Recruiting

Observational Study

Sponsor:

Arizona State University

Code:

NCT06324786

Conditions

Multiple Drug Use

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

IBMT

NF

Study Details

Brief summary:

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

Conditions

Multiple Drug Use

Study ID

NCT06324786

Start date

Sep 1, 2023

Status verified date

May, 2026

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Aug 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Enrollment

35 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

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.

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.

experimental: IBMT + NF

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

sham comparator: Sham NF

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

Interventions

IBMT

IBMT is an effortless mindfulness technique

NF

NF is a mental training technique.

Primary outcome measure

  • 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 ]
  • 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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

YiYuan Tang

4807903577yiyuan@asu.edu

Locations

YiYuan Tang

Recruiting

Phoenix, Arizona, United States, 85004

Contacts

YiYuan Tang

4807903577yiyuan@asu.edu

More Information

Sponsor

Arizona State University

Last update posted

May 4, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Arizona State University on 2026-05-04.