Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00247585
Status:
COMPLETED
Last Update Posted:
2006-12-06
First Post:
2005-11-01
Brief Title:
Hangover Congeners Sleep and Occupational Performance
Sponsor:
National Institute on Alcohol Abuse and Alcoholism NIAAA
Organization:
National Institute on Alcohol Abuse and Alcoholism NIAAA
Study Overview
Official Title:
Hangover Congeners Sleep and Occupational Performance
Status:
COMPLETED
Status Verified Date:
2006-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective is to investigate residual effects of heavy drinking with or without hangover symptoms The primary aim is to test several hypotheses about residual effects of heavy drinking Hypotheses about how heavy drinking affects next-day performance include direct physiological effects of alcohol alcohol withdrawal effects and non-ethanol effects such as congeners or family history of alcohol problems The investigators will test the following hypotheses
1 relative to placebo heavy drinking will degrade next-day performance and this relationship will be mediated in full or in part by quality of sleep
2 a high congener alcoholic beverage will affect performance to a greater degree than a low congener beverage and this relationship will be mediated by severity of hangover symptoms
1 relative to placebo heavy drinking will degrade next-day performance and this relationship will be mediated in full or in part by quality of sleep
2 a high congener alcoholic beverage will affect performance to a greater degree than a low congener beverage and this relationship will be mediated by severity of hangover symptoms
Detailed Description:
The primary aim of the proposed study is to test several hypotheses about residual effects of heavy drinking Hypotheses about how heavy drinking affects next-day performance include direct physiological effects of alcohol eg electrolyte imbalance low blood sugar sleep disturbance alcohol withdrawal effects acetaldehyde toxicity and non-ethanol effects such as congeners or family history of alcohol Swift and Davidson 1998 Using a placebo-controlled randomized trial we will dose participants with placebo or with a high or low congener alcoholic beverage to a level of 010 g BAC the night before they perform exercises on a neurobehavioral evaluation system We will monitor participants sleep to assess sleep disturbance We will collect information on hangover symptoms the morning after dosing We will also collect data on participants family history of drinking problems We will test the following hypotheses
1 relative to placebo heavy drinking will degrade next-day cognitive performance and this relationship will be mediated in full or in part by quality of sleep and
2 a high congener alcoholic beverage will affect performance to a greater degree than a low congener beverage and this relationship will be mediated by severity of hangover symptoms
We will explore whether the residual effects of heavy drinking on next-day cognitive performance are attenuated among participants positive for a family history of alcohol problems relative to family-history-negative participants
A secondary aim is to test the effectiveness of the Psychomotor Vigilance Test PVT a validated measure of fatigue as a fitness-for-duty test We will test whether the PVT can distinguish dosing status alcohol or placebo of participants at the time performance is measured the next day and the extent to which PVT measures correlate with performance scores
Participants will be young adults ages 21-30 who are currently enrolled in an undergraduate college or university or have graduated from a college or university Alcoholic beverages will be bourbon high-congener in soda or vodka low-congener in soda Placebo will be tonic alone We will use a mixed within- and between-subjects design balancing the order of placebo and alcohol administration Performance will be measured using a computer-based neurobehavioral evaluation system
1 relative to placebo heavy drinking will degrade next-day cognitive performance and this relationship will be mediated in full or in part by quality of sleep and
2 a high congener alcoholic beverage will affect performance to a greater degree than a low congener beverage and this relationship will be mediated by severity of hangover symptoms
We will explore whether the residual effects of heavy drinking on next-day cognitive performance are attenuated among participants positive for a family history of alcohol problems relative to family-history-negative participants
A secondary aim is to test the effectiveness of the Psychomotor Vigilance Test PVT a validated measure of fatigue as a fitness-for-duty test We will test whether the PVT can distinguish dosing status alcohol or placebo of participants at the time performance is measured the next day and the extent to which PVT measures correlate with performance scores
Participants will be young adults ages 21-30 who are currently enrolled in an undergraduate college or university or have graduated from a college or university Alcoholic beverages will be bourbon high-congener in soda or vodka low-congener in soda Placebo will be tonic alone We will use a mixed within- and between-subjects design balancing the order of placebo and alcohol administration Performance will be measured using a computer-based neurobehavioral evaluation system
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NIH Grant R01 AA12087-04A1 | None | None | None |