Abstract
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 language | English (US) |
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Pages (from-to) | 223-226 |
Number of pages | 4 |
Journal | Drug and Alcohol Dependence |
Volume | 89 |
Issue number | 2-3 |
DOIs | |
State | Published - Jul 10 2007 |
Keywords
- 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)