ClinicalTrials.gg
RecruitingNCT06994962BAMTECHUpdated May 20, 2026

Multi-Component Breath Alcohol Intervention Phase 3

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. Recruiting at 1 site in United States. Open to participants aged 18 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-20.

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

From the registry’s dates

  • Started May 2025; still recruiting 1 year 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years to 25 Years
Sex
All
01

Study summary

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.

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 planned enrollment of 90 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

Eligibility criteria

  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, 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).
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Factorial assignment
Masking
None (open label)
Enrollment
90 participants (estimated)

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

  • 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

    Device: Alcohol-related mobile health technologies · Behavioral: Motivational interview and psychoeducation on blood/breath alcohol concentration · Behavioral: Higher tech facilitation

  • 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 · Device: Alcohol Education Technology

Interventions

  • DeviceAlcohol-related mobile health technologies

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

    Also known as: Smartphone Breathalyzer, BAC Estimator App, Self-Texting App

  • 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.

  • BehavioralHigher 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.

    Also known as: SmartSip

  • BehavioralAlcohol 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

  • DeviceAlcohol 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

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: 4-week field use period

  2. Acceptability

    Score on acceptability subscale of Modified System Usability Scale

    Time frame: 4-week field use period

  3. Usability

    Score on acceptability subscale of Modified System Usability Scale

    Time frame: 4-week field use period

Secondary outcomes

  1. Drinks per drinking day

    Number of drinks per day during field testing period

    Time frame: 4-week field use period

  2. Estimated blood alcohol content

    Average estimated blood alcohol content reached on drinking days

    Time frame: 4-week field use period

  3. Negative Consequences

    Score on the Young Adult Alcohol Consequences Questionnaire

    Time frame: 4-week field use period

07

Study locations

1 of 1 sites recruiting
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 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

Access criteria: Any qualified investigator upon request

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06994962
Lead sponsor
Northeastern University
Responsible party
Sponsor
First posted
May 29, 2025
Start date
May 1, 2025
Primary completion
Dec 15, 2026 (estimated)
Completion
Jan 31, 2027 (estimated)
Last update
May 20, 2026

Study contacts

Jade Martinez, B.S.
Contact
ja.martinez@northeastern.edu
(617) 373-5132
Allie Farone, M.S.
Contact
a.farone@northeastern.edu
Robert F Leeman, Ph.D.
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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