Multi-Component Breath Alcohol Intervention

NCT ID: NCT06124898

Last Updated: 2025-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

115 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-09

Study Completion Date

2025-09-01

Brief Summary

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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.

Detailed Description

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Conditions

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Alcohol Use Alcohol Drinking Drinking Behavior

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Moderate drinking technologies with "lower tech" facilitation

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.

Group Type EXPERIMENTAL

Alcohol-related mobile health technologies

Intervention Type DEVICE

Participants will be asked to use the three mobile technologies as they choose while drinking for a two-week period.

Motivational interview and psychoeducation on blood/breath alcohol concentration

Intervention Type BEHAVIORAL

Brief 25/30-minute motivational interview and psychoeducation on blood/breath alcohol concentration that includes both personalized and standardized information.

Lower tech facilitation

Intervention Type 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 "higher tech" facilitation

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

Group Type EXPERIMENTAL

Alcohol-related mobile health technologies

Intervention Type DEVICE

Participants will be asked to use the three mobile technologies as they choose while drinking for a two-week period.

Motivational interview and psychoeducation on blood/breath alcohol concentration

Intervention Type BEHAVIORAL

Brief 25/30-minute motivational interview and psychoeducation on blood/breath alcohol concentration that includes both personalized and standardized information.

Higher tech facilitation

Intervention Type 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.

Attention control condition

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.

Group Type ACTIVE_COMPARATOR

Attention control psychoeducation

Intervention Type 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 technology

Intervention Type 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

Interventions

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Alcohol-related mobile health technologies

Participants will be asked to use the three mobile technologies as they choose while drinking for a two-week period.

Intervention Type DEVICE

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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Higher tech facilitation

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.

Intervention Type DEVICE

Attention control psychoeducation

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

Intervention Type BEHAVIORAL

Attention control technology

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

Intervention Type DEVICE

Other Intervention Names

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Smartphone breathalyzer, BAC estimator app and self-texting procedure M.I.

Eligibility Criteria

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Exclusion Criteria

No subject may:

1. Have been in inpatient or intensive outpatient treatment within the past 12 months
2. Have used a smartphone application to facilitate moderate drinking more than 1 time within the past 12 months
3. 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.
4. 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.
5. Be psychotic or otherwise severely psychiatrically disabled
6. 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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role collaborator

Northeastern University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert F Leeman, PhD.

Role: PRINCIPAL_INVESTIGATOR

Northeastern University

Locations

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EDGE Lab

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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R34AA029224-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB22-11-43

Identifier Type: -

Identifier Source: org_study_id

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