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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21DA058415-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 α. This is a participant-specific known-risk tolerance parameter. | up to 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sarah Yip, PhD, MSc | Contact | 203 704 7588 | sarah.yip@yale.edu |
| Name | Affiliation | Role |
|---|---|---|
| Sarah Yip, PhD, MSc | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MRRC at The Anlyan Center | Recruiting | New Haven | Connecticut | 06520 | United States |
This study will submit and share data with OpenNeuro. This will include de-identified demographic data, neuropsychological assessment data, clinical assessment data, and fMRI data (raw).
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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.
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.
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D008279 | Magnetic Resonance Imaging |
| ID | Term |
|---|---|
| D014054 | Tomography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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