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NCT Number: NCT06994962

Multi-Component Breath Alcohol Intervention Phase 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.

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Key information

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northeastern University

Boston, Massachusetts, 02115-5005, United States

Location status: Recruiting

Location contact

Allie Farone, M.S.

CONTACT

[email protected]

Jade Martinez, B.S.

CONTACT

[email protected]

617-697-7169

Robert F Leeman, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

  • Be between the ages of 18-25
  • Be able to read English and complete study evaluations
  • 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
  • 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.
  • Meet, at minimum, DSM-5 criteria for a mild alcohol use disorder (i.e., meet at least 2 diagnostic criteria)
  • 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:

  • Have been in inpatient or intensive outpatient treatment within the past 12 months
  • Have used a smartphone application to facilitate moderate drinking more than 1 time within the past 12 months
  • 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.
  • 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.
  • 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).

Treatment and study plan

Alcohol-related mobile health technologies

Device

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

Motivational interview and psychoeducation on blood/breath alcohol concentration

Behavioral

Brief 25/30-minute motivational interview and psychoeducation on blood/breath alcohol concentration that includes both personalized and standardized information.

Other names: M.I.

Lower tech facilitation

Behavioral

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.

Higher tech facilitation

Behavioral

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

Alcohol Education

Behavioral

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

Alcohol Education Technology

Device

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

Primary outcomes

  1. 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

  2. Acceptability

    Time frame: 4-week field use period

    Score on acceptability subscale of Modified System Usability Scale

  3. Usability

    Time frame: 4-week field use period

    Score on acceptability subscale of Modified System Usability Scale

Secondary outcomes

  1. Drinks per drinking day

    Time frame: 4-week field use period

    Number of drinks per day during field testing period

  2. Estimated blood alcohol content

    Time frame: 4-week field use period

    Average estimated blood alcohol content reached on drinking days

  3. Negative Consequences

    Time frame: 4-week field use period

    Score on the Young Adult Alcohol Consequences Questionnaire

Study contacts

Contact information is provided by the study sponsor or research team.

Allie Farone, M.S.

CONTACT

[email protected]

Jade Martinez, B.S.

CONTACT

[email protected]

(617) 373-5132

Sponsors and collaborators

Lead sponsor

Northeastern University

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Official study title

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

Acronym: BAMTECH

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
May 29, 2025
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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