Alcohol UseNCT02841735
Young Adult Naturalistic Alcohol Study (YANAS) Using Smartphone Technology in a Simulated Laboratory Environment
An observational study of Alcohol Use and Alcohol Drinking, run by University of Florida at 1 site in United States.
Trial summary
It is important to explore use of technology to reduce drinking. The purpose of this research study is to compare different types of mobile technology for their effects on alcohol drinking and ratings of usability among young adults.This study will be conducted in four phases: a web-based screening assessment; brief… 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
- Type of treatment
- Medical device
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to 3 Feb 2018
- Phase
- Observational
- 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
Study population: Interested individuals will contact the study by telephone or by email or will go directly to the study's information page located at www.yanasinfo.org.
Who may be able to join
- Be able to read English and complete assessments
- Drink alcohol regularly
Who cannot join
- Test positive on a urine test for use of certain illegal drugs
- Undergraduate student enrolled in the University of Florida
- Graduate students from the College of Health and Human Performance at the University of Florida
- Pregnant, or breast feeding
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Health Education and Behavior
Gainesville, Florida, 32611
About this study
It is important to explore use of technology to reduce drinking. The purpose of this research study is to compare different types of mobile technology for their effects on alcohol drinking and ratings of usability among young adults.This study will be conducted in four phases: a web-based screening assessment; brief appointment on the day of the alcohol drinking session; alcohol drinking session; 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, web-based interventions, 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 useDevice
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 useDevice
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 procedureDevice
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 | This is a small device that attaches 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 a simulated laboratory. Receives: Device: Smartphone breathalyzer device/app use | |
| BAC estimator app | 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 a simulated laboratory. Receives: Device: BAC estimator app use | |
| Text Messaging | 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 a simulated laboratory. Receives: Device: 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 an alcohol drinking session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2016 (estimated)
- Study startJul 2016
- Primary completion3 Feb 2018
- Study completion3 Feb 2018
Why it stopped: Protocol expired with IRB.
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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert F. Leeman, Ph.D., Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02841735
- Sponsor's protocol ID
- IRB201500990
- Other IDs
- ID00004419
- Status last verified
- Nov 2018
- First submitted
- 20 Jul 2016
- Last updated
- 3 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Young Adult Naturalistic Alcohol Study (YANAS) Using Smartphone Technology in a Simulated Laboratory Environment
- ClinicalTrials.gov ID
- NCT02841735
- Acronym / sponsor ID
- IRB201500990
- Conditions
- Alcohol Use, Alcohol Drinking, Drinking Behavior
- Keywords
- brief intervention, web-based interventions, harm reduction, young adult, college student
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Protocol expired with IRB.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- 3 Feb 2018 (actual)
- Study completion
- 3 Feb 2018 (actual)
- First posted
- 22 Jul 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.
It is important to explore use of technology to reduce drinking. The purpose of this research study is to compare different types of mobile technology for their effects on alcohol drinking and ratings of usability among young adults.This study will be conducted in four phases: a web-based screening assessment; brief appointment on the day of the alcohol drinking session; alcohol drinking session; and a follow-up appointment. Participation in this study will last approximately two months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Smartphone breathalyzer device & app | – | Device: Smartphone breathalyzer device/app useThis is a small device that attaches 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 a simulated laboratory. |
| BAC estimator app | – | Device: 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 a simulated laboratory. |
| Text Messaging | – | Device: 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 a simulated laboratory. |
Who may qualify
- Ages
- 21 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Interested individuals will contact the study by telephone or by email or will go directly to the study's information page located at www.yanasinfo.org.
Key inclusion criteria (2 listed)
- Be able to read English and complete assessments
- Drink alcohol regularly
Key exclusion criteria (4 listed)
- Test positive on a urine test for use of certain illegal drugs
- Undergraduate student enrolled in the University of Florida
- Graduate students from the College of Health and Human Performance at the University of Florida
- Pregnant, or 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. | Device | 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. | Device | 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. | Device | Text Messaging |
Primary outcome
Quantity of alcohol consumption
Time frame: During an alcohol drinking session
Compare forms of mobile technology for their effects on alcohol consumption
Results and safety
The study was stopped early (reason given: Protocol expired with IRB.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2018.
- 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?
An observational study of 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: stopped early, as of the sponsor's last update on 3 Dec 2018. 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 was stopped early (reason given: Protocol expired with IRB.). Results are not available in the source record.
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 an alcohol drinking session). 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 3 Dec 2018.