Alcohol UseBAMTECHNCT06994962
Multi-Component Breath Alcohol Intervention Phase 3
A study testing Alcohol-related mobile health technologies, Motivational interview and psychoeducation on blood/breath alcohol concentration and Lower tech facilitation in people with Alcohol Use and Alcohol Drinking, run by Northeastern University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Use, Alcohol Drinking, Drinking Behavior
- What is being tested?
- Alcohol-related mobile health technologies, Motivational interview and psychoeducation on blood/breath alcohol concentration and Lower tech facilitation
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2025to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Allie Farone, M.S. contact
United States1 site, 1 recruiting
- Recruiting
Northeastern University
Boston, Massachusetts, 02115-5005
Jade Martinez, B.S., 617-697-7169, ja.martinez@northeastern.edu
Allie Farone, M.S., a.farone@northeastern.edu
About this study
Official title: Development and Initial Testing of a Multi-Component Breath Alcohol-Focused Intervention for Young Adults, Stage 3
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.
- Conditions
- Alcohol Use, Alcohol Drinking, Drinking Behavior
- Being tested
- Alcohol-related mobile health technologies, Motivational interview and psychoeducation on blood/breath alcohol concentration, Lower tech facilitation, Higher tech facilitation, Alcohol Education
- Medical subject headings
- Alcohol Drinking, Drinking Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alcohol-related mobile health technologiesDevice
Also called Smartphone Breathalyzer, BAC Estimator App, Self-Texting App
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 concentrationBehavioural
Also called M.I.
Brief 25/30-minute motivational interview and psychoeducation on blood/breath alcohol concentration that includes both personalized and standardized information.
Lower tech facilitationBehavioural
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.
Higher tech facilitationBehavioural
Also called SmartSip
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 EducationBehavioural
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 TechnologyDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Device: Alcohol-related mobile health technologies; Behavioral: Motivational interview and psychoeducation on blood/breath alcohol concentration; Behavioral: Higher tech facilitation |
| Alcohol Education Condition | Active comparator | Brief session administering non-personalized information about alcohol followed by the option to receive educational alcohol-related information via text Receives: Behavioral: Alcohol Education; Device: Alcohol Education Technology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technology utilization
Percentage of reported drinking days on which one reports that moderate drinking technology use has occurred
Measured: 4-week field use period
Acceptability
Score on acceptability subscale of Modified System Usability Scale
Measured: 4-week field use period
Usability
Score on acceptability subscale of Modified System Usability Scale
Measured: 4-week field use period
Secondary outcomes (3)
Drinks per drinking day
Number of drinks per day during field testing period
Measured: 4-week field use period
Estimated blood alcohol content
Average estimated blood alcohol content reached on drinking days
Measured: 4-week field use period
Negative Consequences
Score on the Young Adult Alcohol Consequences Questionnaire
Measured: 4-week field use period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2025
- Study start1 May 2025
- Primary completion15 Dec 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northeastern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Robert F Leeman, Ph.D., Principal investigator, Northeastern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06994962
- Sponsor's protocol ID
- IRB24-12-32
- Acronym
- BAMTECH
- Status last verified
- May 2026
- First submitted
- 20 May 2025
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study materials and datasets with identifiers removed will be shared with other investigators upon request
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Initial Testing of a Multi-Component Breath Alcohol-Focused Intervention for Young Adults, Stage 3
- ClinicalTrials.gov ID
- NCT06994962
- Acronym / sponsor ID
- BAMTECH / IRB24-12-32
- Conditions
- Alcohol Use, Alcohol Drinking, Drinking Behavior
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Northeastern UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 1 May 2025 (actual)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 29 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Moderate drinking technologies with "lower tech" facilitation | Experimental | Device: Alcohol-related mobile health technologies, Behavioral: Motivational interview and psychoeducation on blood/breath alcohol concentration, Behavioral: Lower tech facilitationBrief 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. |
| Moderate drinking technologies with "higher tech" facilitation | Experimental | Device: Alcohol-related mobile health technologies, Behavioral: Motivational interview and psychoeducation on blood/breath alcohol concentration, Behavioral: Higher tech facilitationBrief 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 |
| Alcohol Education Condition | Active comparator | Behavioral: Alcohol Education, Device: Alcohol Education TechnologyBrief session administering non-personalized information about alcohol followed by the option to receive educational alcohol-related information via text |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alcohol-related mobile health technologiesAlso: Smartphone Breathalyzer, BAC Estimator App, Self-Texting AppParticipants will be asked to use the mobile technologies as they choose while drinking for a four-week period. | Device | Moderate drinking technologies with "higher tech" facilitation, Moderate drinking technologies with "lower tech" facilitation |
| Motivational interview and psychoeducation on blood/breath alcohol concentrationAlso: M.I.Brief 25/30-minute motivational interview and psychoeducation on blood/breath alcohol concentration that includes both personalized and standardized information. | Behavioural | Moderate drinking technologies with "higher tech" facilitation, Moderate drinking technologies with "lower tech" facilitation |
| Lower tech facilitationStudy 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. | Behavioural | Moderate drinking technologies with "lower tech" facilitation |
| Higher tech facilitationAlso: SmartSipParticipants 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. | Behavioural | Moderate drinking technologies with "higher tech" facilitation |
| Alcohol EducationBrief 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 | Behavioural | Alcohol Education Condition |
| Alcohol Education TechnologyParticipants will be able to prompt text messages which will provide them one-off trivia facts using information provided during the attention control psychoeducation session | Device | Alcohol Education Condition |
Primary outcome
Technology utilization
Time frame: 4-week field use period
Percentage of reported drinking days on which one reports that moderate drinking technology use has occurred
Acceptability
Time frame: 4-week field use period
Score on acceptability subscale of Modified System Usability Scale
Usability
Time frame: 4-week field use period
Score on acceptability subscale of Modified System Usability Scale
3 secondary outcomes
Drinks per drinking day
Time frame: 4-week field use period
Estimated blood alcohol content
Time frame: 4-week field use period
Negative Consequences
Time frame: 4-week field use period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Individual participant dataSharing planned: Yes. Study materials and datasets with identifiers removed will be shared with other investigators upon request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Allie Farone, M.S. contact
Robert F Leeman, Ph.D. principal investigator
Northeastern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alcohol-related mobile health technologies, Motivational interview and psychoeducation on blood/breath alcohol concentration and Lower tech facilitation in people with Alcohol Use and Alcohol Drinking, run by Northeastern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jade Martinez, B.S. ((617) 373-5132, ja.martinez@northeastern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technology utilization (time frame: 4-week field use period). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.