Alcohol Use DisorderPhase 4NCT03314454
Alcohol Use and Mental Health - Pilot Test of Video-assisted Drinking Topography
A Phase 4 study testing Beer and Videotaped drinking session in people with Alcohol Use Disorder, run by University of Florida at 1 site in United States.
Trial summary
The overall goal is to pilot test and establish a procedure for video-assisted alcohol topography and explore its utility as an indicator of alcohol use disorder. There are 4 phases to this study: 1) pre-screening by phone; 2) in-person screening appointment; 3) the first alcohol drinking session with videotaping; and… Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Beer and Videotaped drinking session
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Oct 2017to 1 Jun 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 55 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
- Healthy adults reporting alcohol consumption in the past 30 days
- Not currently seeking treatment for substance use
- Willingness to provide urine drug screening
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
The overall goal is to pilot test and establish a procedure for video-assisted alcohol topography and explore its utility as an indicator of alcohol use disorder. There are 4 phases to this study: 1) pre-screening by phone; 2) in-person screening appointment; 3) the first alcohol drinking session with videotaping; and 4) follow-up appointment for retest.
Read the detailed description
Alcohol use especially high-risk drinking remains a serious public health concern. Recent calls for "precision intervention" require more in-depth understanding of drinking behavioral patterns for more individualized treatment. Currently, alcohol research has relied on self-reported questionnaire or biomarkers to measure alcohol use. However, self-reports are often subjected to social desirability bias or recall errors; whereas biomarkers are prone to measurement errors, confounders for false positives, and individual variations in alcohol metabolism. There is need for an objective, reliable, and nonintrusive way to measure alcohol use with high ecological validity.
Topography can provide objective measures of consumption behavior patterns in fine grained detail. While it has been widely used in tobacco research, alcohol topography has not been well-studied. Smoking topography has been shown to provide indicative information for nicotine dependence. The investigators hypothesize that alcohol topography can also be used as an objective measure indicative of alcohol use disorder. In this project, the investigators propose to conduct a video-assisted drinking topographical study. The main objectives of this study include: (1) characterize drinking behavioral patterns by converting videotaped drinking episodes into various drinking related parameters (e.g., sipping frequency, sipping interval, sipping duration, rest duration, sipping amount, and etc.); (2) compare drinking behavioral patterns across groups defined by drinking status (social vs. heavy drinkers) and mental health status (depressed vs. non-depressed); and (3) use advanced nonlinear modeling to quantify the behavioral pattern and to derive potential indicators for alcohol use disorder.
This will be the first study to ever use videotaped topography to analyze alcohol drinking behavioral pattern using a quantum model and link it to alcohol use disorder. The study will be conducted in the simulated bar laboratory located in Yon Hall at the University of Florida (UF). Conducting alcohol topography in such a setting greatly enhances ecological validity, further increasing the capacity of this method to capture real life drinking patterns and to potentially detect alcohol use disorder.
- Conditions
- Alcohol Use Disorder
- Being tested
- Beer, Videotaped drinking session
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BeerDrug
Common brands beer with similar calorie (125-150) and alcohol level (approximately 4.5% ABV)
Videotaped drinking sessionDevice
Also called video-assisted topography
Video-assisted alcohol topography to explore its utility as an indicator of alcohol use disorder
| Study group | Role | What they receive |
|---|---|---|
| Elevated Mental Status | Active comparator | Elevated score on Patient Health Questionnaire Receives: Drug: Beer; Device: Videotaped drinking session |
| Non-elevated depressed mood | Active comparator | Lower score on Patient Health Questionnaire Receives: Drug: Beer; Device: Videotaped drinking session |
| Social Drinking status | Active comparator | The social drinker group will be those who consume alcohol regularly but with infrequent heavy drinking days. Receives: Drug: Beer; Device: Videotaped drinking session |
| Heavy drinker status | Active comparator | The heavy drinker group will be those who consume alcohol regularly with frequent heavy drinking days. Receives: Drug: Beer; Device: Videotaped drinking session |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol Topography: Sip Frequency
To explore the potential of using alcohol topography as a noninvasive objective measure of alcohol drinking behavior and the possibility of using the identified behavioral pattern as an indicator for alcohol use disorder. We operationalized alcohol topography in several ways including the present measure: mean number of sips per alcoholic drink
Measured: 60 days (from phone screening to follow-up retest)
Alcohol Topography: Sip Interval
To explore the potential of using alcohol topography as a noninvasive objective measure of alcohol drinking behavior and the possibility of using the identified behavioral pattern as an indicator for alcohol use disorder. We operationalized alcohol topography in several ways including the present measure: mean interval between sips
Measured: 60 days (from phone screening to follow-up retest)
Alcohol Topography: Sip Duration
To explore the potential of using alcohol topography as a noninvasive objective measure of alcohol drinking behavior and the possibility of using the identified behavioral pattern as an indicator for alcohol use disorder. We operationalized alcohol topography in several ways including the present measure: mean sip duration
Measured: 60 days (from phone screening to follow-up retest)
Alcohol Topography: Sip Amount.
To explore the potential of using alcohol topography as a noninvasive objective measure of alcohol drinking behavior and the possibility of using the identified behavioral pattern as an indicator for alcohol use disorder. We operationalized alcohol topography in multiple ways including the current measure: mean amount of beer consumed per sip
Measured: 60 days (from phone screening to follow-up retest)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2017
- Study start12 Oct 2017
- Primary completion15 Dec 2022
- Study completion1 Jun 2023
Why it stopped: This was an internally-funded pilot and priority had to be given to grant-funded projects.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alcohol Use DisorderStudies 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 4
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Leeman, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03314454
- Sponsor's protocol ID
- IRB201700455
- Status last verified
- Dec 2024
- First submitted
- 4 Oct 2017
- Last updated
- 27 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alcohol Use and Mental Health - Pilot Test of Video-assisted Drinking Topography
- ClinicalTrials.gov ID
- NCT03314454
- Acronym / sponsor ID
- IRB201700455
- Conditions
- Alcohol Use Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This was an internally-funded pilot and priority had to be given to grant-funded projects.
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 12 Oct 2017 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 19 Oct 2017 (actual)
- Results
- Posted 27 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall goal is to pilot test and establish a procedure for video-assisted alcohol topography and explore its utility as an indicator of alcohol use disorder. There are 4 phases to this study: 1) pre-screening by phone; 2) in-person screening appointment; 3) the first alcohol drinking session with videotaping; and 4) follow-up appointment for retest.
Detailed description
Alcohol use especially high-risk drinking remains a serious public health concern. Recent calls for "precision intervention" require more in-depth understanding of drinking behavioral patterns for more individualized treatment. Currently, alcohol research has relied on self-reported questionnaire or biomarkers to measure alcohol use. However, self-reports are often subjected to social desirability bias or recall errors; whereas biomarkers are prone to measurement errors, confounders for false positives, and individual variations in alcohol metabolism. There is need for an objective, reliable, and nonintrusive way to measure alcohol use with high ecological validity.
Topography can provide objective measures of consumption behavior patterns in fine grained detail. While it has been widely used in tobacco research, alcohol topography has not been well-studied. Smoking topography has been shown to provide indicative information for nicotine dependence. The investigators hypothesize that alcohol topography can also be used as an objective measure indicative of alcohol use disorder. In this project, the investigators propose to conduct a video-assisted drinking topographical study. The main objectives of this study include: (1) characterize drinking behavioral patterns by converting videotaped drinking episodes into various drinking related parameters (e.g., sipping frequency, sipping interval, sipping duration, rest duration, sipping amount, and etc.); (2) compare drinking behavioral patterns across groups defined by drinking status (social vs. heavy drinkers) and mental health status (depressed vs. non-depressed); and (3) use advanced nonlinear modeling to quantify the behavioral pattern and to derive potential indicators for alcohol use disorder.
This will be the first study to ever use videotaped topography to analyze alcohol drinking behavioral pattern using a quantum model and link it to alcohol use disorder. The study will be conducted in the simulated bar laboratory located in Yon Hall at the University of Florida (UF). Conducting alcohol topography in such a setting greatly enhances ecological validity, further increasing the capacity of this method to capture real life drinking patterns and to potentially detect alcohol use disorder.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Elevated Mental Status | Active comparator | Drug: Beer, Device: Videotaped drinking sessionElevated score on Patient Health Questionnaire |
| Non-elevated depressed mood | Active comparator | Drug: Beer, Device: Videotaped drinking sessionLower score on Patient Health Questionnaire |
| Social Drinking status | Active comparator | Drug: Beer, Device: Videotaped drinking sessionThe social drinker group will be those who consume alcohol regularly but with infrequent heavy drinking days. |
| Heavy drinker status | Active comparator | Drug: Beer, Device: Videotaped drinking sessionThe heavy drinker group will be those who consume alcohol regularly with frequent heavy drinking days. |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Be able to read/write English and complete study assessments
- Drink alcohol
- Healthy adults reporting alcohol consumption in the past 30 days
- Not currently seeking treatment for substance use
- Willingness to provide urine drug screening
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 |
|---|---|---|
| BeerCommon brands beer with similar calorie (125-150) and alcohol level (approximately 4.5% ABV) | Drug | Elevated Mental Status, Heavy drinker status, Non-elevated depressed mood, Social Drinking status |
| Videotaped drinking sessionAlso: video-assisted topographyVideo-assisted alcohol topography to explore its utility as an indicator of alcohol use disorder | Device | Elevated Mental Status, Heavy drinker status, Non-elevated depressed mood, Social Drinking status |
Primary outcome
Alcohol Topography: Sip Frequency
Time frame: 60 days (from phone screening to follow-up retest)
To explore the potential of using alcohol topography as a noninvasive objective measure of alcohol drinking behavior and the possibility of using the identified behavioral pattern as an indicator for alcohol use disorder. We operationalized alcohol topography in several ways including the present measure: mean number of sips per alcoholic drink
Alcohol Topography: Sip Interval
Time frame: 60 days (from phone screening to follow-up retest)
To explore the potential of using alcohol topography as a noninvasive objective measure of alcohol drinking behavior and the possibility of using the identified behavioral pattern as an indicator for alcohol use disorder. We operationalized alcohol topography in several ways including the present measure: mean interval between sips
Alcohol Topography: Sip Duration
Time frame: 60 days (from phone screening to follow-up retest)
To explore the potential of using alcohol topography as a noninvasive objective measure of alcohol drinking behavior and the possibility of using the identified behavioral pattern as an indicator for alcohol use disorder. We operationalized alcohol topography in several ways including the present measure: mean sip duration
Alcohol Topography: Sip Amount.
Time frame: 60 days (from phone screening to follow-up retest)
To explore the potential of using alcohol topography as a noninvasive objective measure of alcohol drinking behavior and the possibility of using the identified behavioral pattern as an indicator for alcohol use disorder. We operationalized alcohol topography in multiple ways including the current measure: mean amount of beer consumed per sip
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 Leeman, PhD 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 4 study testing Beer and Videotaped drinking session in people with Alcohol Use Disorder, 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 5 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 27 Dec 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Alcohol Topography: Sip Frequency (time frame: 60 days (from phone screening to follow-up retest)). The study lists 4 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 27 Dec 2024.