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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: | NCT00218231 |
Many individuals with schizophrenia smoke cigarettes but little is known about the factors that control smoking in people with schizophrenia. The purpose of this trial is to evaluate how bupropion, an antidepressant medication, affects smoking behaviors in individuals with schizophrenia who smoke.
Condition | Intervention | Phase |
---|---|---|
Schizophrenia Tobacco Use Disorder |
Drug: 300 mg/day bupropion-sr Drug: 0 mg/day bupropion-sr |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study |
Official Title: | Transdermal Nicotine and Bupropion-SR in Schizophrenics (Study 2) |
Enrollment: | 48 |
Study Start Date: | January 2004 |
Study Completion Date: | August 2006 |
Primary Completion Date: | August 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
300 mg/day bupropion-sr
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Drug: 300 mg/day bupropion-sr
300 mg/day for 1 week
|
2: Placebo Comparator
0 mg bupropion-sr
|
Drug: 0 mg/day bupropion-sr
0 mg/day bupropion-sr
|
There is a high prevalence of cigarette smoking among people with schizophrenia and few smoking cessation interventions have been developed for these individuals. Bupropion is an antidepressant medication commonly used to treat smoking in smokers without psychiatric disorder. This study compares how smokers with schizophrenia and smokers without psychiatric illness respond to bupropion (0, 300 mg/day).
Participants will be randomly assigned to receive either bupropion or placebo. Study visits will occur after one-week treatment with placebo or bupropion. During study sessions, participants will come to the laboratory at 9 am and will remain abstinent in the laboratory for 5 hrs. Participants will then be assessed for craving and withdrawal symptoms after viewing and handling neutral cues and smoking cues. After that, participants will have a 90-min period to smoke, and smoking topography will be 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, RI | |
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-14002-2, R01-14002-2, DPMC |
Study First Received: | September 16, 2005 |
Last Updated: | August 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00218231 |
Health Authority: | United States: Federal Government |
schizophrenia tobacco dependence nicotine |
Nicotine polacrilex Schizophrenia Smoking Dopamine Nicotine Mental Disorders |
Tobacco Use Disorder Bupropion Substance-Related Disorders Disorders of Environmental Origin Psychotic Disorders Schizophrenia and Disorders with Psychotic Features |
Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses Physiological Effects of Drugs |
Psychotropic Drugs Dopamine Agents Antidepressive Agents, Second-Generation Central Nervous System Agents Pharmacologic Actions Antidepressive Agents |