Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R49CE000946 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Brown University | OTHER |
| University of Michigan | OTHER |
| Centers for Disease Control and Prevention | FED |
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1Caffeinated Alcoholic Beer | Experimental | Caffeinated Alcoholic beer |
|
| 2Non-Caffeinated Alcoholic Beer | Active Comparator | Non-Caffeinated Alcoholic beer |
|
| 3Caffeinated Non-Alcoholic Beer | Active Comparator | Caffeinated Non-Alcoholic Beer |
|
| 4Non-Caffeinated, Non-Alcoholic Beer | Placebo Comparator | Non-Caffeinated, Non-Alcoholic Beer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Caffeinated Alcoholic Beer | Drug | Alcoholic Beer plus Caffeine Citrate powder. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 30 minutes post dosing |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jonathan Howland, PhD, MPH | Boston University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Clinical Research Center, Boston Medical Center | Boston | Massachusetts | 02118 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21134017 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Recruited via newspaper ads and social media.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 1Caffeinated Alcoholic Beer | Caffeinated Alcoholic Beer: Alcoholic Beer plus Caffeine Citrate powder. |
| FG001 | 2Non-Caffeinated Alcoholic Beer | Non-Caffeinated Alcoholic Beer: Alcoholic Non-Caffeinated Beer |
| FG002 | 3Caffeinated Non-Alcoholic Beer | Caffeinated Non-Alcoholic Beer: Non-Alcoholic Beer plus Caffeine Citrate powder. |
| FG003 | 4Non-Alcoholic, Non-Caffeinated Beer | Non-Caffeinated, Non-Alcoholic Beer: Non-Alcoholic Beer |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
We compared participants across groups by age and sex.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 1Caffeinated Alcoholic Beer | Caffeinated Alcoholic Beer: Alcoholic Beer plus Caffeine Citrate powder. |
| BG001 | 2Non-Caffeinated Alcoholic Beer | Non-Caffeinated Alcoholic Beer: Alcoholic Non-Caffeinated Beer |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Driver simulator did not work properly for 6 participants. Their data are not included. | Posted | Mean | Standard Deviation | feet | 30 minutes post dosing |
|
3 years
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 1Caffeinated Alcohol | Caffeinated Alcoholic Beer: Alcoholic Beer plus Caffeine Citrate powder. |
Not provided
Not provided
Difficulties with the driver simulator resulted in invalid data for 6 participants so their results were not included in the lane position deviation results. Inaccurate caffeine doses resulted in exclusion of 12 participants from the trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jonathan Howland, Professor | Boston University | 617 638 5158 | jhowl@bu.edu |
Not provided
| ID | Term |
|---|---|
| D019954 | Neurobehavioral Manifestations |
| D000435 | Alcoholic Intoxication |
| D000428 | Alcohol Drinking |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Non-Caffeinated Alcoholic Beer | Other | Alcoholic Non-Caffeinated Beer |
|
| Caffeinated Non-Alcoholic Beer | Drug | Non-Alcoholic Beer plus Caffeine Citrate powder. |
|
|
| Non-Caffeinated, Non-Alcoholic Beer | Other | Non-Alcoholic Beer |
|
|
| 30 minutes post dosing |
| Driver simulator problems |
|
| Caffeine amount inaccurate |
|
| BG002 | 3Caffeinated Non-Alcoholic Beer | Caffeinated Non-Alcoholic Beer: Non-Alcoholic Beer plus Caffeine Citrate powder. |
| BG003 | 4Non-Alcoholic, Non-Caffeinated Beer | Non-Caffeinated, Non-Alcoholic Beer: Non-Alcoholic Beer |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| 2Non-Caffeinated Alcoholic Beer |
Non-Caffeinated Alcoholic Beer: Alcoholic Non-Caffeinated Beer |
| OG002 | 3Caffeinated Non-Alcoholic Beer | Caffeinated Non-Alcoholic Beer: Non-Alcoholic Beer plus Caffeine Citrate powder. |
| OG003 | 4Non-Alcoholic, Non-Caffeinated Beer | Non-Caffeinated, Non-Alcoholic Beer: Non-Alcoholic Beer |
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | milliseconds | 30 minutes post dosing |
|
|
|
| 0 |
| 29 |
| 0 |
| 29 |
| 0 |
| 29 |
| EG001 | 2Non-Caffeinated Alcohol | Non-Caffeinated Alcoholic Beer: Alcoholic Non-Caffeinated Beer | 0 | 36 | 0 | 36 | 0 | 36 |
| EG002 | 3Caffeinated Non-Alcoholic Beer | Caffeinated Non-Alcoholic Beer: Non-Alcoholic Beer plus Caffeine Citrate powder. | 0 | 27 | 0 | 27 | 0 | 27 |
| EG003 | 4Non-Alcoholic, Non-Caffeinated Beer | Non-Caffeinated, Non-Alcoholic Beer: Non-Alcoholic Beer | 0 | 35 | 0 | 35 | 0 | 35 |
Not provided
Not provided
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D004327 | Drinking Behavior |
| D001519 | Behavior |