Neurofeedback During Naturalistic Stimuli to Reduce Craving in Heroin Addiction

January 14, 2026 updated by: Rita Goldstein, Icahn School of Medicine at Mount Sinai

Brain-to-brain Neurofeedback During Naturalistic Dynamic Stimuli to Reduce Craving in Heroin Addiction

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
28

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Real Neurofeedback
Participants receive real-time fMRI neurofeedback reflecting their own brain activity during a drug-related movie.
Behavioral: 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.
Sham Comparator: Sham (yolked) Neurofeedback
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
Real-time feedback yoked to another participant and not reflective of the participant's own brain activity.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cue/movie-induced craving score
Time Frame: Immediately before and immediately after neurofeedback procedure
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Neurofeedback Score Change
Time Frame: During each 20 minute neurofeedback training session. Participants complete 8 neurofeedback sessions over the course of 4 consecutive days.
Change in neurofeedback performance, reflecting participants' ability to modulate brain activity toward the predefined target pattern. Neurofeedback scores range 0-100, with higher scores indicating more similar brain activity to the target pattern.
During each 20 minute neurofeedback training session. Participants complete 8 neurofeedback sessions over the course of 4 consecutive days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Icahn School of Medicine at Mount Sinai

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Drug Abuse (NIDA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Rita Goldstein, PhD, NARC@mssm.edu

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 20, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 14, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 15, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GCO 22-1694
  • R21DA058801 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).

IPD Sharing Time Frame

Immediately following publication. No end date.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings