Brain Mechanisms of Reducing Polysubstance Use

Not Applicable

Recruiting

• Conditions: Multiple Drug Use
• Interventions: Behavioral: NF; Behavioral: IBMT

• Registration Number: NCT06324786
• Lead Sponsor: Arizona State University

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.

Study Timeline

• Study Start: 2023-09-01
• Study First Submitted: 2024-03-06
• Study First Submitted QC: 2024-03-15
• Study First Posted: 2024-03-22
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-11
• Last Update Posted: 2025-04-15
• Primary Completion: 2026-08-31
• Study Completion: 2026-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NF	NF	An evidence-based intervention - NF can not only provide real-time feedback for practice but also target the self-control networks, suggesting the possibility of augmenting IBMT effects via NF.
IBMT	IBMT	An evidence-based preventive intervention - integrative body-mind training (IBMT) has shown positive effects in reducing stress and improving self-control and brain plasticity. It has bodifulness and mindfulness components.
IBMT + NF	NF	The combined IBMT and NF also show positive effects in reducing substance use.
Sham NF	NF	Sham NF has the same settings as the active NF but does not have correct parameters of stimulation.
IBMT + NF	IBMT	The combined IBMT and NF also show positive effects in reducing substance use.

Primary Outcome Measures

Name	Time	Method
Intervention effects on brain grey matter using fMRI	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	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)	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 Outcome Measures

Name	Time	Method
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	Intervention leads to a significant reduction in craving and substance use measured by substance use questionnaires in PhenX Toolkit

Trial Locations

Locations (1)

YiYuan Tang; 🇺🇸 Phoenix, Arizona, United States