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Clinical Study of Avmacol® for Detoxification of Tobacco Carcinogens in Heavy Smokers

Enrollment Statistics

Actual Registration: 54

  • 49 people randomized (49 of 54 registered)
    • 24 in Arm I: High-Low (24 of 49 randomized)
      • 23 participants completed study
      • 1 participant did not complete study due to adverse event
    • 25 in Arm II: Low-High (25 of 49 randomized)
      • 25 participants completed study
  • 5 people not randomized (5 of 54 registered)
    • 4 were not eligible
    • 1 due to non-compliance

Statistical Analysis and Total Study Population Demographics:

  • Age, years: Median (range)
    • 57 (37, 73)
  • Sex: N (%)
    • Male: 23 (47)
    • Female: 26 (53)
  • Race: N (%)
    • Black or African American: 1 (2)
    • White: 44 (90)
    • More than one: 3 (6)
    • Unknown or not reported: 1 (2)
  • Ethnicity: N (%)
    • Hispanic or Latino: 4 (8)
    • Not Hispanic or Latino: 44 (90)
    • Unknown or not reported: 1 (2)
  • Karnofsky performance status: N (%)
    • 90%: 6 (12)
    • 100%: 43 (88)
  • Tobacco use: Median (range)
    • Pack-years: 36 (24, 60)
    • Cigarettes per day: 20 (10, 30)
  • GST genotype: N (%)
    • GSTM1 null: 23 (47)

Final Analysis Population: 49