Phase 1 Trial of I3C and Sil in Smokers

Inclusion Criteria

• Current smoker of >= 8 cigarettes per day for at least the last 6 months by self-report
• Hemoglobin >= 9 g/dL for women, >= 10 g/dL for men
• Platelet count >= 100 x 10^9/L
• Total bilirubin =< institutional upper limit of normal (=< 1.3 mg/dL for University of Minnesota Medical Center [UMMC])
• Alanine aminotransferase (ALT) =< 1.5 times institutional upper limit of normal
• Creatinine =< 1.4 g/dL
• Able to understand the experimental nature of the study and provide informed written consent

Exclusion Criteria

• Daily proton pump inhibitor, H2-blocker (i.e., ranitidine, famotidine), and/or calcium carbonate use
• History of gastric bypass surgery, gastric banding, bowel resection, malabsorption syndromes such as celiac sprue or pancreatic insufficiency, or other conditions that may affect gastric or intestinal absorption of nutrients
• Use of tobacco products other than cigarettes (i.e. snuff, snuz, smokeless tobacco, cigars, pipes), within 7 days of study registration
• Major or chronic medical disease, including heart disease, poorly controlled diabetes, etc., to be adjudicated by the principal investigator
• Known active malignancy
• History of aerodigestive malignancies
• Women who are pregnant, intend to become pregnant within 3 months of study registration, or who are lactating. Women of childbearing potential must have a negative urine pregnancy test within 14 days of starting the assigned intervention
• Antibiotic use within 2 months of study registration by self-report
• History of respiratory tract cancer
• Known allergy to I3C, Sil, or its components
• Psychiatric and/or social situations that would potentially limit compliance with study requirements