Efficacy and Safety of Dianicline Versus Placebo as an Aid to Smoking Cessation
Phase 3
Completed
- Conditions
- Smoking
- Registration Number
- NCT00356967
- Lead Sponsor
- Sanofi
- Brief Summary
The primary objective is to demonstrate the efficacy of dianicline as an aid to smoking cessation in cigarette smokers. The main secondary objectives are: to assess the craving for cigarettes, nicotine withdrawal symptoms and the safety of dianicline.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 602
Inclusion Criteria
- Outpatients over the legal age smoking at least 10 cigarettes per day for at least 2 months
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Exclusion Criteria
- Insufficient level of motivation
- Another participant in the household
- Patients with current psychotic disorder or major depressive disorder
The investigator will evaluate whether there are other reasons why a patient may not participate.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method and plasma cotinine measurements to assess the continuous abstinence from tobacco smoking at every visit during the last four weeks of treatment through direct inquiry of patients exhaled carbon monoxide testing
- Secondary Outcome Measures
Name Time Method questionnaire of smoking urge Hughes and Hatsukami Minnesota Withdrawal Scale to measure nicotine withdrawal
Trial Locations
- Locations (1)
Sanofi-Aventis Administrative Office
🇸🇪Bromma, Sweden