NCT00109135

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2005

Shorter than P25 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 22, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 25, 2005

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
Last Updated

September 25, 2015

Status Verified

September 1, 2015

Enrollment Period

5 months

First QC Date

April 22, 2005

Last Update Submit

September 24, 2015

Conditions

Smoking

Outcome Measures

Primary Outcomes (1)

  • Quitting smoking after 8 weeks of treatment by measuring lab values and expired breath CO levels

    after 8 weeks of treatment

Interventions

taranabantDRUG
Also known as: MK0364

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Psychiatric diagnoses
  • Certain cancers
  • Patients who use nicotine replacement therapy
  • Patients on a diet regimen

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Morrison MF, Ceesay P, Gantz I, Kaufman KD, Lines CR. Randomized, controlled, double-blind trial of taranabant for smoking cessation. Psychopharmacology (Berl). 2010 Apr;209(3):245-53. doi: 10.1007/s00213-010-1790-2. Epub 2010 Feb 27.

    PMID: 20191360DERIVED

MeSH Terms

Conditions

Smoking

Interventions

N-(3-(4-chlorophenyl)-2-(3-cyanophenyl)-1-methylpropyl)-2-methyl-2-((5-(trifluoromethyl)pyridin-2-yl)oxy)propanamide

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Medical Monitor

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2005

First Posted

April 25, 2005

Study Start

January 1, 2005

Primary Completion

June 1, 2005

Study Completion

June 1, 2005

Last Updated

September 25, 2015

Record last verified: 2015-09