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

Multiple Drug Use Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04261504
• Other study ID #: IRB2018-943
• Secondary ID: R61AT010138
• Status: Completed
• Phase: N/A
• Start date: April 19, 2019
• Est. completion date: February 28, 2023

Study information

• Verified date: May 2024
• Source: Texas Tech University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: February 28, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 23 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Drug Use

Intervention

Behavioral:
• IBMT
mindful presence in a non-judgmental way
• RT
progressive muscle relaxation

Locations

Country	Name	City	State
United States	TTU/UT	Lubbock	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Texas Tech University	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.