title: Nicotine percentage replacement among smokeless tobacco users with nicotine patch.
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.
authors.affiliation: Mayo Clinic College of Medicine, 200 1st Street SW, Rochester, MN 55905, USA. ebbert.jon@mayo.edu
authors.forename: Jon O
authors.initials: JO
authors.lastname: Ebbert
authors.forename: Jason A
authors.initials: JA
authors.lastname: Post
authors.forename: Thomas P
authors.initials: TP
authors.lastname: Moyer
authors.forename: Lowell C
authors.initials: LC
authors.lastname: Dale
authors.forename: Darrell R
authors.initials: DR
authors.lastname: Schroeder
authors.forename: Richard D
authors.initials: RD
authors.lastname: Hurt
mesh_terms: D000279:Administration, Cutaneous; D000328:Adult; D004305:Dose-Response Relationship, Drug; D006801:Humans; D008297:Male; D008875:Middle Aged; D009538:Nicotine / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D014029:Tobacco Use Disorder / Q000097:blood / Q000534:rehabilitation*; D014030:Tobacco, Smokeless; D016896:Treatment Outcome
chemical_list: D009538:Nicotine