A Twelve-Week Study of Varenicline for Safety and Efficacy in Comparison With Placebo for Smoking Cessation

A Twelve-Week, Double-Blind, Placebo-Controlled, Multicenter Study With Follow-up Evaluating the Safety and Efficacy of Varenicline Tartrate 1 MG BID for Smoking Cessation

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00141167

Enrollment

250

Registered

2005-09-01

Start date

2005-02-28

Completion date

2006-01-31

Last updated

2010-09-06

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

Conditions

Smoking Cessation

Brief summary

The primary purpose of this study is to evaluate the safety and efficacy of varenicline given for a twelve week treatment period in comparison with placebo for smoking cessation.

Interventions

DRUGvarenicline

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

* Subjects must have smoked an average of at least 10 cigarettes per day during the past year and over the month prior to the screening visit, with no period of abstinence greater than 3 months in the past year.

Exclusion criteria

* Subjects who have used bupropion, Zyban, or Wellbutrin previously.

Design outcomes

Primary

Measure	Time frame
4 week continuous quit rate ( 4 week CQR ) for weeks 9 -12	—

Secondary

Measure	Time frame
Continuous abstinence rate weeks 9-24	—
Long-term Quit Rate at week 24	—
7 day point prevalence week 12 and 24	—
Results of Minnesota Nicotine Withdrawal Scale	—
Brief Questionnaire of Smoking Urges	—
Smoking Effects Inventory	—

Countries

South Korea, Taiwan

Outcome results

None listed

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