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Neurofeedback During Naturalistic Stimuli to Reduce Craving in Heroin Addiction

Mount Sinai Health System logo

Mount Sinai Health System

Status

Completed

Conditions

Opioid Use Disorder
Heroin Use Disorder
Substance Use Disorder

Treatments

Behavioral: Real-time fMRI Neurofeedback
Behavioral: Sham Real-time fMRI Neurofeedback

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT07344233
GCO 22-1694
R21DA058801 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment

28 patients

Sex

All

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

Single Blind

28 participants in 2 patient groups

Real Neurofeedback
Experimental group
Description:
Participants receive real-time fMRI neurofeedback reflecting their own brain activity during a drug-related movie.
Treatment:
Behavioral: Real-time fMRI Neurofeedback
Sham (yolked) Neurofeedback
Sham Comparator group
Description:
Participants receive sham real-time fMRI neurofeedback yoked to a matched participant and unrelated to their own brain activity.
Treatment:
Behavioral: Sham Real-time fMRI Neurofeedback

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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