An interventional study of Alcohol vs. Placebo in Binge Drinking, sponsored by Baylor University. Completed at 1 site in United States. Open to participants aged 21 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-24.
Sponsored by Baylor University · Not applicable, Interventional, and Basic science
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.
This study will recruit male and female binge drinkers who will participate in a randomized, cross-over, double-blind, placebo-based study to examine the impact of an evening of alcohol vs. placebo/fluid-control on autonomic and cardiovascular control at night and the subsequent morning. The study will utilize established techniques for assessing sleep (polysomnography) and autonomic/cardiovascular control (microneurography, beat-to-beat finger plethysmography, electrocardiogram, etc.). All subjects will undergo a familiarization night in the sleep laboratory prior to their first randomized test session with either alcohol or placebo/fluid-control. Both men and women will be tested to address a secondary aim of determining the impact of sex (male vs. female) and ovarian cycle (early follicular vs. midluteal phase) on sympathetic neural responsiveness to evening alcohol in binge drinkers. Finally, as a tertiary/exploratory aim, participants that have a respiratory disturbance index of ≥5 episodes per hour during the alcohol treatment will be asked to consider one additional overnight session where they will be randomly assigned to either continuous positive airway pressure (CPAP) or sham-CPAP for one additional night of evening alcohol consumption.
71 studies on the registry are indexed under Binge Drinking; 20 are open to participants now.
This study's enrollment of 69 is below the median of 120 across 64 interventional studies indexed under Binge Drinking.
Browse Binge Drinking studies →Baylor University is the lead sponsor of 42 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants first received a fluid control drink (i.e., juice) of the same volume of fluid as the alcohol condition. After at least a one-month washout period, they then received the alcohol condition.
Other: Alcohol vs. Placebo
Participants first received the alcohol condition with 95% ethanol and fruit juice (1:3 ratio). After at least a one-month washout period, they then received the fluid control condition with a volume fluid match.
Other: Alcohol vs. Placebo
Using a randomized, cross-over design, all subjects will consume evening alcohol (and a fluid-control placebo) in a dose that mimics binge drinking.
Also known as: Ethanol
Sympathetic Nerve Activity Burst Frequency
Direct recordings of muscle sympathetic nerve activity (MSNA) from the peroneal nerve using a microelectrode.
Time frame: 1 month
Sympathetic Nerve Activity Burst Incidence
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.
Time frame: 1 month
Spontaneous Sympathetic Baroreflex Sensitivity
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.
Time frame: 1 month
Nocturnal Blood Pressure Dip
Change in nocturnal blood pressure during sleep when compared to evening/morning wakefulness.
Time frame: 1 month
Sleep Quality
Polysomnography will be used to determine the quality of sleep, with a primary focus on the apnea-hypopnea index.
Time frame: 1 month
Sympathetic Reactivity
The change in muscle sympathetic nerve activity during an acute laboratory stressor.
Time frame: 1 month
Participants were recruited by word-of-mouth and advertisements. 169 participants were screened for eligibility.
| Milestone | Fluid Control, Then Alcohol | Alcohol, Then Fluid Control |
|---|---|---|
| Started | 16 | 22 |
| Completed test 1 | 16 | 22 |
| Completed test 2 | 15 | 19 |
| Completed | 15 | 19 |
| Not completed | 1 | 3 |
| Withdrew: Lost to follow-up | 1 | 3 |
Direct recordings of muscle sympathetic nerve activity (MSNA) from the peroneal nerve using a microelectrode.
| Burst/Min | Fluid Control | Alcohol |
|---|---|---|
| Sympathetic Nerve Activity Burst Frequency | 18 ± 9 | 20 ± 8 |
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.
| burst/100 heart beats | Fluid Control | Alcohol |
|---|---|---|
| Sympathetic Nerve Activity Burst Incidence | 31 ± 16 | 31 ± 12 |
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.
| MSNA Bursts/100 heart beats/mmHg | Fluid Control | Alcohol |
|---|---|---|
| Spontaneous Sympathetic Baroreflex Sensitivity | -2 ± 1 | -2 ± 1 |
Change in nocturnal blood pressure during sleep when compared to evening/morning wakefulness.
Results for this outcome have not been posted.
Polysomnography will be used to determine the quality of sleep, with a primary focus on the apnea-hypopnea index.
Results for this outcome have not been posted.
The change in muscle sympathetic nerve activity during an acute laboratory stressor.
Results for this outcome have not been posted.
Collected over On average 1 to 2 months following initial laboratory testing session. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Fluid Control | — | 0/38 (0%) | 2/38 (5.3%) |
| Alcohol | — | 0/38 (0%) | 1/38 (2.6%) |
| Event | Fluid Control | Alcohol |
|---|---|---|
| Presyncope in response to venipunctureNervous system disorders | 2/38 | 0/38 |
| NauseaGastrointestinal disorders | 0/38 | 1/38 |
| Age, Categorical(Participants) | Fluid Control, Then Alcohol | Alcohol, Then Fluid Control | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 16 | 22 | 38 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Fluid Control, Then Alcohol | Alcohol, Then Fluid Control | Total |
|---|---|---|---|
| Female | 9 | 12 | 21 |
| Male | 7 | 10 | 17 |
| Ethnicity (NIH/OMB)(Participants) | Fluid Control, Then Alcohol | Alcohol, Then Fluid Control | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 3 | 4 |
| Not Hispanic or Latino | 13 | 19 | 32 |
| Unknown or Not Reported | 2 | 0 | 2 |
| Race (NIH/OMB)(Participants) | Fluid Control, Then Alcohol | Alcohol, Then Fluid Control | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 3 | 4 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 13 | 19 | 32 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 2 | 0 | 2 |
| Region of Enrollment(participants) | Fluid Control, Then Alcohol | Alcohol, Then Fluid Control | Total |
|---|---|---|---|
| United States | 16 | 22 | 38 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — The scientific field of neural cardiovascular control in humans does not, at present, have a common data repository that would be applicable to this project. However, all data will be stored on secure University server in a de-identified manner, and investigators will make raw data available to individuals, groups, and organizations upon request and when appropriate.
Ran from May 2018 to primary completion in Jul 2022, 49 months.
Results were first posted in Aug 2024, 2 years 1 month after primary completion.
Of 38 interventional studies with no phase under Binge Drinking, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 49. This study's 49 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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