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

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00218218
• Other study ID #: NIDA-14002-1
• Secondary ID: R01-14002-1DPMC
• Status: Completed
• Phase: Phase 2
• First received: September 16, 2005
• Last updated: January 11, 2017
• Start date: June 2002
• Est. completion date: February 2005

Study information

• Verified date: August 2008
• Source: National Institute on Drug Abuse (NIDA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: February 2005
• Est. primary completion date: February 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Disease
• Schizophrenia
• Schizophrenia and Disorders With Psychotic Features
• Schizophrenia Spectrum and Other Psychotic Disorders
• Tobacco Use Disorder

Intervention

Drug:
• Transdermal Nicotine Patch
42 mg transdermal nicotine
• 21 mg transdermal nicotine

• placebo patch

Locations

Country	Name	City	State
United States	Brown University	Providence	Rhode Island
United States	Providence VA Medical Center	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Smoking behavior (measured by automated topography)		after 5 hrs abstinence	No
Secondary	Adverse events (measured by self-report throughout the study)		ongoing	Yes
Secondary	Nicotine withdrawal severity		after 5 hrs abstinence	No
Secondary	Smoking urge		after 5 hrs withdrawal	No