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Randomized Controlled Trial
. 2007 Jul 10;89(2-3):223-6.
doi: 10.1016/j.drugalcdep.2006.12.034. Epub 2007 Feb 14.

Nicotine percentage replacement among smokeless tobacco users with nicotine patch

Jon O Ebbert  1 , Jason A Post, Thomas P Moyer, Lowell C Dale, Darrell R Schroeder, Richard D Hurt
Affiliations
Randomized Controlled Trial

Nicotine percentage replacement among smokeless tobacco users with nicotine patch

Jon O Ebbert et al. Drug Alcohol Depend. .

Abstract

To obtain preliminary evidence on the safety and efficacy of high dose nicotine patch therapy among smokeless tobacco (ST) users who consume > or =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 > or =3 cans/week.

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Figures

Figure 1
Figure 1
Median serum nicotine concentrations by nicotine patch dose among 42 ST users in a phase II pilot study of high dose nicotine patch therapy
Figure 2
Figure 2
Serum nicotine concentrations with nicotine patch versus serum nicotine concentrations with ad lib ST use in a phase II pilot study of high dose nicotine patch therapy for ST users
See this image and copyright information in PMC

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