Nicotine and Smoking Cessation in Schizophrenia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- seven-day point prevalence of smoking reduction, defined as 50 % reduction in serum cotinine levels compared to baseline
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
I
Experiment group received 300 mgs of bupropion, in addition to weekly CBT and nicotine replacement therapy
干预措施: bupropion SR (Drug)
I
Experiment group received 300 mgs of bupropion, in addition to weekly CBT and nicotine replacement therapy
干预措施: Cognitive Behavioral Group Therapy (Behavioral)
I
Experiment group received 300 mgs of bupropion, in addition to weekly CBT and nicotine replacement therapy
干预措施: nicotine replacement therapy (Drug)
II
Placebo group received placebo, in addition to weekly CBT and nicotine replacement therapy
干预措施: Cognitive Behavioral Group Therapy (Behavioral)
II
Placebo group received placebo, in addition to weekly CBT and nicotine replacement therapy
干预措施: nicotine replacement therapy (Drug)
结局指标
主要结局
seven-day point prevalence of smoking reduction, defined as 50 % reduction in serum cotinine levels compared to baseline
时间窗: end of treatment
次要结局
- 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)