Multi-Component Breath Alcohol Intervention

NCT06124898 | Active Not Recruiting

• 2 other identifiers: IRB22-11-43R34AA029224-01
• Study Type: interventional
• Target: 115
• 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, 2-4 weeks

• Acceptability

  Score on acceptability subscale of Modified System Usability Scale

  At the end of the field testing period, 2-4 weeks

• Usability

  Score on acceptability subscale of Modified System Usability Scale

  At the end of the field testing period, 2-4 weeks

Secondary Outcomes (3)

• Drinks per drinking day

  Across the field testing period, 2-4 weeks

• Estimated blood alcohol content

  Across the field testing period, 2-4 weeks

• Negative consquences

  At the end of the field testing period, 2-4 weeks

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; Device: Higher tech facilitation

Attention control condition

ACTIVE COMPARATOR

To be determined attention control condition, which will involve either non-personalized information about alcohol or feedback regarding another health behavior with minimal relationship to alcohol use, followed by related technology use.

Behavioral: Attention control psychoeducation; Device: Attention control technology

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 "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 DEVICE

Participants will use an app developed during the study that will provide protective behavioral strategies and reminders for use of the three moderate drinking technologies during drinking situations.

Moderate drinking technologies with "higher tech" facilitation

Attention control psychoeducation BEHAVIORAL

Brief 25/30-minute psychoeducation on a topic not related to alcohol use that will be developed in the course of the study.

Attention control condition

Attention control technology DEVICE

App or other form of technology that will be developed in the course of the study to deliver information not related to alcohol use

Attention control condition

Eligibility Criteria

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

You may not qualify if:

• No subject may:
• Have been in inpatient or intensive outpatient treatment within the past 12 months
• Have used a smartphone application to facilitate moderate drinking more than 1 time within the past 12 months
• Meet DSM-5 criteria for current substance use disorder with the exception of tobacco use disorder, mild or moderate alcohol use disorder or mild cannabis use disorder.
• History of alcohol withdrawal or medically-assisted detoxification as individuals with this history will likely be in need of more intensive treatment than is offered in this study.
• 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: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• 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: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: May 22, 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 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)