Evaluation of the effects of oral nicotine substitutes (1.5mg lozenge) on the craving in moderate smokers placed in non-smoking situations. A randomized, double-blind, placebo-controlled parallel groups trial.
interventional
N/A
1 country
2
To assess (prospectively) from 30 minutes up to 3 min in a reverse chronological manner the efficacy of a single dose of Nicotine 1.5mg lozenge as compared to placebo on the reduction of craving in moderate smokers in a non-smoking situation.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
Date not reportedClick on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 22, 2023
Actual (reported)Questionnaire of Smoking Urges (QSU)-brief Total score change from baseline at 30 minutes and any earlier times using.
QSU-brief Total score improvement from Baseline.
QSU-brief Total score change from baseline at 45, 60 and 90 minutes.
Area under curve of QSU-brief Total score improvement from baseline over 30 minutes.
• VAS Global evaluation of the craving during the day. • Number of lozenges.
Change from baseline Minnesota Nicotine Withdrawal Scale (MNWS) score at the end of Day 1.
Medical Center Comac Medical Ltd.
Sofia, 1606, Bulgaria
Medical Center Comac Medical Ltd.
Sofia, 1612, Bulgaria
Regulatory Affairs Officer
First Submitted
November 22, 2023
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