Evaluation of the Nicotine Lozenge in Relief of Provoked Acute Craving

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Nicotine

Criteria

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.