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NCT03567434

Alcohol and Neural Cardiovascular Control in Binge Drinkers

Completed NA Results posted Last updated 24 September 2024
What this trial tests

NA trial testing Alcohol vs. Placebo in Binge Drinking in 69 participants. Completed in 1 July 2022.

Timeline
21 May 2018
Primary endpoint
1 July 2022
1 July 2022

Quick facts

Lead sponsorBaylor University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingdouble
Primary purposebasic science
Enrollment69
Start date21 May 2018
Primary completion1 July 2022
Estimated completion1 July 2022
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Baylor University

Who can join

Adults 21 to 40, any sex, with Binge Drinking. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Sympathetic Nerve Activity Burst Frequency Primary · 1 month

Direct recordings of muscle sympathetic nerve activity (MSNA) from the peroneal nerve using a microelectrode.

GroupValue95% CI
Fluid Control18± 9
Alcohol20± 8
Sympathetic Nerve Activity Burst Incidence Primary · 1 month

Direct recordings of muscle sympathetic nerve activity (MSNA) from the peroneal nerve using a microelectrode. Burst incidence is calculated as the number of sympathetic bursts per 100 heartbeats. This measure takes into account varying heart rates on sympathetic activity by normalizing to each individual's heartbeat. Higher calculated number equates to higher sympathetic activity.

GroupValue95% CI
Fluid Control31± 16
Alcohol31± 12
Spontaneous Sympathetic Baroreflex Sensitivity Secondary · 1 month

The linear relationship between beat-to-beat blood pressure and sympathetic nerve activity expressed as bursts/100 heart beats. Sympathetic baroreflex sensitivity is determined using the slope of the weighted linear regression of diastolic blood pressure and MSNA burst incidence. Diastolic blood pressure values of individual cardiac cycles were binned into 3 mmHg intervals, and the MSNA burst incidence was determined and subsequently plotted against corresponding diastolic blood pressure bins.

GroupValue95% CI
Fluid Control-2± 1
Alcohol-2± 1

Adverse events — posted to ClinicalTrials.gov

Time frame: On average 1 to 2 months following initial laboratory testing session. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Fluid Control
Serious: 0/38 (0%)
Deaths: 0
Alcohol
Serious: 0/38 (0%)
Deaths: 0
Other adverse events (2 terms — click to expand)

ReactionSystemFluid ControlAlcohol
Presyncope in response to venipunctureNervous system disorders
NauseaGastrointestinal disorders

Data from ClinicalTrials.gov NCT03567434 adverse events section.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Morning sympathetic activity after evening binge alcohol consumption.
    Greenlund IM, Cunningham HA, Tikkanen AL, Bigalke JA, et al · · 2021 · cited 23× · PMID 33185112 · DOI 10.1152/ajpheart.00743.2020
  2. Evening binge alcohol disrupts cardiovagal tone and baroreflex function during polysomnographic sleep.
    Greenlund IM, Bigalke JA, Tikkanen AL, Durocher JJ, et al · · 2021 · cited 8× · PMID 34015116 · DOI 10.1093/sleep/zsab130
  3. Sex differences in blood pressure responsiveness to spontaneous K-complexes during stage II sleep.
    Greenlund IM, Smoot CA, Carter JR. · · 2021 · cited 4× · PMID 33300855 · DOI 10.1152/japplphysiol.00825.2020
  4. Binge Alcohol Consumption Elevates Sympathetic Transduction to Blood Pressure: A Randomized Controlled Trial.
    Bigalke JA, Greenlund IM, Solis-Montenegro TX, Durocher JJ, et al · · 2024 · cited 3× · PMID 39119705 · DOI 10.1161/hypertensionaha.124.23416

Verify or expand the search:

Other recruiting trials for Binge Drinking

Currently open trials in the same condition.

Other Baylor University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03567434.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing