We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Comparison of Bupropion SR and Placebo for Smoking Cessation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00176449
First Posted: September 15, 2005
Last Update Posted: April 4, 2017
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.
Collaborator:
VA Office of Research and Development
Information provided by (Responsible Party):
Robert W. Buchanan, University of Maryland
  Purpose
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 Intervention Phase
Tobacco Use Disorder Drug: Bupropion SR Drug: Placebo Oral Tablet Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Robert W. Buchanan, University of Maryland:

Primary Outcome Measures:
  • 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 ]
  • 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:
  • 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 ]
  • 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 ]

Enrollment: 52
Study Start Date: April 2001
Study Completion Date: December 2005
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00176449


Locations
United States, Maryland
Maryland Psychiatric REsearch Center
Catonsville, Maryland, United States, 21228
Sponsors and Collaborators
University of Maryland
VA Office of Research and Development
Investigators
Principal Investigator: Elaine E Weiner, MD University of Maryland
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Robert W. Buchanan, Chief, Maryland Psychiatric Research Center, Outpatient Research Program, University of Maryland
ClinicalTrials.gov Identifier: NCT00176449     History of Changes
Other Study ID Numbers: 2407ko
First Submitted: September 13, 2005
First Posted: September 15, 2005
Last Update Posted: April 4, 2017
Last Verified: March 2017

Keywords provided by Robert W. Buchanan, University of Maryland:
Nicotine Dependence
Nicotine Use Disorder
Tobacco Dependence
Tobacco-Use Disorder
Smoking Cessation

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Nicotine
Bupropion
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