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A Study to Investigate a Research Drug as an Aid for Smoking Cessation in Chronic Cigarette Smokers
This study has been completed.
First Received: April 22, 2005   Last Updated: May 13, 2008   History of Changes
Sponsored by: Merck
Information provided by: Merck
ClinicalTrials.gov Identifier: NCT00109135
  Purpose

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


Condition Intervention Phase
Smoking
Drug: taranabant
Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:


Further study details as provided by Merck:

Primary Outcome Measures:
  • Quitting smoking after 8 weeks of treatment by measuring lab values and expired breath CO levels [ Time Frame: after 8 weeks of treatment ] [ Designated as safety issue: No ]

Enrollment: 300
Study Start Date: April 2004
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00109135

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Unaffiliated
  More Information

No publications provided

Responsible Party: Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers: 2005_012, MK0364-007
Study First Received: April 22, 2005
Last Updated: May 13, 2008
ClinicalTrials.gov Identifier: NCT00109135     History of Changes
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Smoking

Additional relevant MeSH terms:
Habits
Smoking

ClinicalTrials.gov processed this record on September 03, 2009