Evaluation of the Nicotine Lozenge in Relief of Provoked Acute Craving

Study Overview
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Brief Summary
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This study is designed to evaluate the ability of a nicotine lozenge to relieve craving for a cigarette compared to a matched placebo (a placebo is like sugar pill and contains no active).

Official Title
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Evaluation of the Nicotine Lozenge in Relief of Provoked Acute Craving

Conditions
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Smoking, Smoking Cessation

Intervention / Treatment
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* Drug: Nicotine lower dose
* Drug: Nicotine higher dose
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Generally healthy smokers who smoke more than 5 cigarettes per day Body mass index (BMI) within the range 19-35 kilogram (kg)/meter (m)^2 Females of childbearing potential who are, in the opinion of the investigator, practicing a reliable method of contraception. Exclusion Criteria: Women who are pregnant or who have a positive urine pregnancy test. Participants with known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients. Clinical Study/Experimental Medication: Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit. Prior Concomitant Medication: Treatment with enzyme altering agents (e.g. carbamazepine, phenytoin, cimetidine, sodium valporate) within 30 days of the craving provocation visit; Use of any prescription psychoactive medication (such as but not limited to antidepressants, antipsychotics, anxiolytics) within 14 days of the craving provocation visit; Participant has used an over-the-counter (OTC) medication such as antihistamines, sedating agents, or any compound that would have a sedating effect within 24 hours of the craving provocation visit; Current use of any nicotine replacement therapy. Substance abuse: Recent history or current history (within the last 1 year) of alcohol or other substance abuse.

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lower dose Nicotine<br>lower dose nicotine lozenge | Drug: Nicotine lower dose<br>* lower dose nicotine lozenge<br>|
| Active Comparator: Higher dose Nicotine<br>higher dose Nicotine lozenge | Drug: Nicotine higher dose<br>* higher dose nicotine lozenge<br>|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change From Baseline in Nicotine Cravings VAS Scores in Light Smokers | Participants completed a nicotine craving assessment consisting of following five items: I have a desire for a cigarette right now, if it were possible I would smoke right now, All I want right now is a cigarette, I have an urge for a cigarette, I crave a cigarette right now. All participants indicated their craving intensity on a pre-drawn 100 mm scale ranging from 0 (disagree) to 100 (agree). At the end of the craving assessment period, mean VAS score (in mm) was measured. | Baseline, 1, 3, 5, 10 and 15 minutes post-treatment | 
| Mean Change From Baseline in Nicotine Cravings VAS Scores in Heavy Smokers | Participants completed a nicotine craving assessment consisting of following five items: I have a desire for a cigarette right now, if it were possible I would smoke right now, All I want right now is a cigarette, I have an urge for a cigarette, I crave a cigarette right now. All participants indicated their craving intensity on a pre-drawn 100 mm scale ranging from 0 (disagree) to 100 (agree). At the end of the craving assessment period, mean VAS score (in mm) was measured. | Baseline, 3 minutes and 15 minutes post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Responders With Improved Craving Scores in Heavy and Light Smokers Group | Responders were defined as participants with an increase of at least one point (on the 100 point VAS scale) from baseline prior to provoked craving paradigm (B1) to baseline post provoked craving paradigm (B2) on the average cravings score. Percentage of these responders was calculated to evaluate the provocation rate. | Baseline prior to provoked craving paradigm, baseline post provoked craving paradigm | 
| Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with study treatment/s. SAE was defined as any untoward medical occurrence that at any dose results in death; is life threatening; requires hospitalization or prolongation of existing hospitalization results in disability/ incapacity; is a congenital anomaly/ birth defect. | Baseline, 0 minute, 60 minutes and 5 days post treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nicotine, Nicotine craving