Risperidone Long-Acting for Alcohol and Schizophrenia Treatment (R-LAST)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 95
- 试验地点
- 8
- 主要终点
- Change Over Time in Frequency of Heavy Drinking Days (Used to Evaluate Treatment Efficacy)
研究概览
简要总结
The purpose of this study is to compare the efficacy of oral risperidone (Risperdal) to risperidone long-acting (Consta) in reducing alcohol use in persons diagnosed with schizophrenia or schizoaffective disorder.
详细描述
Comorbid alcohol/substance use disorder (SUD) in people with schizophrenia is a major concern, both in view of the high frequency of SUD among patients with schizophrenia and the difficulty in managing such patients. Though antipsychotic medications are effective in reducing symptoms and impairment in persons with schizophrenia, the typical antipsychotic agents are of limited value in controlling alcohol/substance use in these patients. Extrapyramidal, dysphoric side effects of conventional neuroleptics may actually promote the use of substances in an attempt to counteract these effects. In addition, medication non-compliance is common among patients with schizophrenia.
Novel antipsychotics have altered treatment expectations and outcomes for patients with severe forms of schizophrenia. A growing number of studies have assessed the effects of oral risperidone in persons with dual disorders. Potential mechanisms of action by which risperidone and other atypical antipsychotics could decrease substance use include being less likely to cause extrapyramidal side effects than typical agents, improving negative symptoms and ameliorating a dysfunction of the brain reward system. Risperidone long-acting injectable medication addresses issues of noncompliance, while avoiding peak blood levels of oral preparations, thereby minimizing EPS and improving negative symptoms of schizophrenia. Risperidone may also facilitate dopamine neurotransmission in the prefrontal cortex and correct a hypothesized dysfunction of the brain reward system.
This study is an open, randomized, controlled study to compare intramuscular long-acting risperidone to oral risperidone with blinded ratings to determine whether the long-acting form of risperidone has greater efficacy in reducing substance use. Patients with schizophrenia or schizoaffective disorder, age 18 to 65, who are taking any single oral antipsychotic medication except clozapine or risperidone long-acting may be enrolled.
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
- None
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
- 否
入选标准
- •Ages 18-65
- •Schizophrenia or schizoaffective disorder
- •Meets the Structured Clinical Interview for DSM-IV (SCID) criteria for an alcohol use disorder
- •Alcohol use on at least 5 days during the 4 weeks prior to randomization
- •Patient is medically stable to start either form of risperidone.
排除标准
- •Current treatment with clozapine.
- •Current treatment with injectable risperidone long-acting.
- •Currently pregnant, planning to become pregnant, or unwilling to use an acceptable form of birth control.
- •Change in medications (dose of current medication, discontinuation of medication, or new medication) in past 30 days.
- •History of or current breast cancer.
- •History of intolerance of or allergy to risperidone or risperidone long-acting.
- •Currently residing in a residential program designed to treat substance use disorders.
- •Current treatment with long-acting, injectable antipsychotic medication will require a review by the medication adjustment group before entering the client into the study.
- •Past treatment with risperidone long-acting will require a review by the medication adjustment group before entering the client into the study.
- •Treatment at baseline with a second antipsychotic medication will require a review by the medication adjustment group before entering the client into the study.
- •Treatment at baseline with a psychotropic agent proposed to curtail substance use will require a review by the medication adjustment group before entering the client into the study.
- •Patients who, in the opinion of the investigator, are judged unsuitable to participate in the study.
研究组 & 干预措施
Risperidone Long Acting
Risperidone Long Acting; aka Risperdal Consta; injectable form
干预措施: Risperidone Long Acting (Drug)
Oral Risperidone
Oral Risperidone; aka Risperdal; oral form
干预措施: oral risperidone (Drug)
结局指标
主要结局
Change Over Time in Frequency of Heavy Drinking Days (Used to Evaluate Treatment Efficacy)
时间窗: 6 months
Frequency of heavy drinking days is obtained each week retrospectively as the number of heavy drinking days during the prior week (assessed by the Timeline Followback Scale). A heavy drinking day is defined as 4 or more drinks per day for a female and 5 or more drinks per day for a male. Mixed models are used to obtain estimates of efficacy from the partial data provided by each subject while adherent to assigned treatment (under the 'missing at random' assumption). The 'explanatory' estimands (target of the mixed model estimation) are defined in terms of population quantities that would have occurred had all subjects remained on assigned treatment throughout the study. The point estimate for each arm is reported under Number.
次要结局
- Average Over Time of Frequency of Drinking Days (Used to Evaluate Treatment Efficacy)(6 months)
- Average Over Time of Positive and Negative Symptoms (Used to Evaluate Treatment Efficacy)(6 months)
- Average Over Time of Global Functioning (Used to Evaluate Treatment Efficacy)(6 months)
- Number of Participants With Medication Adherence(6 months)
- Average Over Time of Severity of Illness and Global Improvement (Used to Evaluate Treatment Efficacy)(6 months)
研究者
Alan Green
Principal Investigator
Dartmouth-Hitchcock Medical Center