Brain Mechanisms of Reducing Polysubstance Use

Multiple Drug Use Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06324786
• Other study ID #: 2024 IBMT NF
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: August 31, 2026

Study information

• Verified date: March 2024
• Source: Arizona State University
• Contact: YiYuan Tang
• Phone: 4807903577
• Email: yiyuan[@]asu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: August 31, 2026
• Est. primary completion date: August 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Drug Use

Intervention

Behavioral:
• IBMT
IBMT is an effortless mindfulness technique
• NF
NF is a mental training technique.

Locations

Country	Name	City	State
United States	YiYuan Tang	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Arizona State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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