Evaluation of the Nicotine Lozenge in Relief of Provoked Acute Craving

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

187 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2010-12-31

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).

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Detailed Description

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Conditions

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Smoking Smoking Cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Lower dose Nicotine

lower dose nicotine lozenge

Group Type ACTIVE_COMPARATOR

Nicotine lower dose

Intervention Type DRUG

lower dose nicotine lozenge

Higher dose Nicotine

higher dose Nicotine lozenge

Group Type ACTIVE_COMPARATOR

Nicotine higher dose

Intervention Type DRUG

higher dose nicotine lozenge

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

placebo

Interventions

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Nicotine lower dose

lower dose nicotine lozenge

Intervention Type DRUG

Nicotine higher dose

higher dose nicotine lozenge

Intervention Type DRUG

Placebo

placebo

Intervention Type DRUG

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No