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Completed

NCT Number: NCT00307203

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

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.

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Key information

Conditions

Tobacco-Use Disorder Behavior Chemically-Induced Disorders Health Behavior Mental Disorders Psychotic Disorders Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Smoking Cessation Substance-Related Disorders Tobacco Use Disorder

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Freedom Trail Clinic

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bupropion SR

Drug

Participants were randomly assigned to receive bupropion SR 150 mg or placebo, once daily for 7 days, then twice daily for 11 weeks.

Other names: Zyban, Wellbutrin

cognitive behavioral group therapy

Behavioral

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 names: CBT

Nicotine Replacement Therapy

Drug

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 names: nicotine patch; nicotine gum

Primary outcomes

  1. seven-day point prevalence of smoking reduction, defined as 50 % reduction in serum cotinine levels compared to baseline

    Time frame: end of treatment

Secondary outcomes

  1. continuous smoking reduction (50 % reduction in weekly expired air carbon monoxide (CO) measurements compared to baseline and self report)

    Time frame: end of treatment

  2. continuous tobacco abstinence (weekly expired CO measurements less than 9 ppm and self report)

    Time frame: end of treatment

  3. psychotic symptoms

    Time frame: continuous and end of treatment

  4. negative side effects

    Time frame: continuous

  5. 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

  6. measures of attention and memory while attempting to quit smoking

    Time frame: end of treatment

  7. health-related quality at the end of the 3-month treatment and 3-month follow-up phases

    Time frame: continuous and end of treatment

  8. weight gain at the end of the 3-month treatment and 3-month follow-up phases

    Time frame: continuous and end of treatment

Sponsors and collaborators

Lead sponsor

National Institute on Drug Abuse (NIDA)

Nih

Registry information

Official study title

Nicotine and Smoking Cessation in Schizophrenia

Important dates

Study start
1998
Primary completion
2004
Study completion
2004
First posted
Mar 27, 2006
Registry last updated
Jan 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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