Longitudinal Neural Fingerprinting of Opioid-use Trajectories

NCT ID: NCT06207162

Last Updated: 2025-08-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-10
• Study Completion Date: 2026-01-31

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).

Detailed Description

MOUD individuals between the ages of 18 and 50 who recently enrolled in methadone treatment at APT Foundation clinics in the greater New Haven area. Investigators will aim to recruit individuals as early as possible in treatment, but individuals may be within the first 6 months of treatment at the time of screening, as this may be necessary to ensure that they are on a stable dose of methadone.

AIM 1 - Longitudinal neural fingerprinting of MOUD to repeatedly characterize neural trajectories of individuals in early methadone treatment.

AIM 2 - Complementary, longitudinal computational phenotyping of MOUD to repeatedly characterize behavioral, computational trajectories of individuals in early methadone treatment.

After participation in the main study, participants will be asked to complete a 15-minute follow up every month for an additional three months.

Conditions

Opioid Use Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

neural fingerprinting of MOUD

Study participants will have one in-person screening (2 hours), 6 in-person visits for fMRI scans conducted biweekly (4 hours), and will be computationally assessed 12 times, once per week for 12 weeks. After participation in the main study, participants will be asked to complete a 15-minute follow up every month for an additional three months

Group Type: EXPERIMENTAL

fMRI

Intervention Type: DIAGNOSTIC_TEST

Participants will be performing tasks while undergoing fMRI. Tasks include Stroop task, Emotion-regulation task and an Ambiguity reward task. There will also be a Resting state: Participants are not presented with any specific stimulus.

Interventions

fMRI

Participants will be performing tasks while undergoing fMRI. Tasks include Stroop task, Emotion-regulation task and an Ambiguity reward task. There will also be a Resting state: Participants are not presented with any specific stimulus.

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sarah Yip, PhD, MSc

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

MRRC at The Anlyan Center

New Haven, Connecticut, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Sarah Yip, PhD, MSc

Role: CONTACT

sarah.yip@yale.edu

203 704 7588

Other Identifiers

1R21DA058415-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2000036564

Identifier Type: -

Identifier Source: org_study_id