Early Phase 1
N=80
Alcohol, Behavior, and Brain Imaging
Alcohol Drinking · Binge Drinking · Drinking Behavior · Substance-Related Disorders · Ethanol
Bottom Line
View on ClinicalTrials.gov: NCT03930446 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Apr 2022
Primary outcome: Primary: Stop Signal Task (SST) — 255; 215 milliseconds
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- Ethanol (Drug); Placebo (Other)
- Age
- Adult · 21+ yrs
- Sex
- All
- Sponsor
- University of Chicago
- Primary completion
- May 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Stop Signal Task (SST) |
255; 215 | — |
Summary
To evaluate the relationship of extraversion to both the acute subjective and behavioral effects of alcohol, and the neural reactivity to the anticipation of reward.
Eligibility Criteria
Inclusion Criteria
- 21-29 years old
- 7-30 alcoholic drinks per week (as reported on PHQ or TLFB)
- At least one binge episode (4 for females/5 for males) per month
- No 'flushing' reaction to alcohol
- Females must be on birth control or in the beginning of follicular phase (1-14 days after start of menstruation)
- BMI 19-26
- High school education or greater, fluent in English
- No night shift work
- No current or past year Axis I psychiatric disorder including drug/alcohol dependence
- No current psychopharmacological treatment
- No lifetime ADHD or prescription for ADHD medication
- No abnormal EKG, cardiovascular illness, high blood pressure
- No medical condition or pharmacological treatment for which alcohol is contraindicated
- Not pregnant, lactating, or planning to become pregnant
- Smoke <6 cigarettes per day
- No previous participation in studies that have used the Stop Task (except IDAC) o Previous Stop Task studies: GOI, CAP, STEM, JAM, MACI, PAC, CAM
Data sourced from ClinicalTrials.gov (NCT03930446). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.