A Comparison of Bupropion SR and Placebo for Smoking Cessation - Full Text View

Sponsor:	University of Maryland
Collaborator:	Department of Veterans Affairs
Information provided by:	University of Maryland
ClinicalTrials.gov Identifier:	NCT00176449

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Comparison of Bupropion SR and Placebo for Smoking Cessation

Resource links provided by NLM:

MedlinePlus related topics: Memory Quitting Smoking Schizophrenia Smoking

Drug Information available for: Bupropion hydrochloride Bupropion

U.S. FDA Resources

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)

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

Department of Veterans Affairs

Investigators

Principal Investigator:

Elaine E Weiner, MD

University of Maryland

More Information

Publications:

Weiner E, Ball MP, Summerfelt A, Gold J, Buchanan RW. Effects of sustained-release bupropion and supportive group therapy on cigarette consumption in patients with schizophrenia. Am J Psychiatry. 2001 Apr;158(4):635-7.

Responsible Party:	Maryland Psychiatric Research Center ( Elaine Weiner/ Principle Investigator )
Study ID Numbers:	2407ko
Study First Received:	September 13, 2005
Last Updated:	January 7, 2009
ClinicalTrials.gov Identifier:	NCT00176449 History of Changes
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:

Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Disease
Molecular Mechanisms of Pharmacological Action
Tobacco Use Disorder
Physiological Effects of Drugs
Psychotropic Drugs
Disorders of Environmental Origin
Pharmacologic Actions

Pathologic Processes
Mental Disorders
Therapeutic Uses
Bupropion
Substance-Related Disorders
Dopamine Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on November 09, 2009