A Study to Investigate a Research Drug as an Aid for Smoking Cessation in Chronic Cigarette Smokers
The purpose of this study is to evaluate the safety and tolerability of an investigational drug that may help individuals to stop smoking...
Brief Summary
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”
The purpose of this study is to evaluate the safety and tolerability of an investigational drug that may help individuals to stop smoking.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
- Study Primary Completion Date: June 2005
Intervention(s) in this Clinical Trial
- Drug: taranabant
Outcome Measures for this Clinical Trial
Primary Measures
- Quitting smoking after 8 weeks of treatment by measuring lab values and expired breath CO levels
- Time Frame: after 8 weeks of treatment
Safety Issue?: No
- Time Frame: after 8 weeks of treatment
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 65 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers
Clinical Trial Investigator Information
Lead Investigator: Merck Industry
Overall Clinical Trial Officials and Contacts
Medical Monitor Study Director
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00109135
Study ID Number: 2005_012
ClinicalTrials.gov Identifier: NCT00109135
Health Authority: United States: Food and Drug Administration
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00109135
