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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00109135
Recruitment Status : Completed
First Posted : April 25, 2005
Last Update Posted : September 25, 2015
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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

Condition or disease Intervention/treatment Phase
Smoking Drug: taranabant Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : January 2005
Primary Completion Date : June 2005
Study Completion Date : June 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Drug: taranabant
    Other Name: MK0364

Primary Outcome Measures :
  1. Quitting smoking after 8 weeks of treatment by measuring lab values and expired breath CO levels [ Time Frame: after 8 weeks of treatment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00109135

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

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
First Posted: April 25, 2005    Key Record Dates
Last Update Posted: September 25, 2015
Last Verified: September 2015