Pilot Study: Preoperative Nicotine Lozenges

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

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.

Study Overview

• Status: Completed
• Conditions: Smoking
• Intervention / Treatment: Drug: Nicotine Lozenge; Behavioral: Abstinence Advisement; Drug: Placebo Lozenge

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.

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: 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 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.; Other Names: Nicorette Lozenge; Behavioral: 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 Comparator: 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.	Behavioral: 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported Time to Last Cigarette		Morning of surgery, pre-operatively
Minnesota Nicotine Withdrawal Score	This item was measured using the Minnesota Nicotine Withdrawal Questionnaire, self-reported for the prior 24 hour period. This questionnaire consists of 15 items, each rated from 0 to 4, with a possible score of 0 to 60. A lower score indicates lesser withdrawal symptoms, and a higher score indicates greater withdrawal symptoms.	Morning of surgery, pre-operatively
Self-reported Abstinence From Smoking		Post-operative day 8

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: David O Warner, MD, Mayo Clinic

Publications and helpful links

General Publications

• Warner DO, Kadimpati S. Nicotine lozenges to promote frief preopve abstinence from smoking: pilot study. Clin Health Promot 2(3):85-88, 2012.

Study record dates

Study Major Dates

• Study Start: August 1, 2006
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: December 21, 2007
• First Submitted That Met QC Criteria: December 21, 2007
• First Posted (Estimate): January 4, 2008

Study Record Updates

• Last Update Posted (Estimate): December 22, 2014
• Last Update Submitted That Met QC Criteria: December 19, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: cigarettes, surgery; Smokers scheduled for elective surgery
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: 06-002759