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Multi-Component Breath Alcohol Intervention Phase 3

Development and Initial Testing of a Multi-Component Breath Alcohol-Focused Intervention for Young Adults, Stage 3

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06994962
Acronym
BAMTECH
Enrollment
90
Registered
2025-05-29
Start date
2025-05-01
Completion date
2027-01-31
Last updated
2026-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Drinking, Alcohol Use, Drinking Behavior

Brief summary

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.

Interventions

BEHAVIORALHigher 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.

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

DEVICEAlcohol 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

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

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

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.

Sponsors

Northeastern University
Lead SponsorOTHER
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 25 Years
Healthy volunteers
Yes

Inclusion criteria

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).

Design outcomes

Primary

MeasureTime frameDescription
Technology utilization4-week field use periodPercentage of reported drinking days on which one reports that moderate drinking technology use has occurred
Acceptability4-week field use periodScore on acceptability subscale of Modified System Usability Scale
Usability4-week field use periodScore on acceptability subscale of Modified System Usability Scale

Secondary

MeasureTime frameDescription
Drinks per drinking day4-week field use periodNumber of drinks per day during field testing period
Estimated blood alcohol content4-week field use periodAverage estimated blood alcohol content reached on drinking days
Negative Consequences4-week field use periodScore on the Young Adult Alcohol Consequences Questionnaire

Countries

United States

Contacts

CONTACTJade Martinez, B.S.
ja.martinez@northeastern.edu(617) 373-5132
CONTACTAllie Farone, M.S.
a.farone@northeastern.edu
PRINCIPAL_INVESTIGATORRobert F Leeman, Ph.D.

Northeastern University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 21, 2026