Skip to main content
OpenTrials
Completed

NCT Number: NCT00439413

Selegiline for Smoking Cessation - 1

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Nicotine Dependence Chemically-Induced Disorders Mental Disorders Substance-Related Disorders Tobacco Use Disorder

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Public & Community Health, College Park, Maryland, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Must be at least 18 years of age
  • Be in good general health
  • Must meet Diagnostic and Statistical Manual-IV (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

Treatment and study plan

Selegiline Transdermal Patch

Drug

Selegiline cm(2) via transdermal system

Other names: STS Patch

Placebo

Drug

Matching placebo via transdermal system

Other names: Placebo Patch

Smoking Cessation Counseling

Behavioral

Subjects were provided with on-site, individual smoking cessation counseling sessions 1x per week for 9 weeks

Primary outcomes

  1. Quit Rate

    Time frame: Study weeks 6 through 9

    The number of subjects in each treatment group who ceased smoking as measured by four weeks of self-reported abstinence confirmed by at least two exhales - carbon monoxide (CO) measurements during the last four weeks of treatment (study weeks 6 through 9).

Secondary outcomes

  1. Abstinence

    Time frame: week 14

    The proportion is determined by dividing the number who achieved abstinence at the end of treatment as defined for the primary outcome measure and are still abstinent by self report and separately by self report with confirmation by exhaled CO by the total number randomized to the treatment group.

Sponsors and collaborators

Lead sponsor

National Institute on Drug Abuse (NIDA)

Nih

Collaborators

  • VA Office of Research and Development

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2009
First posted
Feb 23, 2007
Registry last updated
Feb 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.