Alcohol DrinkingNCT07783061
Reducing Cardiovascular Risks: The Role of Alcohol Use
A study testing Alcohol Abstinence in people with Alcohol Drinking and Drinking Behavior, run by The University of Texas at Arlington at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 26 to 49 years
- Conditions the study is for
- Alcohol Drinking, Drinking Behavior, At-risk Drinking
- What is being tested?
- Alcohol Abstinence
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Sep 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 26 to 49 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 21Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Science and Engineering Innovation and Research Building (SEIR), University of Texas at Arlington
Arlington, Texas, 76010
About this study
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.
Read the detailed description
The overarching objective is to determine the effect of alcohol abstinence on cardiovascular disease risks in individuals who consume alcoholic beverages over the recommended limits. After baseline assessment, participants will be randomly assigned to receive one of the interventions: either continue their usual drinking habits or to abstain from alcohol drinking. Before and after the 8-week intervention, blood pressure and sub-clinical cardiovascular disease risk factors (including arterial stiffness, endothelial function, and sympathetic nerve activity) will be measured. A longitudinal assessment of objective sleep will be performed throughout the study participation. Participants will be asked to maintain their diet and physical activity throughout the study.
- Conditions
- Alcohol Drinking, Drinking Behavior, At-risk Drinking, Cardiovascular Risk Factor, High Blood Pressure
- Being tested
- Alcohol Abstinence, Control arm
- Medical subject headings
- Alcohol Drinking, Drinking Behavior, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alcohol AbstinenceBehavioural
Participants will be instructed to abstain from alcohol for 8 weeks and maintain their usual lifestyle, including diet and physical activity. One week before the intervention, participants will be provided with an Oura Ring and instructed to wear it throughout the study. Every two weeks, participants will meet virtually with the research team (approximately 45 minutes) to receive educational materials and personalized feedback based on phosphatidylethanol (PEth), sleep, and heart rate variability data to support alcohol abstinence. During these meetings, participants will also complete assessments of alcohol use, physical activity, and dietary intake. At week 4, participants will complete a dried blood spot PEth test. Participants will also receive weekly reminders by text message or email to ensure Oura Ring data are uploaded successfully.
Control armOther
Participants will be asked to maintain their usual lifestyle, including alcohol consumption, diet, and physical activity, and will not have access to their study data during the intervention. One week before the intervention, participants will be provided with an Oura Ring and instructed to wear it throughout the study. Every two weeks, participants will meet virtually with the research team (approximately 45 minutes) to complete questionnaires on alcohol use, physical activity, and diet. At week 4, participants will complete a dried blood spot phosphatidylethanol (PEth) test. Participants will also receive weekly reminders by text message or email to ensure Oura Ring data are uploaded successfully.
| Study group | Role | What they receive |
|---|---|---|
| Usual Drinking Habits (Control) | Other | Participants will continue their usual alcohol consumption patterns during the study period and will be instructed not to change their lifestyle including alcohol use, diet, and habitual physical activity. Receives: Other: Control arm |
| Alcohol Abstinence Intervention | Experimental | Participants will be instructed to abstain from alcohol for 8 weeks. Throughout the study period, participants will be asked to maintain their usual diet and level of physical activity and avoid making other lifestyle changes, except for abstaining from alcohol. Receives: Behavioral: Alcohol Abstinence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in in-laboratory central and peripheral blood pressure
In-laboratory central blood pressure will be measured after a 10-min rest in supine position, while in-laboratory peripheral blood pressure will be measured after a 10-min rest in seated position.
Measured: Baseline and after the 8-week intervention
Change in nighttime central and peripheral blood pressure
Blood pressure during nighttime (or sleep) will be measured by using a portable blood pressure monitor.
Measured: Baseline and after the 8-week intervention
Secondary outcomes (3)
Change in arterial stiffness
Carotid to femoral pulse wave velocity (cfPWV), the gold standard for noninvasive arterial stiffness assessment, will be measured.
Measured: Baseline and after the 8-week intervention
Change in endothelial function as measured by brachial artery flow-mediated dilation (FMD)
Brachial artery flow-mediated dilation (FMD), a noninvasive measure of endothelial function, will be assessed using ultrasound.
Measured: Baseline and after the 8-week intervention
Change in muscle sympathetic nerve activity (MSNA)
Muscle sympathetic nerve activity (MSNA) in the leg will be measured at rest using microneurography, a direct invasive assessment of sympathetic neural outflow.
Measured: Baseline and after the 8-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study startOct 2026 (estimated)
- Primary completionAug 2031 (estimated)
- Study completionSep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol DrinkingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Texas at Arlington
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07783061
- Sponsor's protocol ID
- 2026-0383
- Status last verified
- Oct 2026
- First submitted
- 14 Aug 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified participant data collected during this study will be submitted to the NIMH Data Archive (NDA). These data will be made available to qualified researchers for scientific research, educational purposes, and other research-related activities in accordance with NDA data access policies.
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Cardiovascular Risks: The Role of Alcohol Use
- ClinicalTrials.gov ID
- NCT07783061
- Acronym / sponsor ID
- 2026-0383
- Conditions
- Alcohol Drinking, Drinking Behavior, At-risk Drinking, Cardiovascular Risk Factor, High Blood Pressure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- The University of Texas at ArlingtonUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Aug 2031 (estimated)
- Study completion
- Sep 2031 (estimated)
- First posted
- 24 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The overarching objective is to determine the effect of alcohol abstinence on cardiovascular disease risks in individuals who consume alcoholic beverages over the recommended limits. After baseline assessment, participants will be randomly assigned to receive one of the interventions: either continue their usual drinking habits or to abstain from alcohol drinking. Before and after the 8-week intervention, blood pressure and sub-clinical cardiovascular disease risk factors (including arterial stiffness, endothelial function, and sympathetic nerve activity) will be measured. A longitudinal assessment of objective sleep will be performed throughout the study participation. Participants will be asked to maintain their diet and physical activity throughout the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Drinking Habits (Control) | Other | Other: Control armParticipants will continue their usual alcohol consumption patterns during the study period and will be instructed not to change their lifestyle including alcohol use, diet, and habitual physical activity. |
| Alcohol Abstinence Intervention | Experimental | Behavioral: Alcohol AbstinenceParticipants will be instructed to abstain from alcohol for 8 weeks. Throughout the study period, participants will be asked to maintain their usual diet and level of physical activity and avoid making other lifestyle changes, except for abstaining from alcohol. |
Who may qualify
- Ages
- 26 to 49 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alcohol AbstinenceParticipants will be instructed to abstain from alcohol for 8 weeks and maintain their usual lifestyle, including diet and physical activity. One week before the intervention, participants will be provided with an Oura Ring and instructed to wear it throughout the study. Every two weeks, participants will meet virtually with the research team (approximately 45 minutes) to receive educational materials and personalized feedback based on phosphatidylethanol (PEth), sleep, and heart rate variability data to support alcohol abstinence. During these meetings, participants will also complete assessments of alcohol use, physical activity, and dietary intake. At week 4, participants will complete a dried blood spot PEth test. Participants will also receive weekly reminders by text message or email to ensure Oura Ring data are uploaded successfully. | Behavioural | Alcohol Abstinence Intervention |
| Control armParticipants will be asked to maintain their usual lifestyle, including alcohol consumption, diet, and physical activity, and will not have access to their study data during the intervention. One week before the intervention, participants will be provided with an Oura Ring and instructed to wear it throughout the study. Every two weeks, participants will meet virtually with the research team (approximately 45 minutes) to complete questionnaires on alcohol use, physical activity, and diet. At week 4, participants will complete a dried blood spot phosphatidylethanol (PEth) test. Participants will also receive weekly reminders by text message or email to ensure Oura Ring data are uploaded successfully. | Other | Usual Drinking Habits (Control) |
Primary outcome
Change in in-laboratory central and peripheral blood pressure
Time frame: Baseline and after the 8-week intervention
In-laboratory central blood pressure will be measured after a 10-min rest in supine position, while in-laboratory peripheral blood pressure will be measured after a 10-min rest in seated position.
Change in nighttime central and peripheral blood pressure
Time frame: Baseline and after the 8-week intervention
Blood pressure during nighttime (or sleep) will be measured by using a portable blood pressure monitor.
3 secondary outcomes
Change in arterial stiffness
Time frame: Baseline and after the 8-week intervention
Change in endothelial function as measured by brachial artery flow-mediated dilation (FMD)
Time frame: Baseline and after the 8-week intervention
Change in muscle sympathetic nerve activity (MSNA)
Time frame: Baseline and after the 8-week intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: Yes. De-identified participant data collected during this study will be submitted to the NIMH Data Archive (NDA). These data will be made available to qualified researchers for scientific research, educational purposes, and other research-related activities in accordance with NDA data access policies.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alcohol Abstinence in people with Alcohol Drinking and Drinking Behavior, run by The University of Texas at Arlington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chueh-Lung Hwang, PhD, PT (8172729722, chuehlung.hwang@uta.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in in-laboratory central and peripheral blood pressure (time frame: Baseline and after the 8-week intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.