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

NCT ID: NCT04261504

Last Updated: 2024-05-29

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-19

Study Completion Date

2023-02-28

Brief Summary

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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

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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.

Conditions

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Multiple Drug Use

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Integrative Body Mind Training (IBMT)

mindfulness

Group Type EXPERIMENTAL

IBMT

Intervention Type BEHAVIORAL

mindful presence in a non-judgmental way

Relaxation Training (RT)

relaxation

Group Type ACTIVE_COMPARATOR

RT

Intervention Type BEHAVIORAL

progressive muscle relaxation

Interventions

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IBMT

mindful presence in a non-judgmental way

Intervention Type BEHAVIORAL

RT

progressive muscle relaxation

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

23 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role collaborator

Texas Tech University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yi-Yuan Tang

Role: PRINCIPAL_INVESTIGATOR

Texas Tech University

Locations

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TTU/UT

Lubbock, Texas, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

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R61AT010138

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB2018-943

Identifier Type: -

Identifier Source: org_study_id

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