Non-Nicotine Agents for Smoking Cessation
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| ClinicalTrials.gov Identifier: NCT00108537 |
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Recruitment Status
:
Completed
First Posted
: April 18, 2005
Last Update Posted
: April 4, 2008
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Sponsor:
VA Office of Research and Development
Information provided by:
VA Office of Research and Development
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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 |
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 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 |
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 65 Years (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
Information from the National Library of Medicine
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
| United States, Colorado | |
| Denver VA Medical Center | |
| Denver, Colorado, United States, 80220 | |
Sponsors and Collaborators
VA Office of Research and Development
| ClinicalTrials.gov Identifier: | NCT00108537 History of Changes |
| 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:
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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 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 |