Status:
COMPLETED
Counseling and Nicotine Replacement Therapy in Helping Adult Smokers Quit Smoking
Lead Sponsor:
Fox Chase Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Bladder Cancer
Cervical Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 t...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
642 Patients enrolled
Trial Details
Trial ID
NCT00365508
Start Date
February 1 2006
End Date
August 1 2009
Last Update
March 29 2016
Active Locations (10)
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1
Howard University Cancer Center
Washington D.C., District of Columbia, United States, 20060
2
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
3
Medical College of Georgia Cancer Center
Augusta, Georgia, United States, 30912-3500
4
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Burlington County
Mount Holly, New Jersey, United States, 08060-2099