The objective of this study is to determine whether treatment with random nicotine delivery via a nicotine film both before and after the target quit date will facilitate smoking cessation relative to treatment with steady state delivery or placebo. The investigators hypothesize that smoking cessation will be greater in subjects assigned to a random nicotine delivery regimen (as compared to those assigned to a steady state or placebo regimen). The nicotine film product is not part of the standard of care and is not available in non-investigational settings in the United States.
This project is a prospective parallel-group, randomized, double-blind, placebo-controlled study in which 45 current cigarette smokers who are interested in quitting will be randomly allocated to one of three possible nicotine film treatment regimens: 1. Random nicotine delivery (a combination of four 0 mg and 4 mg films daily not to exceed three non-consecutive 4 mg films in one day and to maintain an average of 8 mg of nicotine per day through 7 days for 6 weeks total). 2. Steady state nicotine delivery (2, 2, 2, 2 mg films daily for 6 weeks total) 3. Placebo delivery (0, 0, 0, 0 mg films daily for 6 weeks total) Prior to assignment in one of the above treatment groups, all participants will take part in a 1-week baseline period to assess normal smoking behavior and nicotine dependence. Following randomization to their assigned treatment group at Visit 2, participants will be instructed to smoke cigarettes as they feel necessary over the next two weeks while using the nicotine films as directed (i.e., one film every 3-4 hours for a total of four films per day). After two weeks of pre-cessation treatment, participants will be asked completely cease cigarette smoking and to only use their assigned nicotine films as directed. Participants will be supported in their quitting efforts with regular contacts both in person at the Penn State Milton S. Hershey Medical Center and over the phone.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
45
Three doses of nicotine films will be used in this project: 0 mg, 2 mg, and 4 mg. The active pharmaceutical ingredient in the nicotine film product is nicotine polacrilex (20%, USP). The film has a muco-adhesive property and allows nicotine to be absorbed through the oral mucosa. After placement in the oral cavity, the nicotine film dissolves in less than five minutes. The film is in the form of 1 inch x 1 inch square and weighs about 100 mg. Nicotine films are not available in the United States in a non-investigational setting.
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Change in Number of Cigarettes Smoked Per Day (CPD)
CPD is measured with the use of daily cigarette logs which are completed daily by participants and returned to the study center at each visit. The CPD measure will be the average of the past 7 days.
Time frame: Baseline and 4 weeks after Target Quit Date
Change in Exhaled Carbon Monoxide (CO) Measurement
Mean change in exhaled CO (parts per million \[ppm\])
Time frame: Baseline and 4 weeks after Target Quit Date
Change in Questionnaire of Smoking Urges-Brief (QSU-Brief) Total Score
The QSU-Brief, with a possible total score range of 10 to 70, is an instrument used to measure cigarette craving. A score of 10 on this scale indicates very low cigarette craving, while a score of 70 indicates very high cigarette craving.
Time frame: Baseline and 4 weeks after Target Quit Date
Change in Fagerstrom Test for Nicotine Dependence (FTND) Total Score
Nicotine dependence will be assessed via the FTND, a measure with total scores ranging from 0 (very low dependence) to 10 (very high dependence).
Time frame: Baseline and 4 weeks after Target Quit Date
Subjective Ratings Scale for Nicotine Film Use
The scale is comprised of 21 items. Each item is rated on a scale 1-7, where 1 is equal to not at all and 7 is equal to extremely. The total score is the average score of all 21 items. The total score ranges from 1-7.
Time frame: 4 weeks after Target Quit Date
Side Effects From Nicotine Film Use
Total score ranges from 0 - 36 with lower scores indicating lesser side effects.
Time frame: 4 weeks after Target Quit Date
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