Alcoholic Intoxication, Neurobehavioral Manifestations
Conditions
Keywords
Alcohol abuse, Alcoholic beverages (beer), Residual effects, Psychomotor performance, Psychomotor vigilance test, Neurobehavioral Evaluation System, Family history of alcohol use, Alcoholic Consumption, Unhealthy alcohol use, Alcohol
Brief summary
The primary goal of the study is to assess the residual effects of heavy drinking on academic performance. The investigators will also explore whether these effects differ by family history of alcohol abuse and hangover symptoms, as well as compare males and females with respect to these effects. The primary hypothesis is that intoxication (0.10 g% blood alcohol concentration \[BAC\]) with an alcoholic beverage impairs next-day academic performance, as measured by scores on quizzes, standardized academic achievement tests, and standardized neurobehavioral assessments. The secondary hypothesis is that family-history-positive individuals will show a greater performance decrement the day after heavy drinking than family-history-negative individuals.
Detailed description
The primary goal of the study is to assess the effect of heavy drinking on next day academic performance. A placebo-controlled 2-period crossover design will be used to compare the effects of dosing status on academic performance, with participants serving as their own controls. Participants are dosed on two separate occasions, once with non-alcoholic beverage and the other time with alcoholic beverage sufficient to raise blood alcohol to 0.10 g%. The morning after dosing, participants' academic performance is measured using a standardized achievement test (Graduate Record Exam). Participants' cognition is tested using the the Psychomotor Vigilance Test (PVT). Data on participants' demographics, family history of drinking problems and alcohol use. We are also collecting information on hangover symptoms and sleep quality the morning after dosing, in addition to participants' self ratings of academic performance. The procedure is conducted twice with one week in between, switching the individuals' dosing status, presenting a different, but comparable lecture and reading, and administering a different quiz based on the new lecture and reading and a different, but comparable standardized achievement exam. This design is intended to test the hypothesis that intoxication (0.10 g% BAC) with alcoholic beverage impairs next-day academic performance. Participation involves a total of five sessions over a two week period. Participants are undergraduates who volunteer and meet inclusion criteria. Prior to enrollment, volunteers are screened to ensure they meet initial eligibility criteria. Eligible volunteers receive written instructions regarding participation and are scheduled for the study sessions. Participants report to the study site on the first session for an additional screening by the study physician and go through the informed consent process. Eligible participants report back the next week for their first dosing night where they receive several drinks (alcohol or placebo) sufficient to raise their Breath Alcohol Level (BrAC) to 0.10 g%; the amount of beverage administered is based on their body weight. Those receiving placebo receive the same total quantity of beverage as those receiving alcohol. Both alcohol-dosed and placebo-dosed participants are breath-tested after they have completed their required dose. Participants sleep at the study site and are monitored overnight. The next morning they are awakened and are escorted to the exam room for the performance trials. They return the next week for the second dosing night/dosing morning, and receive either alcohol or placebo, depending on what was administered the previous week, and take different but comparable performance tests.
Interventions
Participants report for their first dosing night where they receive several alcohol/beer drinks sufficient to raise their BrAC to 0.10 g%. Participants are breath-tested after completing their required dose. Participants return in a week for the 2nd session and receive placebo drinks. Participants are breath-tested after completing their placebo drinks.
Participants report for their first night where they receive several placebo drinks. Participants are breath-tested after completing their placebo drinks. Participants return in a week for the 2nd session and receive alcohol drinks sufficient to raise their BrAC to 0.10 g%. Participants are breath-tested after completing their required dose.
Sponsors
Study design
Eligibility
Inclusion criteria
* Ages 21-30 * Currently enrolled in college/university * Have had 5 or more drinks (4 if female) in the last 30 days * Score less than a 5 on the Short Michigan Alcohol Screening Test (SMAST) * No self-reported history of counseling or treatment for substance abuse * Not taking any medication contraindicated for alcohol use or that disrupts sleep * Doesn't have a health condition contraindicated for alcohol use * Has not been diagnosed with a primary sleep disorder * Has not been diagnosed with a mental health disorder * Not currently working night shifts at a job * Not routinely taking medications that affect sleep * If female, is using reliable birth control when necessary * Not a regular smoker * Likes the taste of beer
Exclusion criteria
* Less than age 21 and greater than age 30 * Not currently enrolled in college/university * Hasn't had 5 or more drinks (4 if female) in the last 30 days (not a regular drinker) * Score greater than or equal to 5 on the Short Michigan Alcohol Screening Test (SMAST) * Self-reported history of counseling or treatment for substance abuse * Taking any medication contraindicated for alcohol use or that disrupts sleep * Has a health condition contraindicated for alcohol use * Has been diagnosed with a primary sleep disorder * Has been diagnosed with a mental health disorder * Currently working night shifts at a job * Routinely taking medications that affect sleep * Is a regular smoker * Is currently pregnant or nursing * If female, is not using reliable birth control when necessary * Not a regular drinker * Dislikes the taste of beer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported Residual Effects of Heavy Drinking | next day | This outcome will be measured by the afternoon total mood disturbance score. This is part of the Profile of Mood States Questionnaire (POMS). POMS is a 35 item instrument with Likert responses from 0 to 4 where 0=not at all and 4=extremely. Range of scores can be 0 to 140, lower scores are more favorable. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cognitive Function in Response to Heavy Drinking | next day | This outcome measure will be assessed using the Visual Span Test- Backwards (VST-B). This is the mean maximum span of words repeated backwards correctly. Higher scores are more favorable |
| Academic Function in Response to Heavy Drinking | next day | This outcome will be measured by the mean Graduate Record Exam (GRE) quantitative score. The quantitative score can range from 200-800. Higher scores are more favorable. |
| Reaction Time Affected by Residual Effects of Heavy Drinking | next day | This outcome will be measured with the Continuous Performance Test (CPT) for reaction time in mean milliseconds (ms). Lower reaction times are more favorable. |
| Effectiveness of Psychomotor Vigilance Testing as a Fitness-for-duty Test | next day | This outcome will be assessed with the Psychomotor Vigilance Test (PVT) in median milliseconds. The 10-min PVT measures sustained or vigilant attention by recording response times to visual (or auditory) stimuli that occur at random inter-stimulus intervals. Lower number of milliseconds are associated with greater vigilant attention. |
Countries
United States
Participant flow
Pre-assignment details
239 participants were enrolled but 27 dropped out prior to randomization into the study arms so a total of 212 were randomized.
Participants by arm
| Arm | Count |
|---|---|
| Alcohol, Then Placebo | 94 |
| Placebo, Then Alcohol | 99 |
| Total | 193 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Intervention | Did not complete study | 1 | 0 |
| First Intervention | Did not meet targeted BrAC | 1 | 0 |
| Second Intervention | Did not complete study | 1 | 0 |
| Second Intervention | Did not meet targeted BrAC | 0 | 2 |
| Washout 1 Week | Did not complete study | 6 | 8 |
Baseline characteristics
| Characteristic | Total | Alcohol, Then Placebo | Placebo, Then Alcohol |
|---|---|---|---|
| Age, Continuous | 21.47 years STANDARD_DEVIATION 0.64 | 21.46 years STANDARD_DEVIATION 0.62 | 21.48 years STANDARD_DEVIATION 0.66 |
| Amount of alcohol received Females | 1122 ml STANDARD_DEVIATION 178 | 1137 ml STANDARD_DEVIATION 172 | 1106 ml STANDARD_DEVIATION 187 |
| Amount of alcohol received Males | 1609 ml STANDARD_DEVIATION 288 | 1607 ml STANDARD_DEVIATION 310 | 1611 ml STANDARD_DEVIATION 272 |
| Family history of alcohol problems Adopted | 3 Participants | 2 Participants | 1 Participants |
| Family history of alcohol problems No | 119 Participants | 64 Participants | 55 Participants |
| Family history of alcohol problems Yes | 71 Participants | 28 Participants | 43 Participants |
| Maximum breath alcohol concentration (BrAC) | 0.12 g% STANDARD_DEVIATION 0.01 | 0.12 g% STANDARD_DEVIATION 0.01 | 0.12 g% STANDARD_DEVIATION 0.01 |
| Race/Ethnicity, Customized Asian | 13 Participants | 7 Participants | 6 Participants |
| Race/Ethnicity, Customized Black | 8 Participants | 3 Participants | 5 Participants |
| Race/Ethnicity, Customized Other | 17 Participants | 9 Participants | 8 Participants |
| Race/Ethnicity, Customized White | 155 Participants | 75 Participants | 80 Participants |
| Region of Enrollment United States | 193 participants | 94 participants | 99 participants |
| Sex: Female, Male Female | 86 Participants | 45 Participants | 41 Participants |
| Sex: Female, Male Male | 107 Participants | 49 Participants | 58 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 5 / 193 | 0 / 193 |
| serious Total, serious adverse events | 0 / 193 | 0 / 193 |
Outcome results
Self-reported Residual Effects of Heavy Drinking
This outcome will be measured by the afternoon total mood disturbance score. This is part of the Profile of Mood States Questionnaire (POMS). POMS is a 35 item instrument with Likert responses from 0 to 4 where 0=not at all and 4=extremely. Range of scores can be 0 to 140, lower scores are more favorable.
Time frame: next day
Population: 153 POMS questionnaires were analyzed since 40 of the 193 participants did not return the POMS questionnaire by the next day.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alcohol | Self-reported Residual Effects of Heavy Drinking | 4.3 scores on a scale | Standard Deviation 10.19 |
| Placebo | Self-reported Residual Effects of Heavy Drinking | 1.93 scores on a scale | Standard Deviation 8.39 |
Academic Function in Response to Heavy Drinking
This outcome will be measured by the mean Graduate Record Exam (GRE) quantitative score. The quantitative score can range from 200-800. Higher scores are more favorable.
Time frame: next day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alcohol | Academic Function in Response to Heavy Drinking | 615.75 score on a scale | Standard Deviation 98.92 |
| Placebo | Academic Function in Response to Heavy Drinking | 612.38 score on a scale | Standard Deviation 94.64 |
Cognitive Function in Response to Heavy Drinking
This outcome measure will be assessed using the Visual Span Test- Backwards (VST-B). This is the mean maximum span of words repeated backwards correctly. Higher scores are more favorable
Time frame: next day
Population: Data were analyzed for 186 of the 193 participants since 7 did not complete the VST-B.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alcohol | Cognitive Function in Response to Heavy Drinking | 5.41 backwards words | Standard Deviation 0.89 |
| Placebo | Cognitive Function in Response to Heavy Drinking | 5.67 backwards words | Standard Deviation 1.16 |
Effectiveness of Psychomotor Vigilance Testing as a Fitness-for-duty Test
This outcome will be assessed with the Psychomotor Vigilance Test (PVT) in median milliseconds. The 10-min PVT measures sustained or vigilant attention by recording response times to visual (or auditory) stimuli that occur at random inter-stimulus intervals. Lower number of milliseconds are associated with greater vigilant attention.
Time frame: next day
Population: Data were analyzed for 190 of the 193 participants since 3 did not complete the PVT.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Alcohol | Effectiveness of Psychomotor Vigilance Testing as a Fitness-for-duty Test | 223.40 milliseconds of response time | Standard Deviation 22.81 |
| Placebo | Effectiveness of Psychomotor Vigilance Testing as a Fitness-for-duty Test | 218.57 milliseconds of response time | Standard Deviation 20.25 |
Reaction Time Affected by Residual Effects of Heavy Drinking
This outcome will be measured with the Continuous Performance Test (CPT) for reaction time in mean milliseconds (ms). Lower reaction times are more favorable.
Time frame: next day
Population: Data were analyzed for 187 of the 193 participants since 6 did not complete the CPT.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alcohol | Reaction Time Affected by Residual Effects of Heavy Drinking | 378.77 milliseconds | Standard Deviation 35.48 |
| Placebo | Reaction Time Affected by Residual Effects of Heavy Drinking | 375.98 milliseconds | Standard Deviation 35.82 |