An Investigation of Effectiveness and Safety of Varenicline Tartrate in Helping People Quit Smoking

A Prospective, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Multinational Study Of Efficacy And Safety Of Varenicline Tartrate For Smoking Cessation

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00371813

Enrollment

334

Registered

2006-09-04

Start date

2006-09-30

Completion date

2007-06-30

Last updated

2015-04-22

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

Conditions

Smoking Cessation

Brief summary

To investigate safety and efficacy of varenicline tartrate in helping people quit smoking

Interventions

DRUGVarenicline tartrate

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Current cigarette smokers between the ages of 18 and 75 years, who are motivated to stop smoking

Exclusion criteria

* Patients currently suffering from depression, or have been diagnosed with depression in the last 12 months, or subjects with past or present history of psychosis, panic disorder, or bipolar disorder * Any subject with known severe chronic obstructive pulmonary disease (COPD)

Design outcomes

Primary

Measure	Time frame
To compare 12 weeks of treatment with varenicline 1 mg BID to placebo for smoking cessation, and to evaluate continuous abstinence from smoking for 12 weeks after the treatment period.	—

Secondary

Measure	Time frame
To gather safety data for 12 weeks of treatment with varenicline 1 mg BID or placebo followed by 12 weeks of non-treatment follow-up.	—

Countries

China, Singapore, Thailand

Outcome results

None listed

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