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CompletedNCT00365508Updated Mar 29, 2016Results posted

Counseling and Nicotine Replacement Therapy in Helping Adult Smokers Quit Smoking

A Phase 4 interventional study of nicotine lozenge and nicotine patch in Bladder Cancer, Cervical Cancer and Esophageal Cancer, sponsored by Fox Chase Cancer Center. Completed at 10 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-03-29.

Sponsored by Fox Chase Cancer Center · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
642
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

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

Keywords

  • bladder cancer
  • cervical cancer
  • esophageal cancer
  • gastric cancer
  • renal cell carcinoma
  • adult primary liver cancer
  • non-small cell lung cancer
  • small cell lung cancer
  • pancreatic cancer
  • hypopharyngeal cancer
  • laryngeal cancer
  • lip and oral cavity cancer
  • nasopharyngeal cancer
  • oropharyngeal cancer
  • paranasal sinus and nasal cavity cancer
  • adult acute myeloid leukemia
  • tongue cancer
  • tobacco use disorder
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's enrollment of 642 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Fox Chase Cancer Center is the lead sponsor of 211 studies on the registry; 30 are open to participants now.

Of its 15 completed or terminated interventional studies of FDA-regulated products, 8 (53%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
None (open label)
Enrollment
642 participants (actual)

Study arms

  • 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.

    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).

    Drug: nicotine lozenge

Interventions

  • Drugnicotine lozenge

    nicotine lozenge

  • Drugnicotine patch

    transdermal nicotine patch

    Also known as: transdermal nicotine patch

06

What researchers measure

Primary outcomes

  1. 24-hour Point Prevalence Abstinence at the 6-month Follow up

    Time frame: 6-months

Secondary outcomes

  1. 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

    Time frame: 2 weeks

07

Results

Posted Jan 30, 2013
Limitations and caveats
The study was an effectiveness trial so external vs. internal validity was emphasized. Many participants were lost to follow-up.

Participant flow

Participants were recruited through ads/physician referral at: FCCC, Geisinger Medical Center, Hematology Oncology Associates of Central NY, Howard University, LSU, Main Line Health System, Medical College of GA, Meharry Medical College, Mount Sinai Medical Center (Miami), North Shore University, SUNY Downstate Medical Center, and Virtua Health.

Participant flow — Overall Study
MilestoneNicotine PatchNicotine Lozenge
Started321321
Completed182167
Not completed139154
Withdrew: Lost to follow-up139154

Outcome measures

Primary24-hour Point Prevalence Abstinence at the 6-month Follow up
Time frame:
6-months
Reported as:
Number · participants
24-hour Point Prevalence Abstinence at the 6-month Follow up
participantsArm IArm II
24-hour Point Prevalence Abstinence at the 6-month Follow up5035
Statistical analysis
  • Arm I vs Arm II · Chi-squared · p = .05 (a priori threshold for statistical significance)
SecondaryRate 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

Time frame:
2 weeks
Reported as:
Number · participants
Rate of Compliance During the First 2 Weeks
participantsArm IArm II
Rate of Compliance During the First 2 Weeks23187

Adverse events

Collected over 6 months. Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Arm I—4/321 (1.2%)0/321 (0%)
Arm II—7/321 (2.2%)0/321 (0%)
Most frequent serious events
Most frequent serious events
EventArm IArm II
StrokeCardiac disorders2/3210/321
SeizureNervous system disorders1/3211/321
killed in car accidentInjury, poisoning and procedural complications1/3210/321
Heart diseaseCardiac disorders0/3211/321
ulcerGastrointestinal disorders0/3211/321
appendicitisGastrointestinal disorders0/3211/321
heart attackCardiac disorders0/3211/321
coughRespiratory, thoracic and mediastinal disorders0/3211/321
Abcessed toothSurgical and medical procedures0/3211/321

Baseline characteristics

Age, Continuous
Age, Continuous(years)Arm IArm IITotal
Mean44.7 ± 12.744.8 ± 11.944.7 ± 12.3
Sex: Female, Male
Sex: Female, Male(Participants)Arm IArm IITotal
Female195170365
Male126151277
08

Study locations

10 sites
  • Howard University Cancer Center
    Washington, District of Columbia 20060, United States
  • CCOP - Mount Sinai Medical Center
    Miami Beach, Florida 33140, United States
  • Medical College of Georgia Cancer Center
    Augusta, Georgia 30912-3500, United States
  • Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Burlington County
    Mount Holly, New Jersey 08060-2099, United States
  • Hematology Oncology Associates of Central New York, PC - Northeast Center
    East Syracuse, New York 13057-4510, United States
  • Don Monti Comprehensive Cancer Center at North Shore University Hospital
    Manhasset, New York 11030, United States
  • Geisinger Cancer Institute at Geisinger Health
    Danville, Pennsylvania 17822-0001, United States
  • Fox Chase Cancer Center - Philadelphia
    Philadelphia, Pennsylvania 19111-2497, United States
  • CCOP - Main Line Health
    Wynnewood, Pennsylvania 19096, United States
  • Nashville General Hospital at Meharry
    Nashville, Tennessee 37208, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 29, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00365508
Lead sponsor
Fox Chase Cancer Center
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Aug 17, 2006
Start date
Feb 2006
Primary completion
Aug 2009
Completion
Aug 2009
Results posted
Jan 30, 2013
Last update
Mar 29, 2016

Study contacts

Robert A. Schnoll, PhD
study chair · Fox Chase Cancer Center - Cheltenham

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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