title: Effect of high-dose nicotine patch therapy on tobacco withdrawal symptoms among smokeless tobacco users.
abstract: No pharmacotherapies have been shown to increase long-term (> or = 6-month) abstinence rates among smokeless tobacco (ST) users. Available evidence suggests that underdosing may occur with standard-dose nicotine replacement therapy (NRT) in ST users. We investigated the effect of high-dose nicotine therapy on tobacco withdrawal symptoms among ST users in a randomized, controlled clinical pilot study. A total of 42 ST users using at least 3 cans or pouches per week were randomized to nicotine patch doses of 63, 42, or 21 mg/day or placebo for 8 weeks. Multiple daily assessments of tobacco withdrawal and nicotine toxicity were obtained with an electronic diary. During the first week of nicotine patch therapy, we observed a dose-response relationship such that higher nicotine patch doses were associated with less decreased arousal (chi2 = 6.87, p = .009), less negative affect (chi2 = 3.85, p = .05), and less restlessness (chi2 = 3.90, p = .048). During the second week, higher nicotine patch doses were associated with less decreased arousal (chi2 = 6.77, p = .009). Overall, the frequency of nicotine toxicity symptoms did not differ by dose group. Of specific symptoms, nausea was observed to be more frequent in the 63 mg/day dose group compared with placebo (p = .035). In conclusion, high-dose nicotine patch therapy resulted in a greater reduction of tobacco withdrawal symptoms among ST users using at least 3 cans per week. High-dose nicotine patch therapy is safe and well tolerated in this population of tobacco users.
authors: Mayo Clinic College of Medicine, Rochester, MN 55905, USA. ebbert.jon@mayo.edu
authors: Jon O
authors: JO
authors: Ebbert
authors: Lowell C
authors: LC
authors: Dale
authors: Christi A
authors: CA
authors: Patten
authors: Ivana T
authors: IT
authors: Croghan
authors: Darrell R
authors: DR
authors: Schroeder
authors: Thomas P
authors: TP
authors: Moyer
authors: Richard D
authors: RD
authors: Hurt
mesh_terms: D000287:Administration, Topical; D000328:Adult; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D008297:Male; D009538:Nicotine / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use*; D010865:Pilot Projects; D012867:Skin; D013375:Substance Withdrawal Syndrome / Q000188:drug therapy / Q000453:epidemiology / Q000209:etiology; D011795:Surveys and Questionnaires; D020340:Tobacco Use Cessation / Q000379:methods; D014029:Tobacco Use Disorder / Q000453:epidemiology*; D014030:Tobacco, Smokeless
chemical_list: D009538:Nicotine