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CompletedPhase 4NCT00365508
Official study title

Counseling and Nicotine Replacement Therapy in Helping Adult Smokers Quit Smoking

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiednicotine lozenge and nicotine patch

The study team can explain what participation involves.

Who it may be forBladder Cancer · Cervical Cancer

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Mar 29, 2016 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 4

Interventional

Where is it offered?10 U.S. locations

Locations may change over time.

Who runs it?Fox Chase Cancer Center

Study sponsor

01
Study overview

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
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

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.

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