Provoked Craving Assessment

Smoking Clinical Trial

Official title:

Evaluation of the Nicotine Mini Lozenge in Relief of Provoked Acute Craving

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01506908
• Other study ID #: S7121359
• Status: Completed
• Phase: Phase 2
• Start date: September 2011
• Est. completion date: December 2011

Study information

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

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 323
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Smoking
• Smoking Dependence

Intervention

Drug:
• oral nicotine
oral nicotine replacement product
• Placebo
no active

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	Change From Post-cue Baseline in Nicotine Craving Score at 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.	Post-cue baseline,5 minutes
Secondary	Change From Post-cue Baseline in Nicotine Craving Score at 1 Minute	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.	Post-cue baseline, 1 minute post treatment administration
Secondary	Change From Post-cue Baseline in Nicotine Craving Score at 3 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.	Post-cue Baseline, 3 minutes post treatment administration
Secondary	Change From Post-cue Baseline in Nicotine Craving Score at 7 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.	Post-Cue Baseline, 7 minutes post treatment administration
Secondary	Change From Post-cue Baseline in Nicotine Craving Score at 10 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.	Post-Cue Baseline, 10 minutes post treatment administration
Secondary	Number of Participants With Adverse Events (AEs), Treatment Related 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. 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.	Baseline to Day 5 post treatment administration