Moderate Alcohol and Cardiovascular Health Trial

Exclusion Criteria

• •High alcohol consumption, defined by any one of the following:
• •1. Alcohol Use Disorders Identification Test (AUDIT) score \>5 at screening
• •2. Drinking, on average, \>7 alcoholic beverages/week during the past 6 months
• •3. Drinking 6 or more alcoholic beverages on one occasion during the past 6 months
• •Yale-Brown Obsessive Compulsive Scale-heavy drinking (Y-BOCS-hd) total score of ≥6 on questions 7, 8, and 10
• •Cardiovascular disease event (MI, revascularization procedure, or stroke) within the 6 months prior to randomization
• •AHA Class III-IV heart failure
• •History of alcohol or substance abuse (medical record confirmed or self-reported history)
• •Other intolerance or allergy to alcohol
• •Dual antiplatelet therapy
• •History of gastric bypass surgery
• •Any serious chronic liver disease (e.g., active hepatitis B and C infections) or liver tests (aspartate aminotransferase \[AST\], alanine aminotransferase \[ALT\] and gamma-glutamyl transpeptidase \[GGT\]) \>2 times the upper limit of the normal range using local standards
• •Personal history of any colon or liver cancer
• •Any other cancer with a life expectancy of less than 3 years
• •Diagnosed with breast cancer that required either surgery or removal of breast tissue or chemotherapy
• •Mother or sister ever diagnosed with breast cancer that required either surgery or removal of breast tissue or chemotherapy
• •Estimated glomerular filtration rate (eGFR) \<30 ml/min /1.73m2 or end-stage renal disease (ESRD)
• •Ongoing use of any medication for which alcohol consumption is contraindicated
• •A Patient Health Questionnaire (PHQ-9) ≥15 at screening
• •History of any organ transplant
• •Unintentional weight loss \>10% in last 6 months
• •Currently participating in another clinical trial (intervention trial) with CVD outcomes. Note: Participant must wait until the completion of his/her activities or the completion of the other trial before being screened for MACH15. Local restrictions for entry by participants can be more conservative if mandated.
• •Not willing or able to provide a name and contact information for at least one additional contact person other than self
• •Investigator discretion regarding appropriateness of participation or concern about intervention adherence, including:
• •1. moderate - severe psychiatric illness
• •2. behavioral concerns regarding likelihood of low adherence to trial protocol
• •3. a medical condition likely to limit survival to less than 3 years
• •4. advanced chronic disease, such as dementia, that requires 24-hour care
• •Not willing or able to provide a signed and dated informed consent form
• •Not willing or able to comply with all trial procedures.