NCT06207162 Longitudinal Neural Fingerprinting of Opioid-use Trajectories
| NCT ID | NCT06207162 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Yale University |
| Condition | Opioid Use Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2024-10-10 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 10 participants in total. It began in 2024-10-10 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility 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
Contact & Investigator
Sarah Yip, PhD, MSc
PRINCIPAL INVESTIGATOR
Yale University
Frequently Asked Questions
Who can join the NCT06207162 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 50 Years, studying Opioid Use Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06207162 currently recruiting?
Yes, NCT06207162 is actively recruiting participants. Contact the research team at sarah.yip@yale.edu for enrollment information.
Where is the NCT06207162 trial being conducted?
This trial is being conducted at New Haven, United States.
Who is sponsoring the NCT06207162 clinical trial?
NCT06207162 is sponsored by Yale University. The principal investigator is Sarah Yip, PhD, MSc at Yale University. The trial plans to enroll 10 participants.