Examining brain activity patterns related to opioid relapse during treatment
Functional Connectivity Mechanisms of Opioid Abstinence
This study is testing how brain activity patterns might predict the risk of relapse to opioid use in people who have just started treatment with methadone or buprenorphine.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 240 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | Yale University Academic / other |
| Locations | 1 site (New Haven, Connecticut) |
| Trial ID | NCT06651333 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the functional connectivity patterns in the brain using fMRI to understand the risk of relapse to illicit opioids among individuals undergoing treatment for opioid use disorder. Participants will be those who have recently started treatment with methadone or buprenorphine at the APT Foundation. The study aims to identify brain activity that correlates with relapse risk during this critical period of treatment. By analyzing these patterns, researchers hope to gain insights that could inform future interventions and support strategies for individuals in recovery.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals who have recently initiated treatment for opioid use disorder with methadone or buprenorphine and are eligible for MRI scanning.
Not a fit: Patients with acute psychosis, severe cognitive impairment, or other significant medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved strategies for preventing relapse in individuals undergoing treatment for opioid dependence.
How similar studies have performed: Other studies have explored brain activity in relation to substance use disorders, suggesting that this approach has potential but may still be considered novel in the specific context of opioid relapse.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * recent initiation of methadone or buprenorphine at a clinic or program 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. Exclusion Criteria: * 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.
Where this trial is running
New Haven, Connecticut
- The APT Foundation — New Haven, Connecticut, United States (Recruiting)
Study contacts
- Principal investigator: Sarah Yip, PhD, MSc — Yale University
- Study coordinator: Monica Holler, BS
- Email: monica.holler@yale.edu
- Phone: 203 737 3531
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.