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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00218218

Enrollment

Registered

2005-09-22

Start date

2002-06-30

Completion date

2005-02-28

Last updated

2017-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Nicotine Dependence, Tobacco Dependence

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.

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.

Interventions

DRUGTransdermal Nicotine Patch

42 mg transdermal nicotine

DRUG21 mg transdermal nicotine

DRUGplacebo patch

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame
Smoking behavior (measured by automated topography)	after 5 hrs abstinence

Secondary

Measure	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026