Multi-Component Breath Alcohol Intervention

NCT06124898 | Completed

• 2 other identifiers: IRB22-11-43R34AA029224-01
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

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

  Across the field testing period, 2 weeks

• Acceptability

  Score on acceptability subscale of Modified System Usability Scale

  At the end of the field testing period, 2 weeks

• Usability

  Score on acceptability subscale of Modified System Usability Scale

  At the end of the field testing period, 2 weeks

Secondary Outcomes (3)

• Drinks per drinking day

  Across the field testing period, 2 weeks

• Estimated blood alcohol content

  Across the field testing period, 2 weeks

• Negative consquences

  At the end of the field testing period, 2 weeks

Study Arms (1)

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

Interventions

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.

Also known as: Smartphone breathalyzer, BAC estimator app and self-texting procedure

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 "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

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)

EDGE Lab

Boston, Massachusetts, 02115, United States

Location

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, PhD.

  Northeastern University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 30, 2023
• First Posted: November 9, 2023
• Study Start: November 9, 2023
• Primary Completion: August 29, 2024
• Study Completion: August 29, 2024
• Last Updated: May 14, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Study materials are available 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)