Trial Outcomes & Findings for Alcohol, Behavior, and Brain Imaging (NCT NCT03930446)
NCT ID: NCT03930446
Last Updated: 2022-04-25
Results Overview
The Stop-Signal Task (SST) is a task requiring inhibition of a prepotent motor response. The SST requires participants to respond to a target stimulus as quickly and accurately as possible by pressing a button, but also to withhold their response when they hear an auditory signal. Thus, this task involves a competition between activating and inhibiting processes. The primary outcome variable is change in the stop signal reaction time (SSRT) for the task administered seconds to minutes before and seconds to minutes after stimulation. The theoretical minimum is zero seconds and there is no theoretical maximum. Higher SSRT scores reflect greater impulsivity.
COMPLETED
EARLY_PHASE1
80 participants
Within an hour post-stimulation condition
2022-04-25
Participant Flow
Participant milestones
| Measure |
Ethanol
Subjects will receive 4 color-coded beverages in green or blue cups, containing ethanol (0.2 g/kg per dose, total dose 0.8 g/kg).
Ethanol: The 0.8 g/kg body weight dose of oral alcohol (190-proof ethanol) will be divided into 4 servings of 0.2 g/kg each. The 0.8 g/kg dose is equivalent to 4 standard drinks, where a standard drink is defined as one 12 oz beer, one 5 oz glass of wine, or one 1.5 oz shot of 80 proof alcohol. Women will receive a reduced dose (0.68 g/kg) to account for sex differences in total body water
|
Placebo (Juice)
Subjects will receive 4 color-coded beverages in green or blue cups, containing placebo (Juice).
Placebo: The placebo beverage will consist of the cranberry or orange juice plus 1% alcohol added as a taste mask. All beverages will be sprayed with an alcoholic mist to provide a strong alcoholic scent.
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
|
Overall Study
COMPLETED
|
40
|
40
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Alcohol, Behavior, and Brain Imaging
Baseline characteristics by cohort
| Measure |
Ethanol
n=40 Participants
Subjects will receive 4 color-coded beverages in green or blue cups, containing ethanol (0.2 g/kg per dose, total dose 0.8 g/kg).
Ethanol: The 0.8 g/kg body weight dose of oral alcohol (190-proof ethanol) will be divided into 4 servings of 0.2 g/kg each. The 0.8 g/kg dose is equivalent to 4 standard drinks, where a standard drink is defined as one 12 oz beer, one 5 oz glass of wine, or one 1.5 oz shot of 80 proof alcohol. Women will receive a reduced dose (0.68 g/kg) to account for sex differences in total body water
|
Placebo (Juice)
n=40 Participants
Subjects will receive 4 color-coded beverages in green or blue cups, containing placebo (Juice).
Placebo: The placebo beverage will consist of the cranberry or orange juice plus 1% alcohol added as a taste mask. All beverages will be sprayed with an alcoholic mist to provide a strong alcoholic scent.
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
40 Participants
n=99 Participants
|
40 Participants
n=107 Participants
|
80 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
44 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
9 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=99 Participants
|
40 participants
n=107 Participants
|
80 participants
n=206 Participants
|
|
Education - High School Education
|
40 Participants
n=99 Participants
|
40 Participants
n=107 Participants
|
80 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Within an hour post-stimulation conditionThe Stop-Signal Task (SST) is a task requiring inhibition of a prepotent motor response. The SST requires participants to respond to a target stimulus as quickly and accurately as possible by pressing a button, but also to withhold their response when they hear an auditory signal. Thus, this task involves a competition between activating and inhibiting processes. The primary outcome variable is change in the stop signal reaction time (SSRT) for the task administered seconds to minutes before and seconds to minutes after stimulation. The theoretical minimum is zero seconds and there is no theoretical maximum. Higher SSRT scores reflect greater impulsivity.
Outcome measures
| Measure |
Ethanol
n=40 Participants
Subjects will receive 4 color-coded beverages in green or blue cups, containing ethanol (0.2 g/kg per dose, total dose 0.8 g/kg).
Ethanol: The 0.8 g/kg body weight dose of oral alcohol (190-proof ethanol) will be divided into 4 servings of 0.2 g/kg each. The 0.8 g/kg dose is equivalent to 4 standard drinks, where a standard drink is defined as one 12 oz beer, one 5 oz glass of wine, or one 1.5 oz shot of 80 proof alcohol. Women will receive a reduced dose (0.68 g/kg) to account for sex differences in total body water
|
Placebo (Juice)
n=40 Participants
Subjects will receive 4 color-coded beverages in green or blue cups, containing placebo (Juice).
Placebo: The placebo beverage will consist of the cranberry or orange juice plus 1% alcohol added as a taste mask. All beverages will be sprayed with an alcoholic mist to provide a strong alcoholic scent.
|
|---|---|---|
|
Stop Signal Task (SST)
|
255 milliseconds
Standard Deviation 463
|
215 milliseconds
Standard Deviation 278
|
Adverse Events
Ethanol
Placebo (Juice)
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