Selegiline for Smoking Cessation - 1

This study has been completed.

First Received: February 22, 2007 Last Updated: January 26, 2009 History of Changes

Sponsor:	National Institute on Drug Abuse (NIDA)
Collaborator:	Department of Veterans Affairs
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00439413

Purpose

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.

Condition	Intervention	Phase
Nicotine Dependence	Drug: Selegiline	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Phase 2, Double-Blind, Placebo-Controlled Trial of Selegiline Transdermal System (STS) as an Aid for Smoking Cessation.

Resource links provided by NLM:

MedlinePlus related topics: Quitting Smoking Smoking

Drug Information available for: Selegiline Selegiline hydrochloride

U.S. FDA Resources

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Enrollment:	246
Study Start Date:	June 2007
Study Completion Date:	January 2009
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Selegiline Transdermal

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00439413

Locations

United States, Maryland
Department of Public & Community Health
College Park, Maryland, United States, 20745
United States, New Jersey
Robert Wood Johnson Med School-Tobacco Dep Program
New Brunswick, New Jersey, United States, 08901
United States, Ohio
Tri-State Tobacco and Alcohol Research Center
Cincinnati, Ohio, United States, 45237
United States, Wisconsin
Center For Tobacco Research and Intervention
Milwaukee, Wisconsin, United States, 53233

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

Department of Veterans Affairs

Investigators

Principal Investigator:

Elbert D Glover, Ph.D.

Department of Veterans Affairs

More Information

No publications provided

Responsible Party:	National Institue on Drug Abuse ( Liza Gorgon )
Study ID Numbers:	NIDA-CSP-1022-1
Study First Received:	February 22, 2007
Last Updated:	January 26, 2009
ClinicalTrials.gov Identifier:	NCT00439413 History of Changes
Health Authority:	United States: Food and Drug Administration; United States: Institutional Review Board

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Tobacco Use Disorder
Physiological Effects of Drugs
Antiparkinson Agents
Disorders of Environmental Origin
Enzyme Inhibitors
Neuroprotective Agents

Protective Agents
Pharmacologic Actions
Selegiline
Mental Disorders
Therapeutic Uses
Substance-Related Disorders
Monoamine Oxidase Inhibitors
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 27, 2009