Last updated: 11/04/2018 10:26:42
Nicotine mouth film for craving relief.
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Study to Evaluate Relief of Provoked Acute Craving by Nicotine Mouth Film and Nicotine Lozenge
Trial description: Nicotine mouth film is a new dosage form of nicotine replacement therapy. The purpose of this study is to investigate the craving relief efficacy of nicotine mouth film by comparing mint nicotine mouth film to nicotine lozenge in light smokers using the provoked craving model. The cues used to provoke a craving episode will be the sight and smell of a lit cigarette and the manipulations required to light a cigarette. The smokers will be denied access to cigarettes for 4 hours prior to the provoked craving session in order to precipitate nicotine withdrawal and an increase level of cigarette craving.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
The change from pre-dose post-provocation in craving score at 50 seconds
Timeframe: Pre-dosing post-provocation to 50 seconds
Secondary outcomes:
The change from pre-dose post-provocation in craving score at 3, 5, 7, 10, 15, 20, 25, and 30 minutes
Timeframe: Pre-dosing post-provocation to 3, 5, 7, 10, 15, 20, 25, and 30 minutes
Interventions:
Drug: Nicotine
Enrollment:
320
Observational study model:
Not applicable
Primary completion date:
2012-31-12
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Smoking Cessation
Product
nicotine
Collaborators
Not applicable
Study date(s)
September 2012 to December 2012
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
Yes
- BMI within the range of 19-35 kg/m2;
- Current cigarette smokers who have smoked regularly daily for at least a year,
- Known or suspected intolerance or hypersensitivity to nicotine (or closely related compounds) or any of the stated ingredients in formulation.
- Any participant whose CO level rises during the sequestration period (i.e., the subject’s two expired CO assessments immediately prior to the provoked craving paradigm are higher than the mean baseline CO assessment) and, in the opinion of the investigator, may have smoked during that time.
Inclusion and exclusion criteria
Inclusion criteria:
- BMI within the range of 19-35 kg/m2;
- Current cigarette smokers who have smoked regularly daily for at least a year,
- Participants who smoke their first cigarette more than 30 minutes after waking up
Exclusion criteria:
- Known or suspected intolerance or hypersensitivity to nicotine (or closely related compounds) or any of the stated ingredients in formulation.
- Any participant whose CO level rises during the sequestration period (i.e., the subject’s two expired CO assessments immediately prior to the provoked craving paradigm are higher than the mean baseline CO assessment) and, in the opinion of the investigator, may have smoked during that time.
Trial location(s)
Location
Central Kentucky Research Associates, Inc.
Lexington, KY, United States, 40509
Status
Study Complete
Study documents
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
2012-31-12
Actual study completion date
2012-31-12
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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