Trial Outcomes & Findings for Effects of Alcohol and Mood on Attention (NCT NCT04276779)
NCT ID: NCT04276779
Last Updated: 2025-03-11
Results Overview
A computer-based task that assesses reaction time to naming colors of words presented sequentially. Words are suicide, depressive, positive, and neutral-related. Reaction times that are higher indicate that the content of the word interfered with naming the color (i.e., attentional bias). A score is computed that subtracts reaction time to neutral words from that to suicide words, creating a measure of suicide-related attentional bias. Minimum total score within sample: -113.00 Maximum total score within the sample: 145.92 Higher values indicate more attentional bias (worse outcome).
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
26 participants
Primary outcome timeframe
10 minutes
Results posted on
2025-03-11
Participant Flow
Participant milestones
| Measure |
Alcohol and Negative Mood
Alcohol administration: Participants in the alcoholic beverage group will be provided a dose of 95% alcohol (0.99g/kg for males and 0.90 g/kg for females body weight) distributed in two equally spaced beverages (mixed with orange juice 1:5 ratio). This dose will produce a breath alcohol content ranging between .08-.10.
Negative mood induction: Participants will be randomized to either negative mood induction procedure. Both conditions involve listening to music that reliably induces sad mood, while simultaneously reading self-referent statements that also induce either sad mood. This procedure lasts about 10 minutes and produces a transient mood state that passes by the end of the study.
|
Placebo and Negative Mood
Placebo administration: Individuals in the placebo condition will receive orange juice with 4 ml of alcohol layered on top of the juice. Ethanol will be sprayed on the rims of the glasses.
Negative mood induction: Participants will be randomized to either negative mood induction procedure. Both conditions involve listening to music that reliably induces sad mood, while simultaneously reading self-referent statements that also induce either sad mood. This procedure lasts about 10 minutes and produces a transient mood state that passes by the end of the study.
|
Alcohol and Positive Mood
Alcohol administration: Participants in the alcoholic beverage group will be provided a dose of 95% alcohol (0.99g/kg for males and 0.90 g/kg for females body weight) distributed in two equally spaced beverages (mixed with orange juice 1:5 ratio). This dose will produce a breath alcohol content ranging between .08-.10.
Positive mood induction: Participants will be randomized to either positive mood induction procedure. Both conditions involve listening to music that reliably induces positive mood, while simultaneously reading self-referent statements that also induce either positive mood. This procedure lasts about 10 minutes and produces a transient mood state that passes by the end of the study.
|
Placebo and Positive Mood
Placebo administration: Individuals in the placebo condition will receive orange juice with 4 ml of alcohol layered on top of the juice. Ethanol will be sprayed on the rims of the glasses.
Positive mood induction: Participants will be randomized to either positive mood induction procedure. Both conditions involve listening to music that reliably induces positive mood, while simultaneously reading self-referent statements that also induce either positive mood. This procedure lasts about 10 minutes and produces a transient mood state that passes by the end of the study.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
7
|
7
|
|
Overall Study
COMPLETED
|
6
|
6
|
7
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
data were missing for one participant.
Baseline characteristics by cohort
| Measure |
Alcohol and Negative Mood
n=6 Participants
Alcohol administration: Participants in the alcoholic beverage group will be provided a dose of 95% alcohol (0.99g/kg for males and 0.90 g/kg for females body weight) distributed in two equally spaced beverages (mixed with orange juice 1:5 ratio). This dose will produce a breath alcohol content ranging between .08-.10.
Negative mood induction: Participants will be randomized to either negative mood induction procedure. Both conditions involve listening to music that reliably induces sad mood, while simultaneously reading self-referent statements that also induce either sad mood. This procedure lasts about 10 minutes and produces a transient mood state that passes by the end of the study.
|
Placebo and Negative Mood
n=6 Participants
Placebo administration: Individuals in the placebo condition will receive orange juice with 4 ml of alcohol layered on top of the juice. Ethanol will be sprayed on the rims of the glasses.
Negative mood induction: Participants will be randomized to either negative mood induction procedure. Both conditions involve listening to music that reliably induces sad mood, while simultaneously reading self-referent statements that also induce either sad mood. This procedure lasts about 10 minutes and produces a transient mood state that passes by the end of the study.
|
Alcohol and Positive Mood
n=7 Participants
Alcohol administration: Participants in the alcoholic beverage group will be provided a dose of 95% alcohol (0.99g/kg for males and 0.90 g/kg for females body weight) distributed in two equally spaced beverages (mixed with orange juice 1:5 ratio). This dose will produce a breath alcohol content ranging between .08-.10.
Positive mood induction: Participants will be randomized to either positive mood induction procedure. Both conditions involve listening to music that reliably induces positive mood, while simultaneously reading self-referent statements that also induce either positive mood. This procedure lasts about 10 minutes and produces a transient mood state that passes by the end of the study.
|
Placebo and Positive Mood
n=7 Participants
Placebo administration: Individuals in the placebo condition will receive orange juice with 4 ml of alcohol layered on top of the juice. Ethanol will be sprayed on the rims of the glasses.
Positive mood induction: Participants will be randomized to either positive mood induction procedure. Both conditions involve listening to music that reliably induces positive mood, while simultaneously reading self-referent statements that also induce either positive mood. This procedure lasts about 10 minutes and produces a transient mood state that passes by the end of the study.
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
29.67 years
STANDARD_DEVIATION 7.71 • n=6 Participants
|
28.17 years
STANDARD_DEVIATION 8.50 • n=6 Participants
|
28.50 years
STANDARD_DEVIATION 9.31 • n=7 Participants
|
39.71 years
STANDARD_DEVIATION 18.51 • n=7 Participants
|
31.84 years
STANDARD_DEVIATION 12.51 • n=26 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=6 Participants • data were missing for one participant.
|
5 Participants
n=6 Participants • data were missing for one participant.
|
4 Participants
n=6 Participants • data were missing for one participant.
|
5 Participants
n=7 Participants • data were missing for one participant.
|
16 Participants
n=25 Participants • data were missing for one participant.
|
|
Sex: Female, Male
Male
|
4 Participants
n=6 Participants • data were missing for one participant.
|
1 Participants
n=6 Participants • data were missing for one participant.
|
2 Participants
n=6 Participants • data were missing for one participant.
|
2 Participants
n=7 Participants • data were missing for one participant.
|
9 Participants
n=25 Participants • data were missing for one participant.
|
|
Race/Ethnicity, Customized
East Asian
|
1 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=26 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
1 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=26 Participants
|
|
Race/Ethnicity, Customized
White/European Origin
|
4 Participants
n=6 Participants
|
5 Participants
n=6 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=7 Participants
|
17 Participants
n=26 Participants
|
|
Race/Ethnicity, Customized
South Asian
|
1 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=26 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=26 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=6 Participants
|
6 participants
n=6 Participants
|
7 participants
n=7 Participants
|
7 participants
n=7 Participants
|
26 participants
n=26 Participants
|
|
Sexual orientation
Asexual
|
0 Participants
n=6 Participants • Missing data for one participant.
|
0 Participants
n=6 Participants • Missing data for one participant.
|
0 Participants
n=6 Participants • Missing data for one participant.
|
1 Participants
n=7 Participants • Missing data for one participant.
|
1 Participants
n=25 Participants • Missing data for one participant.
|
|
Sexual orientation
Heterosexual
|
4 Participants
n=6 Participants • Missing data for one participant.
|
6 Participants
n=6 Participants • Missing data for one participant.
|
6 Participants
n=6 Participants • Missing data for one participant.
|
6 Participants
n=7 Participants • Missing data for one participant.
|
22 Participants
n=25 Participants • Missing data for one participant.
|
|
Sexual orientation
Gay
|
1 Participants
n=6 Participants • Missing data for one participant.
|
0 Participants
n=6 Participants • Missing data for one participant.
|
0 Participants
n=6 Participants • Missing data for one participant.
|
0 Participants
n=7 Participants • Missing data for one participant.
|
1 Participants
n=25 Participants • Missing data for one participant.
|
|
Sexual orientation
Bisexual
|
1 Participants
n=6 Participants • Missing data for one participant.
|
0 Participants
n=6 Participants • Missing data for one participant.
|
0 Participants
n=6 Participants • Missing data for one participant.
|
0 Participants
n=7 Participants • Missing data for one participant.
|
1 Participants
n=25 Participants • Missing data for one participant.
|
PRIMARY outcome
Timeframe: 10 minutesPopulation: randomized participants
A computer-based task that assesses reaction time to naming colors of words presented sequentially. Words are suicide, depressive, positive, and neutral-related. Reaction times that are higher indicate that the content of the word interfered with naming the color (i.e., attentional bias). A score is computed that subtracts reaction time to neutral words from that to suicide words, creating a measure of suicide-related attentional bias. Minimum total score within sample: -113.00 Maximum total score within the sample: 145.92 Higher values indicate more attentional bias (worse outcome).
Outcome measures
| Measure |
Alcohol and Negative Mood
n=6 Participants
Alcohol administration: Participants in the alcoholic beverage group will be provided a dose of 95% alcohol (0.99g/kg for males and 0.90 g/kg for females body weight) distributed in two equally spaced beverages (mixed with orange juice 1:5 ratio). This dose will produce a breath alcohol content ranging between .08-.10.
Negative mood induction: Participants will be randomized to either negative mood induction procedure. Both conditions involve listening to music that reliably induces sad mood, while simultaneously reading self-referent statements that also induce either sad mood. This procedure lasts about 10 minutes and produces a transient mood state that passes by the end of the study.
|
Placebo and Negative Mood
n=6 Participants
Placebo administration: Individuals in the placebo condition will receive orange juice with 4 ml of alcohol layered on top of the juice. Ethanol will be sprayed on the rims of the glasses.
Negative mood induction: Participants will be randomized to either negative mood induction procedure. Both conditions involve listening to music that reliably induces sad mood, while simultaneously reading self-referent statements that also induce either sad mood. This procedure lasts about 10 minutes and produces a transient mood state that passes by the end of the study.
|
Alcohol and Positive Mood
n=7 Participants
Alcohol administration: Participants in the alcoholic beverage group will be provided a dose of 95% alcohol (0.99g/kg for males and 0.90 g/kg for females body weight) distributed in two equally spaced beverages (mixed with orange juice 1:5 ratio). This dose will produce a breath alcohol content ranging between .08-.10.
Positive mood induction: Participants will be randomized to either positive mood induction procedure. Both conditions involve listening to music that reliably induces positive mood, while simultaneously reading self-referent statements that also induce either positive mood. This procedure lasts about 10 minutes and produces a transient mood state that passes by the end of the study.
|
Placebo and Positive Mood
n=7 Participants
Placebo administration: Individuals in the placebo condition will receive orange juice with 4 ml of alcohol layered on top of the juice. Ethanol will be sprayed on the rims of the glasses.
Positive mood induction: Participants will be randomized to either positive mood induction procedure. Both conditions involve listening to music that reliably induces positive mood, while simultaneously reading self-referent statements that also induce either positive mood. This procedure lasts about 10 minutes and produces a transient mood state that passes by the end of the study.
|
|---|---|---|---|---|
|
Modified Suicide Stroop Task
|
-10.04 milliseconds
Standard Deviation 81.21
|
20.05 milliseconds
Standard Deviation 39.49
|
10.08 milliseconds
Standard Deviation 55.22
|
6.78 milliseconds
Standard Deviation 71.38
|
SECONDARY outcome
Timeframe: 5 minutesA brief, 2-item questionnaire that assesses state hopelessness will also be assessed. The items were rated on a scale of 1 to 5. The scale score was the sum of the two items. The total possible score for the scale (sum of the two items) ranged from 2 to 10. Higher values indicate a worse outcome.
Outcome measures
| Measure |
Alcohol and Negative Mood
n=6 Participants
Alcohol administration: Participants in the alcoholic beverage group will be provided a dose of 95% alcohol (0.99g/kg for males and 0.90 g/kg for females body weight) distributed in two equally spaced beverages (mixed with orange juice 1:5 ratio). This dose will produce a breath alcohol content ranging between .08-.10.
Negative mood induction: Participants will be randomized to either negative mood induction procedure. Both conditions involve listening to music that reliably induces sad mood, while simultaneously reading self-referent statements that also induce either sad mood. This procedure lasts about 10 minutes and produces a transient mood state that passes by the end of the study.
|
Placebo and Negative Mood
n=6 Participants
Placebo administration: Individuals in the placebo condition will receive orange juice with 4 ml of alcohol layered on top of the juice. Ethanol will be sprayed on the rims of the glasses.
Negative mood induction: Participants will be randomized to either negative mood induction procedure. Both conditions involve listening to music that reliably induces sad mood, while simultaneously reading self-referent statements that also induce either sad mood. This procedure lasts about 10 minutes and produces a transient mood state that passes by the end of the study.
|
Alcohol and Positive Mood
n=7 Participants
Alcohol administration: Participants in the alcoholic beverage group will be provided a dose of 95% alcohol (0.99g/kg for males and 0.90 g/kg for females body weight) distributed in two equally spaced beverages (mixed with orange juice 1:5 ratio). This dose will produce a breath alcohol content ranging between .08-.10.
Positive mood induction: Participants will be randomized to either positive mood induction procedure. Both conditions involve listening to music that reliably induces positive mood, while simultaneously reading self-referent statements that also induce either positive mood. This procedure lasts about 10 minutes and produces a transient mood state that passes by the end of the study.
|
Placebo and Positive Mood
n=7 Participants
Placebo administration: Individuals in the placebo condition will receive orange juice with 4 ml of alcohol layered on top of the juice. Ethanol will be sprayed on the rims of the glasses.
Positive mood induction: Participants will be randomized to either positive mood induction procedure. Both conditions involve listening to music that reliably induces positive mood, while simultaneously reading self-referent statements that also induce either positive mood. This procedure lasts about 10 minutes and produces a transient mood state that passes by the end of the study.
|
|---|---|---|---|---|
|
Brief Hopelessness Measure (Brief-H-Neg)
|
3.17 score on a scale
Standard Deviation 2.40
|
3.33 score on a scale
Standard Deviation 1.51
|
2.57 score on a scale
Standard Deviation 1.13
|
2.29 score on a scale
Standard Deviation 0.76
|
Adverse Events
Negative Mood
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Positive Mood
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Alcohol
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Caitlin Clevenger
University of Alabama at Birmingham
Phone: 205-934-7008
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place