TY - JOUR
T1 - Effect of high-dose nicotine patch therapy on tobacco withdrawal symptoms among smokeless tobacco users
AU - Ebbert, Jon O.
AU - Dale, Lowell C.
AU - Patten, Christi A.
AU - Croghan, Ivana T.
AU - Schroeder, Darrell R.
AU - Moyer, Thomas P.
AU - Hurt, Richard D.
PY - 2007/1
Y1 - 2007/1
N2 - No pharmacotherapies have been shown to increase long-term (≥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 21mg/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 (χ2 = 6.87, p = .009), less negative affect (χ2=3.85, p = .05), and less restlessness (χ2 = 3.90, p = .048). During the second week, higher nicotine patch doses were associated with less decreased arousal (χ2 = 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.
AB - No pharmacotherapies have been shown to increase long-term (≥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 21mg/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 (χ2 = 6.87, p = .009), less negative affect (χ2=3.85, p = .05), and less restlessness (χ2 = 3.90, p = .048). During the second week, higher nicotine patch doses were associated with less decreased arousal (χ2 = 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.
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U2 - 10.1080/14622200601078285
DO - 10.1080/14622200601078285
M3 - Article
C2 - 17365735
AN - SCOPUS:34247842847
SN - 1462-2203
VL - 9
SP - 43
EP - 52
JO - Nicotine and Tobacco Research
JF - Nicotine and Tobacco Research
IS - 1
ER -