Official Title: “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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: February 2004

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.

Intervention(s) in this Clinical Trial

• 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.
• 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.
• 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.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: I
  • Experiment group received 300 mgs of bupropion, in addition to weekly CBT and nicotine replacement therapy
• Placebo Comparator: II
  • Placebo group received placebo, in addition to weekly CBT and nicotine replacement therapy

Primary Measures

• seven-day point prevalence of smoking reduction, defined as 50 % reduction in serum cotinine levels compared to baseline
  • Time Frame: end of treatment
    Safety Issue?: No

Secondary 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
    Safety Issue?: No
• continuous tobacco abstinence (weekly expired CO measurements less than 9 ppm and self report)
  • Time Frame: end of treatment
    Safety Issue?: No
• psychotic symptoms
  • Time Frame: continuous and end of treatment
    Safety Issue?: No
• negative side effects
  • Time Frame: continuous
    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
    Safety Issue?: No
• measures of attention and memory while attempting to quit smoking
  • Time Frame: end of treatment
    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
    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
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: National Institute on Drug Abuse (NIDA)

Overall Clinical Trial Officials and Contacts

A Eden Evins, MD, MPH Principal Investigator Massachusetts General Hospital  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00307203

Study ID Number: K23DA00510

ClinicalTrials.gov Identifier: NCT00307203

Health Authority: United States: Federal Government