Non-Nicotine Agents for Smoking Cessation - Full Text View

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 III

MedlinePlus related topics:

Smoking Smoking Cessation

ChemIDplus related topics:

Bupropion hydrochloride Bupropion Nicotine polacrilex Nicotine tartrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled

Official Title:	Non-Nicotine Agents for Smoking Cessation

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
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

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

Department of Veterans Affairs

More Information

Study ID Numbers:	ADRD-013-01S
First Received:	April 15, 2005
Last Updated:	April 2, 2008
ClinicalTrials.gov Identifier:	NCT00108537
Health Authority:	United States: Federal Government

Keywords provided by Department of Veterans Affairs:

smoking

nicotine

drug therapy

smoking cessation

Study placed in the following topic categories:

Nicotine polacrilex

Smoking

Nicotine

Mental Disorders

Tobacco Use Disorder

Bupropion

Substance-Related Disorders

Disorders of Environmental Origin

Additional relevant MeSH terms:

Neurotransmitter Agents

Cholinergic Agonists

Molecular Mechanisms of Pharmacological Action

Nicotinic Agonists

Physiological Effects of Drugs

Central Nervous System Stimulants

Cholinergic Agents

Pharmacologic Actions

Autonomic Agents

Therapeutic Uses

Ganglionic Stimulants

Peripheral Nervous System Agents

Central Nervous System Agents

ClinicalTrials.gov processed this record on October 07, 2008

Sponsored by:	Department of Veterans Affairs
Information provided by:	Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT00108537