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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: May 22, 2013
Last verified: May 2013
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group 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 [ 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 ]

Enrollment: 48
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
Experimental: 1
Ad lib nicotine lozenges
Drug: nicotine lozenge
ad lib beginning the night before surgery
Placebo Comparator: 2
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
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, Arizona
Mayo Clinic
Scottsdale, Arizona, United States, 85054
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
Last Updated: May 22, 2013
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 November 23, 2014