Evaluation of the Nicotine Lozenge in Relief of Provoked Acute Craving

Completed · Phase 2 · Has a placebo group

Conditions studied: Smoking, Smoking Cessation

In brief

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).

Key facts

Study ID

NCT01466361

Run by

GlaxoSmithKline

People needed

187

Starts

2010-09-01

Expected to finish

2010-12-01

Last updated by the study team

2019-08-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Los Angeles Clinical Trials — Burbank, California, United States

Full record on ClinicalTrials.gov

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