Counseling and Nicotine Replacement Therapy in Helping Adult 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.

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