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Trial record 1 of 1 for:    NCT00176449
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A Comparison of Bupropion SR and Placebo for Smoking Cessation

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: NCT00176449
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : August 16, 2019
US Department of Veterans Affairs
Information provided by (Responsible Party):
Robert Buchanan, University of Maryland, Baltimore

Brief Summary:
The purpose of this study is to examine whether the adjunctive use of bupropion SR in the context of a psychoeducational program modified for people with schizophrenia might improve the likelihood of successful abstinence in this population. If bupropion SR is effective for reducing cigarette smoking, then it will be important to determine if decreased nicotine intake is associated with a worsening of psychotic, anxiety or depressive symptoms. In addition, it would be important to determine the effect that a reduction in nicotine stimulation would have on patient's cognitive functioning, as nicotinic receptors have been shown to regulate attention and memory function, and it is hypothesized that these functions are normalized by acute nicotine administration in people with schizophrenia

Condition or disease Intervention/treatment Phase
Tobacco Use Disorder Drug: Bupropion SR Drug: Placebo Oral Tablet Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Comparison of Bupropion SR and Placebo for Smoking Cessation
Study Start Date : April 2001
Actual Primary Completion Date : December 2005
Actual Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Bupropion SR Drug: Bupropion SR
150mg twice a day (starting with 150mg once a day for three days)

Placebo Comparator: Placebo Drug: Placebo Oral Tablet
Comparable placebo

Primary Outcome Measures :
  1. The Fagerstrom Test for Nicotine Dependence, expired CO level, and urine cotinine will be used to determine if bupropion SR, when used as an adjunct to antipsychotic medication, is superior to placebo for helping patients with schizophrenia improve their [ Time Frame: Expired CO weekly, Fagerstrom baseline and end of study, Urine cotinine baseline, week 2 and week 8 ]
  2. Neuropsychological testing will be used to determine the effects of smoking cessation on patient's attention and memory function. [ Time Frame: Beginning and end of study ]

Secondary Outcome Measures :
  1. BPRS, SANS, EPRS, and body weight will be used to determine the effects of bupropion SR and smoking cessation on patients' positive and negative symptoms, level of functioning, and physical health. [ Time Frame: Baseline, week 2, 4, 8, and 14 ]
  2. To determine whether responses to the Smoking Consequences Questionnaire, Change Assessment Scale, Temptation to Smoke Scale, Decisional Balance Scale, and Smoking Abstinence Self-Efficacy Scale correlate with successful smoking cessation. [ Time Frame: Beginning and end of study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Inclusion Criteria are:

    1. DSM-IV diagnosis of Schizophrenia or schizoaffective disorder
    2. Age: 18-64
    3. Regular half pack a day smokers
    4. Score of at least 4 on the Nicotine Dependency Test

      Exclusion Criteria:

      Exclusion Criteria are:

    1. Seizure disorders, other Neurologic illnesses, or a family history of seizures
    2. A medical condition that could manifest psychiatrically
    3. Currently experiencing a depressive episode
    4. Active substance abuse
    5. Currently receiving bupropion
    6. Pregnant women
    7. Children (<18 years of age)
    8. Two consecutive sodium levels of 130 mmol/L or less

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): NCT00176449

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United States, Maryland
Maryland Psychiatric REsearch Center
Catonsville, Maryland, United States, 21228
Sponsors and Collaborators
University of Maryland, Baltimore
US Department of Veterans Affairs
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Principal Investigator: Elaine E Weiner, MD University of Maryland, College Park
Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Robert Buchanan, Chief, Maryland Psychiatric Research Center, Outpatient Research Program, University of Maryland, Baltimore Identifier: NCT00176449    
Other Study ID Numbers: H-20763
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: August 16, 2019
Last Verified: August 2019
Keywords provided by Robert Buchanan, University of Maryland, Baltimore:
Nicotine Dependence
Nicotine Use Disorder
Tobacco Dependence
Tobacco-Use Disorder
Smoking Cessation
Additional relevant MeSH terms:
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Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors