Last updated: 07/17/2024 17:50:15
Provoked Craving Assessment
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Evaluation of the Nicotine Mini Lozenge in Relief of Provoked Acute Craving
Trial description: Evaluation of the ability of a nicotine mini lozenge to provide early relief of craving for a cigarette in smokers
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Change from post-cue baseline in nicotine craving score at 5 minutes
Timeframe: Post-cue baseline,5 minutes
Secondary outcomes:
Change from post-cue baseline in nicotine craving score at 1 minute
Timeframe: Post-cue baseline, 1 minute post treatment administration
Change from post-cue baseline in nicotine craving score at 3 minutes
Timeframe: Post-cue Baseline, 3 minutes post treatment administration
Change from post-cue baseline in nicotine craving score at 7 minutes
Timeframe: Post-Cue Baseline, 7 minutes post treatment administration
Change from post-cue baseline in nicotine craving score at 10 minutes
Timeframe: Post-Cue Baseline, 10 minutes post treatment administration
Number of participants with Adverse Events (AEs), Treatment Related AEs, and Serious AEs (SAEs)
Timeframe: Baseline to Day 5 post treatment administration
Interventions:
Drug: oral nicotine
Drug: Placebo
Enrollment:
323
Observational study model:
Not applicable
Primary completion date:
2011-31-12
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Smoking Dependence
Product
nicotine
Collaborators
Not applicable
Study date(s)
September 2011 to December 2011
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
Yes
- 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.
- 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
Inclusion and exclusion criteria
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
Trial location(s)
Study documents
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2011-31-12
Actual study completion date
2011-31-12
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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