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Neurofeedback During Naturalistic Stimuli to Reduce Craving in Heroin Addiction

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07344233
Enrollment
28
Registered
2026-01-15
Start date
2025-05-20
Completion date
2025-08-31
Last updated
2026-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heroin Use Disorder, Opioid Use Disorder, Substance Use Disorder

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.

Interventions

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

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

Sponsors

National Institute on Drug Abuse (NIDA)
CollaboratorNIH
Icahn School of Medicine at Mount Sinai
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Cue/movie-induced craving scoreImmediately before and immediately after neurofeedback procedureSelf-reported ratings of heroin craving on a 0-9 point scale, with higher scores indicating higher craving.

Secondary

MeasureTime frameDescription
Neurofeedback Score ChangeDuring 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026