Counseling and Nicotine Replacement Therapy in Helping Adult Smokers Quit Smoking

• Status: Completed
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fox Chase Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Nicotine

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