Provoked Craving Relief Study by NRT

Study Overview
=================
Brief Summary
-----------------
This study is designed to assess the ability of the mint nicotine mouth strip to relieve provoked cigarette craving in light smokers compared to nicotine lozenge and nicotine gum.

Official Title
-----------------
A Pilot Study to Evaluate Relief of Provoked Acute Craving by Nicotine Mouth Strip, Nicorette ® Nicotine Lozenge and Gum

Conditions
-----------------
Smoking Cessation

Intervention / Treatment
-----------------
* Drug: nicotine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Smoking Status: Current cigarette smokers who have smoked regularly for at least a year and smoke their first cigarette more than 30 minutes after waking up. Exclusion Criteria: Allergy/Intolerance: Known or suspected intolerance or hypersensitivity to nicotine (or closely related compounds) or any of the stated ingredients in formulation. Prior Concomitant Medication: a. Treatment with known enzyme altering agents (e.g. carbamazepine, phenytoin, cimetidine, sodium valporate) within 30 days of the craving provocation visit. b. Use of any prescription psychoactive medication (such as but not limited to antidepressants, antipsychotics, anxiolytics) within 14 days of the craving provocation visit. c. Use of any over-the-counter (OTC) medication that affects central nervous system such as antihistamines, sedating agents, or any compound that would have a sedating effect within 24 hours of the craving provocation visit. d. Use of any nicotine replacement therapy or any other treatment for smoking cessation (e.g. bupropion or varenicline) within one month of screening visit. e. Use of any nicotine containing products at any time during the Provocation/Treatment visit. f. Use of any medications noted in the exclusion criteria, or use of any product that would, in the opinion of the investigator, jeopardize the safety of the subject or impact on the validity of the study results. Any disease that, in the opinion of the investigator, may interfere with the absorption, metabolism or excretion of the study product. A medical history that, in the opinion of the investigator, might jeopardise the safety of the subject or the validity of the study results. For example, recent myocardial infarction or cerebrovascular accident (within 12 weeks of the screening visit), phenylketonuria, unstable or worsening angina pectoris, Prinzmetals angina or severe cardiac arrhythmia. Expired Carbon Monoxide (CO): Any subject whose CO level rises during the sequestration period (i.e., the subject's expired CO assessments immediately prior to the provoked craving paradigm are higher than the mean baseline CO assessment) and, in the opinion of the investigator, may have smoked during that time. Alcohol: Consumption of any alcoholic beverage within 24 hours of the craving provocation visit, as indicated by a positive breath alcohol test.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nicotine mouth strip<br>single dose | Drug: nicotine<br>* nicotine in the form of a mouth strip, lozenge and gum<br>|
| Active Comparator: nicotine lozenge<br>single dose | Drug: nicotine<br>* nicotine in the form of a mouth strip, lozenge and gum<br>|
| Active Comparator: nicotine gum<br>single dose | Drug: nicotine<br>* nicotine in the form of a mouth strip, lozenge and gum<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change From Baseline in Nicotine Craving Score on a VAS | 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. | Baseline, 50 seconds, 3, 5, 7, 10, 15, 20, 25 and 30 minutes post treatment administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Log Transformed Area Under the Curve of Nicotine Craving Score (AUC) | AUC between the baseline (pre-dose) and the time of measurement of craving on-treatment was determined. | Baseline, 50 seconds, 3, 5, 7, 10, 15, 20, 25, and 30 minutes post treatment administration | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
craving, provoked craving, smoking cessation, nicotine replacement therapy, NRT