A Study to Investigate a Research Drug as an Aid for Smoking Cessation in Chronic Cigarette Smokers (0364-007)

Phase 2

Completed

• Conditions: Smoking

• Registration Number: NCT00109135
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

The purpose of this study is to evaluate the safety and tolerability of an investigational drug that may help individuals to stop smoking.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-01
• Study First Submitted: 2005-04-22
• Study First Submitted QC: 2005-04-22
• Study First Posted: 2005-04-25
• Primary Completion: 2005-06
• Study Completion: 2005-06
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-24
• Last Update Posted: 2015-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Smoking greater than/equal to 10 cigarettes/day for at least 1 year
• Laboratory tests that meet the criteria of the study
• In overall good health as determined by the investigator

Exclusion Criteria

• Psychiatric diagnoses
• Certain cancers
• Patients who use nicotine replacement therapy
• Patients on a diet regimen

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Quitting smoking after 8 weeks of treatment by measuring lab values and expired breath CO levels	after 8 weeks of treatment