Tracking brain changes in people undergoing treatment for opioid use disorder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This project aims to gather detailed neuroimaging data from individuals receiving medications for opioid use disorder (MOUD) to understand their brain changes over time. The study will focus on participants who are within the first six months of methadone treatment, capturing their neural and behavioral trajectories through repeated assessments. By utilizing fMRI technology, the researchers will identify critical phases in treatment that may indicate increased neural plasticity, potentially guiding future interventions. Participants will also complete monthly follow-ups for three months after the main study.

Why it matters

Who can join: the full rules

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

Where it's running

• MRRC at The Anlyan Center
  New Haven, Connecticut, United States Recruiting

Study contacts

• Principal investigator: Sarah Yip, PhD, MSc — Yale University
• Study coordinator: Sarah Yip, PhD, MSc
• Email: sarah.yip@yale.edu
• Phone: 203 704 7588

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• CBD for Opioid Dependence and Pain on Buprenorphine

  This study tests whether different doses of cannabidiol (CBD) can affect pain and opioid cravings in adults with opioid use disorder who are on buprenorphine, using a short, randomized, placebo-controlled setup.

  Recruiting Early Phase 1 Yale University · West Haven, Connecticut · NCT07886606

• Cebranopadol for opioid withdrawal in adults with chronic pain

  This study tests whether cebranopadol can reduce withdrawal symptoms in adults with chronic pain who are physically dependent on prescribed opioids, compared with placebo.

  Recruiting at 2 sites Phase 2 Adneuris Therapeutics, Inc. · North Canton, Ohio and 1 other locations · NCT07874620

• emPath platform pilot to link and keep adults with opioid use disorder in care in Durham

  This pilot tests a mobile app and telemedicine approach to help adults with opioid use disorder start and stay in MOUD through community outreach in Durham, NC.

  Recruiting Duke University · Durham, North Carolina · NCT07810322

• CB1 Receptors in Opioid Use Disorder Measured with a PET Radioligand

  This study tests CB1 receptor availability in people with opioid use disorder starting opioid agonist therapy and compares them with healthy adults.

  Recruiting Phase 1 Yale University · New Haven, Connecticut · NCT07800520

• STORC: Training a support person plus patient navigation after birth

  We’re testing whether training a designated support person and using patient navigation after delivery helps people with opioid use disorder build recovery resources and stay in treatment.

  Recruiting Friends Research Institute, Inc. · Philadelphia, Pennsylvania · NCT07787039

• Personalized Addiction Treatment Enhancement for Opioid Use Disorder

  A digital platform run by peer recovery supporters will be tested to help adults with opioid use disorder who are on buprenorphine or methadone stay in treatment and improve outcomes.

  Recruiting Rhode Island Hospital · Providence, Rhode Island · NCT07778394

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.