Counseling and Nicotine Replacement Therapy in Helping Adult Smokers Quit Smoking
RATIONALE: Stop-smoking plans, including counseling and nicotine replacement therapy, may help smokers quit smoking. It is not yet known whether counseling and the nicotine lozenge is more effective than counseling and the nicotine patch in helping adult smokers quit smoking.
PURPOSE: This randomized phase III trial is studying counseling and the nicotine lozenge to see how well they work compared to counseling and the nicotine patch in helping smokers quit smoking.
Head and Neck Cancer
Tobacco Use Disorder
Drug: nicotine lozenge
Drug: nicotine patch
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Comparing the Lozenge to the Patch for Smoking Cessation|
- 24-hour Point Prevalence Abstinence at the 6-month Follow up [ Time Frame: 6-months ] [ Designated as safety issue: No ]
- Rate of Compliance During the First 2 Weeks [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]Applied to use of the intervention (number of lozenges/day or number of patches used per week) not considering abstinence
|Study Start Date:||February 2006|
|Study Completion Date:||August 2009|
|Primary Completion Date:||August 2009 (Final data collection date for primary outcome measure)|
Experimental: Arm I
Participants apply a transdermal nicotine patch at 3 different time periods during weeks 3-14; a higher-dose patch is applied for weeks 3-8, a medium-dose patch is applied for weeks 9-10, and a lower-dose patch is applied for weeks 11-14.
Drug: nicotine patch
transdermal nicotine patch
Other Name: transdermal nicotine patch
Experimental: Arm II
Participants receive one oral nicotine lozenge every 1-2 hours in weeks 3-8 (≥ 9 lozenges per day), one lozenge every 2-4 hours in weeks 9-11 (≥ 5 lozenges per day), and 1 lozenge every 4-8 hours in weeks 12-14 (≥ 3 lozenges per day).
Drug: nicotine lozenge
- Compare the efficacy of behavioral counseling and nicotine-replacement therapy with either oral nicotine lozenge (NL) or transdermal nicotine patch (NP), in terms of promoting rates of smoking cessation (e.g., continued abstinence), in adult smokers.
- Examine the degree to which nicotine replacement therapy (NRT) preference, desire to control NRT dosing, irregular smoking schedules, and desire for oral preoccupation moderates the relative efficacy of NL vs NP in promoting smoking cessation.
- Evaluate the impact of the NL on mediators of smoking cessation (i.e., reduced craving, diminished withdrawal symptoms, cue reactivity, and increased perceived control over withdrawal symptoms).
- Compare the rate of compliance with NRT across the 2 treatment arms and examine if compliance rate mediates the effects of NRT on quit rates.
- Examine the potential role of genes related to nicotine dependence such as genes related to nicotine metabolism enzymes (e.g., CYP1A1) or genes related to dopamine concentrations (e.g., DRD2).
OUTLINE: This is a randomized, open-label, multicenter study. Participants are stratified according to study center. Participants are randomized to 1 of 2 intervention arms.
All participants undergo smoking cessation counseling in weeks 1, 3, 5, 7, and 9. Beginning in week 3, participants are asked to quit smoking for 12 weeks (weeks 3-14).
- Arm I: Participants apply a transdermal nicotine patch at 3 different time periods during weeks 3-14; a higher-dose patch is applied for weeks 3-8, a medium-dose patch is applied for weeks 9-10, and a lower-dose patch is applied for weeks 11-14.
- Arm II: Participants receive one oral nicotine lozenge every 1-2 hours in weeks 3-8 (≥ 9 lozenges per day), one lozenge every 2-4 hours in weeks 9-11 (≥ 5 lozenges per day), and 1 lozenge every 4-8 hours in weeks 12-14 (≥ 3 lozenges per day).
The moderating variables (e.g., nicotine replacement-therapy [NRT] preference and the smoker's desire to control NRT dosing) are assessed at baseline. The mediating variables (i.e., reduced craving, diminished withdrawal symptoms, cue reactivity, and increased perceived control over withdrawal symptoms) are assessed at baseline and then at weeks 5, 7, 9, within weeks 14-16, and within weeks 26-28. Continuous abstinence will be measured at week 27.
PROJECTED ACCRUAL: A total of 700 participants will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00365508
|United States, District of Columbia|
|Howard University Cancer Center|
|Washington, District of Columbia, United States, 20060|
|United States, Florida|
|CCOP - Mount Sinai Medical Center|
|Miami Beach, Florida, United States, 33140|
|United States, Georgia|
|Medical College of Georgia Cancer Center|
|Augusta, Georgia, United States, 30912-3500|
|United States, New Jersey|
|Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Burlington County|
|Mount Holly, New Jersey, United States, 08060-2099|
|United States, New York|
|Hematology Oncology Associates of Central New York, PC - Northeast Center|
|East Syracuse, New York, United States, 13057-4510|
|Don Monti Comprehensive Cancer Center at North Shore University Hospital|
|Manhasset, New York, United States, 11030|
|United States, Pennsylvania|
|Geisinger Cancer Institute at Geisinger Health|
|Danville, Pennsylvania, United States, 17822-0001|
|Fox Chase Cancer Center - Philadelphia|
|Philadelphia, Pennsylvania, United States, 19111-2497|
|CCOP - Main Line Health|
|Wynnewood, Pennsylvania, United States, 19096|
|United States, Tennessee|
|Nashville General Hospital at Meharry|
|Nashville, Tennessee, United States, 37208|
|Study Chair:||Robert A. Schnoll, PhD||Fox Chase Cancer Center - Cheltenham|