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

NCT ID: NCT00387946

Last Updated: 2012-02-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 630 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-30
• Study Completion Date: 2007-09-30

Brief Summary

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.

Conditions

Smoking Cessation; Tobacco Use Cessation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

SSR591813L (dianicline)

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Administrative Office

Bridgewater, New Jersey, United States

Administrative Office

Laval, Quebec, Canada

Countries

United States; Canada

References

Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.

Reference Type: DERIVED

PMID: 37142273 (View on PubMed)

Other Identifiers

SSR591813

Identifier Type: -

Identifier Source: secondary_id

EFC5514

Identifier Type: -

Identifier Source: org_study_id