Trial Outcomes & Findings for Residual Effects of Intoxication on Student Performance (NCT NCT00183170)
NCT ID: NCT00183170
Last Updated: 2020-12-08
Results Overview
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.
COMPLETED
PHASE2
239 participants
next day
2020-12-08
Participant Flow
239 participants were enrolled but 27 dropped out prior to randomization into the study arms so a total of 212 were randomized.
Participant milestones
| Measure |
Alcohol, Then Placebo
|
Placebo, Then Alcohol
|
|---|---|---|
|
First Intervention
STARTED
|
103
|
109
|
|
First Intervention
COMPLETED
|
101
|
109
|
|
First Intervention
NOT COMPLETED
|
2
|
0
|
|
Washout 1 Week
STARTED
|
101
|
109
|
|
Washout 1 Week
COMPLETED
|
95
|
101
|
|
Washout 1 Week
NOT COMPLETED
|
6
|
8
|
|
Second Intervention
STARTED
|
95
|
101
|
|
Second Intervention
COMPLETED
|
94
|
99
|
|
Second Intervention
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Alcohol, Then Placebo
|
Placebo, Then Alcohol
|
|---|---|---|
|
First Intervention
Did not complete study
|
1
|
0
|
|
First Intervention
Did not meet targeted BrAC
|
1
|
0
|
|
Washout 1 Week
Did not complete study
|
6
|
8
|
|
Second Intervention
Did not complete study
|
1
|
0
|
|
Second Intervention
Did not meet targeted BrAC
|
0
|
2
|
Baseline Characteristics
The mean and standard deviations of alcohol received for males and females differed so the results are stratified by sex.
Baseline characteristics by cohort
| Measure |
Alcohol, Then Placebo
n=94 Participants
|
Placebo, Then Alcohol
n=99 Participants
|
Total
n=193 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
21.46 years
STANDARD_DEVIATION 0.62 • n=94 Participants
|
21.48 years
STANDARD_DEVIATION 0.66 • n=99 Participants
|
21.47 years
STANDARD_DEVIATION 0.64 • n=193 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=94 Participants
|
41 Participants
n=99 Participants
|
86 Participants
n=193 Participants
|
|
Sex: Female, Male
Male
|
49 Participants
n=94 Participants
|
58 Participants
n=99 Participants
|
107 Participants
n=193 Participants
|
|
Race/Ethnicity, Customized
White
|
75 Participants
n=94 Participants
|
80 Participants
n=99 Participants
|
155 Participants
n=193 Participants
|
|
Race/Ethnicity, Customized
Black
|
3 Participants
n=94 Participants
|
5 Participants
n=99 Participants
|
8 Participants
n=193 Participants
|
|
Race/Ethnicity, Customized
Asian
|
7 Participants
n=94 Participants
|
6 Participants
n=99 Participants
|
13 Participants
n=193 Participants
|
|
Race/Ethnicity, Customized
Other
|
9 Participants
n=94 Participants
|
8 Participants
n=99 Participants
|
17 Participants
n=193 Participants
|
|
Region of Enrollment
United States
|
94 participants
n=94 Participants
|
99 participants
n=99 Participants
|
193 participants
n=193 Participants
|
|
Maximum breath alcohol concentration (BrAC)
|
0.12 g%
STANDARD_DEVIATION 0.01 • n=94 Participants
|
0.12 g%
STANDARD_DEVIATION 0.01 • n=99 Participants
|
0.12 g%
STANDARD_DEVIATION 0.01 • n=193 Participants
|
|
Amount of alcohol received
Males
|
1607 ml
STANDARD_DEVIATION 310 • n=49 Participants • The mean and standard deviations of alcohol received for males and females differed so the results are stratified by sex.
|
1611 ml
STANDARD_DEVIATION 272 • n=58 Participants • The mean and standard deviations of alcohol received for males and females differed so the results are stratified by sex.
|
1609 ml
STANDARD_DEVIATION 288 • n=107 Participants • The mean and standard deviations of alcohol received for males and females differed so the results are stratified by sex.
|
|
Amount of alcohol received
Females
|
1137 ml
STANDARD_DEVIATION 172 • n=45 Participants • The mean and standard deviations of alcohol received for males and females differed so the results are stratified by sex.
|
1106 ml
STANDARD_DEVIATION 187 • n=41 Participants • The mean and standard deviations of alcohol received for males and females differed so the results are stratified by sex.
|
1122 ml
STANDARD_DEVIATION 178 • n=86 Participants • The mean and standard deviations of alcohol received for males and females differed so the results are stratified by sex.
|
|
Family history of alcohol problems
Yes
|
28 Participants
n=94 Participants
|
43 Participants
n=99 Participants
|
71 Participants
n=193 Participants
|
|
Family history of alcohol problems
No
|
64 Participants
n=94 Participants
|
55 Participants
n=99 Participants
|
119 Participants
n=193 Participants
|
|
Family history of alcohol problems
Adopted
|
2 Participants
n=94 Participants
|
1 Participants
n=99 Participants
|
3 Participants
n=193 Participants
|
PRIMARY outcome
Timeframe: next dayPopulation: 153 POMS questionnaires were analyzed since 40 of the 193 participants did not return the POMS questionnaire by the 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.
Outcome measures
| Measure |
Alcohol
n=153 Participants
Results by beverage condition.
|
Placebo
n=153 Participants
Results by beverage condition.
|
|---|---|---|
|
Self-reported Residual Effects of Heavy Drinking
|
4.3 scores on a scale
Standard Deviation 10.19
|
1.93 scores on a scale
Standard Deviation 8.39
|
SECONDARY outcome
Timeframe: next dayPopulation: Data were analyzed for 186 of the 193 participants since 7 did not complete the VST-B.
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
Outcome measures
| Measure |
Alcohol
n=186 Participants
Results by beverage condition.
|
Placebo
n=186 Participants
Results by beverage condition.
|
|---|---|---|
|
Cognitive Function in Response to Heavy Drinking
|
5.41 backwards words
Standard Deviation 0.89
|
5.67 backwards words
Standard Deviation 1.16
|
SECONDARY outcome
Timeframe: next dayThis 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.
Outcome measures
| Measure |
Alcohol
n=193 Participants
Results by beverage condition.
|
Placebo
n=193 Participants
Results by beverage condition.
|
|---|---|---|
|
Academic Function in Response to Heavy Drinking
|
615.75 score on a scale
Standard Deviation 98.92
|
612.38 score on a scale
Standard Deviation 94.64
|
SECONDARY outcome
Timeframe: next dayPopulation: Data were analyzed for 187 of the 193 participants since 6 did not complete the CPT.
This outcome will be measured with the Continuous Performance Test (CPT) for reaction time in mean milliseconds (ms). Lower reaction times are more favorable.
Outcome measures
| Measure |
Alcohol
n=187 Participants
Results by beverage condition.
|
Placebo
n=187 Participants
Results by beverage condition.
|
|---|---|---|
|
Reaction Time Affected by Residual Effects of Heavy Drinking
|
378.77 milliseconds
Standard Deviation 35.48
|
375.98 milliseconds
Standard Deviation 35.82
|
SECONDARY outcome
Timeframe: next dayPopulation: Data were analyzed for 190 of the 193 participants since 3 did not complete the PVT.
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.
Outcome measures
| Measure |
Alcohol
n=190 Participants
Results by beverage condition.
|
Placebo
n=190 Participants
Results by beverage condition.
|
|---|---|---|
|
Effectiveness of Psychomotor Vigilance Testing as a Fitness-for-duty Test
|
223.40 milliseconds of response time
Standard Deviation 22.81
|
218.57 milliseconds of response time
Standard Deviation 20.25
|
Adverse Events
Alcohol
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Alcohol
n=193 participants at risk
Results by beverage condition.
|
Placebo
n=193 participants at risk
Results by beverage condition.
|
|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
2.6%
5/193 • Number of events 5
|
0.00%
0/193
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place