Varenicline and Smoking Cessation in Schizophrenia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Smoking Abstinence - Serum/Urine Measurements
研究概览
简要总结
There is a strong association between smoking and schizophrenia with prevalence rates ranging from 74% to 90%, versus a national average of 30% in nonschizophrenic individuals. A number of hypotheses have been proposed to explain the relationship between high smoking rates and schizophrenia, mostly relating to self-medication primarily for the negative symptoms of schizophrenia. Smoking cessation rates among schizophrenic patients are considerably lower than for other psychiatric disorders. The negative health effects of smoking increase the morbidity and mortality in schizophrenic patients. Currently, the efficacy of bupropion HCl in the treatment of smoking by schizophrenic subjects is inconclusive, and there have not been any published studies of the efficacy of varenicline in schizophrenic subjects. As varenicline appears to be a promising treatment in non-psychiatric patients, it would be useful to expand these studies to examine its effects in schizophrenic patients. Identifying effective and safe means of smoking cessation for this vulnerable population has the potential to reduce morbidity and mortality among individuals with schizophrenia.
详细描述
There is a strong association between smoking and schizophrenia with prevalence rates ranging from 74% to 90%, versus a national average of 30% in nonschizophrenic individuals. A number of hypotheses have been proposed to explain the relationship between high smoking rates and schizophrenia, mostly relating to self-medication primarily for the negative symptoms of schizophrenia. Smoking cessation rates among schizophrenic patients are considerably lower than for other psychiatric disorders. The negative health effects of smoking increase the morbidity and mortality in schizophrenic patients. The smoking cessation agent bupropion HCl has been tested in schizophrenics, but the results on its efficacy are inconclusive. Recent works by different laboratories have shown the safety and efficacy of varenicline, a partial alpha4beta2 and full alpha7 nicotinic acetylcholine receptor agonist, as a smoking cessation agent. However, to date, no published studies have tested the safety and efficacy of varenicline in treatment of nicotine dependence in schizophrenic patients. As varenicline appears to be a promising treatment in non-psychiatric patients, it would be beneficial to examine its effects in schizophrenic patients. The central hypothesis of this application is that treatment with varenicline will safely increase smoking abstinence rates in schizophrenic patients when compared to those receiving placebo. This central hypothesis will be tested and the objectives of this application accomplished by pursuing two Specific Aims: 1) Treatment with varenicline or bupropion HCl for a period of three months will increase smoking abstinence rates in schizophrenic patents when compared to placebo; and 2) Treatment with varenicline or bupropion HCl for a period of three months will not increase psychosis in schizophrenic patients when compared to placebo. For our General Investigational Plan, we will employ a double-blind randomized placebo controlled study to assess varenicline's safety and efficacy. It is our expectation that we will demonstrate that varenicline is safe and effective in decreasing smoking rates in schizophrenic patients without exacerbating psychotic symptoms. Such outcomes will be significant, because they will offer a new treatment for smoking cessation in this vulnerable population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects, 18-75 years old
- •Diagnosis of schizophrenia or schizoaffective disorder based on Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV) criteria
- •Smoking at least 10 cigarettes per day
- •Weight of at least 100 lbs (45.4 kg)
- •Motivation to quit smoking
- •Stabilized psychotic symptoms
- •Provision of informed consent for testing and treatment
排除标准
- •Serious cardiac, renal, hypertensive, pulmonary, endocrine, or neurologic disorder
- •Seizure disorder, recent withdrawal from alcohol or anxiolytics
- •History of bulimia nervosa, anorexia nervosa, or dementia
- •History of depression, panic, or bipolar disorders
- •Pregnancy or lactation
- •Prior use of varenicline or bupropion HCl within three months prior to initiation of the study
- •Current use of other smoking cessation treatments
- •Regular use of non-cigarette tobacco products (> than once/week)
- •Past substance abuse (alcohol or non-nicotine containing drugs) in the preceding 6 months
- •Patients with suicidal ideations or plans
- •Florid psychosis or increasing psychosis following varenicline or bupropion HCl treatment
- •History of, or current, alcohol dependence/abuse
- •Current use of monoamine oxidase inhibitors (MAOI)
研究组 & 干预措施
Sugar Pill
Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.
干预措施: Sugar Pill (Other)
Varenicline
Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.
干预措施: Varenicline (Drug)
Bupropion HCl
Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.
干预措施: Bupropion HCl (Drug)
结局指标
主要结局
Smoking Abstinence - Serum/Urine Measurements
时间窗: Week 12
Measured by blood/urine tests for nicotine and its break-down product cotinine.
Smoking Abstinence - Number of Cigarettes Smoked
时间窗: Week 12
Number of cigarettes smoked at week 12 of the study by self-report.
Smoking Abstinence - Exhaled Carbon Monoxide
时间窗: Week 12
Exhaled carbon monoxide as a biochemical verification of smoking abstinence. Values below are for week 12.
次要结局
- Reduction in Smoking(Week 12)
- Negative Symptoms of Schizophrenia - SANS(Week 12)
- Abnormal Movements - BAS and SAS(Week 12)
- Vital Signs - Pulse(Week 12)
- Depression(Week 12)
- Positive Symptoms of Schizophrenia (SAPS)(Week 12)
- General Psychopathology(Week 12)
- Variability of Standard Error - CPT(Week 12)
- Detectibility (d') of Continuous Performance Test(Week 12)
- Impulsivity and Inattention(Week 12)
- Vital Signs(Week 12)
- Side Effects(Week 12)
- Abstinence-related Symptoms - MNWS and FTND(Week 12)
- Vital Signs - Weight(Week 12)
- Suicidality(Week 12)
- Hit Reaction Time - CPT(Week 12)
- Response Style Indicator (Beta) for CPT(Week 12)
- Abstinence Related Symptoms - WISDM(Week 12)
- Urge to Smoke - MNWS(Week 12)
- Abnormal Movements - AIMS(Week 12)