Multi-Component Breath Alcohol Intervention Phase 3
NCT06994962 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90
Last updated 2026-05-20
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.
Conditions
- Alcohol Use
- Alcohol Drinking
- Drinking Behavior
Interventions
- DEVICE
-
Alcohol-related mobile health technologies
Participants will be asked to use the mobile technologies as they choose while drinking for a four-week period.
- BEHAVIORAL
-
Motivational 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.
- BEHAVIORAL
-
Lower 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.
- BEHAVIORAL
-
Higher 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.
- BEHAVIORAL
-
Alcohol 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
- DEVICE
-
Alcohol 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
Sponsors & Collaborators
-
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
collaborator NIH -
Northeastern University
lead OTHER
Principal Investigators
-
Robert F Leeman, Ph.D. · Northeastern University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- FACTORIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 25 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-05-01
- Primary Completion
- 2026-12-15
- Completion
- 2027-01-31
Countries
- United States
Study Locations
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