Counseling and Nicotine Replacement Therapy in Helping Adult Smokers Quit Smoking

Official Title: “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.

Intervention(s) in this Clinical Trial

• Drug: nicotine
  • Given as a patch or a lozenge

Arms, Groups and Cohorts in this Clinical Trial

• 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.
• 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).

Primary Measures

• Continuous abstinence assessed by the time-line follow-back method (quit day to 6-month follow up)
  • Safety Issue?: No

Secondary Measures

• Rate of compliance at 24 hours and 30 days
  • Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Fox Chase Cancer Center Other

Overall Clinical Trial Officials and Contacts

Robert A. Schnoll, PhD Study Chair Fox Chase Cancer Center - Cheltenham  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00365508

Study ID Number: CDR0000491296

ClinicalTrials.gov Identifier: NCT00365508

Health Authority: United States: Federal Government

Clinical trial summary from the National Cancer Institute's PDQ® database