Multi-Component Breath Alcohol Intervention Phase 3 (BAMTECH)

Northeastern University

Status: Enrolling

Conditions: Alcohol Use; Drinking Behavior; Alcohol Drinking

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06994962

IRB24-12-32

Details and patient eligibility

About

This is the third stage of a three-stage, NIH-funded study to develop and test a multi-modal intervention concerning blood/breath alcohol concentration for young adults who drink heavily. The multimodal intervention will be made up of brief telehealth counseling and psychoeducation and use of three existing mobile technologies. The brief counseling/psychoeducation and mobile technologies provide personalized feedback regarding blood or breath alcohol content. The long-term goal of use of these mobile technologies will be to facilitate moderate drinking. However, the main goals of the proposed research are to learn more about feasibility of our procedures, perceived value of the technologies and ease of use from the research participants' points of view. In this third stage of the study, the investigators will conduct a randomized controlled trial building on the formative research conducted in Stages 1 and 2.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 25 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Be between the ages of 18-25
• Be able to read English and complete study evaluations
• At least occasional heavy episodic drinking (i.e., 4 or more drinks for women and 5 or more drinks for men) over the prior 30 days
• Frequent consumption of 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.

Exclusion criteria

• Severe substance use disorder
• Be psychotic or otherwise severely psychiatrically disabled
• 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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90 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:

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

Behavioral: Lower tech facilitation

Device: Alcohol-related mobile health technologies

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:

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

Behavioral: Higher tech facilitation

Device: Alcohol-related mobile health technologies

Alcohol Education Condition

Active Comparator group

Description:

Brief session administering non-personalized information about alcohol followed by the option to receive educational alcohol-related information via text

Treatment:

Behavioral: Alcohol Education

Device: Alcohol Education Technology