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
  Purpose

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.


Condition Intervention Phase
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
Drug: nicotine patch
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparing the Lozenge to the Patch for Smoking Cessation

Resource links provided by NLM:


Further study details as provided by Fox Chase Cancer Center:

Primary Outcome Measures:
  • 24-hour Point Prevalence Abstinence at the 6-month Follow up [ Time Frame: 6-months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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


Enrollment: 642
Study Start Date: February 2006
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
transdermal nicotine patch
Other Name: transdermal 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
nicotine lozenge
Other Name: nicotine lozenge

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00365508

Locations
United States, District of Columbia
Howard University Cancer Center
Washington, District of Columbia, United States, 20060
United States, Florida
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
United States, Georgia
Medical College of Georgia Cancer Center
Augusta, Georgia, United States, 30912-3500
United States, New Jersey
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Burlington County
Mount Holly, New Jersey, United States, 08060-2099
United States, New York
Hematology Oncology Associates of Central New York, PC - Northeast Center
East Syracuse, New York, United States, 13057-4510
Don Monti Comprehensive Cancer Center at North Shore University Hospital
Manhasset, New York, United States, 11030
United States, Pennsylvania
Geisinger Cancer Institute at Geisinger Health
Danville, Pennsylvania, United States, 17822-0001
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, United States, 19111-2497
CCOP - Main Line Health
Wynnewood, Pennsylvania, United States, 19096
United States, Tennessee
Nashville General Hospital at Meharry
Nashville, Tennessee, United States, 37208
Sponsors and Collaborators
Fox Chase Cancer Center
Investigators
Study Chair: Robert A. Schnoll, PhD Fox Chase Cancer Center - Cheltenham
  More Information

Additional Information:
No publications provided

Responsible Party: Margaret Gibbons, Contact, Fox Chase Cancer Center
ClinicalTrials.gov Identifier: NCT00365508     History of Changes
Other Study ID Numbers: CDR0000491296, FCCC-FCRB-04-003-P, 05-818
Study First Received: August 16, 2006
Results First Received: November 20, 2012
Last Updated: July 12, 2013
Health Authority: United States: Federal Government

Keywords provided by Fox Chase Cancer Center:
tobacco use disorder
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

Additional relevant MeSH terms:
Tobacco Use Disorder
Urinary Bladder Neoplasms
Carcinoma, Renal Cell
Kidney Neoplasms
Uterine Cervical Neoplasms
Esophageal Neoplasms
Head and Neck Neoplasms
Leukemia
Liver Neoplasms
Lung Neoplasms
Stomach Neoplasms
Pancreatic Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Kidney Diseases
Uterine Neoplasms
Genital Neoplasms, Female
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Gastrointestinal Neoplasms
Digestive System Neoplasms

ClinicalTrials.gov processed this record on August 27, 2014