Phase 4 Completed N=642 Randomized Treatment

Counseling and Nicotine Replacement Therapy in Helping Adult Smokers Quit Smoking

Bladder Cancer · Cervical Cancer · Esophageal Cancer · Gastric Cancer

Source: ClinicalTrials.gov NCT00365508 ↗

Enrolled (actual)

642

Serious AEs

1.7%

Results posted

Jan 2013

Primary outcomePrimary: 24-hour Point Prevalence Abstinence at the 6-month Follow up — 50; 35 participants — p=.05

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY 24-hour Point Prevalence Abstinence at the 6-month Follow up	50; 35	.05
SECONDARY Rate of Compliance During the First 2 Weeks	231; 87	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00365508). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.