Clinical trial NCT00586482: Pilot Study: Preoperative Nicotine Lozenges
Official title: The Role of Nicotine Lozenges in Reducing Preoperative Exposure to Cigarette Smoke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Smoking
Keywords: cigarettes, surgery
Smokers scheduled for elective surgery
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2008-01-04
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Current cigarette smoker, defined as \>100 cigarettes lifetime consumption and self report of smoking every day
* Scheduled for elective non-cardiac surgery

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Exhaled Carbon Monoxide Concentration
timeFrame: Morning of surgery, pre-operatively
Secondary outcomes:
measure: Self-reported Abstinence
timeFrame: Morning of surgery, pre-operatively
Other outcomes:
measure: Self-reported Time to Last Cigarette
timeFrame: Morning of surgery, pre-operatively
measure: Minnesota Nicotine Withdrawal Score
timeFrame: Morning of surgery, pre-operatively
measure: Self-reported Abstinence From Smoking
timeFrame: Post-operative day 8
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: David O Warner, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Warner DO, Kadimpati S. Nicotine lozenges to promote frief preopve abstinence from smoking: pilot study. Clin Health Promot 2(3):85-88, 2012.