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) |
|---|---|
| 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 |
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Keywords
- Administration
- Cutaneous
- Nicotine
- Randomized clinical trial
- Smokeless tobacco
- Tobacco alkaloid
- Tobacco use cessation
ASJC Scopus subject areas
- Medicine(all)
- Behavioral Neuroscience
- Toxicology
- Health(social science)
Cite this
Nicotine percentage replacement among smokeless tobacco users with nicotine patch. / Ebbert, Jon Owen; Post, Jason A.; Moyer, Thomas P.; Dale, Lowell C.; Schroeder, Darrell R.; Hurt, Richard D.
In: Drug and Alcohol Dependence, Vol. 89, No. 2-3, 10.07.2007, p. 223-226.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Nicotine percentage replacement among smokeless tobacco users with nicotine patch
AU - Ebbert, Jon Owen
AU - Post, Jason A.
AU - Moyer, Thomas P.
AU - Dale, Lowell C.
AU - Schroeder, Darrell R.
AU - Hurt, Richard D.
PY - 2007/7/10
Y1 - 2007/7/10
N2 - 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.
AB - 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.
KW - Administration
KW - Cutaneous
KW - Nicotine
KW - Randomized clinical trial
KW - Smokeless tobacco
KW - Tobacco alkaloid
KW - Tobacco use cessation
UR - http://www.scopus.com/inward/record.url?scp=34248580112&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=34248580112&partnerID=8YFLogxK
U2 - 10.1016/j.drugalcdep.2006.12.034
DO - 10.1016/j.drugalcdep.2006.12.034
M3 - Article
C2 - 17300878
AN - SCOPUS:34248580112
VL - 89
SP - 223
EP - 226
JO - Drug and Alcohol Dependence
JF - Drug and Alcohol Dependence
SN - 0376-8716
IS - 2-3
ER -