Aspirin and Zileuton and Biomarker Expression in Nasal Tissue of Current Smokers
Condition: Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder
Intervention: Aspirin; Laboratory Biomarker Analysis; Placebo Administration; Placebo Administration; Zileuton
Intervention description: Given PO; Correlative studies; Given aspirin placebo PO; Given zileuton placebo PO; Given PO
Intervention MeSH terms: Aspirin; Zileuton
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 63.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This randomized phase II trial studies the effects of aspirin and zileuton on genes related
      to tobacco use in current smokers. Aspirin and zileuton may interfere with genes related to
      tobacco use and may be useful in preventing lung cancer in current smokers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Current tobacco smokers with >= 20 pack years of self-reported smoking exposure and an
             average use of >= 10 cigarettes/day

          -  Karnofsky >= 70%

          -  Leukocytes >= 3,000/microliter

          -  Absolute neutrophil count >= 1,500/microliter

          -  Hematocrit >= the lower institutional limit

          -  Platelets >= the lower institutional limits

          -  Total bilirubin within normal institutional limits

          -  Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase
             [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT])
             within normal institutional limits

          -  Creatinine =< the upper institutional limits

          -  Prothrombin time (PT)/partial thromboplastin time (PTT) within normal institutional
             limits

          -  Fertile subjects must use adequate contraception (abstinence, barrier methods, or
             birth control pills) prior to study entry and for the duration of study participation;
             women of child-bearing potential and men must agree to use adequate contraception
             (hormonal or barrier method of birth control; abstinence) prior to study entry and for
             the duration of study participation; should a woman become pregnant or suspect she is
             pregnant while participating in this study, she should inform her study physician
             immediately

          -  Participants may have a history of indeterminate pulmonary nodule(s) by chest imaging
             if nodule follow-up has been completed or the study procedures would not interfere
             with nodule follow-up

          -  Ability to understand and the willingness to sign a written informed consent document

        Exclusion Criteria:

          -  History of allergic reaction to aspirin or attributed to compounds of similar chemical
             or biologic composition to aspirin, including other nonsteroidal anti-inflammatory
             drugs (NSAIDs)

          -  Gastric intolerance attributable to ASA or NSAIDs

          -  History of gastric ulcer within the past 5 years (with or without bleeding)

          -  Use of ASA or NSAIDs for more than 5 days per month within 3 months of enrollment

          -  Not willing or are unable to refrain from use of any non-study ASA, NSAIDs and
             leukotriene antagonists during the study period

          -  Adult asthma

          -  Chronic, current or recent (within the past three months) use of leukotriene
             antagonists

          -  Require chronic anticoagulation or anti-platelet therapy

          -  History of bleeding disorder or hemorrhagic stroke

          -  Chronic, current or recent (within the past three months) use of glucocorticoids
             (systemic, topical and/or nasal sprays or steroid topical creams to large body surface
             area); use of steroid topical creams for small body areas (=< 10% body surface) during
             study intervention is allowed

          -  History of chronic sinusitis or recent nasal polyps

          -  History of, or current, active or chronic liver disease even if transaminases have
             normalized

          -  History of allergic reaction to zileuton or attributed to compounds of similar
             chemical or biologic composition to zileuton

          -  Are taking drugs known to interact with zileuton, including theophylline, warfarin,
             and propranolol

          -  Not willing or are unable to limit alcohol consumption to =< 2 alcoholic beverages a
             day during the study period

          -  Pregnant or lactating women; breastfeeding should be discontinued if the mother is
             treated with aspirin; should a woman become pregnant or suspect she is pregnant while
             participating in this study, she should inform her study physician immediately

          -  Participants may not be receiving any other investigational agents

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, or psychiatric illness/social situations that would limit compliance with
             study requirements

          -  Have a known history of inability to absorb an oral agent

          -  Invasive cancer within the past five years except non-melanoma skin cancer

          -  Urine cotinine level, if collected at screening, does not confirm active smoking
             status