Efficacy and Safety of Dianicline Treatment as an Aid to Smoking Cessation in Cigarette Smokers (AMERIDIAN)

This study has been completed.
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: October 12, 2006
Last updated: February 15, 2012
Last verified: February 2012

The primary study 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 safety of dianicline.

Condition Intervention Phase
Smoking Cessation
Tobacco Use Cessation
Drug: SSR591813L (dianicline)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: An International, Seven-week, Double-blind, Placebo-controlled, Two Parallel Group Study to Assess the Efficacy of Dianicline 40 mg Bid as an Aid to Smoking Cessation in Cigarette Smokers

Resource links provided by NLM:

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • To assess the continuous abstinence from tobacco smoking at every visit during the last 4 weeks of treatment period, i.e. from week 4 to week 7, through direct inquiry of patients, exhaled carbon monoxide (CO) testing, and plasma cotinine measurements

Secondary Outcome Measures:
  • Questionnaire of Smoking Urges to assess craving for cigarettes; Hughes and Hatsukami Minnesota Withdrawal Scale to measure nicotine withdrawal, number of smoke-free days, and average number of cigarettes smoked from smoking status interview

Enrollment: 630
Study Start Date: September 2006
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Outpatients, over legal age, smoking at least 10 cigarettes/day as a mean within the 2 months preceding the screening visit.

Exclusion Criteria:

  • Patients who have taken an investigational drug within the past six months prior to the screening visit.
  • Patients who had a previous quit attempt (= or >1 day with the aid of pharmacological adjunct) in the previous three months (before screening).
  • Patients who have smoked or consumed non-tobacco cigarettes or any form of tobacco product (other than cigarettes such as cigars, pipes, smokeless tobacco, etc) more than 3 times within the 3 months preceding the screening visit.
  • Patients who currently present with (based on Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition [DSM-IV]):

    • Psychotic disorder
    • Major depressive episode
  • Pregnant or breast-feeding women.
  • Women of childbearing potential not protected by effective contraceptive method of birth control and/or who are unwilling or unable to be tested for pregnancy. Medically acceptable methods of birth control for this study include approved hormonal contraceptive medications or devices, approved intra-uterine contraceptive devices, use of two combined barrier methods.
  • Patients who have suffered from a myocardial infarction, unstable angina or other major cardiovascular event within the past week prior to screening.
  • Patients who have a history of multiple allergic reactions to medications in two drug classes.
  • Patients who have QTcF > 500 ms on the electrocardiogram (ECG).
  • Patients with mild, moderate or severe renal impairment.
  • Patients who have an abnormal laboratory test of potential clinical significance at screening.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00387946

United States, New Jersey
Administrative Office
Bridgewater, New Jersey, United States, 08807
Canada, Quebec
Administrative Office
Laval, Quebec, Canada
Sponsors and Collaborators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00387946     History of Changes
Other Study ID Numbers: EFC5514, SSR591813
Study First Received: October 12, 2006
Last Updated: February 15, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 16, 2014