Alcohol IntoxicationNCT02722564
Accuracy of Self-estimation of Blood Alcohol Concentration Compared to Object Values
A study testing self estimation of breath alcohol content, breath alcohol content as measured by Alco Sensor IV device and drink a beer in people with Alcohol Intoxication, run by St. Luke's Hospital and Health Network, Pennsylvania at 1 site in United States.
Trial summary
This will be a prospective survey study. The participants will all be volunteers of legal drinking age. Each participant will consume one alcoholic beverage (beer) at a time and then will be asked to verbally estimate their current blood alcohol concentration and if the subject feels they are able to drive. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alcohol Intoxication
- What is being tested?
- self estimation of breath alcohol content, breath alcohol content as measured by Alco Sensor IV device and drink a beer
- Type of treatment
- Injection or infusion, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to Dec 2015
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- over the legal age (21years old) to drink alcohol.
Who cannot join
- Volunteers will be excluded from the study if they suffer from any of the following conditions:
- Alcoholism, Diabetes, Kidney/bladder stones, Kidney disease, Liver disease, Stomach ulcer, Organ transplant patients, Dialysis patients, and patients with alcohol allergies.
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Luke's University Hospital
Bethlehem, Pennsylvania, 18015
About this study
This will be a prospective survey study. The participants will all be volunteers of legal drinking age. Each participant will consume one alcoholic beverage (beer) at a time and then will be asked to verbally estimate their current blood alcohol concentration and if the subject feels they are able to drive. At that time, their BAC level will be measured objectively using a breath alcohol test (BAT) device. The participant will not be told their objective value. This will continue with a verbal estimate and actual BAT reading after every drink until the participant reaches a minimum BAC of 0.10. At this time, participants will continue to be monitored until their BAC falls to 0.08 and they are clinically sober. As their blood alcohol level decreases, the investigators will ask the participant to estimate their level every hour along with an actual reading until reaching 0.08. Statistical analyses will be used to determine how accurate self estimation is in regards to blood alcohol content.
- Conditions
- Alcohol Intoxication
- Being tested
- self estimation of breath alcohol content, breath alcohol content as measured by Alco Sensor IV device, drink a beer
- Medical subject headings
- Alcoholic Intoxication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self estimation of breath alcohol contentBehavioural
breath alcohol content as measured by Alco Sensor IV deviceDevice
drink a beerOther
drink a beer, repeat until breath alcohol content 0.1
| Study group | Role | What they receive |
|---|---|---|
| all study participants | Experimental | subject will self estimate breath alcohol content and their actual BrAC will be recorded as measured by the Alco Sensor IV after each beer ingested. Receives: Behavioral: self estimation of breath alcohol content; Device: breath alcohol content as measured by Alco Sensor IV device; Other: drink a beer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Breath Alcohol Content Between the Estimated Level and the Actual Level as Measured by an Alco Sensor IV Device
The change was measured both when participants' breath alcohol content was ascending to 0.1 and descending to 0.08.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2016 (estimated)
- Study startAug 2015
- Primary completionDec 2015
- Study completionDec 2015
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol IntoxicationStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Luke's Hospital and Health Network, Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Holly Stankewicz, D.O., St. Luke's Hospital and Health Network, Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02722564
- Sponsor's protocol ID
- SLHN 2015-26
- Status last verified
- May 2017
- First submitted
- 16 Oct 2015
- Last updated
- 15 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Kraus CL, Salazar NC, Mitchell JR, Florin WD, Guenther B, Brady D, Swartzwelder SH, White AM. Inconsistencies between actual and estimated blood alcohol concentrations in a field study of college students: do students really know how much they drink? Alcohol Clin Exp Res. 2005 Sep;29(9):1672-6. doi: 10.1097/01.alc.0000179205.24180.4a.
PubMed 16205367
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Self-estimation of Blood Alcohol Concentration Compared to Object Values
- ClinicalTrials.gov ID
- NCT02722564
- Acronym / sponsor ID
- SLHN 2015-26
- Conditions
- Alcohol Intoxication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- St. Luke's Hospital and Health Network, PennsylvaniaUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 30 Mar 2016 (estimated)
- Results
- Posted 15 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This will be a prospective survey study. The participants will all be volunteers of legal drinking age. Each participant will consume one alcoholic beverage (beer) at a time and then will be asked to verbally estimate their current blood alcohol concentration and if the subject feels they are able to drive. At that time, their BAC level will be measured objectively using a breath alcohol test (BAT) device. The participant will not be told their objective value. This will continue with a verbal estimate and actual BAT reading after every drink until the participant reaches a minimum BAC of 0.10. At this time, participants will continue to be monitored until their BAC falls to 0.08 and they are clinically sober. As their blood alcohol level decreases, the investigators will ask the participant to estimate their level every hour along with an actual reading until reaching 0.08. Statistical analyses will be used to determine how accurate self estimation is in regards to blood alcohol content.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| all study participants | Experimental | Behavioral: self estimation of breath alcohol content, Device: breath alcohol content as measured by Alco Sensor IV device, Other: drink a beersubject will self estimate breath alcohol content and their actual BrAC will be recorded as measured by the Alco Sensor IV after each beer ingested. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- over the legal age (21years old) to drink alcohol.
Key exclusion criteria (2 listed)
- Volunteers will be excluded from the study if they suffer from any of the following conditions:
- Alcoholism, Diabetes, Kidney/bladder stones, Kidney disease, Liver disease, Stomach ulcer, Organ transplant patients, Dialysis patients, and patients with alcohol allergies.
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 |
|---|---|---|
| self estimation of breath alcohol content | Behavioural | all study participants |
| breath alcohol content as measured by Alco Sensor IV device | Device | all study participants |
| drink a beerdrink a beer, repeat until breath alcohol content 0.1 | Other | all study participants |
Primary outcome
Change in Breath Alcohol Content Between the Estimated Level and the Actual Level as Measured by an Alco Sensor IV Device
Time frame: 1 day
The change was measured both when participants' breath alcohol content was ascending to 0.1 and descending to 0.08.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16205367Kraus CL, Salazar NC, Mitchell JR, Florin WD, Guenther B, Brady D, Swartzwelder SH, White AM. Inconsistencies between actual and estimated blood alcohol concentrations in a field study of college students: do students really know how much they drink? Alcohol Clin Exp Res. 2005 Sep;29(9):1672-6. doi: 10.1097/01.alc.0000179205.24180.4a.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing self estimation of breath alcohol content, breath alcohol content as measured by Alco Sensor IV device and drink a beer in people with Alcohol Intoxication, run by St. Luke's Hospital and Health Network, Pennsylvania 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 1 inclusion and 2 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 15 May 2017. 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?
Yes. Results are posted in the registry (first posted 15 May 2017). 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?
Change in Breath Alcohol Content Between the Estimated Level and the Actual Level as Measured by an Alco Sensor IV Device (time frame: 1 day). 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 NCT02722564, 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 15 May 2017.