Evaluation of the Nicotine Lozenge in Relief of Provoked Acute Craving

GlaxoSmithKline187 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

187

Conditions

Smoking Smoking Cessation

Interventions

Nicotine lower doseDRUG

lower dose nicotine lozenge

Nicotine higher doseDRUG

higher dose nicotine lozenge

PlaceboDRUG

placebo

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Los Angeles Clinical Trials

Burbank, California, United States

Outcomes

Primary Outcomes

Mean Change From Baseline in Nicotine Cravings VAS Scores in Light Smokers

Participants completed a nicotine craving assessment consisting of following five items: I have a desire for a cigarette right now, if it were possible I would smoke right now, All I want right now is a cigarette, I have an urge for a cigarette, I crave a cigarette right now. All participants indicated their craving intensity on a pre-drawn 100 mm scale ranging from 0 (disagree) to 100 (agree). At the end of the craving assessment period, mean VAS score (in mm) was measured.

Time frame: Baseline, 1, 3, 5, 10 and 15 minutes post-treatment

Mean Change From Baseline in Nicotine Cravings VAS Scores in Heavy Smokers

Time frame: Baseline, 3 minutes and 15 minutes post-treatment

Secondary Outcomes

Percentage of Responders With Improved Craving Scores in Heavy and Light Smokers Group

Responders were defined as participants with an increase of at least one point (on the 100 point VAS scale) from baseline prior to provoked craving paradigm (B1) to baseline post provoked craving paradigm (B2) on the average cravings score. Percentage of these responders was calculated to evaluate the provocation rate.

Time frame: Baseline prior to provoked craving paradigm, baseline post provoked craving paradigm

Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs)

AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with study treatment/s. SAE was defined as any untoward medical occurrence that at any dose results in death; is life threatening; requires hospitalization or prolongation of existing hospitalization results in disability/ incapacity; is a congenital anomaly/ birth defect.

Data from ClinicalTrials.gov

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