Trial Information

Comparing the Lozenge to the Patch for Smoking Cessation

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.