Opioid Use DisorderNCT06207162
Longitudinal Neural Fingerprinting of Opioid-use Trajectories
A study testing fMRI in people with Opioid Use Disorder, run by Yale University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- fMRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Oct 2024to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
MRRC at The Anlyan Center
New Haven, Connecticut, 06520
About this study
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).
Read the 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.
- Conditions
- Opioid Use Disorder
- Being tested
- fMRI
- Keywords
- Medication for Opioid Use Disorder (MOUD)
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fMRIDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: fMRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 12 weeks
Secondary outcomes (1)
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.
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2024
- Study start10 Oct 2024
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Sarah Yip, PhD, MSc, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06207162
- Sponsor's protocol ID
- 2000036564
- Other IDs
- 1R21DA058415-01A1
- Status last verified
- May 2026
- First submitted
- 19 Dec 2023
- Last updated
- 27 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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).
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Neural Fingerprinting of Opioid-use Trajectories
- ClinicalTrials.gov ID
- NCT06207162
- Acronym / sponsor ID
- 2000036564
- Conditions
- Opioid Use Disorder
- Keywords
- Medication for Opioid Use Disorder (MOUD)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 10 Oct 2024 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 16 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| neural fingerprinting of MOUD | Experimental | Diagnostic Test: fMRIStudy 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 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fMRIParticipants 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. | Diagnostic test | neural fingerprinting of MOUD |
Primary outcome
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
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.
1 secondary outcome
Change in Presence or absence of opioid use
Time frame: up to 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Individual participant dataSharing planned: Yes. 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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Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Substance Use Disorders (SUDs)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sarah Yip, PhD, MSc principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fMRI in people with Opioid Use Disorder, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah Yip, PhD, MSc (203 704 7588, sarah.yip@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.