Nicotine Pharmacodynamics With a New Oral Nicotine Replacement Therapy and Nicotine Gum

Study Overview
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Brief Summary
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A comparison of two products for oral nicotine replacement with respect to relief of urges to smoke after single doses of nicotine.

Detailed Description
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This study will be performed at two sites and two-hundred and fifty (250) healthy male and female subjects will be included. Treatments comprise single doses of an experimental Nicotine Replacement Therapy (NRT) and Nicorette Freshfruit gum 4 mg, which are chewed during 30 minutes. All subjects will be given both treatments in a crossover setting. The length of the time interval separating treatment visits, and during which no NRT must be used, will be at least 36 hours. The subjects will abstain from smoking from 8 pm the evening before until the end of each visit. The subjects will take the gums according to instructions from the study personnel. After chewing, used gums will be collected for nicotine analysis. Electronic diaries will be used to collect data. Urges to smoke will be scored on a 100 mm visual analogue scale (VAS) before the start of treatment and during 5 hours thereafter. Subjects will also be monitored to capture any adverse events that may occur.

Official Title
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Nicotine Pharmacodynamics With a New Oral Nicotine Replacement Product and Nicotine Gum 4 mg. A Study in Healthy Smokers

Conditions
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Tobacco Dependence

Intervention / Treatment
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* Drug: Nicotine
* Drug: Nicotine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy subjects, smoking more than 20 cigarettes daily during at least one year preceding inclusion. Body Mass Index (BMI) between 17.5 and 32.0 kg/m2 and a total body weight of at least 55.0 kg. Female participants of child-bearing potential are required to use a medically acceptable means of birth control. A personally signed and dated informed consent document, indicating that the subject has been informed of all pertinent aspects of the study. Exclusion Criteria: Pregnancy, lactation or intended pregnancy. Treatment with an investigational product within one month preceding the first dose of study medication.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 55 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: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental NRT<br>A single 6 mg dose of an experimental Nicotine Replacement Therapy (NRT), with a 36-hour washout between visits. | Drug: Nicotine<br>* A single 6 mg dose of an experimental Nicotine Replacement Therapy (NRT), with a 36-hour washout between visits<br>* Other names: Not yet marketed;|
| Active Comparator: Nicotine GUM<br>A single 4 mg dose of a marketed Nicotine Gum, with a 36-hour washout between visits. | Drug: Nicotine<br>* A single 4 mg dose of a marketed Nicotine Gum, with a 36-hour washout between visits<br>* Other names: Nicorette® Freshfruit gum;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Curve (AUC): Urges to Smoke-vs-Time | Area under urges to smoke-vs.-time curve | During 5 hours post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of Nicotine Released | The amount of nicotine released during product administration. | 30 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smoking Cessation, Nicotine Pharmacodynamics