Multiple Drug Use
Conditions
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.
Interventions
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
Texas Tech University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 23 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Integrative Body Mind Training (IBMT) mindfulness
IBMT: mindful presence in a non-judgmental way | 35 |
| Relaxation Training (RT) relaxation
RT: progressive muscle relaxation | 35 |
| Total | 70 |
Baseline characteristics
| Characteristic | Integrative Body Mind Training (IBMT) | Relaxation Training (RT) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 35 Participants | 35 Participants | 70 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 11 Participants | 11 Participants | 22 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 24 Participants | 24 Participants | 48 Participants |
| Race/Ethnicity, Customized Unknown/Not Reported Ethnicity | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 17 Participants | 18 Participants | 35 Participants |
| Sex: Female, Male Male | 18 Participants | 17 Participants | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 35 | 0 / 35 |
| other Total, other adverse events | 0 / 35 | 0 / 35 |
| serious Total, serious adverse events | 0 / 35 | 0 / 35 |
Outcome results
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).
Time frame: The outcome measure is assessed at baseline and post-intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Integrative Body Mind Training (IBMT) | Brain Changes in Functional Activity | Baseline | 0.7 beta weights | Standard Deviation 1.2 |
| Integrative Body Mind Training (IBMT) | Brain Changes in Functional Activity | Post-Intervention | 1.3 beta weights | Standard Deviation 1.1 |
| Relaxation Training (RT) | Brain Changes in Functional Activity | Baseline | 0.6 beta weights | Standard Deviation 1.3 |
| Relaxation Training (RT) | Brain Changes in Functional Activity | Post-Intervention | 0.9 beta weights | Standard Deviation 2.2 |
p-value: 0.03threshold-free cluster enhancement