Alcohol UseBAMTECHNCT06124898
Multi-Component Breath Alcohol Intervention
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 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. 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
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Nov 2023to 29 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development and Initial Testing of a Multi-Component Breath Alcohol- Focused Intervention for Young Adults
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.
- 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
- 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 and self-texting procedure
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 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.
| 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 |
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: Across the field testing period, 2 weeks
Acceptability
Score on acceptability subscale of Modified System Usability Scale
Measured: At the end of the field testing period, 2 weeks
Usability
Score on acceptability subscale of Modified System Usability Scale
Measured: At the end of the field testing period, 2 weeks
Secondary outcomes (3)
Drinks per drinking day
Number of drinks per day during field testing period
Measured: Across the field testing period, 2 weeks
Estimated blood alcohol content
Average estimated blood alcohol content reached on drinking days
Measured: Across the field testing period, 2 weeks
Negative consquences
Score on the Young Adult Alcohol Consequences Questionnaire
Measured: At the end of the field testing period, 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study start9 Nov 2023
- Primary completion29 Aug 2024
- Study completion29 Aug 2024
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
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, PhD., Principal investigator, Northeastern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06124898
- Sponsor's protocol ID
- IRB22-11-43
- Other IDs
- R34AA029224-01
- Acronym
- BAMTECH
- Status last verified
- May 2026
- First submitted
- 30 Oct 2023
- Last updated
- 14 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 14 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
- ClinicalTrials.gov ID
- NCT06124898
- Acronym / sponsor ID
- BAMTECH / IRB22-11-43
- Conditions
- Alcohol Use, Alcohol Drinking, Drinking Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Northeastern UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 9 Nov 2023 (actual)
- Primary completion
- 29 Aug 2024 (actual)
- Study completion
- 29 Aug 2024 (actual)
- First posted
- 9 Nov 2023 (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 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| 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. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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)
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 and self-texting procedureParticipants will be asked to use the three mobile technologies as they choose while drinking for a two-week period. | Device | 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 "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 |
Primary outcome
Technology utilization
Time frame: Across the field testing period, 2 weeks
Percentage of reported drinking days on which one reports that moderate drinking technology use has occurred
Acceptability
Time frame: At the end of the field testing period, 2 weeks
Score on acceptability subscale of Modified System Usability Scale
Usability
Time frame: At the end of the field testing period, 2 weeks
Score on acceptability subscale of Modified System Usability Scale
3 secondary outcomes
Drinks per drinking day
Time frame: Across the field testing period, 2 weeks
Estimated blood alcohol content
Time frame: Across the field testing period, 2 weeks
Negative consquences
Time frame: At the end of the field testing period, 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 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. This study is not recruiting at the moment.
Robert F Leeman, PhD. 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 14 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technology utilization (time frame: Across the field testing period, 2 weeks). 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 14 May 2026.