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Sponsored by: |
National Institute on Drug Abuse (NIDA) |
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Information provided by: | National Institute on Drug Abuse (NIDA) |
ClinicalTrials.gov Identifier: | NCT00218218 |
Individuals with schizophrenia are three times as likely to smoke cigarettes as individuals without schizophrenia. While a great deal of research has been focused on smoking cessation programs for healthy individuals, little attention has been directed towards developing an effective smoking cessation treatment for schizophrenics. This project will evaluate the effects of 0, 21 and 42 mg transdermal nicotine on smoking, urge to smoke, and nicotine withdrawal symptoms after 5 hrs abstinence in smokers with schizophrenia and heavy-smoking non-psychiatric control smokers.
Condition | Intervention | Phase |
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Schizophrenia and Disorders With Psychotic Features Tobacco Use Disorder Schizophrenia |
Drug: Transdermal Nicotine Patch Drug: 21 mg transdermal nicotine Drug: placebo patch |
Phase II |
Study Type: | Interventional |
Study Design: | Basic Science, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study |
Official Title: | Transdermal Nicotine and Bupropion for Smoking in Schizophrenics (Study 1) |
Enrollment: | 48 |
Study Start Date: | June 2002 |
Study Completion Date: | February 2005 |
Primary Completion Date: | February 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Transdermal nicotine, 42 mg
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Drug: Transdermal Nicotine Patch
42 mg transdermal nicotine
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2: Experimental
Transdermal nicotine, 21 mg
|
Drug: 21 mg transdermal nicotine |
3: Placebo Comparator
placebo patch
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Drug: placebo patch |
Nicotine is the most commonly abused drug among individuals with schizophrenia; at least 60 percent of schizophrenics smoke cigarettes. Nicotine withdrawal may cause a temporary worsening of schizophrenia symptoms, making it especially difficult for these individuals to quit smoking. Little research has been done on the most effective way to control nicotine use in schizophrenic individuals. Transdermal nicotine and bupropion reduce smoking in non-psychiatric smokers, but little is known about the effects of these medications in smokers with schizophrenia. This project examines the effects of 0, 21 and 42 mg transdermal nicotine on smoking behavior and related subjective effects (urge to smoke and nicotine withdrawal symptoms) in smokers with schizophrenia and non-psychiatric heavy smoking controls. Participants come to the laboratory at 9 am, at which time placebo or nicotine patches are applied. After 5 hrs of smoking abstinence, participants undergo a smoking cue reactivity assessment in which craving and withdrawal symptoms are measured after viewing and handling neutral cues and smoking cues. This is followed by 90 min period in which participants can smoke freely, and smoking topography variables are measured.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Rhode Island | |
Providence VA Medical Center | |
Providence, Rhode Island, United States, 02908 | |
Brown University | |
Providence, Rhode Island, United States, 02912 |
Principal Investigator: | Jennifer W. Tidey | Brown University |
Responsible Party: | Brown University ( Jennifer W. Tidey ) |
Study ID Numbers: | NIDA-14002-1, R01-14002-1, DPMC |
Study First Received: | September 16, 2005 |
Last Updated: | August 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00218218 |
Health Authority: | United States: Federal Government |
Nicotine Dependence Tobacco Dependence |
Nicotine polacrilex Schizophrenia Smoking Nicotine Mental Disorders Tobacco Use Disorder |
Bupropion Substance-Related Disorders Disorders of Environmental Origin Psychotic Disorders Schizophrenia and Disorders with Psychotic Features |
Neurotransmitter Agents Disease Cholinergic Agonists Molecular Mechanisms of Pharmacological Action Nicotinic Agonists Physiological Effects of Drugs Central Nervous System Stimulants Cholinergic Agents |
Pharmacologic Actions Pathologic Processes Autonomic Agents Therapeutic Uses Ganglionic Stimulants Peripheral Nervous System Agents Central Nervous System Agents |