Brain Mechanisms of Reducing Polysubstance Use Following a Novel Body-mind Intervention
2 other identifiers
interventional
70
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 19, 2019
CompletedFirst Submitted
Initial submission to the registry
December 22, 2019
CompletedFirst Posted
Study publicly available on registry
February 7, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2023
CompletedResults Posted
Study results publicly available
May 2, 2024
CompletedMay 29, 2024
May 1, 2024
3.9 years
December 22, 2019
March 29, 2024
May 13, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Study Arms (2)
Integrative Body Mind Training (IBMT)
EXPERIMENTALmindfulness
Relaxation Training (RT)
ACTIVE COMPARATORrelaxation
Interventions
Eligibility Criteria
You may qualify if:
- (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.
You may not qualify if:
- (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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
TTU/UT
Lubbock, Texas, 79409, United States
Results Point of Contact
- Title
- Yi-Yuan Tang
- Organization
- Arizona State University
Study Officials
- PRINCIPAL INVESTIGATOR
Yi-Yuan Tang
Texas Tech University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 22, 2019
First Posted
February 7, 2020
Study Start
April 19, 2019
Primary Completion
February 28, 2023
Study Completion
February 28, 2023
Last Updated
May 29, 2024
Results First Posted
May 2, 2024
Record last verified: 2024-05