Pilot Study: Preoperative Nicotine Lozenges

Phase 4

Completed

Conditions: Smoking

Interventions: Drug: Nicotine Lozenge
Drug: Placebo Lozenge
Behavioral: Abstinence Advisement

Registration Number: NCT00586482

Lead Sponsor: Mayo Clinic

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 46

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nicotine lozenge	Nicotine Lozenge	Nicotine lozenges, 2 or 4 mg, taken without restriction by mouth from 7 pm the evening before surgery until surgical admission the next day. Dosed according to time to first morning cigarette; if within 30 minutes of awakening, 4 mg lozenge used. If first cigarette smoked greater than 30 minutes of awakening, 2 mg lozenge used. Subjects also received an abstinence advisement: a brief (approximately 2 minute) behavioral intervention advising abstinence from smoking after 7 pm the night before surgery, the potential benefits of abstinence and to use a lozenge at usual smoking times.
Placebo lozenge	Abstinence Advisement	Placebo lozenges, matching in appearance the 2 and 4 mg active nicotine lozenges, taken by mouth without restriction from 7 pm the night before surgery to the time of surgical admission the next day. Subjects also received an abstinence advisement: a brief (approximately 2 minute) behavioral intervention advising abstinence from smoking after 7 pm the night before surgery, the potential benefits of abstinence and to use a lozenge at usual smoking times.
Nicotine lozenge	Abstinence Advisement	Nicotine lozenges, 2 or 4 mg, taken without restriction by mouth from 7 pm the evening before surgery until surgical admission the next day. Dosed according to time to first morning cigarette; if within 30 minutes of awakening, 4 mg lozenge used. If first cigarette smoked greater than 30 minutes of awakening, 2 mg lozenge used. Subjects also received an abstinence advisement: a brief (approximately 2 minute) behavioral intervention advising abstinence from smoking after 7 pm the night before surgery, the potential benefits of abstinence and to use a lozenge at usual smoking times.
Placebo lozenge	Placebo Lozenge	Placebo lozenges, matching in appearance the 2 and 4 mg active nicotine lozenges, taken by mouth without restriction from 7 pm the night before surgery to the time of surgical admission the next day. Subjects also received an abstinence advisement: a brief (approximately 2 minute) behavioral intervention advising abstinence from smoking after 7 pm the night before surgery, the potential benefits of abstinence and to use a lozenge at usual smoking times.

Primary Outcome Measures

Name	Time	Method
Exhaled Carbon Monoxide Concentration	Morning of surgery, pre-operatively

Secondary Outcome Measures

Name	Time	Method
Self-reported Abstinence	Morning of surgery, pre-operatively	Mean number who reported abstinence from smoking from the the time of baseline assessment until the morning of surgery.