At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 723 enrolled
Drug / intervention
Nicotine +1 moredrug
Likely dose
Nicotine mint lozenge 2 mg or 4 mgAI-extracted
Key inclusion· 4
- ✓Age 18 years or older
- ✓Motivated to quit smoking using nicotine mint lozenge
- ✓Regular daily smoking for at least 1 year
- ✓Able to provide written informed consent
Key exclusion· 12
- ✕Use of other tobacco forms (pipes, cigars, snuff, smokeless tobacco) within 30 days
- ✕Use of other nicotine delivery systems (gum, patch, inhaler, nasal spray) within 30 days
- ✕Smoking other substances (cannabis, cocaine, heroin, ice) within 30 days
- ✕History of alcohol or drug abuse
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multi-center, Randomized, Double-blind, Parallel, Placebo-controlled Clinical Study to Evaluate Efficacy and Safety of Nicotine Mint Lozenge (2mg and 4mg) in Smoking Cessation
In Brief
A Phase 3 clinical trial evaluating Nicotine and Placebo for Smoking. Completed, enrolled 723 participants.
Detailed Summary
A multi-center, randomized, double-blind, placebo-controlled, 4-arm clinical study to evaluate efficacy and safety of nicotine lozenge (2mg and 4mg) in smoking cessation in adult cigarette smokers who are motivated to quit smoking. Successful quitters or participants who smoke occasionally will be followed up after week 24 till 12 months.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSmoking
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartMay 2009
First PostedSep 2009
Primary CompletionMar 2011
TodayJul 2026
First PostedSep 29, 2009
Enrollment StartMay 1, 2009
Primary CompletionMar 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 16.8 years ago
Interventions
Nicotinedrug
2 mg or 4 mg nicotine lozenge
Placebodrug
placebo lozenge