Effects of Random Nicotine Delivery on Smoking Cessation
Condition: Smoking Cessation; Cigarette Smoking; Smoking (Tobacco) Addiction
MeSH terms: Behavior, Addictive
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Nicotine Film
Intervention type(s): Drug
Intervention description(s): 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.
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: smoking cessation; nicotine film; nicotine delivery; random nicotine delivery