Multi-Component Breath Alcohol Intervention Phase 3

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Northeastern University
Study ID
NCT06994962
Status
Recruiting
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Conditions

  • Alcohol Drinking
  • Alcohol Use
  • Drinking Behavior

Eligibility Criteria

Sex
ALL
Age
18 Years - 25 Years
Healthy Volunteers
Accepted

Interventions

  • 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.
  • 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.
  • 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.
  • 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

Study Details

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.

Key Dates

Start date
May 1, 2025
Status verified
May 2026
Primary completion
Dec 15, 2026
Completion
Jan 31, 2027

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION

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.
  • 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
  • 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

Primary Outcome Measure

Technology utilization [ Time Frame: 4-week field use period ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Northeastern UniversityBostonMassachusetts02115-5005
Jade Martinez, B.S.
[email protected]
617-697-7169
Allie Farone, M.S.
[email protected]
Robert F Leeman, PhD (PRINCIPAL_INVESTIGATOR)

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