Pilot Study: Preoperative Nicotine Lozenges

NCT00586482 | Completed Phase 4 Results

• 1 other identifier: 06-002759
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Smoking

Keywords

cigarettes, surgery; Smokers scheduled for elective surgery

Outcome Measures

Primary Outcomes (1)

• Exhaled Carbon Monoxide Concentration

  Morning of surgery, pre-operatively

Secondary Outcomes (1)

• Self-reported Abstinence

  Morning of surgery, pre-operatively

Other Outcomes (3)

• Self-reported Time to Last Cigarette

  Morning of surgery, pre-operatively

• Minnesota Nicotine Withdrawal Score

  Morning of surgery, pre-operatively

• Self-reported Abstinence From Smoking

  Post-operative day 8

Study Arms (2)

Nicotine lozenge

ACTIVE COMPARATOR

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; Behavioral: Abstinence Advisement

Placebo lozenge

PLACEBO COMPARATOR

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; Behavioral: Abstinence Advisement

Interventions

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.

Also known as: Nicorette Lozenge

Nicotine 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.

Placebo lozenge

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.

Nicotine lozenge; Placebo lozenge

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Current cigarette smoker, defined as \>100 cigarettes lifetime consumption and self report of smoking every day
• Scheduled for elective non-cardiac surgery

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related 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.

  RESULT

MeSH Terms

Conditions

Smoking

Interventions

Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

• Title: David O. Warner, MD
• Organization: Mayo Clinic

warner.david@mayo.edu

507-255-4288

Study Officials

• David O Warner, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: January 4, 2008
• Study Start: August 1, 2006
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: December 22, 2014
• Results First Posted: December 22, 2014

Record last verified: 2014-12

Locations

US (1)