Recruiting

fMRI Neurofeedback

Sponsor:

Yale University

Code:

NCT07768007

Conditions

Substance Use Disorder (SUD)

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Not accepted

Interventions

real-time functional magnetic resonance imaging (rt-fMRI) neurofeedback

Study Details

Brief 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 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)

Study ID

NCT07768007

Start date

Aug, 2026

Status verified date

Aug, 2026

Completion date

Feb, 2027

Anticipated

Primary completion date

Feb, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • ≥3 months of methadone treatment for OUD
  • Presence of anhedonia, as assessed via SHAPS
  • Baseline autobiographical memory deficit, as assessed via AMT

Exclusion Criteria:

  • 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

Study Design

Enrollment

3 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

real-time functional magnetic resonance imaging (rt-fMRI) neurofeedback

A non-invasive, non-pharmacological therapeutic tool that enables an individual to learn to modulate their neural activity in order to effect behavioral change.

Primary outcome measure

  • Number of participants who completed the intervention [ Time Frame: Through study completion, up to one month post second neurofeedback session ]
  • Self-report ratings of tolerability [ Time Frame: Up to one month post second neurofeedback session ]

Central Contacts and Locations

Central contacts

Sarah Paprotna

+1 (203) 737-5994sarah.paprotna@yale.edu

Locations

APT Foundation

Recruiting

New Haven, Connecticut, United States, 06520

More Information

Sponsor

Yale University

Last update posted

Aug 31, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Yale University on 2026-08-31.