Multi-Component Breath Alcohol Intervention

Alcohol Drinking Clinical Trial

— BAMTECH  

Official title:

Development and Initial Testing of a Multi-Component Breath Alcohol- Focused Intervention for Young Adults

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06124898
• Other study ID #: IRB22-11-43
• Secondary ID: R34AA029224-01
• Status: Recruiting
• Phase: N/A
• Start date: November 9, 2023
• Est. completion date: February 28, 2025

Study information

• Verified date: January 2024
• Source: Northeastern University
• Contact: Jade Martinez, BS
• Phone: (617)697-7169
• Email: ja.martinez[@]northeastern.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 115
• Est. completion date: February 28, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

Each subject must:

1. Be between the ages of 18-25

2. Be able to read English and complete study evaluations

3. Report at least four days with heavy episodic drinking (i.e., 4 or more drinks for women and 5 or more drinks for men) out of the prior 30 days

4. Report having consumed 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.

5. Meet, at minimum, DSM-5 criteria for a mild alcohol use disorder (i.e., meet at least 2 diagnostic criteria)

6. Self-report interest in using a smartphone app to help reduce drinking with a score of at least 3 on a 0-10 scale indicating at least a degree of openness to using technology to moderate drinking.

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)

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use
• Drinking Behavior

Intervention

Device:
• 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.

Behavioral:
• 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.
• 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.

Device:
• 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.

Behavioral:
• 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.

Device:
• 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

Locations

Country	Name	City	State
United States	EDGE Lab	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Northeastern University	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Acceptability	Score on acceptability subscale of Modified System Usability Scale	At the end of the field testing period, 2-4 weeks
Primary	Usability	Score on acceptability subscale of Modified System Usability Scale	At the end of the field testing period, 2-4 weeks
Secondary	Drinks per drinking day	Number of drinks per day during field testing period	Across the field testing period, 2-4 weeks
Secondary	Estimated blood alcohol content	Average estimated blood alcohol content reached on drinking days	Across the field testing period, 2-4 weeks
Secondary	Negative consquences	Score on the Young Adult Alcohol Consequences Questionnaire	At the end of the field testing period, 2-4 weeks