A double-blind randomized clinical trial of different doses of transdermal nicotine patch for smoking reduction and cessation in long-term hospitalized schizophrenic patients

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Abstract
There have been many studies of smoking cessation using nicotine replacement therapy (NRT) with schizophrenic patients, but none exploring the smoking-reduction effects of varying doses of NRT in long-stay patients with schizophrenia. This study aimed to examine the effect of different doses of the nicotine transdermal patch on smoking-reduction and cessation outcomes in long-term hospitalized schizophrenic patients. A total of 184 subjects participated in a randomized, controlled, double-blind 8-week clinical trial. Participants were randomized into two groups using two different doses of NRT: a high-dose NRT group (31.2 mg for the first 4 weeks, then 20.8 mg for 4 weeks, n = 92) or a low-dose NRT group (20.8 mg for 8 weeks, n = 92). The 7-day point prevalence of abstinence was 2.7 % (5/184). Participants in the low-dose NRT group reduced smoking by 3.1 more cigarettes on average than those in the high-dose group (p = 0.005). However, a repeated measures analysis of variance revealed that the main effect of changes in the number of cigarettes smoked, comparing the two types of treatment across periods, was not significant (p = 0.35, partial eta square = 0.018). In summary, among a cohort of chronic institutionalized schizophrenic patients, smoking cessation and reduction outcomes were not correlated with NRT dose, and the cessation rate was much lower than rates in similar studies. It indicates that long-term hospitalized schizophrenic patients have more difficulties with quitting smoking. More effective integrative smoking cessation programs should be addressed for these patients.

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