Effects of Transdermal Nicotine on Smoking, Craving and Withdrawal in People With Schizophrenia

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Transdermal Nicotine and Bupropion for Smoking in Schizophrenics (Study 1)

Conditions
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Schizophrenia and Disorders With Psychotic Features, Tobacco Use Disorder, Schizophrenia

Intervention / Treatment
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* Drug: Transdermal Nicotine Patch
* Drug: 21 mg transdermal nicotine
* Drug: placebo patch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Smokes between 20 and 50 cigarettes per day Diagnosis of schizophrenia or schizoaffective disorder Exclusion Criteria: If enrolled in the control group, must not be diagnosed with a psychiatric disorder Currently dependent on alcohol or any drug (other than nicotine) Currently trying to quit smoking Currently taking bupropion, desipramine, clonidine, buspirone, or doxepin History of liver disease History of heart attacks or chest pain Allergic to adhesives Pregnant or breastfeeding

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Transdermal nicotine, 42 mg | Drug: Transdermal Nicotine Patch<br>* 42 mg transdermal nicotine<br>* Other names: nicotine patch;|
| Experimental: 2<br>Transdermal nicotine, 21 mg | Drug: 21 mg transdermal nicotine<br> <br> * Other names: nicotine patch;|
| Placebo Comparator: 3<br>placebo patch | Drug: placebo patch<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Smoking behavior (measured by automated topography) |  | after 5 hrs abstinence | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events (measured by self-report throughout the study) |  | ongoing | 
| Nicotine withdrawal severity |  | after 5 hrs abstinence | 
| Smoking urge |  | after 5 hrs withdrawal | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nicotine Dependence, Tobacco Dependence