Real-time Opioid Study

NCT07768007 | Not Yet Recruiting

• 1 other identifier: 2000025618_a
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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)

Outcome Measures

Primary Outcomes (2)

• Number of participants who completed the intervention

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

  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.

  Up to one month post second neurofeedback session

Secondary Outcomes (2)

• Percentage of positive memories recalled as assessed by Autobiographical Memory Test (AMT)

  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)

  Baseline, one week post second neurofeedback session and one month post second neurofeedback session

Study Arms (1)

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.

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

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.

Individuals with OUD

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

APT Foundation

New Haven, Connecticut, 06520, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Neurofeedback

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Biofeedback, Psychology; Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Study Officials

• Michelle Hampson, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

• Kathleen Garrison, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Paprotna

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2026
• First Posted: August 17, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: August 17, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share

Locations

US (1)