Pilot Study: Preoperative Nicotine Lozenges

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Role of Nicotine Lozenges in Reducing Preoperative Exposure to Cigarette Smoke

Conditions
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Smoking

Intervention / Treatment
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* Drug: Nicotine Lozenge
* Drug: Placebo Lozenge
* Behavioral: Abstinence Advisement


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nicotine lozenge<br>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. | Drug: Nicotine Lozenge<br>* Nicotine lozenges, 2 or 4 mg, taken without restriction by mouth from 7 pm the evening before surgery until surgical admission the next day and a 2 minute behavioral intervention. 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.<br>* Other names: Nicorette Lozenge;Behavioral: Abstinence Advisement<br>* 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.<br>|
| Placebo Comparator: Placebo lozenge<br>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. | Drug: Placebo Lozenge<br>* 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 and a 2 minute behavioral intervention.<br>Behavioral: Abstinence Advisement<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exhaled Carbon Monoxide Concentration |  | Morning of surgery, pre-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported Abstinence | Mean number who reported abstinence from smoking from the the time of baseline assessment until the morning of surgery. | Morning of surgery, pre-operatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cigarettes, surgery, Smokers scheduled for elective surgery