Longitudinal Neural Fingerprinting of Opioid-use Trajectories
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: fMRI.
- Who it may be relevant to
- Registry conditions: Opioid Use Disorder. Basic parameters: 18 years — 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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.
Primary outcome measures
- Change in Relationship between functional connectivity within canonical neural networks and within the 'opioid abstinence network' and opioid use [Time frame: up to 12 weeks]
Secondary outcome measures (1)
- Change in Presence or absence of opioid use [Time frame: up to 12 weeks]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
United States · 1 center
- MRRC at The Anlyan Center — New Haven
Identifiers
NCT: NCT06207162 · 2000036564 · 1R21DA058415-01A1