Neurofeedback During Naturalistic Stimuli to Reduce Craving in Heroin Addiction

NCT ID: NCT07344233

Last Updated: 2026-01-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-20
• Study Completion Date: 2025-08-31

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Real Neurofeedback

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

Group Type: EXPERIMENTAL

Real-time fMRI Neurofeedback

Intervention Type: BEHAVIORAL

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

Sham (yolked) Neurofeedback

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

Group Type: SHAM_COMPARATOR

Sham Real-time fMRI Neurofeedback

Intervention Type: BEHAVIORAL

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

Interventions

Real-time fMRI Neurofeedback

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

Intervention Type: BEHAVIORAL

Sham Real-time fMRI Neurofeedback

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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
• 2-4 week abstinence from non-prescribed opioid use/stabilized on medication assisted therapy (MAT) using either methadone and/or buprenorphine.

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Rita Goldstein

Professor of Psychiatry and Neuroscience

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rita Goldstein, PhD

Role: PRINCIPAL_INVESTIGATOR

NARC@mssm.edu

Locations

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Countries

United States

Other Identifiers

R21DA058801

Identifier Type: NIH

Identifier Source: secondary_id

View Link

GCO 22-1694

Identifier Type: -

Identifier Source: org_study_id