Clinical trial NCT00365508: Counseling and Nicotine Replacement Therapy in Helping Adult Smokers Quit Smoking
Official title: Comparing the Lozenge to the Patch for Smoking Cessation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
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
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
Lead sponsor: Fox Chase Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2006-08-17
Enrollment: 642
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 24-hour Point Prevalence Abstinence at the 6-month Follow up
timeFrame: 6-months
Secondary outcomes:
measure: Rate of Compliance During the First 2 Weeks
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Washington
country: United States
facility: Howard University Cancer Center
state: District of Columbia
city: Miami Beach
country: United States
facility: CCOP - Mount Sinai Medical Center
state: Florida
city: Augusta
country: United States
facility: Medical College of Georgia Cancer Center
state: Georgia
city: Mount Holly
country: United States
facility: Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Burlington County
state: New Jersey
city: East Syracuse
country: United States
facility: Hematology Oncology Associates of Central New York, PC - Northeast Center
state: New York
city: Manhasset
country: United States
facility: Don Monti Comprehensive Cancer Center at North Shore University Hospital
state: New York
city: Danville
country: United States
facility: Geisinger Cancer Institute at Geisinger Health
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center - Philadelphia
state: Pennsylvania
city: Wynnewood
country: United States
facility: CCOP - Main Line Health
state: Pennsylvania
city: Nashville
country: United States
facility: Nashville General Hospital at Meharry
state: Tennessee
Study officials:
affiliation: Fox Chase Cancer Center - Cheltenham
name: Robert A. Schnoll, PhD
role: STUDY_CHAIR
References: