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

Sponsor

National Institute on Drug Abuse (NIDA) (NIH)

Overall Status

Completed

CT.gov ID

NCT00218218

Collaborator

(none)

Enrollment

Locations

Arms

32.1

Duration (Months)

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia and Disorders With Psychotic Features Tobacco Use Disorder Schizophrenia	Drug: Transdermal Nicotine Patch Drug: 21 mg transdermal nicotine Drug: placebo patch	Phase 2

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Basic Science

Official Title:

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

Study Start Date :

Jun 1, 2002

Actual Primary Completion Date :

Feb 1, 2005

Actual Study Completion Date :

Feb 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Transdermal nicotine, 42 mg	Drug: Transdermal Nicotine Patch 42 mg transdermal nicotine Other Names: nicotine patch
Experimental: 2 Transdermal nicotine, 21 mg	Drug: 21 mg transdermal nicotine Other Names: nicotine patch
Placebo Comparator: 3 placebo patch	Drug: placebo patch

Arm

Intervention/Treatment

Experimental: 1

Transdermal nicotine, 42 mg

Drug: Transdermal Nicotine Patch

42 mg transdermal nicotine

Other Names:

nicotine patch

Experimental: 2

Transdermal nicotine, 21 mg

Drug: 21 mg transdermal nicotine

Other Names:

nicotine patch

Placebo Comparator: 3

placebo patch

Drug: placebo patch

Outcome Measures

Primary Outcome Measures

Smoking behavior (measured by automated topography) [after 5 hrs abstinence]

Secondary Outcome Measures

Adverse events (measured by self-report throughout the study) [ongoing]
Nicotine withdrawal severity [after 5 hrs abstinence]
Smoking urge [after 5 hrs withdrawal]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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