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Safety and Effectiveness of Sustained Release Bupropion in Treating Individuals With Schizophrenia Who Smoke

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00307203
First Posted: March 27, 2006
Last Update Posted: January 11, 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.
Information provided by:
National Institute on Drug Abuse (NIDA)
  Purpose
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.

Condition Intervention Phase
Tobacco-Use Disorder Schizophrenia Psychotic Disorders Drug: bupropion SR Behavioral: Cognitive Behavioral Group Therapy Drug: nicotine replacement therapy Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Nicotine and Smoking Cessation in Schizophrenia

Resource links provided by NLM:


Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • seven-day point prevalence of smoking reduction, defined as 50 % reduction in serum cotinine levels compared to baseline [ Time Frame: end of treatment ]

Secondary Outcome Measures:
  • continuous smoking reduction (50 % reduction in weekly expired air carbon monoxide (CO) measurements compared to baseline and self report) [ Time Frame: end of treatment ]
  • continuous tobacco abstinence (weekly expired CO measurements less than 9 ppm and self report) [ Time Frame: end of treatment ]
  • psychotic symptoms [ Time Frame: continuous and end of treatment ]
  • negative side effects [ Time Frame: continuous ]
  • 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 ]
  • measures of attention and memory while attempting to quit smoking [ Time Frame: end of treatment ]
  • health-related quality at the end of the 3-month treatment and 3-month follow-up phases [ Time Frame: continuous and end of treatment ]
  • weight gain at the end of the 3-month treatment and 3-month follow-up phases [ Time Frame: continuous and end of treatment ]

Enrollment: 51
Study Start Date: August 1998
Study Completion Date: February 2004
Primary Completion Date: February 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: I
Experiment group received 300 mgs of bupropion, in addition to weekly CBT and nicotine replacement therapy
Drug: bupropion SR
Participants were randomly assigned to receive bupropion SR 150 mg or placebo, once daily for 7 days, then twice daily for 11 weeks.
Other Name: Zyban, Wellbutrin
Behavioral: Cognitive Behavioral Group Therapy
Participants attended a 12-session, 1-hour, weekly smoking cessation group program with 3 to 7 participants led by a psychologist with tobacco treatment specialist training. Subjects set a quit date, and nicotine patches (Habitrol) and nicotine polacrilex gum (Nicorette) were initiated in the fourth week.
Other Name: CBT
Drug: nicotine replacement therapy
Nicotine patch was dosed at 21 mg/d for 4 weeks, 14 mg/d for 2 weeks, and 7 mg/d for 2 weeks, then discontinued. Nicotine gum (2 mg) was distributed for use as needed for craving up to 18 mg/d.
Other Name: nicotine patch; nicotine gum
Placebo Comparator: II
Placebo group received placebo, in addition to weekly CBT and nicotine replacement therapy
Behavioral: Cognitive Behavioral Group Therapy
Participants attended a 12-session, 1-hour, weekly smoking cessation group program with 3 to 7 participants led by a psychologist with tobacco treatment specialist training. Subjects set a quit date, and nicotine patches (Habitrol) and nicotine polacrilex gum (Nicorette) were initiated in the fourth week.
Other Name: CBT
Drug: nicotine replacement therapy
Nicotine patch was dosed at 21 mg/d for 4 weeks, 14 mg/d for 2 weeks, and 7 mg/d for 2 weeks, then discontinued. Nicotine gum (2 mg) was distributed for use as needed for craving up to 18 mg/d.
Other Name: nicotine patch; nicotine gum

Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  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): NCT00307203


Locations
United States, Massachusetts
Freedom Trail Clinic
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: A Eden Evins, MD, MPH Massachusetts General Hospital
  More Information

Publications:
Responsible Party: Ivan Montoya, NIDA
ClinicalTrials.gov Identifier: NCT00307203     History of Changes
Other Study ID Numbers: K23DA000510 ( U.S. NIH Grant/Contract )
DPMC
First Submitted: March 23, 2006
First Posted: March 27, 2006
Last Update Posted: January 11, 2017
Last Verified: September 2008

Keywords provided by National Institute on Drug Abuse (NIDA):
Bupropion
Zyban
Wellbutrin
Smoking cessation
Schizophrenia
Schizoaffective disorder
Cognitive Behavioral Therapy

Additional relevant MeSH terms:
Disease
Schizophrenia
Psychotic Disorders
Mental Disorders
Tobacco Use Disorder
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Substance-Related Disorders
Chemically-Induced 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