Counseling and Nicotine Replacement Therapy in Helping Adult Smokers Quit Smoking

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Margaret Gibbons, Fox Chase Cancer Center
ClinicalTrials.gov Identifier:
NCT00365508
First received: August 16, 2006
Last updated: July 12, 2013
Last verified: July 2013

August 16, 2006
July 12, 2013
February 2006
August 2009   (final data collection date for primary outcome measure)
24-hour Point Prevalence Abstinence at the 6-month Follow up [ Time Frame: 6-months ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00365508 on ClinicalTrials.gov Archive Site
Rate of Compliance During the First 2 Weeks [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Applied to use of the intervention (number of lozenges/day or number of patches used per week) not considering abstinence
Not Provided
Not Provided
Not Provided
 
Counseling and Nicotine Replacement Therapy in Helping Adult Smokers Quit Smoking
Comparing the Lozenge to the Patch for Smoking Cessation

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Bladder Cancer
  • Cervical Cancer
  • Esophageal Cancer
  • Gastric Cancer
  • Head and Neck Cancer
  • Kidney Cancer
  • Leukemia
  • Liver Cancer
  • Lung Cancer
  • Pancreatic Cancer
  • Tobacco Use Disorder
  • Drug: nicotine lozenge
    nicotine lozenge
    Other Name: nicotine lozenge
  • Drug: nicotine patch
    transdermal nicotine patch
    Other Name: transdermal nicotine patch
  • Experimental: 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.
    Intervention: Drug: nicotine patch
  • Experimental: 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).
    Intervention: Drug: nicotine lozenge
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
642
August 2009
August 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00365508
CDR0000491296, FCCC-FCRB-04-003-P, 05-818
No
Margaret Gibbons, Fox Chase Cancer Center
Fox Chase Cancer Center
National Cancer Institute (NCI)
Study Chair: Robert A. Schnoll, PhD Fox Chase Cancer Center - Cheltenham
Fox Chase Cancer Center
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP