Longitudinal Neural Fingerprinting of Opioid-use Trajectories

Opioid Use Disorder Clinical Trial

Official title:

Longitudinal Neural Fingerprinting of Opioid-use Trajectories

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06207162
• Other study ID #: 2000036564
• Secondary ID: 1R21DA058415-01A
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: January 2026

Study information

• Verified date: March 2024
• Source: Yale University
• Contact: Sarah Yip, PhD, MSc
• Phone: 203 704 7588
• Email: sarah.yip[@]yale.edu
• Is FDA regulated: No
• Study type: Interventional

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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: January 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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 DSM-5 psychiatric disorders and 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

Related Conditions & MeSH terms

• Opioid Use Disorder
• Opioid-Related Disorders

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
United States	MRRC at The Anlyan Center	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Presence or absence of opioid use	Relationship between performance on the risk and ambiguity task and opioid use over 12 weekly sessions. Parameters are computed from the participant's choice data during task performance at each weekly time point. The primary task parameter is a. This is a participant-specific known-risk tolerance parameter.	up to 12 weeks