Multi-Component Breath Alcohol Intervention Phase 3

Not Applicable

Recruiting

• Conditions: Alcohol Use; Alcohol Drinking; Drinking Behavior

• Registration Number: NCT06994962
• Lead Sponsor: Northeastern University

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study Start: 2025-05-01
• Study First Submitted: 2025-05-20
• Study First Submitted QC: 2025-05-20
• Last Update Submitted: 2025-05-28
• Study First Posted: 2025-05-29
• Last Update Posted: 2025-06-03
• Primary Completion: 2026-05-01
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Technology utilization	4-week field use period	Percentage of reported drinking days on which one reports that moderate drinking technology use has occurred
Acceptability	4-week field use period	Score on acceptability subscale of Modified System Usability Scale
Usability	4-week field use period	Score on acceptability subscale of Modified System Usability Scale

Secondary Outcome Measures

Name	Time	Method
Drinks per drinking day	4-week field use period	Number of drinks per day during field testing period
Estimated blood alcohol content	4-week field use period	Average estimated blood alcohol content reached on drinking days
Negative Consequences	4-week field use period	Score on the Young Adult Alcohol Consequences Questionnaire

Trial Locations

Locations (1)

Northeastern University; 🇺🇸 Boston, Massachusetts, United States