Effect of Bupropion on Smoking Behavior in Smokers 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: NCT00218231
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:
Many individuals with schizophrenia smoke cigarettes but little is known about the factors that control smoking in people with schizophrenia. The purpose of this trial is to evaluate how bupropion, an antidepressant medication, affects smoking behaviors in individuals with schizophrenia who smoke.

Condition or disease Intervention/treatment Phase
Schizophrenia Tobacco Use Disorder Drug: 300 mg/day bupropion-sr Drug: 0 mg/day bupropion-sr Phase 2

Detailed Description:

There is a high prevalence of cigarette smoking among people with schizophrenia and few smoking cessation interventions have been developed for these individuals. Bupropion is an antidepressant medication commonly used to treat smoking in smokers without psychiatric disorder. This study compares how smokers with schizophrenia and smokers without psychiatric illness respond to bupropion (0, 300 mg/day).

Participants will be randomly assigned to receive either bupropion or placebo. Study visits will occur after one-week treatment with placebo or bupropion. During study sessions, participants will come to the laboratory at 9 am and will remain abstinent in the laboratory for 5 hrs. Participants will then be assessed for craving and withdrawal symptoms after viewing and handling neutral cues and smoking cues. After that, participants will have a 90-min period to smoke, and smoking topography will be measured.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Transdermal Nicotine and Bupropion-SR in Schizophrenics (Study 2)
Study Start Date : January 2004
Actual Primary Completion Date : August 2006
Actual Study Completion Date : August 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
300 mg/day bupropion-sr
Drug: 300 mg/day bupropion-sr
300 mg/day for 1 week
Other Name: zyban, wellbutrin
Placebo Comparator: 2
0 mg bupropion-sr
Drug: 0 mg/day bupropion-sr
0 mg/day bupropion-sr
Other Name: placebo

Primary Outcome Measures :
  1. Smoking behavior [ Time Frame: after 5 hrs abstinence ]

Secondary Outcome Measures :
  1. Adverse events [ Time Frame: ongoing ]
  2. urge to smoke [ Time Frame: after 5 hrs abstinence ]
  3. nicotine withdrawal symptoms [ 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, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Diagnosed with schizophrenia or schizo-affective disorder
  • Smokes between 20 and 50 cigarettes per day
  • Moderate to high nicotine dependence score
  • Interest in quitting smoking

Exclusion Criteria:

  • Currently trying to quit smoking
  • Seizure disorder or lowered seizure threshold due to anorexia, bulimia, head trauma, diabetes with insulin, or hypoglycemics
  • Alcohol or drug use disorders
  • Requires certain medications
  • 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): NCT00218231

United States, Rhode Island
Providence VA Medical Center, RI
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: NCT00218231     History of Changes
Other Study ID Numbers: NIDA-14002-2
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):
tobacco dependence

Additional relevant MeSH terms:
Tobacco Use Disorder
Schizophrenia Spectrum and Other Psychotic Disorders
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
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Agents
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors