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(申请人提供)：大麻是美国最常用的非法物质。以前的研究表明，非典型抗精神病药物减少了患有和不患有精神病的受试者的药物使用频率和数量。到目前为止，还没有评估非典型抗精神病药物在减少大麻使用障碍个人的大麻和其他物质使用方面的有效性的对照研究。我们推测，非典型抗精神病药物奎硫平是改善大麻使用障碍受试者物质使用结果的有效药物。在这项初步研究中，我们将在大量吸食大麻的人(即依赖大麻并每周吸烟三次或三次以上的人)中测试这一假设。由于这些大量吸食大麻的人中有50%报告在吸烟时有精神病经历(即阳性症状减轻)，并有复发精神病症状的风险，因此我们将把这项试点临床试验集中在这一亚群的大麻使用者身上，以提高这项研究的风险/收益比，并针对可能也受益于奎硫平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的疗效的对照研究，评估非典型抗精神病药物在这一人群中的药物使用和临床结果的有效性对于改善这些人的预后至关重要。因此，这项随机、双盲、安慰剂对照研究的目的是评估120名有大麻依赖史、近期精神症状减轻(一年内)、每周使用大麻3次或以上的非典型抗精神病药物(奎硫平)的疗效，目的是：(1)减少大麻和其他物质的使用；以及(2)防止精神病经历的复发。我们还将评估奎硫平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周的、随机、双盲、安慰剂对照的奎硫平研究，它将包括对症状、物质使用和副作用的全面评估。这项研究将通过提供关于易患精神病的重度大麻使用者非典型抗精神病药物治疗的相对有效性和耐受性的独特数据，使该领域受益。这项研究将为未来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的研究奠定基础。 与公共卫生相关：大麻是美国使用最多的非法物质，没有推荐的药理学干预措施来减少大麻依赖受试者的药物使用并改善临床结果。因此，如果这项研究证明了非典型抗精神病药物对改善这些人的预后的有效性，那么它可能具有很高的公共卫生相关性。