Counseling and Nicotine Replacement Therapy in Helping Adult Smokers Quit Smoking
Condition: Bladder Cancer; Cervical Cancer; Esophageal Cancer; Gastric Cancer; Head and Neck Cancer; Kidney Cancer; Leukemia; Liver Cancer; Lung Cancer; Pancreatic Cancer; Tobacco Use Disorder
MeSH terms: Lung Neoplasms; Pancreatic Neoplasms; Stomach Neoplasms; Uterine Cervical Neoplasms; Urinary Bladder Neoplasms; Esophageal Neoplasms; Liver Neoplasms; Tobacco Use Disorder
Intervention: nicotine lozenge; nicotine patch
Intervention description: nicotine lozenge; transdermal nicotine patch
Intervention MeSH terms: Nicotine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Enrollment: 642.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: 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

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.
    

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