Efficacy and Safety of Dianicline Versus Placebo as an Aid to Smoking Cessation

An International 7-Week, Double-Blind, Placebo-Controlled, 2-Parallel Group Study to Assess the Efficacy of Dianicline 40 mg BID as an Aid to Smoking Cessation in Cigarette Smokers

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00356967

Acronym

EURODIAN

Enrollment

602

Registered

2006-07-27

Start date

2006-06-30

Completion date

2007-06-30

Last updated

2008-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smoking

Keywords

smoking, cessation, tobacco, smoking cessation, tobacco use cessation

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.

Interventions

DRUGdianicline

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* 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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
questionnaire of smoking urge	—
Hughes and Hatsukami Minnesota Withdrawal Scale to measure nicotine withdrawal	—

Countries

Belgium, Denmark, France, Norway, Spain, Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026