Opioid Use DisorderNCT07344233
Neurofeedback During Naturalistic Stimuli to Reduce Craving in Heroin Addiction
A study testing Real-time fMRI Neurofeedback in people with Opioid Use Disorder and Substance Use Disorder, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Opioid Use Disorder, Substance Use Disorder, Heroin Use Disorder
- What is being tested?
- Real-time fMRI Neurofeedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 20 May 2025to 31 Aug 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: 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.
- Being tested
- Real-time fMRI Neurofeedback, Sham Real-time fMRI Neurofeedback
- Medical subject headings
- Opioid-Related Disorders, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real-time fMRI NeurofeedbackBehavioural
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 NeurofeedbackBehavioural
Real-time feedback yoked to another participant and not reflective of the participant's own brain activity.
| Study group | Role | What they receive |
|---|---|---|
| Real Neurofeedback | Experimental | Participants receive real-time fMRI neurofeedback reflecting their own brain activity during a drug-related movie. Receives: 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. Receives: Behavioral: Sham Real-time fMRI Neurofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cue/Movie-induced Craving Score
Self-reported ratings of heroin craving on a 0-9 point scale, with higher scores indicating higher craving.
Measured: Immediately before and immediately after neurofeedback procedure (average 17 min MRI scan)
Secondary outcomes (1)
Neurofeedback Score Change
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.
Measured: During each 20 minute neurofeedback training session. Participants complete 8 neurofeedback sessions over the course of 4 consecutive days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start20 May 2025
- Primary completion31 Aug 2025
- Study completion31 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Rita Goldstein, Icahn School of Medicine at Mount Sinai
- Investigators
- Rita Goldstein, PhD, Principal investigator, NARC@mssm.edu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07344233
- Sponsor's protocol ID
- GCO 22-1694
- Other IDs
- R21DA058801
- Status last verified
- Sep 2026
- First submitted
- 14 Jan 2026
- Last updated
- 21 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).