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

Not Applicable

Completed

• Conditions: Multiple Drug Use
• Interventions: Behavioral: IBMT; Behavioral: RT

• Registration Number: NCT04261504
• Lead Sponsor: Texas Tech University

Brief Summary

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

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 Timeline

• Study Start: 2019-04-19
• Study First Submitted: 2019-12-22
• Study First Submitted QC: 2020-02-06
• Study First Posted: 2020-02-07
• Primary Completion: 2023-02-28
• Study Completion: 2023-02-28
• Results First Submitted: 2024-03-29
• Results First Submitted QC: 2024-04-08
• Status Verified: 2024-05
• Results First Posted: 2024-05-02
• Last Update Submitted: 2024-05-13
• Last Update Posted: 2024-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Integrative Body Mind Training (IBMT)	IBMT	mindfulness
Relaxation Training (RT)	RT	relaxation

Primary Outcome Measures

Name	Time	Method
Brain Changes in Functional Activity	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).

Trial Locations

Locations (1)

TTU/UT; 🇺🇸 Lubbock, Texas, United States