Selegiline for Smoking Cessation - 1

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00439413
First received: February 22, 2007
Last updated: August 24, 2011
Last verified: August 2011
  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 2

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


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
Experimental: 1 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Principal Investigator: Elbert D Glover, Ph.D. Department of Veterans Affairs
  More Information

Publications:
Responsible Party: National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT00439413     History of Changes
Obsolete Identifiers: NCT00462514
Other Study ID Numbers: NIDA-CSP-1022-1
Study First Received: February 22, 2007
Last Updated: August 24, 2011
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

ClinicalTrials.gov processed this record on September 30, 2014