Counseling and Nicotine Replacement Therapy in Helping Adult Smokers Quit Smoking

Phase 4

Completed

• Conditions: Bladder Cancer; Gastric Cancer; Cervical Cancer; Esophageal Cancer; Kidney Cancer; Head and Neck Cancer; Leukemia; Pancreatic Cancer; Liver Cancer; Lung Cancer
• Interventions: Drug: nicotine patch; Drug: nicotine lozenge

• Registration Number: NCT00365508
• Lead Sponsor: Fox Chase Cancer Center

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 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.

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 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.

Study Timeline

• Study Start: 2006-02
• Study First Submitted: 2006-08-16
• Study First Submitted QC: 2006-08-16
• Study First Posted: 2006-08-17
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Results First Submitted: 2012-11-20
• Results First Submitted QC: 2012-12-20
• Results First Posted: 2013-01-30
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-01
• Last Update Posted: 2016-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 642

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Arm I	nicotine patch	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	nicotine lozenge	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).

Primary Outcome Measures

Name	Time	Method
24-hour Point Prevalence Abstinence at the 6-month Follow up	6-months

Secondary Outcome Measures

Name	Time	Method
Rate of Compliance During the First 2 Weeks	2 weeks	Applied to use of the intervention (number of lozenges/day or number of patches used per week) not considering abstinence

Trial Locations

Locations (10)

Medical College of Georgia Cancer Center; 🇺🇸 Augusta, Georgia, United States

Hematology Oncology Associates of Central New York, PC - Northeast Center; 🇺🇸 East Syracuse, New York, United States

Geisinger Cancer Institute at Geisinger Health; 🇺🇸 Danville, Pennsylvania, United States

Fox Chase Cancer Center - Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States

CCOP - Mount Sinai Medical Center; 🇺🇸 Miami Beach, Florida, United States

Don Monti Comprehensive Cancer Center at North Shore University Hospital; 🇺🇸 Manhasset, New York, United States

Howard University Cancer Center; 🇺🇸 Washington, District of Columbia, United States

Nashville General Hospital at Meharry; 🇺🇸 Nashville, Tennessee, United States

CCOP - Main Line Health; 🇺🇸 Wynnewood, Pennsylvania, United States

Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Burlington County; 🇺🇸 Mount Holly, New Jersey, United States