ClinicalTrials.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

In context

Alcohol Drinking

701 studies on the registry are indexed under Alcohol Drinking; 133 are open to participants now.

This study's enrollment of 24 is below the median of 122 across 607 interventional studies indexed under Alcohol Drinking.

Browse Alcohol Drinking studies →

Lead sponsor

Northeastern University is the lead sponsor of 55 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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)
05

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.

06

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

07

Study locations

1 site
  • EDGE Lab
    Boston, Massachusetts 02115, United States
08

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, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code

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

Access criteria: Any qualified investigator upon request

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2023 to primary completion in Aug 2024, 9 months.

Of 328 non-industry interventional studies with no phase under Alcohol Drinking, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 45. This study's 9 months is below that.

Counting every sponsor, half of 336 studies reached it within 24 months; a quarter within 10 and three quarters within 45.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 30, 2023
First posted
Nov 9, 2023
StartActual
Nov 9, 2023
Primary completionActual
Aug 29, 2024
CompletionActual
Aug 29, 2024
Last update
May 14, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06124898
Lead sponsor
Northeastern University
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
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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