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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
51
Participants were randomly assigned to receive bupropion SR 150 mg or placebo, once daily for 7 days, then twice daily for 11 weeks.
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.
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.
Freedom Trail Clinic
Boston, Massachusetts, United States
seven-day point prevalence of smoking reduction, defined as 50 % reduction in serum cotinine levels compared to baseline
Time frame: end of treatment
continuous smoking reduction (50 % reduction in weekly expired air carbon monoxide (CO) measurements compared to baseline and self report)
Time frame: end of treatment
continuous tobacco abstinence (weekly expired CO measurements less than 9 ppm and self report)
Time frame: end of treatment
psychotic symptoms
Time frame: continuous and end of treatment
negative side effects
Time frame: continuous
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
measures of attention and memory while attempting to quit smoking
Time frame: end of treatment
health-related quality at the end of the 3-month treatment and 3-month follow-up phases
Time frame: continuous and end of treatment
weight gain at the end of the 3-month treatment and 3-month follow-up phases
Time frame: continuous and end of treatment
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