The goal of this pilot study is to determine the feasibility and potential effect size of
nicotine lozenges as an adjunct to maintain brief preoperative abstinence, defined as not
smoking the day of surgery.
Nicotine replacement therapy (NRT) helps patients maintain prolonged abstinence; whether it
might also be efficacious in helping smokers maintain preoperative "fasting" from smoking is
not known. A goal of this study is to determine how to best decrease smokers' exposure to
cigarette smoke immediately before surgery. The specific aim of this study is to test the
hypothesis that NRT in the form of nicotine lozenges will decrease the exposure to cigarette
smoke prior to surgery. This is a randomized, double blinded, placebo controlled clinical
trial examining the efficacy of the nicotine lozenge in increasing preoperative abstinence
from cigarettes in patients scheduled for elective surgery. Current smokers scheduled for
any of a wide variety of elective surgical procedures will be recruited in the Mayo Clinic
Rochester Preoperative Evaluation Center. and will receive a brief practice-based
intervention encouraging preoperative abstinence for at least 12 hours before admission to
the surgical facility. They will be randomized to receive either active or placebo lozenge.
- Current cigarette smoker, defined as >100 cigarettes lifetime consumption and self
report of smoking every day
- Scheduled for elective non-cardiac surgery
- An inability to understand consent procedures
- History of an allergic reaction to nicotine replacement therapy
- History of sustained ventricular tachycardia
- Untreated hyperthyroidism or pheochromocytoma
- Currently utilizing pharmacologic agents specifically to treat nicotine dependence,
including nicotine replacement therapy and bupropion (for a stop-smoking indication)
- Active (within the past 12 months) non-nicotine drug dependence
- Females who are pregnant or lactating
- Patients with phenylketonuria, because the lozenges contain aspartame, which is
metabolized to phenylalanine.
- Lack of access to a telephone, as one follow-up will be performed using this means.