A Study to Investigate a Research Drug as an Aid for Smok... | NCT00109135

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

NCT00109135

Sponsor

Merck Sharp & Dohme LLC

Status

Completed

Last Update Posted

Sep 25, 2015Estimated

Enrollment

300Actual

Phase

Phase 2

Conditions

Smoking

Interventions

taranabant

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2005

Primary Completion Date

Jun 2005Actual

Completion Date

Jun 2005Actual

First Submitted Date

Apr 22, 2005

First Submission Date that Met QC Criteria

Apr 22, 2005

First Posted Date

Apr 25, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 24, 2015

Last Update Posted Date

Sep 25, 2015Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

300Actual

Name	Type	Description	Arm Group Labels	Other Names
taranabant	Drug			MK0364

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Quitting smoking after 8 weeks of treatment by measuring lab values and expired breath CO levels		after 8 weeks of treatment

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Medical Monitor		Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20191360	Derived	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.

ID	Type	Description	Link
2005_012
MK-0364-007