Recruiting

Observational Study

Sponsor:

Yale University

Code:

NCT06207162

Conditions

Opioid Use Disorder

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Not accepted

Interventions

fMRI

Study Details

Brief summary:

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).

Conditions

Opioid Use Disorder

Study ID

NCT06207162

Start date

Oct 10, 2024

Status verified date

May, 2026

Completion date

Jan, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: neural fingerprinting of MOUD

Study participants will have one in-person screening (2 hours), 6 in-person visits for fMRI scans conducted biweekly (4 hours), and will be computationally assessed 12 times, once per week for 12 weeks. After participation in the main study, participants will be asked to complete a 15-minute follow up every month for an additional three months

Interventions

fMRI

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.

Primary outcome measure

  • Change in Relationship between functional connectivity within canonical neural networks and within the 'opioid abstinence network' and opioid use [ Time Frame: up to 12 weeks ]

Central Contacts and Locations

Central contacts

Sarah Yip, PhD, MSc

203 704 7588sarah.yip@yale.edu

Locations

MRRC at The Anlyan Center

Recruiting

New Haven, Connecticut, United States, 06520

More Information

Sponsor

Yale University

Last update posted

May 27, 2026

Last verified

May, 2026

Keywords

  • Medication for Opioid Use Disorder (MOUD)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Yale University on 2026-05-27.