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.

Study Overview

• Status: Completed
• Conditions: Multiple Drug Use
• Intervention / Treatment: Behavioral: IBMT; Behavioral: RT

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Lubbock, Texas, United States, 79409
      • TTU/UT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 23 years (Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Integrative Body Mind Training (IBMT); mindfulness	Behavioral: IBMT; mindful presence in a non-judgmental way
Active Comparator: Relaxation Training (RT); relaxation	Behavioral: RT; progressive muscle relaxation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Brain Changes in Functional Activity	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).	The outcome measure is assessed at baseline and post-intervention.

Collaborators and Investigators

• Sponsor: Texas Tech University
• Collaborators: National Center for Complementary and Integrative Health (NCCIH)
• Investigators: Principal Investigator: Yi-Yuan Tang, Texas Tech University

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2019
• Primary Completion (Actual): February 28, 2023
• Study Completion (Actual): February 28, 2023

Study Registration Dates

• First Submitted: December 22, 2019
• First Submitted That Met QC Criteria: February 6, 2020
• First Posted (Actual): February 7, 2020

Study Record Updates

• Last Update Posted (Actual): May 29, 2024
• Last Update Submitted That Met QC Criteria: May 13, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: IRB2018-943; R61AT010138 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No