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Search / Trial NCT06651333

fMRI and Opioid Abstinence

Launched by YALE UNIVERSITY · Oct 18, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Relapse

ClinConnect Summary

This clinical trial is studying how certain brain activity patterns may relate to the risk of relapse in people recovering from opioid dependence. The researchers are particularly interested in those who have recently started treatment with medications like methadone or buprenorphine, which help manage opioid withdrawal and cravings. By using brain scans (called fMRI), they hope to understand how these patterns can predict if someone might return to using illicit opioids during their treatment.

To be eligible for the study, participants should be between 18 and 65 years old and have started treatment at the APT Foundation in the last six months. They must also be able to safely undergo an MRI scan and commit to attending study visits. However, individuals with severe mental health issues, significant cognitive impairments, or certain medical conditions may not qualify. Participants will undergo brain scans and assessments, and while the study aims to gather important information, it also seeks to create a better understanding of how to support recovery from opioid use.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • recent initiation of methadone or buprenorphine at APT Foundation within the last 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.

About Yale University

Yale University, a prestigious Ivy League institution located in New Haven, Connecticut, is renowned for its commitment to advancing medical research and clinical innovation. With a rich history of academic excellence and a robust infrastructure for scientific inquiry, Yale serves as a leading sponsor for clinical trials aimed at improving patient care and developing new therapeutic approaches. The university's multidisciplinary teams of researchers and clinicians collaborate to conduct rigorous and ethical studies, leveraging cutting-edge technologies and methodologies to address critical health challenges. Through its dedication to fostering an environment of inquiry and discovery, Yale University plays a pivotal role in translating research findings into clinical practice, ultimately enhancing health outcomes for diverse populations.

Locations

New Haven, Connecticut, United States

Patients applied

0 patients applied

Trial Officials

Sarah Yip, PhD, MSc

Principal Investigator

Yale University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported