Multi-Component Breath Alcohol Intervention Phase 3

NCT06994962 | Recruiting

• 1 other identifier: IRB24-12-32
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Use; Alcohol Drinking; Drinking Behavior

Outcome Measures

Primary Outcomes (3)

• Technology utilization

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

  4-week field use period

• Acceptability

  Score on acceptability subscale of Modified System Usability Scale

  4-week field use period

• Usability

  Score on acceptability subscale of Modified System Usability Scale

  4-week field use period

Secondary Outcomes (3)

• Drinks per drinking day

  4-week field use period

• Estimated blood alcohol content

  4-week field use period

• Negative Consequences

  4-week field use period

Study Arms (3)

Moderate drinking technologies with "lower tech" facilitation

EXPERIMENTAL

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.

Device: Alcohol-related mobile health technologies; Behavioral: Motivational interview and psychoeducation on blood/breath alcohol concentration; Behavioral: Lower tech facilitation

Moderate drinking technologies with "higher tech" facilitation

EXPERIMENTAL

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

Device: Alcohol-related mobile health technologies; Behavioral: Motivational interview and psychoeducation on blood/breath alcohol concentration; Behavioral: Higher tech facilitation

Alcohol Education Condition

ACTIVE COMPARATOR

Brief session administering non-personalized information about alcohol followed by the option to receive educational alcohol-related information via text

Behavioral: Alcohol Education; Device: Alcohol Education Technology

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.

Also known as: Smartphone Breathalyzer, BAC Estimator App, Self-Texting App

Moderate drinking technologies with "higher tech" facilitation; Moderate drinking technologies with "lower tech" facilitation

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.

Also known as: M.I.

Moderate drinking technologies with "higher tech" facilitation; Moderate drinking technologies with "lower tech" facilitation

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.

Moderate drinking technologies with "lower tech" facilitation

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.

Also known as: SmartSip

Moderate drinking technologies with "higher tech" facilitation

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 Condition

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

Alcohol Education Condition

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Northeastern University: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Northeastern University

Boston, Massachusetts, 02115-5005, United States

RECRUITING

MeSH Terms

Conditions

Alcohol Drinking; Drinking Behavior

Interventions

Motivational Interviewing; Ethanol

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services; Alcohols; Organic Chemicals

Study Officials

• Robert F Leeman, Ph.D.

  Northeastern University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jade Martinez, B.S.

CONTACT

(617) 373-5132; ja.martinez@northeastern.edu

Allie Farone, M.S.

CONTACT

a.farone@northeastern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2025
• First Posted: May 29, 2025
• Study Start: May 1, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 3, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Study materials are available to qualified investigators at any time upon request. Datasets with identifiers removed will be available after publication of the main outcome paper from the study
• Access Criteria: Any qualified investigator upon request

Locations

US (1)