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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-06-30

Study Completion Date

2005-02-28

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.

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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.

Conditions

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Schizophrenia and Disorders With Psychotic Features Tobacco Use Disorder Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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1

Transdermal nicotine, 42 mg

Group Type EXPERIMENTAL

Transdermal Nicotine Patch

Intervention Type DRUG

42 mg transdermal nicotine

2

Transdermal nicotine, 21 mg

Group Type EXPERIMENTAL

21 mg transdermal nicotine

Intervention Type DRUG

3

placebo patch

Group Type PLACEBO_COMPARATOR

placebo patch

Intervention Type DRUG

Interventions

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Transdermal Nicotine Patch

42 mg transdermal nicotine

Intervention Type DRUG

21 mg transdermal nicotine

Intervention Type DRUG

placebo patch

Intervention Type DRUG

Other Intervention Names

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nicotine patch nicotine patch

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes