- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00365508
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
District of Columbia
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Washington, District of Columbia, United States, 20060
- Howard University Cancer Center
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-
Florida
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Miami Beach, Florida, United States, 33140
- CCOP - Mount Sinai Medical Center
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-
Georgia
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Augusta, Georgia, United States, 30912-3500
- Medical College of Georgia Cancer Center
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-
New Jersey
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Mount Holly, New Jersey, United States, 08060-2099
- Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Burlington County
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New York
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East Syracuse, New York, United States, 13057-4510
- Hematology Oncology Associates of Central New York, PC - Northeast Center
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Manhasset, New York, United States, 11030
- Don Monti Comprehensive Cancer Center at North Shore University Hospital
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Pennsylvania
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Danville, Pennsylvania, United States, 17822-0001
- Geisinger Cancer Institute at Geisinger Health
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Philadelphia, Pennsylvania, United States, 19111-2497
- Fox Chase Cancer Center - Philadelphia
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Wynnewood, Pennsylvania, United States, 19096
- CCOP - Main Line Health
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Tennessee
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Nashville, Tennessee, United States, 37208
- Nashville General Hospital at Meharry
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
transdermal nicotine patch
Other Names:
|
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).
|
nicotine lozenge
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
24-hour Point Prevalence Abstinence at the 6-month Follow up
Time Frame: 6-months
|
6-months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of Compliance During the First 2 Weeks
Time Frame: 2 weeks
|
Applied to use of the intervention (number of lozenges/day or number of patches used per week) not considering abstinence
|
2 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Robert A. Schnoll, PhD, Fox Chase Cancer Center - Cheltenham
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- non-small cell lung cancer
- esophageal cancer
- bladder cancer
- gastric cancer
- pancreatic cancer
- renal cell carcinoma
- tongue cancer
- small cell lung cancer
- cervical cancer
- oropharyngeal cancer
- laryngeal cancer
- hypopharyngeal cancer
- adult primary liver cancer
- lip and oral cavity cancer
- nasopharyngeal cancer
- paranasal sinus and nasal cavity cancer
- adult acute myeloid leukemia
- tobacco use disorder
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Digestive System Diseases
- Substance-Related Disorders
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Urologic Diseases
- Urinary Bladder Diseases
- Uterine Neoplasms
- Genital Neoplasms, Female
- Uterine Cervical Diseases
- Uterine Diseases
- Endocrine System Diseases
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Stomach Diseases
- Endocrine Gland Neoplasms
- Liver Diseases
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Head and Neck Neoplasms
- Esophageal Diseases
- Pancreatic Diseases
- Uterine Cervical Neoplasms
- Stomach Neoplasms
- Lung Neoplasms
- Tobacco Use Disorder
- Urinary Bladder Neoplasms
- Pancreatic Neoplasms
- Liver Neoplasms
- Esophageal Neoplasms
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Cholinergic Agents
- Ganglionic Stimulants
- Nicotinic Agonists
- Cholinergic Agonists
- Nicotine
Other Study ID Numbers
- CDR0000491296
- FCCC-FCRB-04-003-P (Other Identifier: Community Clinical Oncology Program Network)
- 05-818 (Other Identifier: Fox Chase Cancer Center)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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