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

National Institutes of Health (NIH)

Status and phase: Completed; Phase 2

Conditions: Tobacco Use Disorder; Schizophrenia; Schizophrenia and Disorders With Psychotic Features

Treatments: Drug: placebo patch; Drug: 21 mg transdermal nicotine; Drug: Transdermal Nicotine Patch

Study type: Interventional

Funder types: NIH

Identifiers

NCT00218218

R01-14002-1

NIDA-14002-1

DPMC

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 48 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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48 participants in 3 patient groups, including a placebo group

1

Experimental group

Description:

Transdermal nicotine, 42 mg

Treatment:

Drug: Transdermal Nicotine Patch

2

Experimental group

Description:

Transdermal nicotine, 21 mg

Treatment:

Drug: 21 mg transdermal nicotine

3

Placebo Comparator group

Description:

placebo patch

Treatment:

Drug: placebo patch