Maintenance of Smoking Cessation
Conditions
Keywords
abstinence, maintenance
Brief summary
The primary study objective is to evaluate the efficacy of 2 dose levels of rimonabant (5 mg and 20 mg) for the maintenance of abstinence from smoking. Secondary objectives are to evaluate the effect of rimonabant on craving and weight, the clinical and biological safety of 2 doses of rimonabant rimonabant during a 12-month treatment period and to evaluate the pharmacokinetics of the drug.
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 10 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 |
|---|---|
| Time to smoking relapse from the point of re-randomization (Week 10) through Week 32 | — |
| Smoking relapse defined as: any 7 or more consecutive days of smoking (even a puff) or any 2 consecutive days of smoking 5 or more cigarettes per day | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy: Time to smoking relapse from Week 10 to Week 52, craving, body weight change in abstainers, lipid parameters | — |
| Safety data | — |
Countries
Australia, Canada, United States
Outcome results
None listed