Pilot Study: Preoperative Nicotine Lozenges

Completed · Phase 4 · Has a placebo group

Conditions studied: Smoking

In brief

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.

Key facts

Study ID

NCT00586482

Run by

Mayo Clinic

People needed

46

Starts

2006-08-01

Expected to finish

2013-01-01

Last updated by the study team

2014-12-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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.

Where it is running

• Mayo Clinic — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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