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Safety and Effectiveness of Sustained Release Bupropion in Treating Individuals With Schizophrenia Who Smoke
This study has been completed.
Study NCT00307203   Information provided by National Institute on Drug Abuse (NIDA)
First Received: March 23, 2006   Last Updated: September 2, 2008   History of Changes

March 23, 2006
September 2, 2008
August 1998
February 2004   (final data collection date for primary outcome measure)
seven-day point prevalence of smoking reduction, defined as 50 % reduction in serum cotinine levels compared to baseline [ Time Frame: end of treatment ] [ Designated as safety issue: No ]
seven-day point prevalence of smoking reduction, defined as 50 % reduction in serum cotinine levels compared to baseline
Complete list of historical versions of study NCT00307203 on ClinicalTrials.gov Archive Site
  • continuous smoking reduction (50 % reduction in weekly expired air carbon monoxide (CO) measurements compared to baseline and self report) [ Time Frame: end of treatment ] [ Designated as safety issue: No ]
  • continuous tobacco abstinence (weekly expired CO measurements less than 9 ppm and self report) [ Time Frame: end of treatment ] [ Designated as safety issue: No ]
  • psychotic symptoms [ Time Frame: continuous and end of treatment ] [ Designated as safety issue: No ]
  • negative side effects [ Time Frame: continuous ] [ Designated as safety issue: Yes ]
  • negative and depressive symptoms compared to baseline at the end of the 3-month treatment and 3-month follow-up phases [ Time Frame: continuous and end of treatment ] [ Designated as safety issue: No ]
  • measures of attention and memory while attempting to quit smoking [ Time Frame: end of treatment ] [ Designated as safety issue: No ]
  • health-related quality at the end of the 3-month treatment and 3-month follow-up phases [ Time Frame: continuous and end of treatment ] [ Designated as safety issue: No ]
  • weight gain at the end of the 3-month treatment and 3-month follow-up phases [ Time Frame: continuous and end of treatment ] [ Designated as safety issue: No ]
  • continuous smoking reduction (50 % reduction in weekly expired air carbon monoxide (CO) measurements compared to baseline and self report)
  • continuous tobacco abstinence (weekly expired CO measurements less than 9 ppm and self report)
  • psychotic symptoms
  • negative side effects
  • negative and depressive symptoms compared to baseline at the end of the 3-month treatment and 3-month follow-up phases
  • measures of attention and memory while attempting to quit smoking
  • health-related quality at the end of the 3-month treatment and 3-month follow-up phases
  • weight gain at the end of the 3-month treatment and 3-month follow-up phases
 
Safety and Effectiveness of Sustained Release Bupropion in Treating Individuals With Schizophrenia Who Smoke
Nicotine and Smoking Cessation in Schizophrenia

Many individuals with schizophrenia smoke cigarettes. Individuals in the schizophrenic population often find it difficult to quit smoking. The purpose of this trial is to determine the safety and effectiveness of bupropion in treating individuals with schizophrenia who smoke.

Schizophrenia affects 1 % of the population. Among individuals with schizophrenia, between 74 and 92 % smoke cigarettes regularly. Heavy smoking represents a significant and neglected public health problem for people with schizophrenia; smoking cessation treatment is often overlooked as part of the psychiatric care for such individuals.

The most effective treatment for smoking cessation described to date is sustained release (SR) bupropion. Past research suggests that SR bupropion may be especially effective in individuals with depressive symptoms, including individuals with schizophrenia. The purpose of this trial is to evaluate the safety and efficacy of SR bupropion, when combined with cognitive behavioral therapy (CBT), in individuals with schizophrenia.

This trial will last 12 weeks. Participants will be randomly assigned to receive SR bupropion or placebo. All participants will receive weekly CBT. Participants will be followed for 3 months following completion of the 12-week treatment session.

Phase IV
Interventional
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
  • Tobacco-Use Disorder
  • Schizophrenia
  • Psychotic Disorders
  • Drug: bupropion SR
  • Behavioral: Cognitive Behavioral Group Therapy
  • Drug: nicotine replacement therapy
  • Experimental: Experiment group received 300 mgs of bupropion, in addition to weekly CBT and nicotine replacement therapy
  • Placebo Comparator: Placebo group received placebo, in addition to weekly CBT and nicotine replacement therapy
Evins AE, Cather C, Culhane MA, Birnbaum A, Horowitz J, Hsieh E, Freudenreich O, Henderson DC, Schoenfeld DA, Rigotti NA, Goff DC. A 12-week double-blind, placebo-controlled study of bupropion sr added to high-dose dual nicotine replacement therapy for smoking cessation or reduction in schizophrenia. J Clin Psychopharmacol. 2007 Aug;27(4):380-6.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
51
February 2004
February 2004   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Meets DSM-IV criteria for schizophrenia or schizoaffective disorder
  • Receiving a stable dose of antipsychotic medication for at least 1 month prior to study entry
  • Smokes at least 10 cigarettes per day
  • Wishes to stop smoking
  • Attended last three scheduled clinic visits, prior to study entry

Exclusion Criteria:

  • Significant medical or neurologic illness
  • History of severe head injury with loss of consciousness
  • Treated with monoamine oxidase inhibitors or carbamazepine in the 14 days prior to study entry
  • Taking clozapine at doses greater than 500 mg/d without an anticonvulsant
  • Currently undergoing an acute exacerbation of psychotic symptoms
  • Current or history of bulimia or anorexia
  • Current excessive water intake
  • Recent history of mania
  • Known allergy or hypersensitivity to bupropion
  • Current substance abuse other than tobacco, nicotine replacement treatment, or smokeless tobacco
  • Currently receiving treatment with bupropion
  • Pregnant or breastfeeding
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00307203
Ivan Montoya, NIDA
K23DA00510, DPMC
National Institute on Drug Abuse (NIDA)
 
Principal Investigator: A Eden Evins, MD, MPH Massachusetts General Hospital
National Institute on Drug Abuse (NIDA)
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP