Counseling and Nicotine Replacement Therapy in Helping Adult Smokers Quit Smoking

Lung Cancer Clinical Trial

Official title:

Comparing the Lozenge to the Patch for Smoking Cessation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00365508
• Other study ID #: CDR0000491296
• Secondary ID: FCCC-FCRB-04-003
• Status: Completed
• Phase: Phase 4
• First received: August 16, 2006
• Last updated: July 12, 2013
• Start date: February 2006
• Est. completion date: August 2009

Study information

• Verified date: July 2013
• Source: Fox Chase Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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 rates of smoking cessation (e.g., continued abstinence), in adult smokers.

• Examine the degree to which nicotine replacement therapy (NRT) preference, desire to control NRT dosing, irregular smoking schedules, and desire for oral preoccupation moderates the relative efficacy of NL vs NP in promoting smoking cessation.

• Evaluate the impact of the NL on mediators of smoking cessation (i.e., reduced craving, diminished withdrawal symptoms, cue reactivity, and increased perceived control over withdrawal symptoms).

Secondary

• Compare the rate of compliance with NRT across the 2 treatment arms and examine if compliance rate mediates the effects of NRT on quit rates.

• Examine the potential role of genes related to nicotine dependence such as genes related to nicotine metabolism enzymes (e.g., CYP1A1) or genes related to dopamine concentrations (e.g., DRD2).

OUTLINE: This is a randomized, open-label, multicenter study. Participants are stratified according to study center. Participants are randomized to 1 of 2 intervention arms.

All participants undergo smoking cessation counseling in weeks 1, 3, 5, 7, and 9. Beginning in week 3, participants are asked to quit smoking for 12 weeks (weeks 3-14).

• Arm I: Participants apply a transdermal nicotine patch at 3 different time periods during weeks 3-14; a higher-dose patch is applied for weeks 3-8, a medium-dose patch is applied for weeks 9-10, and a lower-dose patch is applied for weeks 11-14.

• Arm II: Participants receive one oral nicotine lozenge every 1-2 hours in weeks 3-8 (≥ 9 lozenges per day), one lozenge every 2-4 hours in weeks 9-11 (≥ 5 lozenges per day), and 1 lozenge every 4-8 hours in weeks 12-14 (≥ 3 lozenges per day).

The moderating variables (e.g., nicotine replacement-therapy [NRT] preference and the smoker's desire to control NRT dosing) are assessed at baseline. The mediating variables (i.e., reduced craving, diminished withdrawal symptoms, cue reactivity, and increased perceived control over withdrawal symptoms) are assessed at baseline and then at weeks 5, 7, 9, within weeks 14-16, and within weeks 26-28. Continuous abstinence will be measured at week 27.

PROJECTED ACCRUAL: A total of 700 participants will be accrued for this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 642
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bladder Cancer
• Cervical Cancer
• Esophageal Cancer
• Esophageal Neoplasms
• Gastric Cancer
• Head and Neck Cancer
• Head and Neck Neoplasms
• Kidney Cancer
• Leukemia
• Liver Cancer
• Liver Neoplasms
• Lung Cancer
• Pancreatic Cancer
• Pancreatic Neoplasms
• Stomach Neoplasms
• Tobacco Use Disorder
• Urinary Bladder Neoplasms
• Uterine Cervical Neoplasms

Intervention

Drug:
• nicotine lozenge
nicotine lozenge
• nicotine patch
transdermal nicotine patch

Locations

Country	Name	City	State
United States	Medical College of Georgia Cancer Center	Augusta	Georgia
United States	Geisinger Cancer Institute at Geisinger Health	Danville	Pennsylvania
United States	Hematology Oncology Associates of Central New York, PC - Northeast Center	East Syracuse	New York
United States	Don Monti Comprehensive Cancer Center at North Shore University Hospital	Manhasset	New York
United States	CCOP - Mount Sinai Medical Center	Miami Beach	Florida
United States	Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Burlington County	Mount Holly	New Jersey
United States	Nashville General Hospital at Meharry	Nashville	Tennessee
United States	Fox Chase Cancer Center - Philadelphia	Philadelphia	Pennsylvania
United States	Howard University Cancer Center	Washington	District of Columbia
United States	CCOP - Main Line Health	Wynnewood	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Fox Chase Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24-hour Point Prevalence Abstinence at the 6-month Follow up		6-months	No
Secondary	Rate of Compliance During the First 2 Weeks	Applied to use of the intervention (number of lozenges/day or number of patches used per week) not considering abstinence	2 weeks	No