Evaluation of the Nicotine Lozenge in Relief of Provoked Acute Craving

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Smoking; Smoking Cessation

Treatments: Drug: Nicotine lower dose; Drug: Placebo; Drug: Nicotine higher dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT01466361

S7120994

Details and patient eligibility

About

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).

Enrollment: 187 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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187 participants in 3 patient groups, including a placebo group

Lower dose Nicotine

Active Comparator group

Description:

lower dose nicotine lozenge

Treatment:

Drug: Nicotine lower dose

Higher dose Nicotine

Active Comparator group

Description:

higher dose Nicotine lozenge

Treatment:

Drug: Nicotine higher dose

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo