Multi-Component Breath Alcohol Intervention (BAMTECH)

May 12, 2026 updated by: Northeastern University

Development and Initial Testing of a Multi-Component Breath Alcohol- Focused Intervention for Young Adults

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • EDGE Lab

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Moderate drinking technologies with "lower tech" facilitation
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.
Device: Alcohol-related mobile health technologies
Participants will be asked to use the three mobile technologies as they choose while drinking for a two-week period.
Other Names:
  • Smartphone breathalyzer, BAC estimator app and self-texting procedure
Behavioral: Motivational interview and psychoeducation on blood/breath alcohol concentration
Brief 25/30-minute motivational interview and psychoeducation on blood/breath alcohol concentration that includes both personalized and standardized information.
Other Names:
  • M.I.
Behavioral: Lower tech facilitation
Study staff will review instructions for technology use closely with participants and guide them in use of existing phone technologies as reminders for use of the three moderate drinking technologies during drinking situations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Technology utilization
Time Frame: Across the field testing period, 2 weeks
Percentage of reported drinking days on which one reports that moderate drinking technology use has occurred
Across the field testing period, 2 weeks
Acceptability
Time Frame: At the end of the field testing period, 2 weeks
Score on acceptability subscale of Modified System Usability Scale
At the end of the field testing period, 2 weeks
Usability
Time Frame: At the end of the field testing period, 2 weeks
Score on acceptability subscale of Modified System Usability Scale
At the end of the field testing period, 2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Drinks per drinking day
Time Frame: Across the field testing period, 2 weeks
Number of drinks per day during field testing period
Across the field testing period, 2 weeks
Estimated blood alcohol content
Time Frame: Across the field testing period, 2 weeks
Average estimated blood alcohol content reached on drinking days
Across the field testing period, 2 weeks
Negative consquences
Time Frame: At the end of the field testing period, 2 weeks
Score on the Young Adult Alcohol Consequences Questionnaire
At the end of the field testing period, 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northeastern University

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

  • Principal Investigator: Robert F Leeman, PhD., Northeastern University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 9, 2023

Primary Completion (Actual)

August 29, 2024

Study Completion (Actual)

August 29, 2024

Study Registration Dates

First Submitted

October 30, 2023

First Submitted That Met QC Criteria

November 6, 2023

First Posted (Actual)

November 9, 2023

Study Record Updates

Last Update Posted (Actual)

May 14, 2026

Last Update Submitted That Met QC Criteria

May 12, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB22-11-43
  • R34AA029224-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Study materials and datasets with identifiers removed will be shared with other investigators upon request

IPD Sharing Time Frame

Study materials are available at any time upon request. Datasets with identifiers removed will be available after publication of the main outcome paper from the study

IPD Sharing Access Criteria

Any qualified investigator upon request

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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