NCT00387946

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
630

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Sep 2006

Shorter than P25 for phase_3

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 12, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 13, 2006

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

February 17, 2012

Status Verified

February 1, 2012

Enrollment Period

1 year

First QC Date

October 12, 2006

Last Update Submit

February 15, 2012

Conditions

Smoking CessationTobacco Use Cessation

Keywords

smokingcessationtobacco

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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

Interventions

SSR591813L (dianicline)DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Administrative Office

Bridgewater, New Jersey, 08807, United States

Location

Administrative Office

Laval, Quebec, Canada

Location

Related Publications (1)

  • 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.

    PMID: 37142273DERIVED

MeSH Terms

Conditions

Smoking CessationTobacco Use CessationSmoking

Interventions

dianicline

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Clinical Sciences & Operations

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2006

First Posted

October 13, 2006

Study Start

September 1, 2006

Primary Completion

September 1, 2007

Study Completion

September 1, 2007

Last Updated

February 17, 2012

Record last verified: 2012-02

Locations

US(1)CA(1)