Smoking Cessation
Conditions
Keywords
abstinence, nicotine patch
Brief summary
The primary objective is to compare the efficacy of rimonabant 20 mg OD fixed dose plus nicotine patch 21 mg OD with the combination rimonabant 20 mg OD fixed dose plus placebo patch on abstinence from smoking in cigarette smokers motivated to quit. Secondary objectives are to evaluate the clinical and biological safety of rimonabant associated with nicotine replacement therapy during a 9-week treatment period and to evaluate the effect of the combination on weight and craving.
Interventions
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Smokers smoking at least 15 cigarettes/day as a mean within the 2 months preceding the screening visit * Motivated to quit with a score greater than or equal to 6 on the ten-point Motivation Scale
Exclusion criteria
* non tobacco cigarettes consumption * chronic use of marijuana * pregnancy * breastfeeding * any clinically significant disease that might interfere with the efficacy or safety evaluation of the study drug * Concomitant use of drugs as an aid to smoking cessation or that might induce weight change
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Prolonged abstinence from smoking during the last 4 weeks of treatment reported by the subject and confirmed by exhaled carbon monoxide (CO) measurements | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy: mean change of the total score of Questionnaire on Smoking Urges (QSU) brief scale, categorical change in body weight in subjects with Body Mass Index lower than 30 kg/m² at baseline who achieve prolonged abstinence | — |
| Safety data | — |
Countries
United States
Outcome results
None listed