CClinicalTrials.gg
CompletedNCT06124898BAMTECHUpdated May 14, 2026

Multi-Component Breath Alcohol Intervention

An interventional study of Alcohol-related mobile health technologies and Motivational interview and psychoeducation on blood/breath alcohol concentration in Alcohol Use, Alcohol Drinking and Drinking Behavior, sponsored by Northeastern University. Completed at 1 site in United States. Open to participants aged 18 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-14.

Sponsored by Northeastern University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Not applicable
Ages
18 Years to 25 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Alcohol Use
  • Alcohol Drinking
  • Drinking Behavior
03

Who can participate

Ages eligible
18 Years to 25 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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)
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • 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 · Behavioral: Motivational interview and psychoeducation on blood/breath alcohol concentration · Behavioral: Lower tech facilitation

Interventions

  • DeviceAlcohol-related mobile health technologies

    Participants will be asked to use the three mobile technologies as they choose while drinking for a two-week period.

    Also known as: Smartphone breathalyzer, BAC estimator app and self-texting procedure

  • BehavioralMotivational 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.

    Also known as: M.I.

  • BehavioralLower 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.

05

What researchers measure

Primary outcomes

  1. Technology utilization

    Percentage of reported drinking days on which one reports that moderate drinking technology use has occurred

    Time frame: Across the field testing period, 2 weeks

  2. Acceptability

    Score on acceptability subscale of Modified System Usability Scale

    Time frame: At the end of the field testing period, 2 weeks

  3. Usability

    Score on acceptability subscale of Modified System Usability Scale

    Time frame: At the end of the field testing period, 2 weeks

Secondary outcomes

  1. Drinks per drinking day

    Number of drinks per day during field testing period

    Time frame: Across the field testing period, 2 weeks

  2. Estimated blood alcohol content

    Average estimated blood alcohol content reached on drinking days

    Time frame: Across the field testing period, 2 weeks

  3. Negative consquences

    Score on the Young Adult Alcohol Consequences Questionnaire

    Time frame: At the end of the field testing period, 2 weeks

06

Study locations

1 site
  • EDGE Lab
    Boston, Massachusetts 02115, United States
07

References and documents

Individual participant data

Plan to share: Yes — Study materials and datasets with identifiers removed will be shared with other investigators upon request

Supporting information: Study protocol, Sap, Icf, Csr, Analytic code

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06124898
Lead sponsor
Northeastern University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Responsible party
Sponsor
First posted
Nov 9, 2023
Start date
Nov 9, 2023
Primary completion
Aug 29, 2024
Completion
Aug 29, 2024
Last update
May 14, 2026

Study contacts

Robert F Leeman, PhD.
principal investigator · Northeastern University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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