Pilot Study: Preoperative Nicotine Lozenges

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
David Warner, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00586482
First received: December 21, 2007
Last updated: December 19, 2014
Last verified: December 2014
  Purpose

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.


Condition Intervention Phase
Smoking
Drug: Nicotine Lozenge
Drug: Placebo Lozenge
Behavioral: Abstinence Advisement
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Role of Nicotine Lozenges in Reducing Preoperative Exposure to Cigarette Smoke

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Exhaled Carbon Monoxide Concentration [ Time Frame: Morning of surgery, pre-operatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Self-reported Abstinence [ Time Frame: Morning of surgery, pre-operatively ] [ Designated as safety issue: No ]
    Mean number who reported abstinence from smoking from the the time of baseline assessment until the morning of surgery.


Other Outcome Measures:
  • Self-reported Time to Last Cigarette [ Time Frame: Morning of surgery, pre-operatively ] [ Designated as safety issue: No ]
  • Minnesota Nicotine Withdrawal Score [ Time Frame: Morning of surgery, pre-operatively ] [ Designated as safety issue: No ]
    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.

  • Self-reported Abstinence From Smoking [ Time Frame: Post-operative day 8 ] [ Designated as safety issue: No ]

Enrollment: 46
Study Start Date: August 2006
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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. 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.

Subjects also received an 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.

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.
Other Name: Nicorette Lozenge
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.
Placebo Comparator: 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.

Subjects also received an 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.

Drug: 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.

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00586482

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: David O Warner, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: David Warner, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00586482     History of Changes
Other Study ID Numbers: 06-002759
Study First Received: December 21, 2007
Results First Received: November 26, 2014
Last Updated: December 19, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Mayo Clinic:
cigarettes, surgery
Smokers scheduled for elective surgery

Additional relevant MeSH terms:
Nicotine
Autonomic Agents
Cholinergic Agents
Cholinergic Agonists
Ganglionic Stimulants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Nicotinic Agonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 23, 2015