Non-Nicotine Agents for Smoking Cessation

This study has been completed.

First Received: April 15, 2005 Last Updated: April 2, 2008 History of Changes

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

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

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

No publications provided

Study ID Numbers:	ADRD-013-01S
Study First Received:	April 15, 2005
Last Updated:	April 2, 2008
ClinicalTrials.gov Identifier:	NCT00108537 History of Changes
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
Neurotransmitter Agents
Tobacco Use Disorder
Nicotinic Agonists
Disorders of Environmental Origin
Central Nervous System Stimulants
Cholinergic Agents

Smoking
Mental Disorders
Nicotine
Bupropion
Substance-Related Disorders
Peripheral Nervous System Agents

Additional relevant MeSH terms:

Nicotine polacrilex
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cholinergic Agonists
Tobacco Use Disorder
Nicotinic Agonists
Physiological Effects of Drugs
Disorders of Environmental Origin
Central Nervous System Stimulants
Cholinergic Agents

Pharmacologic Actions
Mental Disorders
Nicotine
Autonomic Agents
Therapeutic Uses
Substance-Related Disorders
Ganglionic Stimulants
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 03, 2009