Pilot Study: Preoperative Nicotine Lozenges

Smoking Clinical Trial

Official title:

The Role of Nicotine Lozenges in Reducing Preoperative Exposure to Cigarette Smoke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00586482
• Other study ID #: 06-002759
• Status: Completed
• Phase: Phase 4
• First received: December 21, 2007
• Last updated: December 19, 2014
• Start date: August 2006
• Est. completion date: January 2013

Study information

• Verified date: December 2014
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

Nicotine replacement therapy (NRT) helps patients maintain prolonged abstinence; whether it might also be efficacious in helping smokers maintain preoperative "fasting" from smoking is not known. A goal of this study is to determine how to best decrease smokers' exposure to cigarette smoke immediately before surgery. The specific aim of this study is to test the hypothesis that NRT in the form of nicotine lozenges will decrease the exposure to cigarette smoke prior to surgery. This is a randomized, double blinded, placebo controlled clinical trial examining the efficacy of the nicotine lozenge in increasing preoperative abstinence from cigarettes in patients scheduled for elective surgery. Current smokers scheduled for any of a wide variety of elective surgical procedures will be recruited in the Mayo Clinic Rochester Preoperative Evaluation Center. and will receive a brief practice-based intervention encouraging preoperative abstinence for at least 12 hours before admission to the surgical facility. They will be randomized to receive either active or placebo lozenge.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Smoking

Intervention

Drug:
• Nicotine Lozenge
Nicotine lozenges, 2 or 4 mg, taken without restriction by mouth from 7 pm the evening before surgery until surgical admission the next day and a 2 minute behavioral intervention. Dosed according to time to first morning cigarette; if within 30 minutes of awakening, 4 mg lozenge used. If first cigarette smoked greater than 30 minutes of awakening, 2 mg lozenge used.
• Placebo Lozenge
Placebo lozenges, matching in appearance the 2 and 4 mg active nicotine lozenges, taken by mouth without restriction from 7 pm the night before surgery to the time of surgical admission the next day and a 2 minute behavioral intervention.

Behavioral:
• Abstinence Advisement
A brief (approximately 2 minute) behavioral intervention advising abstinence from smoking after 7 pm the night before surgery, the potential benefits of abstinence and to use a lozenge at usual smoking times.

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

References & Publications (1)

Warner DO, Kadimpati S. Nicotine lozenges to promote frief preopve abstinence from smoking: pilot study. Clin Health Promot 2(3):85-88, 2012.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Self-reported Time to Last Cigarette		Morning of surgery, pre-operatively	No
Other	Minnesota Nicotine Withdrawal Score	This item was measured using the Minnesota Nicotine Withdrawal Questionnaire, self-reported for the prior 24 hour period. This questionnaire consists of 15 items, each rated from 0 to 4, with a possible score of 0 to 60. A lower score indicates lesser withdrawal symptoms, and a higher score indicates greater withdrawal symptoms.	Morning of surgery, pre-operatively	No
Other	Self-reported Abstinence From Smoking		Post-operative day 8	No
Primary	Exhaled Carbon Monoxide Concentration		Morning of surgery, pre-operatively	No
Secondary	Self-reported Abstinence	Mean number who reported abstinence from smoking from the the time of baseline assessment until the morning of surgery.	Morning of surgery, pre-operatively	No