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OpenTrials
Completed

NCT Number: NCT00356967

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

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.

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Key information

Conditions

Smoking Behavior Health Behavior Smoking Cessation Tobacco Use Cessation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sanofi-Aventis Administrative Office, Diegem, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

dianicline

Drug

Primary outcomes

  1. to assess the continuous abstinence from tobacco smoking at every visit during the last four weeks of treatment through direct inquiry of patients

  2. exhaled carbon monoxide testing

  3. and plasma cotinine measurements

Secondary outcomes

  1. questionnaire of smoking urge

  2. Hughes and Hatsukami Minnesota Withdrawal Scale to measure nicotine withdrawal

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

An International 7-Week, Double-Blind, Placebo-Controlled, 2-Parallel Group Study to Assess the Efficacy of Dianicline 40 mg BID as an Aid to Smoking Cessation in Cigarette Smokers

Acronym: EURODIAN

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Jul 27, 2006
Registry last updated
Dec 19, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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