Efficacy and Safety of Dianicline Versus Placebo as an Aid to Smoking Cessation

Sanofi602 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

602

Conditions

Smoking

Interventions

dianiclineDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Outpatients over the legal age smoking at least 10 cigarettes per day for at least 2 months 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.

Locations (6)

Sanofi-Aventis Administrative Office

Diegem, Belgium

Sanofi-Aventis Administrative Office

Hørsholm, Denmark

Sanofi-Aventis Administrative Office

Paris, France

Sanofi-Aventis Administrative Office

Lysaker, Norway

Outcomes

Primary Outcomes

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

and plasma cotinine measurements

Secondary Outcomes

questionnaire of smoking urge

Hughes and Hatsukami Minnesota Withdrawal Scale to measure nicotine withdrawal

Data from ClinicalTrials.gov

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