CClinicalTrials.gg
RecruitingNCT07768007Updated Sep 14, 2026

Real-time Opioid Study

An interventional study of real-time functional magnetic resonance imaging (rt-fMRI) neurofeedback in Substance Use Disorder (SUD), sponsored by Yale University. Recruiting at 1 site in United States. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-09-14.

Sponsored by Yale University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
3
Allocation
Not applicable
Ages
18 Years to 50 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Substance Use Disorder (SUD)
03

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • ≥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

Exclusion criteria

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
3 participants (estimated)

Study 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.

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

Interventions

  • Devicereal-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.

05

What researchers measure

Primary outcomes

  1. Number of participants who completed the intervention

    Number of participants who completed the full intervention of those enrolled.

    Time frame: Through study completion, up to one month post second neurofeedback session

  2. 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.

    Time frame: Up to one month post second neurofeedback session

Secondary outcomes

  1. 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.

    Time frame: Baseline, one week post second neurofeedback session and one month post second neurofeedback session

  2. 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).

    Time frame: Baseline, one week post second neurofeedback session and one month post second neurofeedback session

06

Study locations

1 of 1 sites recruiting
  • APT Foundation
    New Haven, Connecticut 06520, United States
    Recruiting
07

References and documents

Individual participant data

Plan to share: Yes — De-identified data will be shared with other researchers.

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07768007
Lead sponsor
Yale University
Responsible party
Sponsor
First posted
Aug 17, 2026
Start date
Sep 8, 2026
Primary completion
Feb 2027 (estimated)
Completion
Feb 2027 (estimated)
Last update
Sep 14, 2026

Study contacts

Sarah Paprotna
Contact
sarah.paprotna@yale.edu
+1 (203) 737-5994
Michelle Hampson, PhD
principal investigator · Yale University
Kathleen Garrison, PhD
principal investigator · Yale University

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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