Pilot Study of a New Nicotine Replacement Therapy

Study Overview
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Brief Summary
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Pilot study of a new nicotine replacement therapy for smoking cessation.

Detailed Description
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This will be a pilot study of a new nicotine replacement therapy with two different directions for use in smoking cessation.

Official Title
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Pilot Study on Usage Patterns of a Novel Nicotine Replacement Therapy - A Multi-Center, Open, 3-Week Randomized Low Intervention Study of Two Different Directions for Use in Smokers Motivated to Quit

Conditions
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Smoking Cessation

Intervention / Treatment
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* Drug: Nicotine replacement therapy
* Drug: Nicotine replacement therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years or older male and female cigarette smokers motivated and willing to stop smoking female participants of child-bearing potential should use a medically acceptable means of birth control evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study and consents to participate Exclusion Criteria: unstable angina pectoris or myocardial infarction during the previous 3 months pregnancy, lactation or intended pregnancy (non-pregnancy will be verified by urine pregnancy test for female participants of child-bearing potential) participation in other clinical trials within the previous three months and during study participation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Standard NRT user direction | Drug: Nicotine replacement therapy<br>* Nicotine replacement therapy with Standard NRT user direction<br>* Other names: NRT;|
| Experimental: 2<br>Novel NRT user direction | Drug: Nicotine replacement therapy<br>* Nicotine replacement therapy with a Novel NRT user direction<br>* Other names: NRT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean hourly and daily number of doses used |  | throughout study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean number of NRT use occasions per day |  | Week 1, 2, and 3 | 
| Ratings of craving/urge to smoke and withdrawal symptoms |  | Day 1-14, and Day 20 | 
| Self-reported continuous abstinence from smoking, verified by an exhaled CO level of less than 10 ppm |  | Day 1-21 | 
| Cotinine levels |  | At baseline and week 3 | 
| Product acceptability |  | At week 3 visit | 
| Safety Assessments will consist of monitoring and recording all non-serious Adverse Events and Serious Adverse Events , their frequency, severity, seriousness, and relationship to the investigational product. |  | throughout duration of the study (+ 30 days for spontaneous SAEs) |