Counseling and Nicotine Replacement Therapy in Helping Adult Smokers Quit Smoking

NCT ID: NCT00365508

Last Updated: 2016-03-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 642 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-02-28
• Study Completion Date: 2009-08-31

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.

Conditions

Bladder Cancer; Cervical Cancer; Esophageal Cancer; Gastric Cancer; Head and Neck Cancer; Kidney Cancer; Leukemia; Liver Cancer; Lung Cancer; Pancreatic Cancer; Tobacco Use Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

nicotine patch

Intervention Type: DRUG

transdermal nicotine patch

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).

Group Type: EXPERIMENTAL

nicotine lozenge

Intervention Type: DRUG

nicotine lozenge

Interventions

nicotine lozenge

nicotine lozenge

Intervention Type: DRUG

nicotine patch

transdermal nicotine patch

Intervention Type: DRUG

Other Intervention Names

transdermal nicotine patch

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Fox Chase Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert A. Schnoll, PhD

Role: STUDY_CHAIR

Fox Chase Cancer Center - Cheltenham

Locations

Howard University Cancer Center

Washington D.C., District of Columbia, United States

CCOP - Mount Sinai Medical Center

Miami Beach, Florida, United States

Medical College of Georgia Cancer Center

Augusta, Georgia, United States

Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Burlington County

Mount Holly, New Jersey, 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

Geisinger Cancer Institute at Geisinger Health

Danville, Pennsylvania, United States

Fox Chase Cancer Center - Philadelphia

Philadelphia, Pennsylvania, United States

CCOP - Main Line Health

Wynnewood, Pennsylvania, United States

Nashville General Hospital at Meharry

Nashville, Tennessee, United States

Countries

United States

References

Theodoulou A, Fanshawe TR, Leavens E, Theodoulou E, Wu AD, Heath L, Stewart C, Nollen N, Ahluwalia JS, Butler AR, Hajizadeh A, Thomas J, Lindson N, Hartmann-Boyce J. Differences in the effectiveness of individual-level smoking cessation interventions by socioeconomic status. Cochrane Database Syst Rev. 2025 Jan 27;1(1):CD015120. doi: 10.1002/14651858.CD015120.pub2.

Reference Type: DERIVED

PMID: 39868569 (View on PubMed)

Other Identifiers

FCCC-FCRB-04-003-P

Identifier Type: OTHER

Identifier Source: secondary_id

05-818

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000491296

Identifier Type: -

Identifier Source: org_study_id