Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Non-Nicotine Agents for Smoking Cessation

This study has been completed.
Information provided by:
Department of Veterans Affairs Identifier:
First received: April 15, 2005
Last updated: April 2, 2008
Last verified: October 2006

The primary objective of this study is to determine which is the better approach to smoking cessation in veterans: bupropion combined with transdermal nicotine or high dose nicotine replacement therapy (NRT) using transdermal nicotine combined with nicotine inhaler.

Condition Intervention Phase
Tobacco Use Disorder
Drug: bupropion and transdermal patch
Drug: transdermal patch and nicotine inhaler
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
Official Title: Non-Nicotine Agents for Smoking Cessation

Resource links provided by NLM:

Further study details as provided by Department of Veterans Affairs:

Study Start Date: October 2003
Estimated Study Completion Date: September 2005
Detailed Description:

This study is a two-arm open-label, randomized controlled trial of bupropion combined with transdermal nicotine versus high dose NRT (transdermal nicotine and nicotine inhaler) with all subjects receiving a behavioral counseling program for smoking cessation.


Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Readiness to set a quit date in the next two weeks,
  • Current smoking of at least 15 cigarettes a day

Exclusion Criteria:

  • Current untreated depression or receiving treatment for depression,
  • History of seizures, major head injury, or other predisposition for seizures
  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 identifier: NCT00108537

United States, Colorado
Denver VA Medical Center
Denver, Colorado, United States, 80220
Sponsors and Collaborators
  More Information

No publications provided Identifier: NCT00108537     History of Changes
Other Study ID Numbers: ADRD-013-01S
Study First Received: April 15, 2005
Last Updated: April 2, 2008
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
drug therapy
smoking cessation

Additional relevant MeSH terms:
Tobacco Use Disorder
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders processed this record on February 27, 2015