Bladder Cancer Clinical Trial
Counseling and Nicotine Replacement Therapy in Helping Adult Smokers Quit Smoking
Summary
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.
Full Description
OBJECTIVES:
Primary
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).
Secondary
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.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Smokes at least 10 cigarettes a day on average for the past year
No prior diagnosis of cancer (unless completed treatment AND no evidence of disease within the past 5 years)
Able to use nicotine replacement therapy
PATIENT CHARACTERISTICS:
Able to communicate in English
Must reside in the geographic area for ≥ 6 months
Current asthma, ulcer, or diabetes allowed provided medical clearance from the participant's physician is obtained
No evidence of drug or alcohol abuse
No known HIV positivity
No heart disease, including any of the following:
Current diagnosis of coronary artery disease
Abnormal heart rhythm or an arrhythmia
Heart failure
Heart valve disease
Congenital heart disease
Heart muscle disease or cardiomyopathy
Pericardial disease
Aorta disease
Vascular disease
Myocardial infarction
High blood pressure (defined as blood pressure > 140/90 mm Hg) not receiving antihypertensive medication
History of or current high blood pressure controlled by antihypertensive medication and having medical clearance from physician allowed
No allergy to adhesive tape or latex
Not pregnant or nursing
Negative pregnancy test
Fertile participants must use effective contraception during and for ≥ 1 month prior to and after completion of study treatment
PRIOR CONCURRENT THERAPY:
At least 30 days since prior and no concurrent benzodiazepine (e.g., diazepam, alprazolam, or lorazepam)
At least 6 months since prior antiretroviral medications
At least 6 months since prior and no concurrent medication for depression (e.g., phenelzine sulfate, pargyline hydrochloride, tranylcypromine sulfate, paroxetine hydrochloride, sertraline hydrochloride, fluoxetine hydrochloride)
No concurrent antipsychotics (e.g., lithium) or theophylline
No concurrent substance abuse treatment
No concurrent bupropion hydrochloride
No other concurrent pharmacologic aid or any other form of formal assistance for smoking cessation
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There are 10 Locations for this study
Washington District of Columbia, 20060, United States
Miami Beach Florida, 33140, United States
Augusta Georgia, 30912, United States
Mount Holly New Jersey, 08060, United States
East Syracuse New York, 13057, United States
Manhasset New York, 11030, United States
Danville Pennsylvania, 17822, United States
Philadelphia Pennsylvania, 19111, United States
Wynnewood Pennsylvania, 19096, United States
Nashville Tennessee, 37208, United States
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