Drug Use DisorderNCT06651333
fMRI and Opioid Abstinence
An observational study of Drug Use Disorder and Opioid Dependence, run by Yale University at 2 sites in United States.
Trial summary
This project examines functional connectivity patterns associated with subsequent relapse to illicit opioids during treatment for OUD. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Drug Use Disorder, Opioid Dependence, Opioid-Related Disorders
- What is being tested?
- fMRI
- How many people
- 240 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 Dec 2024to Nov 2029
- Phase
- Observational
- 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
Study population: Participants will be individuals with primary opioid use disorder who are at least 18 years old and enrolled in formal MOUD treatment (either methadone or buprenorphine) for less than 6 months. Investigators will recruit a sample that is 50% female and 50% male.
Who may be able to join
- recent initiation of methadone or buprenorphine at a clinic, program, or doctor within the past year (i.e., period of time during which treatment drop-out and risk for relapse is highest);
- eligibility for MRI scanning;
- ability to commit to study visits.
Who cannot join
- current acute psychosis, mania, or suicidal ideation with intent, 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;
- severe cognitive impairment as determined via trained clinical research staff through consent process and during consent quiz or as indicated by a PROMIS Cognitive Function tscore <30 (i.e., severe impairment)
- past or present history of intellectual disability, developmental disorder, or neurological disease;
- head trauma with loss of consciousness >30 min;
- organ dysfunction or any unstable or untreated medical conditions that may interfere with study participation.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Hartford Healthcare
Hartford, Connecticut, 06102
Monica Holler, 203-278-1107, monica.holler@yale.edu
Vaughn Steele
- Recruiting
The APT Foundation
New Haven, Connecticut, 06520
About this study
Official title: Functional Connectivity Mechanisms of Opioid Abstinence
This project examines functional connectivity patterns associated with subsequent relapse to illicit opioids during treatment for OUD.
- Being tested
- fMRI
- Keywords
- Relapse
- Medical subject headings
- Substance-Related Disorders, Opioid-Related Disorders, Recurrence
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, Drug cue task, and Cognitive behavioral therapy task. Participants are not presented with any specific stimulus.
| Study group | Role | What they receive |
|---|---|---|
| Methadone | Participants initiated into methadone within the past 6 months will receive fMRI and cognitive assessment battery. Receives: Diagnostic Test: fMRI | |
| Buprenorphrine | Participants initiated into buprenorphine within the past 6 months will receive fMRI and cognitive assessment battery. Receives: Diagnostic Test: fMRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Illicit opioid-use
Defined as the percent days of self-reported use of illicit opioids (assessed at monthly visits for 6-months following neuroimaging), with the exception of primary type of MOUD (i.e., methadone for methadone treated individuals, buprenorphine for buprenorphine treated individuals).
Measured: At monthly visits for 6 months following neuroimaging
Secondary outcomes (1)
MOUD retention
Percentage of visits attended out of visits expected based on electronic health record data and time line follow back.
Measured: up to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2024
- Study start12 Dec 2024
- Primary completionNov 2029 (estimated)
- Study completionNov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 240 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
- NCT06651333
- Sponsor's protocol ID
- 2000038046
- Other IDs
- 1R01DA060631-01
- Status last verified
- Aug 2026
- First submitted
- 18 Oct 2024
- Last updated
- 7 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- 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 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Connectivity Mechanisms of Opioid Abstinence
- ClinicalTrials.gov ID
- NCT06651333
- Acronym / sponsor ID
- 2000038046
- Keywords
- Relapse
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 12 Dec 2024 (actual)
- Primary completion
- Nov 2029 (estimated)
- Study completion
- Nov 2029 (estimated)
- First posted
- 21 Oct 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 examines functional connectivity patterns associated with subsequent relapse to illicit opioids during treatment for OUD.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methadone | – | Diagnostic Test: fMRIParticipants initiated into methadone within the past 6 months will receive fMRI and cognitive assessment battery. |
| Buprenorphrine | – | Diagnostic Test: fMRIParticipants initiated into buprenorphine within the past 6 months will receive fMRI and cognitive assessment battery. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Participants will be individuals with primary opioid use disorder who are at least 18 years old and enrolled in formal MOUD treatment (either methadone or buprenorphine) for less than 6 months. Investigators will recruit a sample that is 50% female and 50% male.
Key inclusion criteria (3 listed)
- recent initiation of methadone or buprenorphine at a clinic, program, or doctor within the past year (i.e., period of time during which treatment drop-out and risk for relapse is highest);
- eligibility for MRI scanning;
- ability to commit to study visits.
Key exclusion criteria (6 listed)
- current acute psychosis, mania, or suicidal ideation with intent, 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;
- severe cognitive impairment as determined via trained clinical research staff through consent process and during consent quiz or as indicated by a PROMIS Cognitive Function tscore <30 (i.e., severe impairment)
- past or present history of intellectual disability, developmental disorder, or neurological disease;
- head trauma with loss of consciousness >30 min;
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, Drug cue task, and Cognitive behavioral therapy task. Participants are not presented with any specific stimulus. | Diagnostic test | Buprenorphrine, Methadone |
Primary outcome
Illicit opioid-use
Time frame: At monthly visits for 6 months following neuroimaging
Defined as the percent days of self-reported use of illicit opioids (assessed at monthly visits for 6-months following neuroimaging), with the exception of primary type of MOUD (i.e., methadone for methadone treated individuals, buprenorphine for buprenorphine treated individuals).
1 secondary outcome
MOUD retention
Time frame: up to 9 months
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 7 Aug 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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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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Drug Use Disorder and Opioid Dependence, run by Yale University at 2 sites 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 6 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 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Monica Holler (203-278-1107, monica.holler@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Illicit opioid-use (time frame: At monthly visits for 6 months following neuroimaging). 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 7 Aug 2026.