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Preoperative Nicotine Lozenges
This study is currently recruiting participants.
Verified by Mayo Clinic, December 2007
Sponsored by: Mayo Clinic
Information provided by: Mayo Clinic
ClinicalTrials.gov Identifier: NCT00586482
  Purpose

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. The 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 elective surgery 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. The primary outcome measure will be exhaled carbon monoxide (CO) concentration measured in the preoperative holding area. The secondary outcome measures will be the self-reported duration of preoperative abstinence from cigarettes, and the self-reported point prevalence abstinence rate measured one week postoperatively.


Condition Intervention Phase
Smoking
Drug: nicotine lozenge
Drug: Placebo lozenge
Phase IV

MedlinePlus related topics: Smoking
Drug Information available for: Nicotine polacrilex Nicotine tartrate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Efficacy Study
Official Title: The Role of Nicotine Lozenges in Reducing Preoperative Exposure to Cigarette Smoke

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Exhaled Carbon Monoxide [ Time Frame: morning of surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Self-reported time of last cigarette [ Time Frame: morning of surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: August 2006
Estimated Study Completion Date: August 2009
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Ad lib nicotine lozenges
Drug: nicotine lozenge
ad lib beginning the night before surgery
2: Placebo Comparator
Placebo lozenge
Drug: Placebo lozenge
Ad lib beginning the night before surgery

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Current cigarette smoker
  • Scheduled for elective surgery

Exclusion Criteria:

  • Receiving therapy for tobacco use
  • contraindications to nicotine
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00586482

Contacts
Contact: David O Warner, MD 507-255-4288 warner.david@mayo.edu

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

Responsible Party: Mayo Clinic ( David O. Warner, M.D./Professor of Anesthesiology )
Study ID Numbers: 06-002759
Study First Received: December 21, 2007
Last Updated: December 21, 2007
ClinicalTrials.gov Identifier: NCT00586482  
Health Authority: United States: Food and Drug Administration

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

Study placed in the following topic categories:
Nicotine polacrilex
Smoking
Nicotine

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

ClinicalTrials.gov processed this record on January 14, 2009