A Comparison of Bupropion SR and Placebo for Smoking Cessation

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Robert W. Buchanan, M.D., University of Maryland
ClinicalTrials.gov Identifier:
NCT00176449
First received: September 13, 2005
Last updated: January 18, 2013
Last verified: January 2013
  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
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]

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
Placebo Comparator: Placebo

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00176449

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

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Robert W. Buchanan, M.D., Chief, Maryland Psychiatric Research Center, Outpatient Research Program, University of Maryland
ClinicalTrials.gov Identifier: NCT00176449     History of Changes
Other Study ID Numbers: 2407ko
Study First Received: September 13, 2005
Last Updated: January 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Maryland:
Nicotine Dependence
Nicotine Use Disorder
Tobacco Dependence
Tobacco-Use Disorder
Smoking Cessation

Additional relevant MeSH terms:
Smoking
Tobacco Use Disorder
Habits
Substance-Related Disorders
Mental Disorders
Bupropion
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014