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

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ClinicalTrials.gov Identifier: NCT00218218
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : January 12, 2017
Information provided by:

September 16, 2005
September 22, 2005
January 12, 2017
June 2002
February 2005   (Final data collection date for primary outcome measure)
Smoking behavior (measured by automated topography) [ Time Frame: after 5 hrs abstinence ]
  • Craving
  • Withdrawal severity
  • Smoking Behavior
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 ]
  • Nicotine withdrawal severity [ Time Frame: after 5 hrs abstinence ]
  • Smoking urge [ Time Frame: after 5 hrs withdrawal ]
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.
Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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.
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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
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