Effects of Random Nicotine Delivery on Smoking Cessation

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:

• 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).
• Steady state nicotine delivery (2, 2, 2, 2 mg films daily for 6 weeks total)
• 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.

Inclusion criteria

• Aged 18-55
• Smoke ≥10 cigarettes/day for at least the past 12 months
• Exhaled CO measurement ≥6 ppm at baseline visit
• Interested in completely ceasing cigarette consumption and using a nicotine film product as directed
• Willing to attend regular visits over a 6-week period (not planning to move, not planning extended vacation, no planned surgeries)
• Able to read and write in English
• Able to understand and consent to study procedures

Exclusion criteria

• Unstable or significant medical conditions and conditions such as elevated blood pressure (systolic >159 mmHg or diastolic >99mmHg at baseline), COPD, and those conditions that are likely to affect biomarker data such as kidney or liver disease
• Individuals with sodium-restricted diet, heart disease, recent heart attack, irregular heartbeat, stomach ulcers, or diabetes as well as those taking prescription medications for depression or asthma as indicated under "Warnings" section on FDA approved NRT Drug Facts Label
• More than weekly use in the past 3 months of illegal drugs or prescription drugs that are not being used for medically prescribed purposes
• Use of non-cigarette nicotine delivery product in the prior 7 days (including cigars, pipes, chew, snus, hookah, electronic cigarette and marijuana mixed with tobacco)
• Use of an FDA approved cessation medication in the past 7 days (any NRT, Chantix, Wellbutrin)
• Women who are pregnant (verified by urine pregnancy test at baseline visit), trying to become pregnant, or nursing
• Uncontrolled mental illness or substance abuse or inpatient treatment for these conditions in the past 6 months
• Any previous adverse reaction to NRT
• Any other condition, serious illness, or situation that would, in the investigator's opinion, make it unlikely that the participant could comply with the study protocol
• Other member of household currently participating in the study