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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00387946
First received: October 12, 2006
Last updated: February 15, 2012
Last verified: February 2012
  Purpose

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)
  Eligibility

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

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

Locations
United States, New Jersey
Administrative Office
Bridgewater, New Jersey, United States, 08807
Canada, Quebec
Administrative Office
Laval, Quebec, Canada
Sponsors and Collaborators
Sanofi
Investigators
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:
smoking
cessation
tobacco

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

ClinicalTrials.gov processed this record on April 16, 2014