Sativex associated with behavioural-prevention relapse strategy as treatment for

描述（由申请人提供）：大麻是世界上和美国使用最广泛的非法药物。目前，还没有发现有效的药物治疗大麻依赖。在这里，我们将首次在一项试点研究中评估使用大麻素药物的潜力(SATIVEX(R)；经批准在加拿大用于医疗用途)作为大麻依赖的替代疗法。本研究的目的是：i)比较接受12周SATIVEX(R)喷雾联合动机增强疗法和认知行为疗法（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)喷雾与MET/CBT干预的受试者与接受12周安慰剂喷雾与MET/CBT干预的受试者的大麻渴望和戒断评分；iii)收集生物样本（每周三次尿液样本和每周三次血浆样本），并与NIDA-IRP内的科学家合作，确定测量这些生物样本中大麻素的能力，以评估在研究过程中合法（SATIVEX(R)）或非法大麻素（大麻）的暴露情况。这项为期两年的试点研究将在45名受试者中评估SATIVEX(R)的耐受性并收集有关疗效的信息。5名受试者将采用开放标签设计，40名受试者将采用随机、双盲、安慰剂对照设计，在n=40名门诊受试者中进行大麻依赖治疗（20名受试者服用SATIVEX(R)， 20名受试者服用安慰剂）。试验的药物治疗阶段将持续12周，同时两组患者每周接受动机增强疗法和认知行为疗法（MET/CBT）的联合治疗。在目标戒烟日期后6个月将会有随访。成果措施将包括戒断大麻使用、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壁画内研究项目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.