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

This study has been completed.
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00218218
First received: September 16, 2005
Last updated: August 19, 2008
Last verified: August 2008

September 16, 2005
August 19, 2008
June 2002
February 2005   (final data collection date for primary outcome measure)
Smoking behavior (measured by automated topography) [ Time Frame: after 5 hrs abstinence ] [ Designated as safety issue: No ]
  • Smoking Behavior
  • Craving
  • Withdrawal severity
Complete list of historical versions of study NCT00218218 on ClinicalTrials.gov Archive Site
  • Adverse events (measured by self-report throughout the study) [ Time Frame: ongoing ] [ Designated as safety issue: Yes ]
  • Nicotine withdrawal severity [ Time Frame: after 5 hrs abstinence ] [ Designated as safety issue: No ]
  • Smoking urge [ Time Frame: after 5 hrs withdrawal ] [ Designated as safety issue: No ]
Adverse events
Not Provided
Not Provided
 
Effects of Transdermal Nicotine on Smoking, Craving and Withdrawal in People With Schizophrenia
Transdermal Nicotine and Bupropion for Smoking in Schizophrenics (Study 1)

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Basic Science
  • Schizophrenia and Disorders With Psychotic Features
  • Tobacco Use Disorder
  • Schizophrenia
  • Drug: Transdermal Nicotine Patch
    42 mg transdermal nicotine
    Other Name: nicotine patch
  • Drug: 21 mg transdermal nicotine
    Other Name: nicotine patch
  • Drug: placebo patch
  • Experimental: 1
    Transdermal nicotine, 42 mg
    Intervention: Drug: Transdermal Nicotine Patch
  • Experimental: 2
    Transdermal nicotine, 21 mg
    Intervention: Drug: 21 mg transdermal nicotine
  • Placebo Comparator: 3
    placebo patch
    Intervention: Drug: placebo patch
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
February 2005
February 2005   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00218218
NIDA-14002-1, R01-14002-1, DPMC
No
Jennifer W. Tidey, Brown University
National Institute on Drug Abuse (NIDA)
Not Provided
Principal Investigator: Jennifer W. Tidey Brown University
National Institute on Drug Abuse (NIDA)
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP