RECRUITING

Longitudinal Neural Fingerprinting of Opioid-use Trajectories

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

Longitudinal Neural Fingerprinting of Opioid-use Trajectories

Quick Facts

Study Start:2024-10-10
Study Completion:2026-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06207162

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 50 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * within the first 6 months of methadone treatment for OUD and on a stable dose of methadone
  2. * eligibility for MRI scanning
  3. * willing to commit to longitudinal study visits
  1. * current psychosis, mania, or suicidal ideation with intent, as assessed during screening with the SCID-5
  2. * current co-occurring severe substance-use disorders (excluding nicotine and opioids), as assessed during screening with the SCID-5
  3. * 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)
  4. * 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)
  5. * Past or present history of intellectual disability or developmental disorder
  6. * Neurological disease (including seizures or epilepsy) as assessed by self-report and by consulting clinic records
  7. * Head trauma with loss of consciousness of more than 30 minutes
  8. * Organ dysfunction or any unstable or untreated medical conditions that may alter cerebral function or interfere with study participation

Contacts and Locations

Study Contact

Sarah Yip, PhD, MSc
CONTACT
203 704 7588
sarah.yip@yale.edu

Principal Investigator

Sarah Yip, PhD, MSc
PRINCIPAL_INVESTIGATOR
Yale School of Medicine

Study Locations (Sites)

MRRC at The Anlyan Center
New Haven, Connecticut, 06520
United States

Collaborators and Investigators

Sponsor: Yale University

  • Sarah Yip, PhD, MSc, PRINCIPAL_INVESTIGATOR, Yale School of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-10
Study Completion Date2026-01

Study Record Updates

Study Start Date2024-10-10
Study Completion Date2026-01

Terms related to this study

Keywords Provided by Researchers

  • Medication for Opioid Use Disorder (MOUD)

Additional Relevant MeSH Terms

  • Opioid Use Disorder