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

National Institutes of Health (NIH)

Status and phase: Completed; Phase 4

Conditions: Psychotic Disorders; Schizophrenia; Tobacco-Use Disorder

Treatments: Drug: nicotine replacement therapy; Drug: bupropion SR; Behavioral: Cognitive Behavioral Group Therapy

Study type: Interventional

Funder types: NIH

Identifiers

NCT00307203

K23DA000510

DPMC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 51 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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51 participants in 2 patient groups, including a placebo group

I

Experimental group

Description:

Experiment group received 300 mgs of bupropion, in addition to weekly CBT and nicotine replacement therapy

Treatment:

Behavioral: Cognitive Behavioral Group Therapy

Drug: bupropion SR

Drug: nicotine replacement therapy

II

Placebo Comparator group

Description:

Placebo group received placebo, in addition to weekly CBT and nicotine replacement therapy

Treatment:

Behavioral: Cognitive Behavioral Group Therapy

Drug: nicotine replacement therapy