Alcohol UsePhase 1/2STEADYNCT02963818
Smartphone Technology: Young Adult Drinking
A Phase 1/2 study testing Smartphone breathalyzer device/app use, BAC estimator app use and Text messaging procedure in people with Alcohol Use and Alcohol Drinking, run by University of Florida at 1 site in United States.
Trial summary
Exploring technology based tools to reduce drinking is important. The purpose of this research study is to compare different BAC monitoring apps for their effects on alcohol drinking and ratings of usability among young adults.This study will be conducted in six phases: a web-based and in-person screening assessment… Read more about this study
- Who is it for?
- Ages 21 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Use, Alcohol Drinking, Drinking Behavior
- What is being tested?
- Smartphone breathalyzer device/app use, BAC estimator app use and Text messaging procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to 20 Jun 2020
- Phase
- Phase 1/2
- 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 21 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Be able to read/write English and complete study assessments
- Drink alcohol regularly
Who cannot join
- Test positive on a urine test for use of certain illegal drugs
- Undergraduate student enrolled at the University of Florida
- Graduate students from the College of Health and Human Performance at the University of Florida
- Pregnant, or currently breast feeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Smartphone Technology Effects on Alcohol Drinking Among Young (STEADY) Adults Study
Exploring technology based tools to reduce drinking is important. The purpose of this research study is to compare different BAC monitoring apps for their effects on alcohol drinking and ratings of usability among young adults.This study will be conducted in six phases: a web-based and in-person screening assessment; brief counseling session on the day before the alcohol drinking session; brief appointment on the day of the alcohol drinking session; alcohol drinking session; two-week field period; and a follow-up appointment. Participation in this study will last approximately two months.
- Conditions
- Alcohol Use, Alcohol Drinking, Drinking Behavior
- Being tested
- Smartphone breathalyzer device/app use, BAC estimator app use, Text messaging procedure
- Keywords
- Brief intervention, Harm reduction, Young adult, College Student
- Medical subject headings
- Alcohol Drinking, Drinking Behavior, Harm Reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartphone breathalyzer device/app useOther
Participants randomized to this condition will be able to blow into the smartphone breathalyzer after consuming each alcoholic drink, which produces an accurate breath alcohol reading on the app. These breath alcohol readings may inform participants' subsequent decisions regarding drinking.
BAC estimator app useOther
Participants randomized to this condition will be able to make an entry into the BAC estimator app after consuming each alcoholic drink, which produces an estimated blood alcohol concentration based on the individual's sex, weight, number of alcoholic drinks and time spent drinking alcohol. These estimated blood alcohol concentrations may inform participants' subsequent decisions regarding drinking.
Text messaging procedureOther
Participants randomized to this condition will be instructed to send a text to a smartphone they will use for the study after each alcoholic drink. A consideration of the number of texts sent may inform participants' subsequent decisions regarding drinking.
| Study group | Role | What they receive |
|---|---|---|
| Smartphone breathalyzer device & app | Experimental | This is a small device that connects to a smartphone with an accompanying app that produces accurate breath alcohol readings when a user blows into a small tube attached to the device. Participants randomized to this study condition will have the opportunity to use this device and app during an alcohol drinking session in an actual bar and during a two-week field period. Receives: Other: Smartphone breathalyzer device/app use |
| BAC estimator app | Experimental | This is an app that produces estimated blood alcohol content (eBAC) readings based on sex, weight, number of drinks and time taken to consume drinks. Participants randomized to this study condition will have the opportunity to use this app during an alcohol drinking session in an actual bar and during a two-week field period. Receives: Other: BAC estimator app use |
| Text Messaging | Experimental | A procedure whereby one sends a text message to the phone one is using after each alcoholic drink. Participants randomized to this study condition will have the opportunity to the text messaging procedure during an alcohol drinking session in an actual bar and during a two-week field period. Receives: Other: Text messaging procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantity of alcohol consumption
Compare forms of mobile technology for their effects on alcohol consumption
Measured: During one alcohol drinking session, an average of 2 hours
Secondary outcomes (1)
Quantity of alcohol consumption
Compare forms of mobile technology for their effects on alcohol consumption
Measured: two-week field period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2016 (estimated)
- Study startNov 2016
- Primary completion20 Jun 2019
- Study completion20 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol UseStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- 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, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02963818
- Sponsor's protocol ID
- IRB201600614-N
- Other IDs
- R21AA023368
- Acronym
- STEADY
- Status last verified
- Feb 2024
- First submitted
- 8 Nov 2016
- Last updated
- 26 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Leeman RF, Berey BL, Frohe T, Rowland BHP, Martens MP, Fucito LM, Stellefson M, Nixon SJ, O'Malley SS. A combined laboratory and field test of a smartphone breath alcohol device and blood alcohol concentration estimator to facilitate moderate drinking among young adults. Psychol Addict Behav. 2022 Sep;36(6):710-723. doi: 10.1037/adb0000780. Epub 2021 Nov 11.
PubMed 34766785
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smartphone Technology Effects on Alcohol Drinking Among Young (STEADY) Adults Study
- ClinicalTrials.gov ID
- NCT02963818
- Acronym / sponsor ID
- STEADY / IRB201600614-N
- Conditions
- Alcohol Use, Alcohol Drinking, Drinking Behavior
- Keywords
- Brief intervention, Harm reduction, Young adult, College Student
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Nov 2016
- Primary completion
- 20 Jun 2019 (actual)
- Study completion
- 20 Jun 2020 (actual)
- First posted
- 15 Nov 2016 (estimated)
- 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.
Exploring technology based tools to reduce drinking is important. The purpose of this research study is to compare different BAC monitoring apps for their effects on alcohol drinking and ratings of usability among young adults.This study will be conducted in six phases: a web-based and in-person screening assessment; brief counseling session on the day before the alcohol drinking session; brief appointment on the day of the alcohol drinking session; alcohol drinking session; two-week field period; and a follow-up appointment. Participation in this study will last approximately two months.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Smartphone breathalyzer device & app | Experimental | Other: Smartphone breathalyzer device/app useThis is a small device that connects to a smartphone with an accompanying app that produces accurate breath alcohol readings when a user blows into a small tube attached to the device. Participants randomized to this study condition will have the opportunity to use this device and app during an alcohol drinking session in an actual bar and during a two-week field period. |
| BAC estimator app | Experimental | Other: BAC estimator app useThis is an app that produces estimated blood alcohol content (eBAC) readings based on sex, weight, number of drinks and time taken to consume drinks. Participants randomized to this study condition will have the opportunity to use this app during an alcohol drinking session in an actual bar and during a two-week field period. |
| Text Messaging | Experimental | Other: Text messaging procedureA procedure whereby one sends a text message to the phone one is using after each alcoholic drink. Participants randomized to this study condition will have the opportunity to the text messaging procedure during an alcohol drinking session in an actual bar and during a two-week field period. |
Who may qualify
- Ages
- 21 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Be able to read/write English and complete study assessments
- Drink alcohol regularly
Key exclusion criteria (4 listed)
- Test positive on a urine test for use of certain illegal drugs
- Undergraduate student enrolled at the University of Florida
- Graduate students from the College of Health and Human Performance at the University of Florida
- Pregnant, or currently breast feeding
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 |
|---|---|---|
| Smartphone breathalyzer device/app useParticipants randomized to this condition will be able to blow into the smartphone breathalyzer after consuming each alcoholic drink, which produces an accurate breath alcohol reading on the app. These breath alcohol readings may inform participants' subsequent decisions regarding drinking. | Other | Smartphone breathalyzer device & app |
| BAC estimator app useParticipants randomized to this condition will be able to make an entry into the BAC estimator app after consuming each alcoholic drink, which produces an estimated blood alcohol concentration based on the individual's sex, weight, number of alcoholic drinks and time spent drinking alcohol. These estimated blood alcohol concentrations may inform participants' subsequent decisions regarding drinking. | Other | BAC estimator app |
| Text messaging procedureParticipants randomized to this condition will be instructed to send a text to a smartphone they will use for the study after each alcoholic drink. A consideration of the number of texts sent may inform participants' subsequent decisions regarding drinking. | Other | Text Messaging |
Primary outcome
Quantity of alcohol consumption
Time frame: During one alcohol drinking session, an average of 2 hours
Compare forms of mobile technology for their effects on alcohol consumption
1 secondary outcome
Quantity of alcohol consumption
Time frame: two-week field period
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 26 Feb 2024.
- Derived from this study: PubMed 34766785Leeman RF, Berey BL, Frohe T, Rowland BHP, Martens MP, Fucito LM, Stellefson M, Nixon SJ, O'Malley SS. A combined laboratory and field test of a smartphone breath alcohol device and blood alcohol concentration estimator to facilitate moderate drinking among young adults. Psychol Addict Behav. 2022 Sep;36(6):710-723. doi: 10.1037/adb0000780. Epub 2021 Nov 11.
- Individual participant dataSharing planned: No
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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, Ph.D. principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Smartphone breathalyzer device/app use, BAC estimator app use and Text messaging procedure in people with Alcohol Use and Alcohol Drinking, run by University of Florida 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 2 inclusion and 4 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 26 Feb 2024. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Quantity of alcohol consumption (time frame: During one alcohol drinking session, an average of 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02963818, which also lists 1 linked publication.
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 26 Feb 2024.