Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00307203
First received: March 23, 2006
Last updated: September 2, 2008
Last verified: September 2008
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

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 ] [ 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 ]

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00307203

Locations
United States, Massachusetts
Freedom Trail Clinic
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
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: K23DA00510, DPMC
Study First Received: March 23, 2006
Last Updated: September 2, 2008
Health Authority: United States: Federal Government

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
Mental Disorders
Psychotic Disorders
Schizophrenia
Tobacco Use Disorder
Chemically-Induced Disorders
Pathologic Processes
Schizophrenia and Disorders with Psychotic Features
Substance-Related Disorders
Bupropion
Nicotine
Antidepressive Agents
Antidepressive Agents, Second-Generation
Autonomic Agents
Central Nervous System Agents
Cholinergic Agents
Cholinergic Agonists
Dopamine Agents
Dopamine Uptake Inhibitors
Ganglionic Stimulants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Nicotinic Agonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014