Brain Mechanisms of Reducing Polysubstance Use

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

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

Study Overview

• Status: Recruiting
• Conditions: Multiple Drug Use
• Intervention / Treatment: Behavioral: IBMT; Behavioral: NF

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 Type: Interventional
• Enrollment (Estimated): 35
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: YiYuan Tang; Phone Number: 4807903577; Email: yiyuan@asu.edu

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85004
      • Recruiting
      • YiYuan Tang
      • Contact: YiYuan Tang; Phone Number: 4807903577; Email: yiyuan@asu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: IBMT; IBMT is an effortless mindfulness technique
Experimental: 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.	Behavioral: NF; NF is a mental training technique.
Experimental: IBMT + NF; The combined IBMT and NF also show positive effects in reducing substance use.	Behavioral: IBMT; IBMT is an effortless mindfulness technique; Behavioral: NF; NF is a mental training technique.
Sham Comparator: Sham NF; Sham NF has the same settings as the active NF but does not have correct parameters of stimulation.	Behavioral: NF; NF is a mental training technique.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intervention effects on brain function using Functional Magnetic Resonance Imaging (fMRI)	Brain connectivity changes such as anterior and posterior cingulate cortex measured by fMRI resting state imaging	The outcome measures are assessed in-person at baseline, 2-4 weeks and 3 months
Intervention effects on brain white matter using fMRI	Brain white matter changes such as anterior and posterior cingulate cortex measured by fMRI diffusion tensor imaging	The outcome measures are assessed in-person at baseline, 2-4 weeks and 3 months
Intervention effects on brain grey matter using fMRI	Brain volume changes such as anterior and posterior cingulate cortex measured by fMRI structural imaging	The outcome measures are assessed in-person at baseline, 2-4 weeks and 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intervention effects on addiction behavior using substance use questionnaires in PhenX Toolkit	Intervention leads to a significant reduction in craving and substance use measured by substance use questionnaires in PhenX Toolkit	The outcome measures are assessed in-person at baseline, 2-4 weeks and 3 months

Collaborators and Investigators

• Sponsor: Arizona State University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027

Study Registration Dates

• First Submitted: March 6, 2024
• First Submitted That Met QC Criteria: March 15, 2024
• First Posted (Actual): March 22, 2024

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: May 1, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 2024 IBMT NF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No