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Non-Nicotine Agents for Smoking Cessation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00108537
Recruitment Status : Completed
First Posted : April 18, 2005
Last Update Posted : April 4, 2008
Sponsor:
Information provided by:
VA Office of Research and Development

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Tobacco Use Disorder Drug: bupropion and transdermal patch Drug: transdermal patch and nicotine inhaler Phase 3

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Non-Nicotine Agents for Smoking Cessation
Study Start Date : October 2003
Study Completion Date : September 2005

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Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00108537


Locations
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United States, Colorado
Denver VA Medical Center
Denver, Colorado, United States, 80220
Sponsors and Collaborators
US Department of Veterans Affairs
More Information
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ClinicalTrials.gov Identifier: NCT00108537    
Other Study ID Numbers: ADRD-013-01S
First Posted: April 18, 2005    Key Record Dates
Last Update Posted: April 4, 2008
Last Verified: October 2006
Keywords provided by VA Office of Research and Development:
smoking
nicotine
drug therapy
smoking cessation
Additional relevant MeSH terms:
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Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Bupropion
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
 Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Agents
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors