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 range
18 Years
Sex
ALL
See this in plain English?
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.