Multi-Component Breath Alcohol Intervention Phase 3

NCT ID: NCT06994962

Last Updated: 2025-06-03

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

RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-01

Study Completion Date

2026-12-31

Brief Summary

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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

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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 mobile technologies as they choose while drinking for a four-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 mobile technologies as they choose while drinking for a four-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 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.

Alcohol Education Condition

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

Group Type ACTIVE_COMPARATOR

Alcohol Education

Intervention Type 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 Technology

Intervention Type 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

Interventions

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Alcohol-related mobile health technologies

Participants will be asked to use the mobile technologies as they choose while drinking for a four-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, SmartSip, that will provide protective behavioral strategies and reminders for use of the three moderate drinking technologies during drinking situations.

Intervention Type BEHAVIORAL

Alcohol Education

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

Intervention Type BEHAVIORAL

Alcohol Education Technology

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

Intervention Type DEVICE

Other Intervention Names

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Smartphone Breathalyzer BAC Estimator App Self-Texting App M.I. SmartSip

Eligibility Criteria

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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)
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, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Northeastern University

Locations

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Northeastern University

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jade Martinez, B.S.

Role: CONTACT

(617) 373-5132

Allie Farone, M.S.

Role: CONTACT

Facility Contacts

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Jade Martinez, B.S.

Role: primary

617-697-7169

Allie Farone, M.S.

Role: backup

Other Identifiers

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IRB24-12-32

Identifier Type: -

Identifier Source: org_study_id

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