mechanistic insight into the neurobiological basis of recovery. Once characterized, such trajectories may be used in the identification of specific therapeutic windows for additional intervention (e.g., times of increased neural plasticity) and in the design of novel tailored interventions based on known brain mechanisms (e.g., behavioral therapy, neurostimulation, neurofeedback).
What's being tested
- fMRI
Intervention · DIAGNOSTIC TEST
Participants will be performing tasks while undergoing fMRI. Tasks include Stroop task, Emotion-regulation task and an Ambiguity reward task. There will also be a Resting state: Participants are not presented with any specific stimulus.
Study details
- Sponsor
- Yale University
- Conditions
- Opioid Use Disorder
- Enrolling
- 10 people
- Starts
- 2024-10-10
- Est. completion
- 2027-01
- Design
- Open-label, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 50 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- Within the first 6 months of methadone treatment for OUD and on a stable dose of methadone
- Eligibility for MRI scanning
- Willing to commit to longitudinal study visits
You can't join if
- Current psychosis, mania, or suicidal ideation with intent, as assessed during screening with the SCID-5
- Current co-occurring severe substance-use disorders (excluding nicotine and opioids), 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 (these individuals will be allowed to enroll at a later date once stable)
- Severe cognitive impairment (determined through consent process conducted by trained clinical research staff and during consent quiz or as indicated by a PROMIS Cognitive Function t-score <30 (i.e., score indicating severe impairment)
- Past or present history of intellectual disability or developmental disorder
- Neurological disease (including seizures or epilepsy) as assessed by self-report and by consulting clinic records
- Head trauma with loss of consciousness of more than 30 minutes
- Organ dysfunction or any unstable or untreated medical conditions that may alter cerebral function or interfere with study participation
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openMRRC at The Anlyan Center
New Haven, Connecticut, United States
Recruiting
Study team
Sponsor
Yale University
Study ID 2000036564
Principal investigator
Sarah Yip, PhD, MSc
Yale University
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.