Status:
COMPLETED
Evaluation of the Nicotine Lozenge in Relief of Provoked Acute Craving
Lead Sponsor:
GlaxoSmithKline
Conditions:
Smoking
Smoking Cessation
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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).
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
187 Patients enrolled
Trial Details
Trial ID
NCT01466361
Start Date
September 1 2010
End Date
December 1 2010
Last Update
August 28 2019
Active Locations (1)
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1
Los Angeles Clinical Trials
Burbank, California, United States, 91505