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

Sponsor

National Institute on Drug Abuse (NIDA) (NIH)

Overall Status

Completed

CT.gov ID

NCT00307203

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Tobacco-Use Disorder Schizophrenia Psychotic Disorders	Drug: bupropion SR Behavioral: Cognitive Behavioral Group Therapy Drug: nicotine replacement therapy	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

51 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

Nicotine and Smoking Cessation in Schizophrenia

Study Start Date :

Aug 1, 1998

Actual Primary Completion Date :

Feb 1, 2004

Actual Study Completion Date :

Feb 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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 Names: 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 Names: 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 Names: 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 Names: nicotine patch; nicotine gum

Arm

Intervention/Treatment

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 Names:

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 Names:

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 Names:

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

Other Names:

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 Names:

nicotine patch; nicotine gum

Outcome Measures

Primary Outcome Measures

seven-day point prevalence of smoking reduction, defined as 50 % reduction in serum cotinine levels compared to baseline [end of treatment]

Secondary Outcome Measures

continuous smoking reduction (50 % reduction in weekly expired air carbon monoxide (CO) measurements compared to baseline and self report) [end of treatment]
continuous tobacco abstinence (weekly expired CO measurements less than 9 ppm and self report) [end of treatment]
psychotic symptoms [continuous and end of treatment]
negative side effects [continuous]
negative and depressive symptoms compared to baseline at the end of the 3-month treatment and 3-month follow-up phases [continuous and end of treatment]
measures of attention and memory while attempting to quit smoking [end of treatment]
health-related quality at the end of the 3-month treatment and 3-month follow-up phases [continuous and end of treatment]
weight gain at the end of the 3-month treatment and 3-month follow-up phases [continuous and end of treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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