CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 46 enrolled
Drug / intervention
Nicotine Lozenge +2 moredrug
Likely dose
Nicotine Lozenge 4 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00586482
NCT00586482Phase 4Completed

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

Mayo Clinic·interventional·Posted Jan 4, 2008·Updated Dec 22, 2014

In Brief

A Phase 4 clinical trial evaluating Nicotine Lozenge, Placebo Lozenge, and 1 other intervention for Smoking. Completed, enrolled 46 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSmoking
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 4, 2008
Enrollment StartAug 1, 2006
Primary CompletionJan 1, 2013
TodayJul 2, 2026
Enrollment to primary: 6.4 yearsPosted 18.5 years ago

Interventions

Nicotine Lozengedrug

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.

Placebo Lozengedrug

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 Advisementbehavioral

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.