Brief Summary

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.

Trial Health

On Track

Trial Health Score

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

Enrollment

602

participants targeted

Target at P75+ for phase_3

Timeline

Completed

Started Jun 2006

Shorter than P25 for phase_3

Geographic Reach

6 countries

6 active sites

Status

completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

1 year study duration

Study Start

First participant enrolled

June 1, 2006

Completed

2 months until next milestone

First Submitted

Initial submission to the registry

July 26, 2006

Completed

1 day until next milestone

First Posted

Study publicly available on registry

July 27, 2006

Completed

10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed

Last Updated

December 19, 2008

Status Verified

December 1, 2008

Enrollment Period

1 year

First QC Date

July 26, 2006

Last Update Submit

December 18, 2008

Conditions

Smoking

Keywords

smokingcessationtobaccosmoking cessationtobacco use cessation

Outcome Measures

Primary Outcomes (3)

to assess the continuous abstinence from tobacco smoking at every visit during the last four weeks of treatment through direct inquiry of patients
exhaled carbon monoxide testing
and plasma cotinine measurements

Secondary Outcomes (2)

questionnaire of smoking urge
Hughes and Hatsukami Minnesota Withdrawal Scale to measure nicotine withdrawal

Interventions

dianiclineDRUG

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Outpatients over the legal age smoking at least 10 cigarettes per day for at least 2 months

You may not qualify if:

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.

Contact the study team to confirm eligibility.