Trial of Nicotine Nasal Spray as an Aid for Smoking Cessation in Schizophrenia
Status:
Completed
Trial end date:
2012-08-01
Target enrollment:
Participant gender:
Summary
This R01 grant describes a randomized, double-blind, placebo-controlled trial of nicotine
nasal spray (NNS) as an aid for smoking cessation in 60 individuals with schizophrenia. The
objectives of this study are to determine the efficacy of NNS with behavioral intervention
for smoking cessation in smokers with schizophrenia. It is hypothesized that the quit rate of
subjects who receive NNS and behavioral intervention will be significantly greater than the
quit rate of the control group who will receive the placebo spray plus same behavioral
intervention. Quit rate is defined as the proportion of individuals who self report no
tobacco use during weeks 5 through 8 confirmed by exhaled carbon monoxide (CO) less than 10
parts per million during these 4 weeks. The investigators will also assess abstinence rates
at Study Weeks 12 and 20 on the NNS and at weeks 26 and 52 after the medication has been
stopped. Since studies of this group suggest high relapse rates when treatments are
discontinued (Evins et al., 2005; George et al., 2000; George et al., 2002a), the
investigators will continue NNS treatment for a total of 20 weeks.