Provoked Craving Assessment

Phase 2

Completed

• Conditions: Smoking Dependence; Smoking
• Interventions: Drug: oral nicotine; Drug: Placebo

• Registration Number: NCT01506908
• Lead Sponsor: GlaxoSmithKline

Brief Summary

Evaluation of the ability of a nicotine mini lozenge to provide early relief of craving for a cigarette in smokers

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Study First Submitted: 2011-12-15
• Study First Submitted QC: 2012-01-05
• Study First Posted: 2012-01-10
• Results First Submitted: 2013-12-12
• Results First Submitted QC: 2013-12-12
• Results First Posted: 2014-01-30
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-07
• Last Update Posted: 2019-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 323

Inclusion Criteria

• Current cigarette smokers who have smoked regularly, and smoke more than 20 cigarettes per day on a regular basis for at least a year;
• Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history.

Exclusion Criteria

• Any disease that may interfere with the absorption, metabolism or excretion of the study product.
• A medical condition that might jeopardise the safety of the subject or the validity of the study results. For example, recent myocardial infarction or cerebrovascular incident (within 12 weeks of the screening visit), phenylketonuria, unstable or worsening angina pectoris, Prinzmetals angina or severe cardiac arrhythmia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nicotine Polacrilex mint mini lozenge	oral nicotine	-
placebo	Placebo	mint mini lozenge with no active

Primary Outcome Measures

Name	Time	Method
Change From Post-cue Baseline in Nicotine Craving Score at 5 Minutes	Post-cue baseline,5 minutes	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 was measured.

Secondary Outcome Measures

Name	Time	Method
Change From Post-cue Baseline in Nicotine Craving Score at 1 Minute	Post-cue baseline, 1 minute post treatment administration	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 was measured.
Change From Post-cue Baseline in Nicotine Craving Score at 3 Minutes	Post-cue Baseline, 3 minutes post treatment administration	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 was measured.
Change From Post-cue Baseline in Nicotine Craving Score at 10 Minutes	Post-Cue Baseline, 10 minutes post treatment administration	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 was measured.
Number of Participants With Adverse Events (AEs), Treatment Related AEs, and Serious AEs (SAEs)	Baseline to Day 5 post treatment administration	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. Treatment related AE was defined as any AE considered to be possibly, probably or highly probably related to study medication. 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.
Change From Post-cue Baseline in Nicotine Craving Score at 7 Minutes	Post-Cue Baseline, 7 minutes post treatment administration	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 was measured.

Trial Locations

Locations (1)

Los Angeles Clinical Trials; 🇺🇸 Burbank, California, United States