Provoked Craving Assessment

Study Overview
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Brief Summary
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Evaluation of the ability of a nicotine mini lozenge to provide early relief of craving for a cigarette in smokers

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

Conditions
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Smoking, Smoking Dependence

Intervention / Treatment
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* Drug: oral nicotine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Current cigarette smokers who have smoked regularly, and smoke more than 20 cigarettes per day on a regular basis for at least a year; Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history. Exclusion Criteria: Any disease that may interfere with the absorption, metabolism or excretion of the study product. A medical condition that might jeopardise the safety of the subject or the validity of the study results. For example, recent myocardial infarction or cerebrovascular incident (within 12 weeks of the screening visit), phenylketonuria, unstable or worsening angina pectoris, Prinzmetals angina or severe cardiac arrhythmia

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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Accepts Healthy Volunteers

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: Nicotine Polacrilex mint mini lozenge<br> | Drug: oral nicotine<br>* oral nicotine replacement product<br>|
| Placebo Comparator: placebo<br>mint mini lozenge with no active | Drug: Placebo<br>* no active<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Post-cue Baseline in Nicotine Craving Score at 5 Minutes | 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 was measured. | Post-cue baseline,5 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Post-cue Baseline in Nicotine Craving Score at 1 Minute | 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 was measured. | Post-cue baseline, 1 minute post treatment administration | 
| Change From Post-cue Baseline in Nicotine Craving Score at 3 Minutes | 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 was measured. | Post-cue Baseline, 3 minutes post treatment administration | 
| Change From Post-cue Baseline in Nicotine Craving Score at 7 Minutes | 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 was measured. | Post-Cue Baseline, 7 minutes post treatment administration | 
| Change From Post-cue Baseline in Nicotine Craving Score at 10 Minutes | 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 was measured. | Post-Cue Baseline, 10 minutes post treatment administration | 
| Number of Participants With Adverse Events (AEs), Treatment Related 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. Treatment related AE was defined as any AE considered to be possibly, probably or highly probably related to study medication. 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 to Day 5 post treatment administration | 

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