Alcohol Intoxication Clinical Trial
Official title:
Acute and Residual Effects of Beer VS. Caffeinated Beer On Simulated Driving
Verified date | July 2016 |
Source | Boston University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 144 |
Est. completion date | October 2009 |
Est. primary completion date | October 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 21 Years to 30 Years |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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) - 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. |
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)
Country | Name | City | State |
---|---|---|---|
United States | General Clinical Research Center, Boston Medical Center | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Boston University | Brown University, University of Michigan |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Simulated Driving Task, Psychomotor Vigilance Test, Profile of Mood States, Subjective Hangover Ratings | Acute and Residual Immediate Exposures | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04230460 -
Cannabis Impairment Detection Application (CIDA)
|
N/A | |
Terminated |
NCT04192448 -
Men, Mood, and Attention Study: Examination of Alcohol, State Anger, and Emotion Regulation Sexual Aggression
|
N/A | |
Recruiting |
NCT05779774 -
WayToServePlus: Improving Responsible Alcohol Service Ph II
|
N/A | |
Completed |
NCT03449095 -
Understanding Alcohol Reward in Social Context
|
N/A | |
Completed |
NCT02861807 -
Mindfulness-Based Intervention and Transcranial Direct Current Brain Stimulation to Reduce Heavy Drinking
|
N/A | |
Completed |
NCT01688245 -
A Text Message Behavioral Intervention to Reduce Alcohol Consumption in Young Adults
|
N/A | |
Completed |
NCT01783223 -
Prevalence of Chronic Inebriates to the Emergency Department and Suitability for Sobering House Services
|
||
Completed |
NCT05028413 -
Evaluating Perceived Fitness to Drive While Intoxicated
|
N/A | |
Not yet recruiting |
NCT06419647 -
Tracking Mood: The Effects of Daily Mood Tracking VAS on Alcohol Consumption in Adult Heavy Drinkers
|
N/A | |
Active, not recruiting |
NCT00608686 -
Neurosteroids and Acute Alcohol Intoxication in Humans
|
Phase 1 | |
Recruiting |
NCT05701865 -
Biphasic Effects of Acute Alcohol Intoxication on Bystander Intervention
|
N/A | |
Recruiting |
NCT05757089 -
Efficacy of the Dietary Food Supplement ALCOFILTRUM in Alleviating Alcohol Hangover Symptoms
|
N/A | |
Recruiting |
NCT04912492 -
Promoting Prosocial Bystander Behavior in Intoxicated Men: Evaluation of RealConsent2.0
|
N/A | |
Active, not recruiting |
NCT04564599 -
The Rise of Ride Sharing Companies and Trends in Impaired Driving Accidents
|
||
Not yet recruiting |
NCT04229732 -
Trials of Ventilation Assisted Substance Elimination Via the Lung - Ethanol (VASEL - Ethanol)
|
N/A | |
Recruiting |
NCT06065657 -
Effect of Nutritional Ketosis on Alcohol Metabolism
|
Phase 2/Phase 3 | |
Recruiting |
NCT03242161 -
Development of LabPatch-alcohol as a Noninvasive Skin Patch to Detect Blood Alcohol Concentrations
|
Early Phase 1 | |
Recruiting |
NCT04931095 -
The Impact of Oral Cannabis Administration and Co-Administration of Alcohol on Impairment
|
Phase 1 | |
Active, not recruiting |
NCT03467191 -
Behavioral Alcohol Responses (BAR) Study
|
Early Phase 1 | |
Recruiting |
NCT06264791 -
Stress-motivated Alcohol Use as a Value-based Decision-making Process
|
N/A |