Trial Outcomes & Findings for Behavior Brain Responses (NCT NCT03964350)
NCT ID: NCT03964350
Last Updated: 2025-01-31
Results Overview
Participants will complete The Drug Effects Questionnaire during the initial baseline session to determine their subjective alcohol profile. The Drug Effects Questionnaire (DEQ) is a visual analog scale questionnaire that assesses the extent to which subjects experience four subjective states : "Feel Drug", "Feel High", "Like Drug", and "Want More". All sub-scales ("Feel Drug", "Feel High", "Like Drug", and "Want More") are scored on a visual analogue scale (scroll bar on computer screen) ranging from 0-100. 100 represents the highest score for that subjective state, and the higher the score, the worse the outcome.
COMPLETED
EARLY_PHASE1
30 participants
At expected peak drug effect (30 min post drink administration)
2025-01-31
Participant Flow
Participant milestones
| Measure |
Placebo First (0 g/kg), Then Ethanol (0.4 g/kg), Then Ethanol (0.8 g/kg)
Participants who received placebo first, then low dose ethanol then high dose ethanol
|
Placebo (0 g/kg), Then Ethanol (0.8 g/kg), Then Ethanol (0.4 g/kg)
participants who received placebo, then high dose ethanol then low dose ethanol
|
Ethanol (0.4 g/kg), Then Ethanol (0.8 g/kg), Then Placebo (0 g/kg)
participants who received low dose ethanol, then high dose ethanol, then placebo
|
Ethanol First (0.8 g/kg) Then Ethanol (0.4 g/kg), Then Placebo (0 g/kg)
Participants who received high dose ethanol first, then low dose ethanol, then placebo
|
Ethanol First (0.8 g/kg), Then Placebo (0 g/kg), Then Ethanol (0.4 g/kg),
Participants who received high dose ethanol first, then placebo, then low dose ethanol
|
Ethanol First (0.4 g/kg), Then Placebo (0 g/kg), Then Ethanol (0.8 g/kg),
Participants who received low dose ethanol first, then placebo, then high dose ethanol
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
5
|
3
|
6
|
6
|
4
|
|
Overall Study
Sedative-like Effects
|
3
|
3
|
1
|
3
|
3
|
2
|
|
Overall Study
Stimulant Like Effects
|
3
|
2
|
2
|
3
|
3
|
2
|
|
Overall Study
COMPLETED
|
6
|
5
|
3
|
6
|
6
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Behavior Brain Responses
Baseline characteristics by cohort
| Measure |
Sedative-like Effects (All Study)
n=15 Participants
Subjects that experienced more sedative like effects
|
Stimulant-like (All Study)
n=15 Participants
Subjects that experienced more stimulant-like effects
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
>21 years of age
|
15 years
n=5 Participants
|
15 years
n=7 Participants
|
30 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
15 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
Education - High School Education
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At expected peak drug effect (30 min post drink administration)Participants will complete The Drug Effects Questionnaire during the initial baseline session to determine their subjective alcohol profile. The Drug Effects Questionnaire (DEQ) is a visual analog scale questionnaire that assesses the extent to which subjects experience four subjective states : "Feel Drug", "Feel High", "Like Drug", and "Want More". All sub-scales ("Feel Drug", "Feel High", "Like Drug", and "Want More") are scored on a visual analogue scale (scroll bar on computer screen) ranging from 0-100. 100 represents the highest score for that subjective state, and the higher the score, the worse the outcome.
Outcome measures
| Measure |
Placebo (Gelatin)
n=30 Participants
Subjects gelatin vehicle.
|
Ethanol (0.4 g/kg)
n=30 Participants
Low dose ethanol
|
Ethanol (0.8 g/kg)
n=30 Participants
High dose ethanol
|
|---|---|---|---|
|
Change in Subjective Effects as Assessed by Score on "Feel Drug", "Feel High", "Like Drug", and "Want More" Subscales of the Drug Effects Questionnaire Across Sessions
"Feel Drug"
|
3.65 units on a scale
Standard Deviation 15.9
|
45.5 units on a scale
Standard Deviation 24.9
|
62.3 units on a scale
Standard Deviation 20.3
|
|
Change in Subjective Effects as Assessed by Score on "Feel Drug", "Feel High", "Like Drug", and "Want More" Subscales of the Drug Effects Questionnaire Across Sessions
"Feel High"
|
3.0 units on a scale
Standard Deviation 15.9
|
33.7 units on a scale
Standard Deviation 27.4
|
47.0 units on a scale
Standard Deviation 32.8
|
|
Change in Subjective Effects as Assessed by Score on "Feel Drug", "Feel High", "Like Drug", and "Want More" Subscales of the Drug Effects Questionnaire Across Sessions
"Like Drug"
|
10.0 units on a scale
Standard Deviation 19.7
|
48.3 units on a scale
Standard Deviation 22.7
|
60.9 units on a scale
Standard Deviation 22.8
|
|
Change in Subjective Effects as Assessed by Score on "Feel Drug", "Feel High", "Like Drug", and "Want More" Subscales of the Drug Effects Questionnaire Across Sessions
"Want More"
|
10.1 units on a scale
Standard Deviation 23.6
|
39.6 units on a scale
Standard Deviation 30.4
|
45.3 units on a scale
Standard Deviation 31.2
|
Adverse Events
Ethanol (0.4 g/kg)
Placebo (Gelatin Vehicle)
Ethanol (0.8 g/kg)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place