Sativex associated with behavioural-prevention relapse strategy as treatment for

描述(申请人提供)：大麻是世界上和美国使用最广泛的非法药物。目前，还没有找到治疗大麻依赖的有效药物治疗方法。在这里，我们将首次在一项试点研究中评估使用大麻类药物(Sativex(R)；在加拿大被批准用于医疗用途)作为大麻依赖替代疗法的可能性。我们研究的目的是：i)比较接受12周Sativex(R)喷雾剂联合动机增强疗法和认知行为治疗(MET/CBT)干预的受试者与接受12周安慰剂喷雾联合MET/CBT干预的受试者的大麻使用情况；ii)比较接受12周Sativex(R)喷雾剂联合MET/CBT干预的受试者与接受12周安慰剂喷雾联合MET/CBT干预的受试者的大麻渴望和戒断程度；Iii)收集生物样本(尿样每周三次，血浆样本每周一次)，并与NIDA-IRP的科学家合作，确定在研究过程中测量这些生物样本中大麻类物质的能力，以评估接触合法(Sativex(R))或非法大麻类(大麻)的情况。这项为期两年的试验性研究将评估Sativex(R)的耐受性，并收集有关Sativex(R)在45名受试者中疗效的信息。5名受试者将使用开放标签设计进行治疗，40名受试者使用随机、双盲、安慰剂对照设计治疗大麻依赖，n=40名非卧床受试者(20名服用Sativex(R)的受试者和20名服用安慰剂的受试者)。试验的药物治疗阶段将持续12周，同时对两组患者每周进行联合动力增强疗法和认知-行为疗法(MET/CBT)。在目标戒烟日期后6个月内将有跟踪调查。结果措施将包括戒除大麻使用，减少大麻使用量，以及渴望/戒断和其他精神症状。多份血液和尿液样本将与NIDA校内研究计划的科学家合作进行分析。

DESCRIPTION (provided by applicant): Cannabis is the most widely used illicit drug in the world and in the United States. Currently, no effective pharmacological treatment has been found for treatment of cannabis dependence. Here, we will evaluate for the first time in a pilot study the potential of using a cannabinoid medication (SATIVEX(R); approved for medical use in Canada) as a substitution therapy for cannabis dependence. The objectives of our study are: i) To compare cannabis use in subjects receiving 12 weeks SATIVEX(R) Spray associated with Motivational Enhancement Therapy and Cognitive Behavioral Therapy (MET/CBT) intervention vs. subjects receiving 12 weeks Placebo Spray associated with MET/CBT intervention; ii) To compare ratings of cannabis cravings and withdrawal in subjects receiving 12 weeks SATIVEX(R) Spray associated with MET/CBT intervention vs. subjects receiving 12 weeks Placebo Spray associated with MET/CBT intervention; iii) To collect biological samples (urine samples three times weekly and plasma sample weekly) and collaborate with scientists within the NIDA-IRP to determine the ability of measuring cannabinoids in those biological samples to assess exposure to licit (SATIVEX(R)) or illicit cannabinoids (cannabis) during the course of the study. This pilot two-year study will evaluate the tolerability and collect information on efficacy of SATIVEX(R) in 45 subjects. 5 subjects will be treated using an open-label design and 40 subjects using a randomized, double-blind, placebo-controlled design for cannabis dependence in n=40 ambulatory subjects (20 subjects on SATIVEX(R) and 20 subjects on placebo). The medication phase of the trial will continue for a total of 12 weeks, concurrent with weekly sessions of combined Motivational Enhancement Therapy and Cognitive-Behavioral Therapy (MET/CBT) for both groups. There will be follow up until 6 months after the target quit date. Outcomes measures will include abstinence from cannabis use, reduction in amount of cannabis used, as well as craving/withdrawal and other psychiatric symptoms. Multiples blood and urine sample will be analyzed in collaboration with scientists from the intra-mural research program of NIDA.