Reducing Cardiovascular Risks: The Role of Alcohol Use
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 26 Years to 49 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 8 weeks
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "In this randomized, controlled trial, men and women aged 26 to 49 years who regularly consume alcohol and have high blood pressure will be assigned by chance to either stop drinking alcohol or continue their usual drinking habits for 8 weeks."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether stopping alcohol for 8 weeks improves blood pressure and heart and blood vessel health. It is for adults ages 26 to 49 who regularly drink alcohol and have high blood pressure. People will be placed by chance in a group that stops drinking or keeps its usual drinking habits.
The purpose of this study is to learn whether avoiding alcohol can improve heart and blood vessel health in adults who regularly drink alcohol and have high blood pressure. High blood pressure is a major risk factor for cardiovascular disease (CVD), including heart attack and stroke. In this randomized, controlled trial, men and women aged 26 to 49 years who regularly consume alcohol and have high blood pressure will be assigned by chance to either stop drinking alcohol or continue their usual drinking habits for 8 weeks. Researchers will compare changes in blood pressure and other cardiovascular disease risk factors between the two groups. The information gained from this study may help researchers and health care providers better understand the effects of alcohol consumption on cardiovascular health and whether alcohol abstinence can reduce heart disease risk, especially in adults with high blood pressure.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Men and women ages 26 to 49.
- Drink above recommended limits, based on a PEth blood test of at least 20 ng/dL or an alcohol-use survey score of at least 8 for men or 7 for women.
- Blood pressure with a top number of 120–160, a bottom number of 80–100, or both.
Who can't join
- Past heart or blood vessel disease, heart attack, or stroke; certain abnormal heart and blood pressure results during an exercise test; or blood pressure with a top number over 160 and a bottom number over 100.
- Take more than one blood pressure drug or other prescribed medicines, except birth control pills.
- Certain mental health or developmental conditions, including autism, ADHD, bipolar disorder, major depression, or schizophrenia; substance use disorders; or an alcohol problem shown by a diagnosis, PEth level of at least 400 ng/mL, or alcohol-use survey score of at least 25.
- Tobacco or listed nicotine product use in the past 6 months, including vaping or nicotine gum; or illegal or recreational drug use more than 3 times in the past month and more than 15 times in your life.
- Type 1 or 2 diabetes with fasting blood sugar of at least 126 mg/dL; kidney disease with creatinine over 1.5 mg/dL; liver disease with liver tests over 3 times the normal limit; or anemia (low red blood cells) with hemoglobin below 8 g/dL.
- Long-term inflammatory disease, such as cancer; autoimmune disease, where the body attacks itself; listed lung diseases, including pneumonia; or brain and nerve diseases, including seizures and past brain injury.
- Body mass index (BMI), a measure of weight compared with height, below 18.5 or at least 40; weight change over 5% in the past 6 months; sleep apnea, which causes breathing pauses during sleep; or night-shift work.
- Pregnant, planning pregnancy during the study, breastfeeding, or past menopause.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion criteria * Men and women aged 26 to 49 years * At-risk drinkers who drink over the recommended limits, defined as those with PEth (≥20 ng/dL) or those with a U.S. Alcohol Use Disorders Identification Test (USAUDIT) score ≥8/7 for men/women * Elevated blood pressure or hypertension (systolic blood pressure: 120-160 mmHg and/or diastolic blood pressure 80-100 mmHg) Exclusion criteria * History of CVD or cardiovascular events (e.g., stroke, myocardial infarction) * The presence of myocardial ischemia or arrhythmias with abnormal ECG and blood pressure during a clinically-supervised maximal graded exercise test * Hypertension (systolic \>160 mmHg and diastolic \>100 mmHg) * On more than one anti-hypertensive medication, or on other physician-prescribed medications (but not including oral contraceptives) * Major psychiatric disorders, including autism, ADHD, bipolar disorder, major depression, schizophrenia, and substance use disorders * Alcohol use disorder, PEth ≥400 ng/mL, or USAUDIT score ≥ 25 * Current or history of any tobacco use in the past 6 months (including, but not limited to, cigarettes, e-cigarettes, hookah, Nicorette, snus and chewing tobacco) * Current or history of illicit and recreational drug use (more than 3 times in the past month and more than 15 times in their lifetime) * Diabetes type 1 \& type 2 with fasting blood glucose ≥126 mg/dL * Presence of renal disease with a creatinine \> 1.5 mg/dL * Presence of liver disease with liver enzymes \> 3x the upper limits of normal * Anemia with a hemoglobin \< 8 g/dL * Diagnosis of chronic inflammatory disease such as, but not limited to, cancer * Diagnosis of chronic autoimmune diseases such as, but not limited to lupus, multiple sclerosis, rheumatoid arthritis * Diagnosis of chronic obstructive pulmonary disease, pulmonary fibrosis, pneumonia, lung cancer, and cystic fibrosis * Diagnosis of neurological diseases, including seizure disorders, Alzheimer's disease, Parkinson's disease, multiple sclerosis, stroke, traumatic brain injury, and peripheral neuropathies * Body mass index \<18.5 or ≥40 kg/m2 * Unstable body weight (\>5% change during the past 6 months) * Obstructive sleep apnea * Night-shift work * Women who are pregnant (or intend to become pregnant while participating in study), breastfeeding, or postmenopausal
Study sites (1)
TX
- Science and Engineering Innovation and Research Building (SEIR), University of Texas at Arlington · Arlington, TX 76010More trials in Arlington