Counseling and Nicotine Replacement Therapy in Helping Adult Smokers Quit Smoking

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Comparing the Lozenge to the Patch for Smoking Cessation

Conditions
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Bladder Cancer, Cervical Cancer, Esophageal Cancer, Gastric Cancer, Head and Neck Cancer, Kidney Cancer, Leukemia, Liver Cancer, Lung Cancer, Pancreatic Cancer, Tobacco Use Disorder

Intervention / Treatment
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* Drug: nicotine lozenge
* Drug: nicotine patch


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I<br>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<br>* transdermal nicotine patch<br>* Other names: transdermal nicotine patch;|
| Experimental: Arm II<br>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<br>* nicotine lozenge<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24-hour Point Prevalence Abstinence at the 6-month Follow up |  | 6-months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Compliance During the First 2 Weeks | Applied to use of the intervention (number of lozenges/day or number of patches used per week) not considering abstinence | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bladder cancer, cervical cancer, esophageal cancer, gastric cancer, renal cell carcinoma, adult primary liver cancer, non-small cell lung cancer, small cell lung cancer, pancreatic cancer, hypopharyngeal cancer, laryngeal cancer, lip and oral cavity cancer, nasopharyngeal cancer, oropharyngeal cancer, paranasal sinus and nasal cavity cancer, adult acute myeloid leukemia, tongue cancer, tobacco use disorder