Multi-Component Breath Alcohol Intervention (BAMTECH)

Northeastern University

Status: Enrolling

Conditions: Alcohol Use; Drinking Behavior; Alcohol Drinking

Treatments: Device: Attention control technology; Device: Higher tech facilitation; Device: Alcohol-related mobile health technologies; Behavioral: Lower tech facilitation; Behavioral: Attention control psychoeducation; Behavioral: Motivational interview and psychoeducation on blood/breath alcohol concentration

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06124898

R34AA029224-01 (U.S. NIH Grant/Contract)

IRB22-11-43

Details and patient eligibility

About

This is the first stage of a three-stage, NIH-funded study to develop and test initially a multi-modal intervention concerning blood/breath alcohol concentration for young adults. The multimodal intervention will be made up of brief telehealth counseling and psychoeducation and use of three mobile technologies to facilitate moderate drinking. In the first stage of the study, we will conduct formative research to obtain input from the study population, test initially the telehealth version of the brief counseling and psychoeducation and to develop a simple, "low tech" approach to coaching participants to use the three mobile technologies in typical drinking situations. Participation will last approximately one month.

Enrollment: 115 estimated patients

Sex: All

Ages: 18 to 25 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Each subject must:

1. Be between the ages of 18-25
2. Be able to read English and complete study evaluations
3. Report at least four days with heavy episodic drinking (i.e., 4 or more drinks for women and 5 or more drinks for men) out of the prior 30 days
4. Report having consumed at least one alcoholic drink during a minimum of 12 days out of the prior 30 so that subjects will have multiple opportunities to use the moderate drinking technologies during the intervention period.
5. Meet, at minimum, DSM-5 criteria for a mild alcohol use disorder (i.e., meet at least 2 diagnostic criteria)
6. Self-report interest in using a smartphone app to help reduce drinking with a score of at least 3 on a 0-10 scale indicating at least a degree of openness to using technology to moderate drinking.

Exclusion Criteria

No subject may:

1. Have been in inpatient or intensive outpatient treatment within the past 12 months
2. Have used a smartphone application to facilitate moderate drinking more than 1 time within the past 12 months
3. Meet DSM-5 criteria for current substance use disorder with the exception of tobacco use disorder, mild or moderate alcohol use disorder or mild cannabis use disorder.
4. History of alcohol withdrawal or medically-assisted detoxification as individuals with this history will likely be in need of more intensive treatment than is offered in this study.
5. Be psychotic or otherwise severely psychiatrically disabled
6. Report a history of a medical condition that would contraindicate the consumption of alcohol (e.g., liver disease, cardiac abnormality, pancreatitis, diabetes, neurological problems, and gastrointestinal disorders)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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115 participants in 3 patient groups

Moderate drinking technologies with "lower tech" facilitation

Experimental group

Description:

Brief motivational-interviewing-based counseling followed by use of three moderate drinking technologies (breath alcohol device and app, blood alcohol content estimator app and self-texting procedure) with "lower tech" facilitation.

Treatment:

Device: Alcohol-related mobile health technologies

Behavioral: Lower tech facilitation

Behavioral: Motivational interview and psychoeducation on blood/breath alcohol concentration

Moderate drinking technologies with "higher tech" facilitation

Experimental group

Description:

Brief motivational-interviewing-based counseling followed by use of three moderate drinking technologies (breath alcohol device and app, blood alcohol content estimator app and self-texting procedure) with "higher tech" facilitation

Treatment:

Device: Alcohol-related mobile health technologies

Device: Higher tech facilitation

Behavioral: Motivational interview and psychoeducation on blood/breath alcohol concentration

Attention control condition

Active Comparator group

Description:

To be determined attention control condition, which will involve either non-personalized information about alcohol or feedback regarding another health behavior with minimal relationship to alcohol use, followed by related technology use.

Treatment:

Behavioral: Attention control psychoeducation

Device: Attention control technology