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.
ClinicalTrials.gov Identifier:
First received: April 22, 2005
Last updated: September 24, 2015
Last verified: September 2015
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00109135

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00109135     History of Changes
Other Study ID Numbers: 0364-007  2005_012  MK-0364-007 
Study First Received: April 22, 2005
Last Updated: September 24, 2015
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on May 30, 2016