Neurobehavioral ManifestationsPhase 1/2NCT00515294
Acute and Residual Effects of Caffeinated Beer
A Phase 1/2 study testing Caffeinated Alcoholic Beer, Non-Caffeinated Alcoholic Beer and Caffeinated Non-Alcoholic Beer in people with Neurobehavioral Manifestations and Drug Related Sleep Disturbance, run by Boston University at 1 site in United States.
Trial summary
The aim of this study is to develop information about the acute and residual effects of a new product being targeted to young adults. Using a double placebo-controlled 2 X 2 factorial model study design, we will compare the acute and residual effects on driving impairment of caffeinated alcohol, non-caffeinated… Read more about this study
- Who is it for?
- Ages 21 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Neurobehavioral Manifestations, Drug Related Sleep Disturbance, Alcohol Intoxication
- What is being tested?
- Caffeinated Alcoholic Beer, Non-Caffeinated Alcoholic Beer and Caffeinated Non-Alcoholic Beer
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 154 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Oct 2009
- Phase
- Phase 1/2
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- College students, graduate students, or recent graduates
- Between the ages of 21 and 30 years inclusive (as verified by valid drivers license)
- Who, if a student, reports good academic standing
- Have not been diagnosed with a sleep disorder
- Are not daily smokers
- At least occasionally in the past month, consume five drinks (for men) or more (four or more if female [based on Flannery et al 2002]) during a single drinking episode
- Have a valid drivers license, so as to include only people who know how to drive.
Who cannot join
- Scores of 5 or more on a screening measure for alcoholism (the short version of the Michigan Alcohol Screening Test [SMAST])
- A history of counseling or treatment for chronic substance abuse by self-report
- Daily smoker (to mitigate confounding of caffeine by nicotine withdrawal, or acute nicotine administration, smokers will be excluded from participation)
- Current use of medications that affect the sleep/wake cycle or daytime alertness or that are contraindicated for alcohol
- Presence of a health condition that contraindicates alcohol
- Diagnosis of a sleep disorder (sleep apnea, narcolepsy, periodic limb movement, restless legs syndrome, circadian rhythm disorder, and insomnia)
Show all 13Show fewer
- Use of recreational drugs (e.g., marijuana) while participating in the study
- Working overnight shifts
- Female and pregnant, nursing, or not using reliable birth control
- Participants who have traveled across two or more time zones in the last month will be rescheduled for later participation (minimum of 1 month from time-zone travel)
- On average consume greater than 4 cups of coffee per day (>400 mg/day)
- Participants who report ever getting motion sick during screening or become motion sick after practicing on the driving simulator during Session 1.
- Weigh more than 230 Lbs.
Trial locations and contacts
1 site in 1 country.
United States1 site
General Clinical Research Center, Boston Medical Center
Boston, Massachusetts, 02118
About this study
Official title: Acute and Residual Effects of Beer VS. Caffeinated Beer On Simulated Driving
The aim of this study is to develop information about the acute and residual effects of a new product being targeted to young adults. Using a double placebo-controlled 2 X 2 factorial model study design, we will compare the acute and residual effects on driving impairment of caffeinated alcohol, non-caffeinated alcohol, caffeinated placebo, and non-caffeinated placebo. Under the alcohol conditions, participants will receive sufficient alcoholic beverage to attain a blood alcohol concentration (BAC) of .12 g%. Participants will be 144 undergraduate and graduate students, and recent college graduates.
Read the detailed description
Caffeinated alcoholic beverages target young adults with the promise that the caffeine will counteract the sedating effects of alcohol and thus let the consumer remain alert and active longer, while continuing to drink. It is likely that in the minds of some young people, this promise also translates into the idea that mixing caffeine with alcohol allows one to drive more safely than would be possible after having consumed an equivalent amount of non-caffeinated alcoholic beverage. These are dangerous assumptions because (1) alertness may not indicate the absence of impairment under intoxication and (2) next-day impairment from the residual effects of heavy drinking may be exacerbated by mixing caffeine and alcohol. We will compare the acute and residual effects of caffeinated and non-caffeinated beer in terms of a highly relevant outcome - the ability to drive safely.
The long-term objectives of this program of research are to investigate factors that predict or contribute to performance decrements after alcohol ingestion, with a focus on behaviors most relevant to public health, such as driving. The primary specific aims of the proposed work are:
AIM 1: To compare the acute effects of caffeinated alcohol, non-caffeinated alcohol, caffeinated placebo, and non-caffeinated placebo on driving-related impairment, as measured by performance on a driving simulator and the Psychomotor Vigilance Test (PVT), a test of sustained attention/reaction time. We hypothesize that caffeinated beverage will result in less impaired simulated driving ability and better PVT performance acutely, compared to non-caffeinated beverage, but that performance on these measures following both caffeinated and non-caffeinated beverage be impaired relative to placebo beverages.
AIM 2: To compare the residual effects of caffeinated alcohol, non-caffeinated alcohol, caffeinated placebo, and non-caffeinated placebo on next-day driving-related impairment, as measured by a driving simulator and the PVT. We hypothesize that caffeinated beverage will result in greater impairment in next-day simulated driving and attention/reaction time, relative to non-caffeinated beverage, and that performance following both caffeinated and non-caffeinated alcoholic beverages will be impaired relative to corresponding placebo beverages.
AIM 3: To compare the acute effects of caffeinated alcohol, non-caffeinated alcohol, caffeinated placebo, and non-caffeinated placebo on self-rated ability to drive, as measured by a self assessment of ability-to-drive questionnaire, and estimate of blood alcohol concentration (BAC). We hypothesize that caffeinated alcoholic beverages will result in greater confidence in ability to drive and lower estimates of BAC, compared to non-caffeinated alcoholic beverages, but that for both alcoholic beverages, confidence in driving ability will be lower and estimates of BAC will be greater, relative to placebos.
AIM 4: To compare the residual effects of caffeinated alcohol, non-caffeinated alcohol, caffeinated placebo, and non-caffeinated placebo on self-rated ability to drive. We hypothesize that caffeinated alcoholic beverage will result in lower confidence in ability to drive and higher estimates of BAC, compared to non-caffeinated alcoholic beverage, but that for both alcoholic beverages, confidence in driving ability will be lower and estimates of BAC will be greater, relative to placebo.
- Being tested
- Caffeinated Alcoholic Beer, Non-Caffeinated Alcoholic Beer, Caffeinated Non-Alcoholic Beer, Non-Caffeinated, Non-Alcoholic Beer
- Keywords
- Caffeine, Alcohol, Alcohol Consumption, Residual Effects, Family History, Psychomotor Vigilance Test, Driving Simulation, Reaction Time
- Medical subject headings
- Neurobehavioral Manifestations, Alcoholic Intoxication, Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caffeinated Alcoholic BeerDrug
Also called 69mg caffeine/12oz glass of regular beer
Alcoholic Beer plus Caffeine Citrate powder.
Non-Caffeinated Alcoholic BeerOther
Alcoholic Non-Caffeinated Beer
Caffeinated Non-Alcoholic BeerDrug
Also called 69mg caffeine/12oz glass of non-alcoholic beer
Non-Alcoholic Beer plus Caffeine Citrate powder.
Non-Caffeinated, Non-Alcoholic BeerOther
Also called Placebo
Non-Alcoholic Beer
| Study group | Role | What they receive |
|---|---|---|
| 1Caffeinated Alcoholic Beer | Experimental | Caffeinated Alcoholic beer Receives: Drug: Caffeinated Alcoholic Beer |
| 2Non-Caffeinated Alcoholic Beer | Active comparator | Non-Caffeinated Alcoholic beer Receives: Other: Non-Caffeinated Alcoholic Beer |
| 3Caffeinated Non-Alcoholic Beer | Active comparator | Caffeinated Non-Alcoholic Beer Receives: Drug: Caffeinated Non-Alcoholic Beer |
| 4Non-Caffeinated, Non-Alcoholic Beer | Placebo comparator | Non-Caffeinated, Non-Alcoholic Beer Receives: Other: Non-Caffeinated, Non-Alcoholic Beer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lane Position Deviation
The reported lane position deviation indicates the position of the car relative to the center line in feet in the driver simulator. A deviation of 0 indicates no deviation from the center line (the car is positioned farthest from the road edge). Negative numbers indicate deviations to the right of the center line with the car positioned within the lane closer to the road edge. Positive numbers indicate deviations to the left of the center line with the car positioned in the lane of oncoming traffic closer to the road edge
Measured: 30 minutes post dosing
Secondary outcomes (1)
Psycho-motor Vigilance Test (PVT)
Participants completed 10 test trials to assess their psycho-motor response using a hand held box that randomly starts a scroll of numbers in milliseconds and as soon as it starts to scroll the participant needs to press a button to stop the scrolling. The mean and standard deviations for the 10 tests were calculated as a single outcome score for each study arm. Response times were measured in milliseconds. The lower the number of milliseconds the faster the response to the random stimuli.
Measured: 30 minutes post dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2007 (estimated)
- Study startOct 2006
- Primary completionOct 2009
- Study completionOct 2009
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 Neurobehavioral ManifestationsStudies of the same condition, open and under way.
- More trials run by Boston UniversityThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- Brown University, University of Michigan, Centers for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Jonathan Howland, PhD, MPH, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00515294
- Sponsor's protocol ID
- H-26002
- Other IDs
- R49CE000946
- Status last verified
- May 2017
- First submitted
- 9 Aug 2007
- Last updated
- 28 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Howland J, Rohsenow DJ, Arnedt JT, Bliss CA, Hunt SK, Calise TV, Heeren T, Winter M, Littlefield C, Gottlieb DJ. The acute effects of caffeinated versus non-caffeinated alcoholic beverage on driving performance and attention/reaction time. Addiction. 2011 Feb;106(2):335-41. doi: 10.1111/j.1360-0443.2010.03219.x. Epub 2010 Dec 6.
PubMed 21134017
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute and Residual Effects of Beer VS. Caffeinated Beer On Simulated Driving
- ClinicalTrials.gov ID
- NCT00515294
- Acronym / sponsor ID
- H-26002
- Keywords
- Caffeine, Alcohol, Alcohol Consumption, Residual Effects, Family History, Psychomotor Vigilance Test, Driving Simulation, Reaction Time
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- Brown University, University of Michigan, Centers for Disease Control and Prevention
- Study start
- Oct 2006
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 13 Aug 2007 (estimated)
- Results
- Posted 28 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to develop information about the acute and residual effects of a new product being targeted to young adults. Using a double placebo-controlled 2 X 2 factorial model study design, we will compare the acute and residual effects on driving impairment of caffeinated alcohol, non-caffeinated alcohol, caffeinated placebo, and non-caffeinated placebo. Under the alcohol conditions, participants will receive sufficient alcoholic beverage to attain a blood alcohol concentration (BAC) of .12 g%. Participants will be 144 undergraduate and graduate students, and recent college graduates.
Detailed description
Caffeinated alcoholic beverages target young adults with the promise that the caffeine will counteract the sedating effects of alcohol and thus let the consumer remain alert and active longer, while continuing to drink. It is likely that in the minds of some young people, this promise also translates into the idea that mixing caffeine with alcohol allows one to drive more safely than would be possible after having consumed an equivalent amount of non-caffeinated alcoholic beverage. These are dangerous assumptions because (1) alertness may not indicate the absence of impairment under intoxication and (2) next-day impairment from the residual effects of heavy drinking may be exacerbated by mixing caffeine and alcohol. We will compare the acute and residual effects of caffeinated and non-caffeinated beer in terms of a highly relevant outcome - the ability to drive safely.
The long-term objectives of this program of research are to investigate factors that predict or contribute to performance decrements after alcohol ingestion, with a focus on behaviors most relevant to public health, such as driving. The primary specific aims of the proposed work are:
AIM 1: To compare the acute effects of caffeinated alcohol, non-caffeinated alcohol, caffeinated placebo, and non-caffeinated placebo on driving-related impairment, as measured by performance on a driving simulator and the Psychomotor Vigilance Test (PVT), a test of sustained attention/reaction time. We hypothesize that caffeinated beverage will result in less impaired simulated driving ability and better PVT performance acutely, compared to non-caffeinated beverage, but that performance on these measures following both caffeinated and non-caffeinated beverage be impaired relative to placebo beverages.
AIM 2: To compare the residual effects of caffeinated alcohol, non-caffeinated alcohol, caffeinated placebo, and non-caffeinated placebo on next-day driving-related impairment, as measured by a driving simulator and the PVT. We hypothesize that caffeinated beverage will result in greater impairment in next-day simulated driving and attention/reaction time, relative to non-caffeinated beverage, and that performance following both caffeinated and non-caffeinated alcoholic beverages will be impaired relative to corresponding placebo beverages.
AIM 3: To compare the acute effects of caffeinated alcohol, non-caffeinated alcohol, caffeinated placebo, and non-caffeinated placebo on self-rated ability to drive, as measured by a self assessment of ability-to-drive questionnaire, and estimate of blood alcohol concentration (BAC). We hypothesize that caffeinated alcoholic beverages will result in greater confidence in ability to drive and lower estimates of BAC, compared to non-caffeinated alcoholic beverages, but that for both alcoholic beverages, confidence in driving ability will be lower and estimates of BAC will be greater, relative to placebos.
AIM 4: To compare the residual effects of caffeinated alcohol, non-caffeinated alcohol, caffeinated placebo, and non-caffeinated placebo on self-rated ability to drive. We hypothesize that caffeinated alcoholic beverage will result in lower confidence in ability to drive and higher estimates of BAC, compared to non-caffeinated alcoholic beverage, but that for both alcoholic beverages, confidence in driving ability will be lower and estimates of BAC will be greater, relative to placebo.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1Caffeinated Alcoholic Beer | Experimental | Drug: Caffeinated Alcoholic BeerCaffeinated Alcoholic beer |
| 2Non-Caffeinated Alcoholic Beer | Active comparator | Other: Non-Caffeinated Alcoholic BeerNon-Caffeinated Alcoholic beer |
| 3Caffeinated Non-Alcoholic Beer | Active comparator | Drug: Caffeinated Non-Alcoholic BeerCaffeinated Non-Alcoholic Beer |
| 4Non-Caffeinated, Non-Alcoholic Beer | Placebo comparator | Other: Non-Caffeinated, Non-Alcoholic BeerNon-Caffeinated, Non-Alcoholic Beer |
Who may qualify
- Ages
- 21 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- College students, graduate students, or recent graduates
- Between the ages of 21 and 30 years inclusive (as verified by valid drivers license)
- Who, if a student, reports good academic standing
- Have not been diagnosed with a sleep disorder
- Are not daily smokers
Key exclusion criteria (13 listed)
- Scores of 5 or more on a screening measure for alcoholism (the short version of the Michigan Alcohol Screening Test [SMAST])
- A history of counseling or treatment for chronic substance abuse by self-report
- Daily smoker (to mitigate confounding of caffeine by nicotine withdrawal, or acute nicotine administration, smokers will be excluded from participation)
- Current use of medications that affect the sleep/wake cycle or daytime alertness or that are contraindicated for alcohol
- Presence of a health condition that contraindicates alcohol
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 |
|---|---|---|
| Caffeinated Alcoholic BeerAlso: 69mg caffeine/12oz glass of regular beerAlcoholic Beer plus Caffeine Citrate powder. | Drug | 1Caffeinated Alcoholic Beer |
| Non-Caffeinated Alcoholic BeerAlcoholic Non-Caffeinated Beer | Other | 2Non-Caffeinated Alcoholic Beer |
| Caffeinated Non-Alcoholic BeerAlso: 69mg caffeine/12oz glass of non-alcoholic beerNon-Alcoholic Beer plus Caffeine Citrate powder. | Drug | 3Caffeinated Non-Alcoholic Beer |
| Non-Caffeinated, Non-Alcoholic BeerAlso: PlaceboNon-Alcoholic Beer | Other | 4Non-Caffeinated, Non-Alcoholic Beer |
Primary outcome
Lane Position Deviation
Time frame: 30 minutes post dosing
The reported lane position deviation indicates the position of the car relative to the center line in feet in the driver simulator. A deviation of 0 indicates no deviation from the center line (the car is positioned farthest from the road edge). Negative numbers indicate deviations to the right of the center line with the car positioned within the lane closer to the road edge. Positive numbers indicate deviations to the left of the center line with the car positioned in the lane of oncoming traffic closer to the road edge
1 secondary outcome
Psycho-motor Vigilance Test (PVT)
Time frame: 30 minutes post dosing
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21134017Howland J, Rohsenow DJ, Arnedt JT, Bliss CA, Hunt SK, Calise TV, Heeren T, Winter M, Littlefield C, Gottlieb DJ. The acute effects of caffeinated versus non-caffeinated alcoholic beverage on driving performance and attention/reaction time. Addiction. 2011 Feb;106(2):335-41. doi: 10.1111/j.1360-0443.2010.03219.x. Epub 2010 Dec 6.
- 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.
Jonathan Howland, PhD, MPH principal investigator
Boston University
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 Caffeinated Alcoholic Beer, Non-Caffeinated Alcoholic Beer and Caffeinated Non-Alcoholic Beer in people with Neurobehavioral Manifestations and Drug Related Sleep Disturbance, run by Boston 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 7 inclusion and 13 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 28 Jun 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 28 Jun 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?
Lane Position Deviation (time frame: 30 minutes post dosing). 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 NCT00515294, 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 28 Jun 2017.