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 — DEVICE
    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 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 OUD
    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.

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

Locations (1)

FacilityCityStateZIPSite coordinators
APT FoundationNew HavenConnecticut06520-

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