Real-time Opioid Study
Part of paid clinical trials in New Haven, Connecticut.
- Sponsor
- Yale University
- Study ID
- NCT07768007
- Status
- Not Yet Recruiting
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Conditions
- Substance Use Disorder (SUD)
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 50 Years
- Healthy Volunteers
- Not accepted
Interventions
- real-time functional magnetic resonance imaging (rt-fMRI) neurofeedback — DEVICEA non-invasive, non-pharmacological therapeutic tool that enables an individual to learn to modulate their neural activity in order to effect behavioral change.
Study Details
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.
Key Dates
- First listed
- Aug 17, 2026
- Start date
- Aug 31, 2026
- Status verified
- Jul 2026
- Primary completion
- Feb 28, 2027
- Completion
- Feb 28, 2027
Study Design
- Enrollment
- 3 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Individuals with OUDParticipants 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.
Primary Outcome Measure
Number of participants who completed the intervention [ Time Frame: Through study completion, up to one month post second neurofeedback session ]
Central Contacts
- Sarah Paprotna+1 (203) 737-5994
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| APT Foundation | New Haven | Connecticut | 06520 | - |
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