NCT06338215 · RECRUITING
Advice of Moderate Drinking Pattern Versus Advice on Abstention on Major Disease and Mortality
This trial is testing whether advising moderate drinkers to follow a Mediterranean-style drinking pattern — moderate amounts, no binge drinking, preference for red wine — leads to health outcomes no worse than advising full abstention. It is tracking all-cause mortality, heart disease, cancer, diabetes, and dementia over four years. This is a Phase N/A behavioral trial, meaning it tests advice and lifestyle guidance, not a drug or device.
You may qualify 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're excluded 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 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 sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2024-12-12