Selegiline for Smoking Cessation - 1 - Tabular View

Tracking Information

First Received Date ^ICMJE

February 22, 2007

Last Updated Date

January 26, 2009

Start Date ^ICMJE

June 2007

Primary Completion Date

August 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Quit Rate [ Time Frame: weekly ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Quit Rate

Change History

Complete list of historical versions of study NCT00439413 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Craving [ Time Frame: weekly ] [ Designated as safety issue: No ]
Depression [ Time Frame: screening, weeks 4, 8, 10 ] [ Designated as safety issue: No ]
Mood [ Time Frame: screening, weeks 4, 8, 10 ] [ Designated as safety issue: No ]
Safety [ Time Frame: weekly ] [ Designated as safety issue: Yes ]
Abstinence [ Time Frame: weeks 24, 26 ] [ Designated as safety issue: No ]
Weight gain / loss [ Time Frame: screen, weeks 10, 26 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Craving
Depression
Mood
Safety
Abstinence
Weight gain / loss

Descriptive Information

Brief Title ^ICMJE

Selegiline for Smoking Cessation - 1

Official Title ^ICMJE

Phase 2, Double-Blind, Placebo-Controlled Trial of Selegiline Transdermal System (STS) as an Aid for Smoking Cessation.

Brief Summary

The purpose of this study is designed to examine the effects of Selegiline Transdermal System and behavioral intervention in smoking cessation as compared to behavioral intervention alone.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Nicotine Dependence

Intervention ^ICMJE

Drug: Selegiline

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

246

Completion Date

January 2009

Primary Completion Date

August 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Must be at least 18 years of age
Be in good general health
Must meet DSM-IV diagnostic criteria for nicotine dependence
Be currently smoking > 15 cigarettes/day, and have smoked cigarettes for the past 5 years
Subjects must be motivated to quite smoking
If female and of child bearing potential, agrees to use birth control and subject
Subject must be able to understand and provide written informed consent.

Exclusion

Criteria:

Please contact site for more information

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00439413

Responsible Party

Liza Gorgon, National Institue on Drug Abuse

Study ID Numbers ^ICMJE

NIDA-CSP-1022-1

Study Sponsor ^ICMJE

National Institute on Drug Abuse (NIDA)

Collaborators ^ICMJE

Department of Veterans Affairs

Investigators ^ICMJE

Principal Investigator:

Elbert D Glover, Ph.D.

Department of Veterans Affairs

Information Provided By

National Institute on Drug Abuse (NIDA)

Verification Date

January 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP