Brain Mechanisms of Reducing Polysubstance Use

NCT06324786 | Recruiting

• 1 other identifier: 2024 IBMT NF
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Multiple Drug Use

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• 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 Arms (4)

IBMT

EXPERIMENTAL

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

NF

EXPERIMENTAL

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

IBMT + NF

EXPERIMENTAL

The combined IBMT and NF also show positive effects in reducing substance use.

Behavioral: IBMT; Behavioral: NF

Sham NF

SHAM COMPARATOR

Sham NF has the same settings as the active NF but does not have correct parameters of stimulation.

Behavioral: NF

Interventions

IBMT BEHAVIORAL

IBMT is an effortless mindfulness technique

IBMT; IBMT + NF

NF BEHAVIORAL

NF is a mental training technique.

IBMT + NF; NF; Sham NF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Arizona State University: lead

Study Sites (1)

YiYuan Tang

Phoenix, Arizona, 85004, United States

RECRUITING

Central Study Contacts

YiYuan Tang

CONTACT

4807903577; yiyuan@asu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: mindfulness or/and active/sham neurofeedback

Study Record Dates

• First Submitted: March 6, 2024
• First Posted: March 22, 2024
• Study Start: September 1, 2023
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-05

Locations

US (1)