Neurofeedback During Naturalistic Stimuli to Reduce Craving in Heroin Addiction

NCT07344233 | Completed

• 2 other identifiers: GCO 22-1694R21DA058801
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

Support groups are an important component of addiction treatment, where individuals at more stable stages of their recovery help others by sharing personal experiences. This phenomenon suggests that the brain states of individuals further along in their recovery process may be useful in guiding those who are at an earlier stage. In this project, the researchers will test this idea and develop a personalized therapeutic tool based on real-time fMRI neurofeedback, whereby individuals with heroin use disorder (iHUD) early in treatment will learn to modulate their own brain state to more closely align with iHUD who are at later stages of treatment. Specifically, iHUD exhibit heightened reactivity to naturalistic drug cues in brain networks underlying salience attribution, reward processing, executive function and others. This fMRI brain hyperactivity pattern is reduced, concomitant with craving reductions, with about 3 months of inpatient treatment. In this neurofeedback project, iHUD who are beginning treatment will view naturalistic drug cues and receive feedback about how similar their brain activity is to the target recovery pattern, learning to modulate their own brain activity to reduce drug cue reactivity and craving. This study will offer insights into the mechanisms of recovery in addiction, particularly as coordinated across individuals with shared experience and goals. If successful, the neurofeedback-based training may lead to new brain-based and personalized tools for recovery in this devastating disorder.

Conditions

Opioid Use Disorder; Substance Use Disorder; Heroin Use Disorder

Outcome Measures

Primary Outcomes (1)

• Cue/movie-induced craving score

  Self-reported ratings of heroin craving on a 0-9 point scale, with higher scores indicating higher craving.

  Immediately before and immediately after neurofeedback procedure

Secondary Outcomes (1)

• Neurofeedback Score Change

  During each 20 minute neurofeedback training session. Participants complete 8 neurofeedback sessions over the course of 4 consecutive days.

Study Arms (2)

Real Neurofeedback

EXPERIMENTAL

Participants receive real-time fMRI neurofeedback reflecting their own brain activity during a drug-related movie.

Behavioral: Real-time fMRI Neurofeedback

Sham (yolked) Neurofeedback

SHAM COMPARATOR

Participants receive sham real-time fMRI neurofeedback yoked to a matched participant and unrelated to their own brain activity.

Behavioral: Sham Real-time fMRI Neurofeedback

Interventions

Real-time fMRI Neurofeedback BEHAVIORAL

Real-time feedback reflecting the similarity between participant's brain activity patterns and a predefined target while viewing a drug-related movie.

Real Neurofeedback

Sham Real-time fMRI Neurofeedback BEHAVIORAL

Real-time feedback yoked to another participant and not reflective of the participant's own brain activity.

Sham (yolked) Neurofeedback

Eligibility Criteria

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

You may qualify if:

• Ability to understand, give informed consent and perform the tasks
• males and females 18-64 years of age at the time of enrollment in the study
• DSM-5 diagnosis of opioid use disorder with heroin as the primary drug of choice
• currently enrolled in a treatment facility for heroin use as the primary concern
• week abstinence from non-prescribed opioid use/stabilized on medication assisted therapy (MAT) using either methadone and/or buprenorphine.

You may not qualify if:

• present or past history of a neurodevelopmental, neurological, or a psychotic disorder
• head trauma with loss of consciousness for more than 30 min
• use of medications (current or in the last 6 months) with known CNS effects which may alter cerebral function, with the exception of psychotropics for the treatment of pain/depression/anxiety/PTSD (e.g. SSRIs) or as otherwise determined by the Principle Investigator
• current medical illness and/or evident infection
• being pregnant or nursing
• contraindications to the MRI environment

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA): collaborator
• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Rita Goldstein, PhD

  NARC@mssm.edu

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry and Neuroscience

Study Record Dates

• First Submitted: January 14, 2026
• First Posted: January 15, 2026
• Study Start: May 20, 2025
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Immediately following publication. No end date.
• Access Criteria: Researchers who provide a methodologically sound proposal. Any purpose. Specify Other Mechanism Researchers who provide a methodologically sound proposal. Any purpose. Proposals should be directed to NARC@mssm.edu. To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)