Improving Substance Use and Clinical Outcomes in Heavy Cannabis Users

改善重度大麻使用者的药物使用和临床结果

• 批准号: 7991192
• 负责人: SERGE SEVY
• 金额: $ 24.86万
• 依托单位: FEINSTEIN INSTITUTE FOR MEDICAL RESEARCH
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-07-01 至 2012-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7991192
• 关键词: Adverse effects; Alcohol or Other Drugs use; Antipsychotic Agents; Attenuated; Cannabis; Chronic; Clinical; Clinical Trials; Controlled Study; Data; Disease; Double-Blind Method; Effectiveness; Epidemiologic Studies; Frequencies; Future; Individual; Intervention; Knowledge; Long-Term Effects; Marijuana Dependence; Modeling; Moods; Outcome; Pharmaceutical Preparations; Pilot Projects; Placebos; Population; Psychotic Disorders; Randomized; Recommendation; Recording of previous events; Recurrence; Relative (related person); Reporting; Risk; Smoke; Smoking; Subgroup; Symptoms; Testing; Time; United States; atypical antipsychotic; base; comparative efficacy; craving; experience; functional outcomes; high risk; improved; outcome forecast; placebo controlled study; prevent; psychosocial; public health relevance; quetiapine; response; risk benefit ratio; sobriety

DESCRIPTION (provided by applicant): Cannabis is the most used illicit substance in the United States. Previous studies suggest that atypical antipsychotics decrease the frequency and the amount of substance use in subjects with and without psychotic illness. So far, there are no controlled studies assessing the effectiveness of atypical antipsychotics for decreasing cannabis and other substance use in individuals with cannabis use disorders. We postulate that the atypical antipsychotic quetiapine is an effective agent for improving substance use outcomes in subjects with cannabis use disorders. In this pilot study, we will test this hypothesis in heavy cannabis users (i.e., individuals who are cannabis dependent and smoke three times or more per week). Because 50% of these heavy cannabis users report histories of psychotic experiences (i.e., attenuated positive symptoms) while smoking and are at risk for recurring psychotic symptoms, we will focus this pilot clinical trial on this subgroup of cannabis users in order to increase the risk/benefit ratio of this study and target a population that may also benefit from the antipsychotic effect of quetiapine. Considering the lack of controlled studies assessing the efficacy of atypical antipsychotics in heavy cannabis users, assessing the effectiveness of an atypical antipsychotic medication on substance use and clinical outcomes in this population is critical for improving the prognosis of these individuals. Thus, the aims of this randomized, double-blind, placebo-controlled study are to assess the efficacy of an atypical antipsychotic (quetiapine) in 120 subjects with cannabis dependence, a recent history (within a year) of attenuated psychotic symptoms, and using cannabis 3 times or more per week for: (1) decreasing the use of cannabis and other substances; and (2) preventing the recurrence of psychotic experiences. We will also assess the effects of quetiapine on craving and mood, and its tolerability. This project will be a 12-week, randomized, double-blind, placebo-controlled study with quetiapine and it will include a comprehensive assessment of symptoms, substance use, and side effects. This study will benefit the field by providing unique data on the relative efficacy and tolerability of treatment with atypical antipsychotics in heavy cannabis users with a vulnerability to psychosis. This study will be the basis for future studies assessing the long-term efficacy and tolerability of atypical antipsychotics in individuals with cannabis use disorders. PUBLIC HEALTH RELEVANCE: Cannabis is the most used illicit substance in the United States, and there are no recommended pharmacological intervention for decreasing substance use and improving clinical outcomes in subjects with cannabis dependence. Thus, this study could have high public health relevance if it demonstrates the efficacy of an atypical antipsychotic for improving the prognosis of these individuals.

描述（由申请人提供）：大麻是美国使用最多的非法物质。以往的研究表明，非典型抗精神病药物减少的频率和数量的物质使用的受试者和无精神病。到目前为止，还没有对照研究评估非典型抗精神病药物对减少大麻和其他物质使用的有效性。我们假设非典型抗精神病药物奎替鲁是一种有效的药物，用于改善大麻使用障碍患者的药物使用结果。在这项试点研究中，我们将在重度大麻使用者中测试这一假设（即，大麻依赖者和每周吸烟三次或更多的人）。因为这些重度大麻使用者中有50%报告有精神病经历的历史（即，减弱的阳性症状），同时吸烟，并有复发精神病症状的风险，我们将把这项试点临床试验集中在大麻使用者的这一亚组，以增加这项研究的风险/效益比，并针对也可能受益于奎替鲁的抗精神病作用的人群。考虑到缺乏评估非典型抗精神病药物在重度大麻使用者中疗效的对照研究，评估非典型抗精神病药物对该人群物质使用和临床结局的有效性对于改善这些个体的预后至关重要。 因此，本随机、双盲、安慰剂对照研究的目的是评估非典型抗精神病药的疗效（quetiabine）在120例大麻依赖受试者中，（一年内）精神病症状减弱，每周使用大麻3次或以上，用于：（1）减少大麻和其他物质的使用;（2）预防精神病经历的复发。我们还将评估quetioline对渴望和情绪的影响，以及它的耐受性。该项目将是一项为期12周，随机，双盲，安慰剂对照的研究，其中包括对症状，物质使用和副作用的综合评估。 这项研究将通过提供关于非典型抗精神病药物治疗易患精神病的重度大麻使用者的相对疗效和耐受性的独特数据而使该领域受益。这项研究将是未来研究的基础，评估非典型抗精神病药物在大麻使用障碍患者中的长期疗效和耐受性。 公共卫生相关性：大麻是美国使用最多的非法物质，没有推荐的药物干预措施来减少大麻依赖受试者的物质使用和改善临床结局。因此，这项研究可能有很高的公共卫生相关性，如果它证明了一种非典型抗精神病药物的疗效，改善这些人的预后。