Last updated: 07/17/2024 17:49:56
Evaluation of the nicotine lozenge in relief of provoked acute craving
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Evaluation of the nicotine lozenge in relief of provoked acute craving
Trial description: This study is designed to evaluate the ability of a nicotine lozenge to relieve craving for a cigarette compared to a matched placebo (a placebo is like sugar pill and contains no active).
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Mean change from baseline in nicotine cravings VAS scores in light smokers
Timeframe: Baseline, 1, 3, 5, 10 and 15 minutes post-treatment
Mean change from baseline in nicotine cravings VAS scores in heavy smokers
Timeframe: Baseline, 3 minutes and 15 minutes post-treatment
Secondary outcomes:
Percentage of responders with improved craving scores in heavy and light smokers group
Timeframe: Baseline prior to provoked craving paradigm, baseline post provoked craving paradigm
Number of participants with Adverse Events (AEs) and Serious AEs (SAEs)
Timeframe: Baseline, 0 minute, 60 minutes and 5 days post treatment
Interventions:
Drug: Nicotine lower dose
Drug: Nicotine higher dose
Drug: Placebo
Enrollment:
187
Observational study model:
Not applicable
Primary completion date:
2010-31-12
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Smoking
Product
nicotine
Collaborators
Not applicable
Study date(s)
September 2010 to December 2010
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Generally healthy smokers who smoke more than 5 cigarettes per day
- Body mass index (BMI) within the range 19-35 kilogram (kg)/meter (m)^2
- Women who are pregnant or who have a positive urine pregnancy test.
- Participants with known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
Inclusion and exclusion criteria
Inclusion criteria:
- Generally healthy smokers who smoke more than 5 cigarettes per day
- Body mass index (BMI) within the range 19-35 kilogram (kg)/meter (m)^2
- Females of childbearing potential who are, in the opinion of the investigator, practicing a reliable method of contraception.
Exclusion criteria:
- Women who are pregnant or who have a positive urine pregnancy test.
- Participants with known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
- Clinical Study/Experimental Medication: Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit.
- Prior Concomitant Medication: Treatment with enzyme altering agents (e.g. carbamazepine, phenytoin, cimetidine, sodium valporate) within 30 days of the craving provocation visit; Use of any prescription psychoactive medication (such as but not limited to antidepressants, antipsychotics, anxiolytics) within 14 days of the craving provocation visit; Participant has used an over-the-counter (OTC) medication such as antihistamines, sedating agents, or any compound that would have a sedating effect within 24 hours of the craving provocation visit; Current use of any nicotine replacement therapy.
- Substance abuse: Recent history or current history (within the last 1 year) of alcohol or other substance abuse.
Trial location(s)
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
2010-31-12
Actual study completion date
2010-31-12
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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