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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00218218
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : January 12, 2017
Information provided by:
National Institute on Drug Abuse (NIDA)

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.

Condition or disease Intervention/treatment Phase
Schizophrenia and Disorders With Psychotic Features Tobacco Use Disorder Schizophrenia Drug: Transdermal Nicotine Patch Drug: 21 mg transdermal nicotine Drug: placebo patch Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Transdermal Nicotine and Bupropion for Smoking in Schizophrenics (Study 1)
Study Start Date : June 2002
Actual Primary Completion Date : February 2005
Actual Study Completion Date : February 2005

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
Transdermal nicotine, 42 mg
Drug: Transdermal Nicotine Patch
42 mg transdermal nicotine
Other Name: nicotine patch

Experimental: 2
Transdermal nicotine, 21 mg
Drug: 21 mg transdermal nicotine
Other Name: nicotine patch

Placebo Comparator: 3
placebo patch
Drug: placebo patch

Primary Outcome Measures :
  1. Smoking behavior (measured by automated topography) [ Time Frame: after 5 hrs abstinence ]

Secondary Outcome Measures :
  1. Adverse events (measured by self-report throughout the study) [ Time Frame: ongoing ]
  2. Nicotine withdrawal severity [ Time Frame: after 5 hrs abstinence ]
  3. Smoking urge [ Time Frame: after 5 hrs withdrawal ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00218218

United States, Rhode Island
Providence VA Medical Center
Providence, Rhode Island, United States, 02908
Brown University
Providence, Rhode Island, United States, 02912
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
Principal Investigator: Jennifer W. Tidey Brown University

Responsible Party: Jennifer W. Tidey, Brown University Identifier: NCT00218218     History of Changes
Other Study ID Numbers: NIDA-14002-1
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: January 12, 2017
Last Verified: August 2008

Keywords provided by National Institute on Drug Abuse (NIDA):
Nicotine Dependence
Tobacco Dependence

Additional relevant MeSH terms:
Tobacco Use Disorder
Schizophrenia Spectrum and Other Psychotic Disorders
Pathologic Processes
Mental Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action