Evaluation of the Nicotine Lozenge in Relief of Provoked Acute Craving

Phase 2

Completed

Interventions: Drug: Nicotine lower dose
Drug: Nicotine higher dose
Drug: Placebo

Brief Summary: 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).

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Lower dose Nicotine	Nicotine lower dose	lower dose nicotine lozenge
Higher dose Nicotine	Nicotine higher dose	higher dose Nicotine lozenge
Placebo	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Mean Change From Baseline in Nicotine Cravings VAS Scores in Heavy Smokers	Baseline, 3 minutes and 15 minutes post-treatment	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.
Mean Change From Baseline in Nicotine Cravings VAS Scores in Light Smokers	Baseline, 1, 3, 5, 10 and 15 minutes post-treatment	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Responders With Improved Craving Scores in Heavy and Light Smokers Group	Baseline prior to provoked craving paradigm, baseline post provoked craving paradigm	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.
Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs)	Baseline, 0 minute, 60 minutes and 5 days post treatment	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.