N/A
N=28
Sex Differences in Risk for Alcohol Abuse
Alcohol Abuse
Bottom Line
View on ClinicalTrials.gov: NCT04543942 ↗Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcome: Primary: Brain Activation During Response Inhibition (BARI) - Alcohol Infusion — 1.83; 2.41 BOLD activation
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Alcohol (Drug); Saline (Drug)
- Age
- Adult · 21+ yrs
- Sex
- All
- Sponsor
- Mark Fillmore
- Primary completion
- May 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Brain Activation During Response Inhibition (BARI) - Alcohol Infusion |
1.83; 2.41 | — |
| PRIMARY Brain Activation During Response Inhibition (BARI) - Saline Infusion |
1.32; 2.64 | — |
| SECONDARY Estradiol Levels - Alcohol Infusion |
21.5; 71.3 | — |
| SECONDARY Estradiol Levels - Saline Infusion |
23.5; 63.3 | — |
| SECONDARY Progesterone Levels - Alcohol Infusion |
0.28; 4.1 | — |
| SECONDARY Progesterone Levels - Saline Infusion |
0.29; 3.81 | — |
| SECONDARY Testosterone Levels - Alcohol Infusion |
544.7; 39.0 | — |
| SECONDARY Testosterone Levels - Saline Infusion |
454.61; 23.7 | — |
| SECONDARY Biphasic Alcohol Effects Score - Stimulation - Alcohol Infusion |
32.2; 23.8 | — |
| SECONDARY Biphasic Alcohol Effects Score - Sedation - Alcohol Infusion |
13.8; 16.3 | — |
| SECONDARY Biphasic Alcohol Effects Scale (BAES) - Stimulation - Saline Infusion |
25.1; 16.9 | — |
| SECONDARY Biphasic Alcohol Effects Scale (BAES) - Sedation - Saline |
7.7; 8.9 | — |
| SECONDARY Drug Effects Questionnaire Score - Feel - Alcohol Infusion |
73.4; 61.7 | — |
| SECONDARY Drug Effects Questionnaire Score - Like - Alcohol Infusion |
83.4; 65.4 | — |
| SECONDARY Drug Effects Questionnaire (DEQ) - Feel - Saline Infusion |
11.8; 8.3 | — |
| SECONDARY Drug Effects Questionnaire (DEQ) - Like - Saline Infusion |
50.5; 48.8 | — |
Summary
This study will determine the neural and hormonal mechanisms underlying sex differences in sensitivity to the disinhibiting effects of alcohol in heavy drinkers.
Eligibility Criteria
Inclusion Criteria
- heavy drinking
- Alcohol Use Disorder Identification Test score above 7
- right-handed
- BMI between 19 and 26
- high school education
- fluent in English
- women must have regular menstrual cycles
- not using hormonal contraceptives
Exclusion Criteria
- drug use disorder (SCID, DSM-5), other than nicotine or caffeine
- meets withdrawal criteria
- history of physical or psychiatric disease
- contraindication for fMRI
- pregnant or breastfeeding
- smoking more than 5 cigarettes per day
Data sourced from ClinicalTrials.gov (NCT04543942). 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.