Evaluation of the Nicotine Lozenge in Relief of Provoked Acute Craving

Smoking Cessation Clinical Trial

Official title:

Evaluation of the Nicotine Lozenge in Relief of Provoked Acute Craving

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01466361
• Other study ID #: S7120994
• Status: Completed
• Phase: Phase 2
• Start date: September 2010
• Est. completion date: December 2010

Study information

• Verified date: August 2019
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 187
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Smoking
• Smoking Cessation

Intervention

Drug:
• Nicotine lower dose
lower dose nicotine lozenge
• Nicotine higher dose
higher dose nicotine lozenge
• Placebo
placebo

Locations

Country	Name	City	State
United States	Los Angeles Clinical Trials	Burbank	California

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, 1, 3, 5, 10 and 15 minutes post-treatment
Primary	Mean Change From Baseline in Nicotine Cravings VAS Scores in Heavy 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.	Baseline, 3 minutes and 15 minutes post-treatment
Secondary	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.	Baseline prior to provoked craving paradigm, baseline post provoked craving paradigm
Secondary	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.	Baseline, 0 minute, 60 minutes and 5 days post treatment