Menu
Recruiting NCT06324786

Brain Mechanisms of Reducing Polysubstance Use

No phase Interventional Multiple Drug Use

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: IBMT, NF.
Who it may be relevant to
Registry conditions: Multiple Drug Use. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • 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]
Secondary outcome measures (1)
  • Intervention effects on addiction behavior using substance use questionnaires in PhenX Toolkit [Time frame: The outcome measures are assessed in-person at baseline, 2-4 weeks and 3 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Basic science

Study locations

United States · 1 center
  • YiYuan Tang — Phoenix

Identifiers

NCT: NCT06324786 · 2024 IBMT NF

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗