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Completed

NCT Number: NCT00586482

Pilot Study: Preoperative Nicotine Lozenges

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.

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Key information

Conditions

Smoking Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nicotine Lozenge

Drug

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.

Other names: Nicorette Lozenge

Placebo lozenge

Drug

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.

Abstinence Advisement

Behavioral

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.

Primary outcomes

  1. Exhaled Carbon Monoxide Concentration

    Time frame: Morning of surgery, pre-operatively

Secondary outcomes

  1. Self-reported Abstinence

    Time frame: Morning of surgery, pre-operatively

    Mean number who reported abstinence from smoking from the the time of baseline assessment until the morning of surgery.

Other outcomes

  1. Self-reported Time to Last Cigarette

    Time frame: Morning of surgery, pre-operatively

  2. Minnesota Nicotine Withdrawal Score

    Time frame: Morning of surgery, pre-operatively

    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.

  3. Self-reported Abstinence From Smoking

    Time frame: Post-operative day 8

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2013
Study completion
2013
First posted
Jan 4, 2008
Registry last updated
Dec 22, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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