Longitudinal Neural Fingerprinting of Opioid-use Trajectories

Status Not yet recruiting

Clinical Trial 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).

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06207162
Study type	Interventional
Source	Yale University
Contact	Sarah Yip, PhD, MSc
Phone	203 704 7588
Email	sarah.yip@yale.edu
Status	Not yet recruiting
Phase	N/A
Start date	April 2024
Completion date	January 2026

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.