Compares treatment options for All Cause Mortality
Official title Advice of Moderate Drinking Pattern Versus Advice on Abstention on Major Disease and Mortality
ClinicalTrials.gov ID: NCT06338215
What this study is testing
- What it's testing
- The goal of this clinical trial is to test two advices on alcohol drinking in more than 10.000 Spanish adult drinkers (men of 50 or more years and women of 55 or more years). The main question it aims to answer is to test the non-inferiority advice of a moderate alcohol drinking pattern on all-cause mortality and other chronic disease like cardiovascular disease, cancer or type 2 diabetes.
- Time commitment: about 4 years
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 75. Healthy volunteers may be eligible.
You may be able to join if
- Males aged 50-70 years, Women aged 55-75 years
- Drinkers of any alcoholic beverage initially consuming 3 or more but 40 or less drinks/wk
- Projected life expectancy more than 5 years (according to the judgment of their attending physician)
- Willing to receive advice during up to 4 years on how to improve their alcohol intake making it healthier
You likely can't join if
- Participants without smartphone or a computer (or tablet) with Internet connection.
- Drinkers of less than 30 g of pure alcohol/wk or more than 400 g of pure alcohol/wk
- Illiteracy, inability/unwillingness to give written consent or communicate with study staff, or inadequate abilities for the use of on-line...
- Participants with any sever psychiatric condition or with a diagnosis of cognitive impairment or dementia.
- Participants with liver cirrhosis or prior liver cancer.
- Patients with a recent diagnosis of breast cancer (diagnosed in the last 10 years).
See the full eligibility criteria
- Males aged 50-70 years, Women aged 55-75 years
- Drinkers of any alcoholic beverage initially consuming 3 or more but 40 or less drinks/wk
- Projected life expectancy more than 5 years (according to the judgment of their attending physician)
- Willing to receive advice during up to 4 years on how to improve their alcohol intake making it healthier
- Participants without smartphone or a computer (or tablet) with Internet connection.
- Drinkers of less than 30 g of pure alcohol/wk or more than 400 g of pure alcohol/wk
- Illiteracy, inability/unwillingness to give written consent or communicate with study staff, or inadequate abilities for the use of on-line technologies
- Participants with any sever psychiatric condition or with a diagnosis of cognitive impairment or dementia.
- Participants with liver cirrhosis or prior liver cancer.
- Patients with a recent diagnosis of breast cancer (diagnosed in the last 10 years).
- Patients under habitual use of high-dose medications that completely preclude any use of alcohol. Most of these patients will be already excluded by the second or fourth exclusion criteria.
The study team makes the final eligibility decision.
Where it's taking place
- Pamplona, Navarre, Spain
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 4 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years to 75 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Pamplona, Navarre, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.