Early Effects of a New Oral Nicotine Replacement Product and NiQuitin™ Lozenge

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 compares a new oral Nicotine Replacement Therapy (NRT) product with NiQuitin™ lozenge 2 mg and 4 mg, respectively, after 5 hours of witnessed nicotine abstinence with respect to urges to smoke during the first 5 minutes after start of treatment. Single doses of each treatment are given during separate treatment visits scheduled in a crossover setting with randomized treatment sequences. The study will include 200 healthy smokers between 19-55 years, who have been smoking at least 10 cigarettes daily during at least one year preceding inclusion, and who smoke within 30 minutes of waking up. Subjects, study personnel and monitor will be aware of what type of product is administered at a given visit, but not of the administered dose of the lozenge.

Official Title
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Nicotine Pharmacodynamics With a New Oral Nicotine Replacement Product and NiQuitin™ Lozenge: A Study in Healthy Smokers

Conditions
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Smoking Cessation

Intervention / Treatment
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* Drug: Nicotine
* Drug: Nicotine
* Drug: Nicotine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy smokers, smoking at least 10 cigarettes daily during at least one year preceding inclusion, and smoking within 30 minutes of waking up. 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. Use of NRT, bupropion, or varenicline, or history of a quit attempt later than 3 months before screening visit. Treatment with an investigational product, other than those described in the protocol, between 1 month preceding the first treatment visit and the last treatment visit of the study. Prior regular use of any of the investigational products.

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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LHN1548<br>Two single doses of an experimental Nicotine Replacement Therapy (NRT) 2 mg, with five hours between treatments. Seven hours duration of total follow-up period. | Drug: Nicotine<br>* Two single doses of experimental Nicotine Replacement Therapy (NRT) 2 mg, with five hours between treatments. Seven hours duration of total follow-up period<br>* Other names: Not yet marketed;|
| Active Comparator: 2019706<br>Two single doses of Nicotine Lozenge 2 mg, with five hours between treatments. Seven hours duration of total follow-up period. | Drug: Nicotine<br>* Two single doses of Nicotine Lozenge 2 mg, with five hours between treatments. Seven hours duration of total follow-up period.<br>* Other names: NiQuitin™ lozenge 2 mg;|
| Active Comparator: 2020005<br>Two single doses of Nicotine Lozenge 4 mg, with five hours between treatments. Seven hours duration of total follow-up period. | Drug: Nicotine<br>* Two single doses of Nicotine Lozenge 4 mg, with five hours between treatments. Seven hours duration of total follow-up period.<br>* Other names: NiQuitinTM lozenge 4 mg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Areas under the linearly interpolated urges to smoke vs. time curve evaluated in a hierarchical order starting with the 5 minutes' evaluation (AUC5min, AUC3min, AUC1min) |  | from time zero following 5 hours of smoking abstinence (baseline), until 5 minutes, until 3 minutes, and until 1 minute, respectively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Areas under the linearly interpolated urges to smoke vs. time curve (AUC10min) |  | from time zero following 5 hours of smoking abstinence (baseline), until 10 minutes thereafter | 
| Time to a 25%, 50%, 75%, and 90% reduction from baseline intensity of urges to smoke score |  | from time zero following 5 hours of smoking abstinence (baseline), until 2 hours thereafter | 
| Proportion of subjects reaching 25%, 50%, 75% and 90% reduction of urges to smoke |  | from time zero following 5 hours of smoking abstinence (baseline), until 2 hours thereafter | 
| Study treatment acceptability, evaluated using pair-wise treatment comparisons of ordered categorical-scale assessments |  | At the end of three separate visits, at least 36 hours apart | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smoking Cessation, VAS, Urges to smoke