Selegiline for Smoking Cessation - 1

Nicotine Dependence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00439413
• Other study ID #: NIDA-CSP-1022-1
• Status: Completed
• Phase: Phase 2
• First received: February 22, 2007
• Last updated: August 24, 2011
• Start date: June 2007
• Est. completion date: January 2009

Study information

• Verified date: August 2011
• Source: National Institute on Drug Abuse (NIDA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Other known NCT identifiers

• NCT00462514

Recruitment information / eligibility

• Status: Completed
• Enrollment: 246
• Est. completion date: January 2009
• Est. primary completion date: August 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nicotine Dependence

Intervention

Drug:
• Selegiline
Transdermal

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
National Institute on Drug Abuse (NIDA)	VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (1)

Kahn R, Gorgon L, Jones K, McSherry F, Glover ED, Anthenelli RM, Jackson T, Williams J, Murtaugh C, Montoya I, Yu E, Elkashef A. Selegiline transdermal system (STS) as an aid for smoking cessation. Nicotine Tob Res. 2012 Mar;14(3):377-82. doi: 10.1093/ntr — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quit Rate		weekly	No
Secondary	Craving		weekly	No
Secondary	Depression		screening, weeks 4, 8, 10	No
Secondary	Mood		screening, weeks 4, 8, 10	No
Secondary	Safety		weekly	Yes
Secondary	Abstinence		weeks 24, 26	No
Secondary	Weight gain / loss		screen, weeks 10, 26	No