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NCT00109135 Clinical Trial

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

Smoking Clinical Trial

Official title:
A Double-Blind, Multicenter, Randomized, Titrated-Dose, Placebo-Controlled, Study of MK0364 (4 mg to 8 mg) in Chronic Cigarette Smokers as an Aid for Smoking Cessation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00109135
Other study ID # 0364-007
Secondary ID 2005_012MK-0364-
Status Completed
Phase Phase 2
First received April 22, 2005
Last updated September 24, 2015
Start date January 2005
Est. completion date June 2005

Study information
Verified date September 2015
Source Merck Sharp & Dohme Corp.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 300
Est. completion date June 2005
Est. primary completion date June 2005
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• taranabant

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Merck Sharp & Dohme Corp.

Outcome
Type Measure Description Time frame Safety issue
Primary Quitting smoking after 8 weeks of treatment by measuring lab values and expired breath CO levels after 8 weeks of treatment No
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