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| ID | Type | Description | Link |
|---|---|---|---|
| R01-14002-1 | |||
| DPMC |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Transdermal nicotine, 42 mg |
|
| 2 | Experimental | Transdermal nicotine, 21 mg |
|
| 3 | Placebo Comparator | placebo patch |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transdermal Nicotine Patch | Drug | 42 mg transdermal nicotine |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Smoking behavior (measured by automated topography) | after 5 hrs abstinence |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events (measured by self-report throughout the study) | ongoing | |
| Nicotine withdrawal severity | after 5 hrs abstinence | |
| Smoking urge |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer W. Tidey | Brown University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Providence VA Medical Center | Providence | Rhode Island | 02908 | United States | ||
| Brown University |
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| 21 mg transdermal nicotine | Drug |
|
|
| placebo patch | Drug |
|
| after 5 hrs withdrawal |
| Providence |
| Rhode Island |
| 02912 |
| United States |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D014029 | Tobacco Use Disorder |
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
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| ID | Term |
|---|---|
| D061485 | Tobacco Use Cessation Devices |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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