Non-Nicotine Agents for Smoking Cessation

This study has been completed.

Sponsor:

Information provided by:

VA Office of Research and Development

ClinicalTrials.gov Identifier:

NCT00108537

First received: April 15, 2005

Last updated: April 2, 2008

Last verified: October 2006

History of Changes

Purpose

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:

MedlinePlus related topics: Quitting Smoking Smoking

Drug Information available for: Nicotine tartrate Bupropion Nicotine polacrilex

U.S. FDA Resources

Further study details as provided by VA Office of Research and Development:


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.

Eligibility


Ages Eligible for Study:	18 Years to 65 Years (Adult)
Genders Eligible for Study:	Both
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

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: NCT00108537

Locations


United States, Colorado
Denver VA Medical Center
Denver, Colorado, United States, 80220

Sponsors and Collaborators

VA Office of Research and Development

More Information


ClinicalTrials.gov 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 VA Office of Research and Development:


smoking nicotine drug therapy smoking cessation

Additional relevant MeSH terms:


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

ClinicalTrials.gov processed this record on September 28, 2016

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