Substance Use Disorder (SUD)NCT07768007
Real-time Opioid Study
A study testing real-time functional magnetic resonance imaging (rt-fMRI) neurofeedback in people with Substance Use Disorder (SUD), run by Yale University at 1 site in United States.
Trial summary
This feasibility study collects initial data on the use of an fMRI neurofeedback protocol for treating anhedonia in methadone-treated individuals with opioid use disorder (OUD). The intervention tested has previously been shown to reduce anhedonia in individuals with depression and this study is collecting… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Substance Use Disorder (SUD)
- What is being tested?
- real-time functional magnetic resonance imaging (rt-fMRI) neurofeedback
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Sep 2026to Feb 2027
- Phase
- Interventional
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
- ≥3 months of methadone treatment for OUD
- Presence of anhedonia, as assessed via SHAPS
- Room for improvement in specific autobiographical memory recall, as assessed via AMT
Who cannot join
- Failure to pass an MRI screening
- Women who are pregnant
- Psychosis, as assessed via Yale PRIME Early Psychosis Screening Test
- Serious suicidal ideation
- Serious medical condition
- Legally blind
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
APT Foundation
New Haven, Connecticut, 06520
About this study
Official title: Neurofeedback to Reduce Anhedonia and Improve Outcomes in Opioid Use Disorder: a Feasibility Study
This feasibility study collects initial data on the use of an fMRI neurofeedback protocol for treating anhedonia in methadone-treated individuals with opioid use disorder (OUD). The intervention tested has previously been shown to reduce anhedonia in individuals with depression and this study is collecting first-in-human data in an OUD population. Investigators will assess tolerability of the intervention and collect preliminary data from 2-3 subjects monitoring changes in anhedonia, non-substance-related autobiographical memory recall, and meaning in life.
- Conditions
- Substance Use Disorder (SUD)
- Being tested
- real-time functional magnetic resonance imaging (rt-fMRI) neurofeedback
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
real-time functional magnetic resonance imaging (rt-fMRI) neurofeedbackDevice
A non-invasive, non-pharmacological therapeutic tool that enables an individual to learn to modulate their neural activity in order to effect behavioral change.
| Study group | Role | What they receive |
|---|---|---|
| Individuals with OUD | Experimental | Participants will complete five study visits. They will receive neurofeedback at two separate scanning sessions (sessions 2-3). Neurofeedback scans will include rest, neurofeedback, and transfer (i.e., no feedback) runs, one week apart. Receives: Device: real-time functional magnetic resonance imaging (rt-fMRI) neurofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who completed the intervention
Number of participants who completed the full intervention of those enrolled.
Measured: Through study completion, up to one month post second neurofeedback session
Self-report ratings of tolerability
Questionnaire where participants indicate how worthwhile participating in the study was on a 1-7 Likert scale. Total score range 1-7 with higher numbers indicating greater tolerability.
Measured: Up to one month post second neurofeedback session
Secondary outcomes (2)
Percentage of positive memories recalled as assessed by Autobiographical Memory Test (AMT)
A psychological assessment used to measure how specifically an individual can recall positive personal, life-related events.
Measured: Baseline, one week post second neurofeedback session and one month post second neurofeedback session
Changes in anhedonia, as assessed by the Snaith-Hamilton Pleasure Scale (SHAPS)
Total score range 0-14 with higher scores reflecting a higher level of anhedonia (the inability to experience pleasure).
Measured: Baseline, one week post second neurofeedback session and one month post second neurofeedback session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study start8 Sep 2026
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Use Disorder (SUD)Studies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michelle Hampson, PhD, Principal investigator, Yale UniversityKathleen Garrison, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07768007
- Sponsor's protocol ID
- 2000025618_a
- Status last verified
- Sep 2026
- First submitted
- 11 Aug 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: De-identified data will be shared with other researchers.