Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
National Institute on Drug Abuse (NIDA) |
---|---|
Information provided by: | National Institute on Drug Abuse (NIDA) |
ClinicalTrials.gov Identifier: | NCT00124683 |
Schizophrenic individuals are typically nicotine dependent smokers who find it difficult to quit smoking. The purpose of this study is to determine the effectiveness of bupropion SR (commonly known as Zyban) in combination with a nicotine transdermal patch (NTP), in helping schizophrenic individuals quit smoking. In addition, this study will evaluate how the combination of bupropion SR and NTP affects psychiatric symptoms and medication side effects.
Condition | Intervention | Phase |
---|---|---|
Tobacco Use Cessation Tobacco Use Disorder Schizophrenia |
Drug: Bupropion Drug: nicotine transdermal patch |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Optimizing Treatment for Schizophrenic Smokers |
Enrollment: | 59 |
Study Start Date: | September 2001 |
Study Completion Date: | May 2007 |
Arms | Assigned Interventions |
---|---|
1: Experimental
Nicotine Patch + Bupropion
|
Drug: Bupropion Drug: nicotine transdermal patch |
2: Placebo Comparator
Nicotine patch + placebo
|
Drug: nicotine transdermal patch |
Past research on the use of the NTP, atypical antipsychotics, and bupropion in schizophrenic individuals to aid in smoking cessation has been encouraging. The purpose of this study is to compare bupropion SR to a placebo to determine its effectiveness when used in combination with an NTP to help schizophrenic individuals quit smoking.
Participants in this double-blind, placebo-controlled study will be randomly assigned to receive either the NTP (21 mg/day) and placebo or the NTP and bupropion SR (300 mg/day). Participants will begin taking one pill each day of bupropion SR (150 mg/day) or placebo at the start of the second week of the study. After three days, the dose of bupropion SR or placebo will increase to 2 pills each day. Participants will continue this dosing regimen until the end of Week 10. Throughout the 10-week study, participants will receive weekly group therapy.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | NIDA-13672-1, R01-13672-1, DPMC |
Study First Received: | July 26, 2005 |
Last Updated: | August 1, 2007 |
ClinicalTrials.gov Identifier: | NCT00124683 History of Changes |
Health Authority: | United States: Federal Government |
Dopamine Uptake Inhibitors Nicotine polacrilex Neurotransmitter Agents Tobacco Use Disorder Nicotinic Agonists Psychotropic Drugs Disorders of Environmental Origin Cholinergic Agents Schizophrenia Dopamine |
Mental Disorders Nicotine Bupropion Substance-Related Disorders Dopamine Agents Psychotic Disorders Peripheral Nervous System Agents Antidepressive Agents, Second-Generation Antidepressive Agents Schizophrenia and Disorders with Psychotic Features |
Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Cholinergic Agonists Molecular Mechanisms of Pharmacological Action Nicotinic Agonists Physiological Effects of Drugs Psychotropic Drugs Disorders of Environmental Origin Cholinergic Agents Schizophrenia Nicotine Mental Disorders |
Therapeutic Uses Ganglionic Stimulants Substance-Related Disorders Antidepressive Agents, Second-Generation Schizophrenia and Disorders with Psychotic Features Antidepressive Agents Tobacco Use Disorder Pharmacologic Actions Autonomic Agents Bupropion Dopamine Agents Peripheral Nervous System Agents Central Nervous System Agents |