Clinical trial NCT00218218: Effects of Transdermal Nicotine on Smoking, Craving and Withdrawal in People With Schizophrenia
Official title: Transdermal Nicotine and Bupropion for Smoking in Schizophrenics (Study 1)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Schizophrenia and Disorders With Psychotic Features
Tobacco Use Disorder
Schizophrenia
Keywords: Nicotine Dependence
Tobacco Dependence
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
First posted: 2005-09-22
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Smoking behavior (measured by automated topography)
timeFrame: after 5 hrs abstinence
Secondary outcomes:
measure: Adverse events (measured by self-report throughout the study)
timeFrame: ongoing
measure: Nicotine withdrawal severity
timeFrame: after 5 hrs abstinence
measure: Smoking urge
timeFrame: after 5 hrs withdrawal
Other outcomes:
Locations:
city: Providence
country: United States
facility: Providence VA Medical Center
state: Rhode Island
city: Providence
country: United States
facility: Brown University
state: Rhode Island
Study officials:
affiliation: Brown University
name: Jennifer W. Tidey
role: PRINCIPAL_INVESTIGATOR
References: