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OpenTrials
Completed

NCT Number: NCT07344233

Neurofeedback During Naturalistic 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.

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Key information

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Icahn School of Medicine at Mount Sinai

New York, 10029, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Sham Real-time fMRI neurofeedback

Behavioral

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 15, 2026
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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