Phase 4
Completed N=46
Pilot Study: Preoperative Nicotine Lozenges
Source: ClinicalTrials.gov NCT00586482 ↗Enrolled (actual)
46
Serious AEs
0.0%
Results posted
Dec 2014
Primary outcomePrimary: Exhaled Carbon Monoxide Concentration — 8.3; 12.7 Parts per million — p=0.12
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Exhaled Carbon Monoxide Concentration |
8.3; 12.7 | 0.12 |
| SECONDARY Self-reported Abstinence |
16; 13 | 0.23 |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00586482). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.