Pilot Study: Preoperative Nicotine Lozenges (NCT00586482) | Clinical Trial Compass
CompletedPhase 4
Pilot Study: Preoperative Nicotine Lozenges
United States46 participantsStarted 2006-08
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.