Comparing advice on moderate drinking versus abstention for health outcomes

A Non-inferiority Randomized Trial Testing an Advice of Moderate Drinking Pattern Versus Advice on Abstention on Major Disease and Mortality

This study is testing whether giving advice on moderate drinking or complete abstention is better for the health of adults over 50 in Spain.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 10000 (estimated)
• Ages: 50 Years to 75 Years
• Sex: All
• Sponsor: Clinica Universidad de Navarra, Universidad de Navarra (other)
• Locations: 1 site (Pamplona, Navarre)
• Trial ID: NCT06338215 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effects of two different alcohol consumption advisories on health outcomes in over 10,000 Spanish adults aged 50 and older. Participants will be randomly assigned to receive either advice on moderate alcohol consumption following a Mediterranean pattern or advice on complete abstention. The study will last for four years, with participants receiving guidance on their drinking habits and monitoring for all-cause mortality and chronic diseases such as cardiovascular disease and type 2 diabetes. The goal is to determine if moderate drinking is non-inferior to abstention in preventing health issues.

Who should consider this trial

Good fit: Ideal candidates are men aged 50-70 and women aged 55-75 who currently consume between 3 and 40 alcoholic drinks per week.

Not a fit: Patients with severe psychiatric conditions, liver cirrhosis, or recent breast cancer diagnoses may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide evidence for more effective alcohol consumption guidelines that balance health risks and benefits.

How similar studies have performed: While there have been nonrandomized studies suggesting benefits of moderate drinking, this trial represents a novel approach with a rigorous randomized controlled design.

Eligibility criteria

Inclusion 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

Exclusion Criteria:

1. Participants without smartphone or a computer (or tablet) with Internet connection.
2. Drinkers of less than 30 g of pure alcohol/wk or more than 400 g of pure alcohol/wk
3. Illiteracy, inability/unwillingness to give written consent or communicate with study staff, or inadequate abilities for the use of on-line technologies
4. Participants with any sever psychiatric condition or with a diagnosis of cognitive impairment or dementia.
5. Participants with liver cirrhosis or prior liver cancer.
6. Patients with a recent diagnosis of breast cancer (diagnosed in the last 10 years).
7. 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.

Where this trial is running

Pamplona, Navarre

• University of Navarra — Pamplona, Navarre, Spain (RECRUITING)

Study contacts

• Principal investigator: Miguel A Martinez-Gonzalez, MD, MPH, PhD — University of Navarra
• Study coordinator: Miguel A Martinez-Gonzalez, MD, MPH, PhD

Conditions: All Cause Mortality, Cardiovascular Diseases, Invasive Cancer, Liver Cirrhosis, Type 2 Diabetes, Depression, Dementia, Injury Traumatic