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Clinical Trials/NCT06324786
NCT06324786
Recruiting
Not Applicable

Brain Mechanisms of Reducing Polysubstance Use Following a Novel Body-mind Intervention 2

Arizona State University1 site in 1 country35 target enrollmentSeptember 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Multiple Drug Use
Sponsor
Arizona State University
Enrollment
35
Locations
1
Primary Endpoint
Intervention effects on brain grey matter using fMRI
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

The proposed study will test whether neurofeedback (NF) could optimize integrative body-mind training (IBMT) practice.

Detailed Description

The proposed study will test whether real-time NF could optimize IBMT practice and improve effects in reducing polysubstance use through targeting self-control networks in the brain.

Registry
clinicaltrials.gov
Start Date
September 1, 2023
End Date
August 31, 2026
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • At least 18 years old
  • Free of any psychiatric diagnoses or medication (besides a substance use disorder (SUD) to alcohol, tobacco, or cannabis)
  • In the past month, at least 4 episodes of heavy episodic drinking; at least 3 occasions of cannabis use; and daily cigarette use for at least the past month
  • Normal or corrected-to-normal vision
  • Written informed consent
  • No previous meditation or NF experiences

Exclusion Criteria

  • Any psychiatric diagnoses other than an SUD
  • Medical disorder(s) that may affect the central nervous system; medications that affect the central and autonomic nervous system; or a positive pregnancy test result (females)
  • Excluding cannabis, evidence of recent (past month) illicit drug use

Outcomes

Primary Outcomes

Intervention effects on brain grey matter using fMRI

Time Frame: The outcome measures are assessed in-person at baseline, 2-4 weeks and 3 months

Brain volume changes such as anterior and posterior cingulate cortex measured by fMRI structural imaging

Intervention effects on brain white matter using fMRI

Time Frame: The outcome measures are assessed in-person at baseline, 2-4 weeks and 3 months

Brain white matter changes such as anterior and posterior cingulate cortex measured by fMRI diffusion tensor imaging

Intervention effects on brain function using Functional Magnetic Resonance Imaging (fMRI)

Time Frame: The outcome measures are assessed in-person at baseline, 2-4 weeks and 3 months

Brain connectivity changes such as anterior and posterior cingulate cortex measured by fMRI resting state imaging

Secondary Outcomes

  • Intervention effects on addiction behavior using substance use questionnaires in PhenX Toolkit(The outcome measures are assessed in-person at baseline, 2-4 weeks and 3 months)

Study Sites (1)

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