Pilot Study: Preoperative Nicotine Lozenges

• Status: Completed
• Trial end date: 2013-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Treatments: Nicotine

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.