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Completed

NCT Number: NCT06124898

Multi-Component Breath Alcohol Intervention

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.

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Key information

Conditions

Alcohol Use Alcohol Drinking Behavior Drinking Behavior

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

EDGE Lab

Boston, Massachusetts, 02115, United States

Who can participate

Healthy volunteers accepted: Yes

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

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

  • 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)

Treatment and study plan

Alcohol-related mobile health technologies

Device

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

Other names: Smartphone breathalyzer, BAC estimator app and self-texting procedure

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.

Primary outcomes

  1. Technology utilization

    Time frame: Across the field testing period, 2 weeks

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

  2. Acceptability

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

    Score on acceptability subscale of Modified System Usability Scale

  3. Usability

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

    Score on acceptability subscale of Modified System Usability Scale

Secondary outcomes

  1. Drinks per drinking day

    Time frame: Across the field testing period, 2 weeks

    Number of drinks per day during field testing period

  2. Estimated blood alcohol content

    Time frame: Across the field testing period, 2 weeks

    Average estimated blood alcohol content reached on drinking days

  3. Negative consquences

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

    Score on the Young Adult Alcohol Consequences Questionnaire

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

Acronym: BAMTECH

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 9, 2023
Registry last updated
May 14, 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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