N/A
N=38
Alcohol and Neural Cardiovascular Control in Binge Drinkers
Binge Drinking
Bottom Line
View on ClinicalTrials.gov: NCT03567434 ↗Enrolled (actual)
38
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcome: Primary: Sympathetic Nerve Activity Burst Frequency — 18; 20 Burst/Min — p=0.283
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Alcohol vs. Placebo (Other)
- Age
- Adult · 21+ yrs
- Sex
- All
- Sponsor
- Baylor University
- Primary completion
- Jul 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sympathetic Nerve Activity Burst Frequency |
18; 20 | 0.283 |
| PRIMARY Sympathetic Nerve Activity Burst Incidence |
31; 31 | — |
| SECONDARY Spontaneous Sympathetic Baroreflex Sensitivity |
-2; -2 | 0.888 |
Summary
This study evaluates the impact of evening alcohol consumption on sympathetic activity and baroreflex function in binge drinkers. Our central hypothesis is that evening binge alcohol consumption will lead to sympathetic overactivity and blunted baroreflex function.
Eligibility Criteria
Inclusion Criteria
- Men and women age 21 - 40 years
- Binge drinkers as defined by a pattern of consuming ≥4 drinks if female (≥5 drinks if males) in ≤ 2 hours on more than one occasion within the past 6 months, and at least once in the past 30 days. The National Institute of Alcohol Abuse and Alcoholism (NIAAA) definition of a "drink" will be used.
- Women must be eumenorrheic and premenopausal with regular and consistent menstrual cycles (i.e., ~25-30 days ovarian/uterine cycles that include 2-7 days of menstruation)
- Willingness to abstain from exercise and caffeine at least 12 hours prior to any autonomic and cardiovascular testing, and abstain from alcohol 24 hours prior to any autonomic and cardiovascular testing (unless experimentally administered).
Exclusion Criteria
- Body mass index ≥ 35 kg/m2
- Smokers
- A physician diagnosis of diabetes
- Pregnancy
- Taking any cardiovascular medications
- Severe obstructive sleep apnea as determined by an apnea-hypopnea index of ≥ 30 episodes per hour
- Moderate-to-severe Alcohol Use Disorder (AUD) as determined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-V)
- Individuals suspected to have mutant alcohol dehydrogenase 2 (ALDH2) isoenzyme as determined using a validated flushing questionnaire
- Women using hormonal contraceptives (i.e., oral, intrauterine, etc.) in the prior 6 months
Data sourced from ClinicalTrials.gov (NCT03567434). 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.