Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp. Identifier:
First received: April 22, 2005
Last updated: October 16, 2014
Last verified: October 2014

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
Drug: taranabant
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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 Sharp & Dohme Corp.:

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: January 2005
Study Completion Date: June 2005
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: taranabant
    Other Name: MK0364

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00109135

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Study Director: Medical Monitor
  More Information

No publications provided by Merck Sharp & Dohme Corp.

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00109135     History of Changes
Other Study ID Numbers: 0364-007, 2005_012, MK-0364-007
Study First Received: April 22, 2005
Last Updated: October 16, 2014
Health Authority: United States: Food and Drug Administration processed this record on March 03, 2015