Tracking brain changes in people undergoing treatment for opioid use disorder
Longitudinal Neural Fingerprinting of Opioid-use Trajectories
NA · Yale University · NCT06207162
This study is trying to see how brain changes in people getting treatment for opioid use disorder with methadone happen over time to help improve future treatments.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | Yale University (other) |
| Locations | 1 site (New Haven, Connecticut) |
| Trial ID | NCT06207162 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 50 who are within the first six months of stable methadone treatment for opioid use disorder.
Not a fit: Patients with current severe mental health issues, significant cognitive impairment, or those not on a stable dose of methadone may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and effective treatment strategies for individuals with opioid use disorder.
How similar studies have performed: While there have been studies on neuroimaging in opioid use disorder, this longitudinal approach focusing on neural trajectories during treatment phases is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
New Haven, Connecticut
- 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
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.
Conditions: Opioid Use Disorder, Medication for Opioid Use Disorder