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Completed

NCT Number: NCT04261504

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

The proposed study will examine brain mechanisms of a brief mindfulness intervention - integrative body-mind training (IBMT) on alcohol, tobacco, and cannabis (ATC) reduction.

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Key information

Conditions

Age range

18 year–23 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

TTU/UT

Lubbock, Texas, 79409, United States

About this study

The R61 phase of the proposed study will examine brain mechanisms of a brief mindfulness intervention - integrative body-mind training (IBMT) that targets at self-control networks in the brain, and test IBMT effects on alcohol, tobacco, and cannabis (ATC) reduction.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • (1) at least 18 years old;
  • (2) free of any psychiatric diagnoses or medication (besides a substance use disorder to alcohol, tobacco, or cannabis);
  • (3) in the past month, at least 4 episode of heavy episodic drinking; at least 3 occasion of cannabis use; and daily cigarette use for at least the past month;
  • (4) normal or corrected-to-normal vision;
  • (5) written informed consent;
  • (6) no previous meditation or neurofeedback (NF) experiences.

Exclusion criteria

  • (1) any psychiatric diagnoses other than a substance use disorder;
  • (2) 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);
  • (3) excluding cannabis, evidence of recent (past month) illicit drug use.

Treatment and study plan

IBMT

Behavioral

mindful presence in a non-judgmental way

RT

Behavioral

progressive muscle relaxation

Primary outcomes

  1. Brain Changes in Functional Activity

    Time frame: The outcome measure is assessed at baseline and post-intervention.

    70 participants with polysubstance use are assessed by changes of brain in functional activity of anterior cingulate cortex before (baseline) and post-intervention (2 weeks).

Sponsors and collaborators

Lead sponsor

Texas Tech University

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Feb 7, 2020
Registry last updated
May 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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