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.
Checked against the public recordLast updated Mar 29, 2016 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 4
- Sponsor
- Fox Chase Cancer Center
- Interventions being studied
- Drug: nicotine lozenge; Drug: nicotine patch
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Howard University Cancer CenterWashington D.C., District of Columbia
- CCOP - Mount Sinai Medical CenterMiami Beach, Florida
- Medical College of Georgia Cancer CenterAugusta, Georgia
- Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Burlington CountyMount Holly, New Jersey
- Hematology Oncology Associates of Central New York, PC - Northeast CenterEast Syracuse, New York
- Don Monti Comprehensive Cancer Center at North Shore University HospitalManhasset, New York
- Geisinger Cancer Institute at Geisinger HealthDanville, Pennsylvania
- Fox Chase Cancer Center - PhiladelphiaPhiladelphia, Pennsylvania
- CCOP - Main Line HealthWynnewood, Pennsylvania
- Nashville General Hospital at MeharryNashville, Tennessee
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 29, 2016. Always confirm current availability with the study team.