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

Condition(s) targeted: Tobacco-Use Disorder; Schizophrenia; Psychotic Disorders

Intervention: SR Bupropion (Drug); Cognitive Behavioral Group Therapy (Behavioral)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: National Institute on Drug Abuse (NIDA)

Official(s) and/or principal investigator(s):
A Eden Evins, MD, MPH, Principal Investigator, Affiliation: Massachusetts General Hospital

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.

Official title: Nicotine and Smoking Cessation in Schizophrenia

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study

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

Secondary outcome:

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

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.

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Freedom Trail Clinic, Boston, Massachusetts 02114, United States

Starting date: August 1998
Last updated: January 15, 2008