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Provoked Craving Assessment

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01506908
First received: December 15, 2011
Last updated: February 6, 2014
Last verified: December 2013

December 15, 2011
February 6, 2014
September 2011
December 2011   (final data collection date for primary outcome measure)
Change From Post-cue Baseline in Nicotine Craving Score at 5 Minutes [ Time Frame: Post-cue baseline,5 minutes ] [ Designated as safety issue: No ]
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.
average score [ Time Frame: during Visit 2, 5 minutes post dosing ] [ Designated as safety issue: No ]
VAS Craving Assessment
Complete list of historical versions of study NCT01506908 on ClinicalTrials.gov Archive Site
  • Change From Post-cue Baseline in Nicotine Craving Score at 1 Minute [ Time Frame: Post-cue baseline, 1 minute post treatment administration ] [ Designated as safety issue: No ]
    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 [ Time Frame: Post-cue Baseline, 3 minutes post treatment administration ] [ Designated as safety issue: No ]
    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 7 Minutes [ Time Frame: Post-Cue Baseline, 7 minutes post treatment administration ] [ Designated as safety issue: No ]
    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 [ Time Frame: Post-Cue Baseline, 10 minutes post treatment administration ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline to Day 5 post treatment administration ] [ Designated as safety issue: Yes ]
    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.
  • assess the incidence and severity of adverse events [ Time Frame: from the start of the smoking abstinence sequestration period and until 5 days following last administration of the investigational product ] [ Designated as safety issue: Yes ]
    To assess the incidence and severity of adverse events
  • average score [ Time Frame: during Visit 2, 5 minutes post dosing ] [ Designated as safety issue: No ]
    VAS Craving Assessment at 1, 3, 7 and 10 minutes post dosing
Not Provided
Not Provided
 
Provoked Craving Assessment
Evaluation of the Nicotine Mini Lozenge in Relief of Provoked Acute Craving

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Smoking Dependence
  • Smoking
  • Drug: oral nicotine
    oral nicotine replacement product
  • Drug: Placebo
    no active
  • Active Comparator: Nicotine Polacrilex mint mini lozenge
    Intervention: Drug: oral nicotine
  • Placebo Comparator: placebo
    mint mini lozenge with no active
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
323
December 2011
December 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01506908
S7121359
No
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP