Multi-Component Breath Alcohol Intervention Phase 3 (BAMTECH)

May 18, 2026 updated by: Northeastern University

Development and Initial Testing of a Multi-Component Breath Alcohol-Focused Intervention for Young Adults, Stage 3

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

90

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 Contact

Study Contact Backup

Study Locations

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

  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).

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: Randomized
  • Interventional Model: Factorial 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.
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.
Device: Alcohol-related mobile health technologies
Participants will be asked to use the mobile technologies as they choose while drinking for a four-week period.
Other Names:
  • Smartphone Breathalyzer
  • BAC Estimator App
  • Self-Texting App
Experimental: Moderate drinking technologies with "higher 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 "higher tech" facilitation
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.
Device: Alcohol-related mobile health technologies
Participants will be asked to use the mobile technologies as they choose while drinking for a four-week period.
Other Names:
  • Smartphone Breathalyzer
  • BAC Estimator App
  • Self-Texting App
Behavioral: Higher tech facilitation
Participants will use an app developed during the study, SmartSip, that will provide protective behavioral strategies and reminders for use of the three moderate drinking technologies during drinking situations.
Other Names:
  • SmartSip
Active Comparator: Alcohol Education Condition
Brief session administering non-personalized information about alcohol followed by the option to receive educational alcohol-related information via text
Behavioral: Alcohol Education
Brief 25/30-minute psychoeducation on generalized alcohol use providing information about alcohol and its effects, adapted from the National Institute on Alcohol Abuse and Alcoholism (NIAAA) Rethinking Drinking resources
Device: Alcohol Education Technology
Participants will be able to prompt text messages which will provide them one-off trivia facts using information provided during the attention control psychoeducation session

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Technology utilization
Time Frame: 4-week field use period
Percentage of reported drinking days on which one reports that moderate drinking technology use has occurred
4-week field use period
Acceptability
Time Frame: 4-week field use period
Score on acceptability subscale of Modified System Usability Scale
4-week field use period
Usability
Time Frame: 4-week field use period
Score on acceptability subscale of Modified System Usability Scale
4-week field use period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Drinks per drinking day
Time Frame: 4-week field use period
Number of drinks per day during field testing period
4-week field use period
Estimated blood alcohol content
Time Frame: 4-week field use period
Average estimated blood alcohol content reached on drinking days
4-week field use period
Negative Consequences
Time Frame: 4-week field use period
Score on the Young Adult Alcohol Consequences Questionnaire
4-week field use period

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, Ph.D., 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)

May 1, 2025

Primary Completion (Estimated)

December 15, 2026

Study Completion (Estimated)

January 31, 2027

Study Registration Dates

First Submitted

May 20, 2025

First Submitted That Met QC Criteria

May 20, 2025

First Posted (Actual)

May 29, 2025

Study Record Updates

Last Update Posted (Actual)

May 20, 2026

Last Update Submitted That Met QC Criteria

May 18, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB24-12-32

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 to qualified investigators 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.

Clinical Trials on Alcohol Drinking

Clinical Trials on Motivational interview and psychoeducation on blood/breath alcohol concentration

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Jamaica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe