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

Eligibility Criteria


Inclusion Criteria

  • Male or female current tobacco smokers with ≥ 20 pack years of self-reported smoking exposure and a current average use of ≥ 10 cigarettes/day.
  • Age ≥18 years.
  • Karnofsky performance scale ≥ 70% (see Appendix A).
  • Participants must have normal organ and marrow function as defined below:
    • Leukocytes ≥3,000/microliter
    • Absolute neutrophil count ≥1,500/microliter
    • Platelets ≥100,000/microliter
    • Total bilirubin ≤ 2 x institutional upper limit of normal (ULN)
    • AST (SGOT)/ALT (SGPT) ≤ 1.5 x ULN
    • Creatinine ≤ ULN
  • Fertile subjects must use adequate contraception (abstinence, barrier methods, or birth control pills) prior to study entry and for the duration of study participation. The effects of Avmacol® on the developing human fetus are unknown. For this reason 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.
  • Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria

  • History of invasive cancer within the past 2 years, with the exception of excised and cured non-melanoma skin cancer or carcinoma in situ of the cervix.
  • Chronic, current or recent (within the past 2 weeks) use of systemic steroid doses equivalent to prednisone > 5 mg daily for continued use > 14 days. Use of inhaled steroids, nasal sprays, and topical creams for small body areas is allowed.
  • Participants may not be receiving any other investigational agents.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to Avmacol®.
  • 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.
  • Pregnant or lactating women.