Nicotine percentage replacement among smokeless tobacco users with nicotine patch

Jon O. Ebbert, Jason A. Post, Thomas P. Moyer, Lowell C. Dale, Darrell R. Schroeder, Richard D. Hurt

Research output: Contribution to journalArticlepeer-review

8 Scopus citations


To obtain preliminary evidence on the safety and efficacy of high dose nicotine patch therapy among smokeless tobacco (ST) users who consume ≥3 cans of ST per week, we conducted a randomized, placebo-controlled clinical trial with 42 ST users randomized to nicotine patch doses of 21, 42, and 63 mg/day or placebo. Serum nicotine concentrations were measured during ad libitum ST use and nicotine replacement therapy, and percentages of nicotine replacement were calculated. We observed substantial inter-subject variability in nicotine concentrations with ad lib ST use. The mean percentage replacement of ad lib ST use serum nicotine concentrations approximated 100% with the 42 mg/day patch dose (mean ± S.D., 98.4% ± 45%). Dosing with the 21 mg/day nicotine patch was associated with mean "under-replacement" (53.2% ± 17.1%), and the 63 mg/day nicotine was associated with mean "over-replacement" (159.2% ± 121.9%). We observed symptoms of nausea consistent with nicotine toxicity in two subjects in the 63 mg/day group while no subjects in the 42 mg/day reported these symptoms. We conclude that the use of 42 mg/day nicotine patch therapy is safe and should be considered as initial therapy in the clinical setting among ST users who use ≥3 cans/week.

Original languageEnglish (US)
Pages (from-to)223-226
Number of pages4
JournalDrug and Alcohol Dependence
Issue number2-3
StatePublished - Jul 10 2007


  • Administration
  • Cutaneous
  • Nicotine
  • Randomized clinical trial
  • Smokeless tobacco
  • Tobacco alkaloid
  • Tobacco use cessation

ASJC Scopus subject areas

  • Toxicology
  • Pharmacology
  • Psychiatry and Mental health
  • Pharmacology (medical)


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