Longitudinal Neural Fingerprinting of Opioid-use Trajectories

NCT06207162 | Recruiting

• 2 other identifiers: 20000365641R21DA058415-01A1
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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).

Conditions

Opioid Use Disorder

Keywords

Medication for Opioid Use Disorder (MOUD)

Outcome Measures

Primary Outcomes (1)

• Change in Relationship between functional connectivity within canonical neural networks and within the 'opioid abstinence network' and opioid use

  Relationship between functional connectivity within canonical neural networks and within the 'opioid abstinence network' and opioid use over 6 biweekly sessions. Functional connectivity is computed as the Pearson's correlation between two brain regions, or 'nodes'. This will be done in a pairwise manner to obtain connectivity values for all possible node pairs in the Shen atlas, a 268-node atlas covering the cortex, subcortex and cerebellum. Correlation coefficients are transformed to Z-scores using Fisher's r-to-z transformation. Connectivity within a given network is defined as the mean of the Z values for all of the edges (connection between two node pairs) within the network.

  up to 12 weeks

Secondary Outcomes (1)

• Change in Presence or absence of opioid use

  up to 12 weeks

Study Arms (1)

neural fingerprinting of MOUD

EXPERIMENTAL

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

Diagnostic Test: fMRI

Interventions

fMRI 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.

neural fingerprinting of MOUD

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

MRRC at The Anlyan Center

New Haven, Connecticut, 06520, United States

RECRUITING

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Sarah Yip, PhD, MSc

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Yip, PhD, MSc

CONTACT

203 704 7588; sarah.yip@yale.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2023
• First Posted: January 16, 2024
• Study Start: October 10, 2024
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: August 29, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Time Frame: All data will be deposited to OpenNeuro starting 24 months after data collection begins and will be deposited every six months thereafter. OpenNeuro policy states that any data uploaded to their repository becomes publicly available under a Creative Commons CC0 license after a 36-month period beginning from first successful version of the dataset.
• Access Criteria: OpenNeuro policy states that any data uploaded to their repository becomes publicly available under a Creative Commons (CC) license after a 36-month period beginning from first successful version of the dataset. Users create an account with OpenNeuro account in order to download BIDS formatted files and any associated metadata.

Locations

US (1)