Department of Experimental Psychology and Helmholtz Institute, Faculty of Social and Behavioural Sciences, Utrecht University, Utrecht, The Netherlands.
Altrecht Academic Anxiety Centre, Utrecht, The Netherlands.
BMC Psychiatry. 2019 Feb 13;19(1):69. doi: 10.1186/s12888-019-2022-x.
Phobic anxiety disorders are among the most prevalent psychiatric disorders and are burdensome in terms of loss of quality of life and work productivity. Evidence-based treatments are relatively successful in the majority of patients, especially exposure therapy. However, a substantial subset of patients fails to achieve or stay in remission. Preclinical and genetic research have yielded evidence that the cannabinoid system is involved in the extinction of fear, presumed to underlie the beneficial effects of exposure therapy in phobic disorders. A cannabinoid constituent that may enhance endocannabinoid signaling is cannabidiol (CBD), a non-psychoactive component of cannabis. Hence, the addition of CBD to exposure therapy is expected to strengthen effects of treatment. To determine the added benefit of CBD on exposure therapy, we conduct a randomized controlled trial, in which patients in whom previous treatment as usual has not yielded sufficient response receive either CBD or placebo preceding 8 exposure sessions in a double-blind fashion. A subsidiary aim is to explore which (combination of) clinical, behavioral and genetic profiles of patients are related to treatment response.
METHODS/DESIGN: This is an 8-week multicenter, randomized, double-blind, placebo-controlled trial. Seventy-two patients with social phobia or panic disorder with agoraphobia with incomplete response to earlier treatment will be included from outpatient clinics in the Netherlands. Patients are randomized to augmentation of exposure therapy with 300 mg CBD or placebo. The study medication is administered orally, 2 h preceding each of the eight 90 min exposure sessions. Measurements will take place at baseline, first administration of medication, every session, mid-treatment, last administration of medication, post-treatment and at 3 and 6 months' follow-up. The primary outcome measure is the score on the Fear Questionnaire (FQ). In addition, determinants of the expected treatment enhancing effect of CBD will be explored.
This is the first trial to investigate whether the addition of CBD to exposure therapy is effective in reducing phobic symptoms in treatment refractory patients with social phobia or panic disorder with agoraphobia.
Netherlands Trial Register NTR5100 . Registered 13 March 2015. Protocol version: issue date 17 Jan 2018, protocol amendment number 7.
恐惧症焦虑障碍是最常见的精神疾病之一，会降低生活质量和工作生产力，给患者带来沉重负担。基于证据的治疗方法在大多数患者中相对成功，尤其是暴露疗法。然而，相当一部分患者无法达到或保持缓解状态。临床前和遗传研究已经证明，大麻素系统参与了恐惧的消除，这被认为是暴露疗法在恐惧症中的有益效果的基础。大麻素系统的一种大麻素成分，即大麻二酚（CBD），可能增强内源性大麻素信号，它是大麻的非精神活性成分。因此，在暴露疗法中添加 CBD 有望增强治疗效果。为了确定 CBD 对暴露疗法的额外益处，我们进行了一项随机对照试验，在该试验中，对于先前常规治疗未产生足够反应的患者，在接受 8 次暴露治疗之前，以双盲方式给予 CBD 或安慰剂。次要目的是探索哪些（组合）患者的临床、行为和遗传特征与治疗反应相关。
方法/设计：这是一项 8 周的多中心、随机、双盲、安慰剂对照试验。将从荷兰的门诊诊所招募 72 名社交恐惧症或伴有广场恐怖症的惊恐障碍患者，他们对早期治疗反应不完全。患者被随机分配到暴露疗法加用 300mg CBD 或安慰剂。研究药物口服，在每次 90 分钟的 8 次暴露治疗前 2 小时给药。测量将在基线、首次给药、每次治疗、治疗中期、末次给药、治疗后以及 3 个月和 6 个月随访时进行。主要结局指标是恐惧问卷（FQ）的评分。此外，还将探索 CBD 预期治疗增强作用的决定因素。
这是第一项研究，旨在探讨在社交恐惧症或伴有广场恐怖症的惊恐障碍治疗抵抗患者中，在暴露疗法中添加 CBD 是否能有效减轻恐惧症症状。
荷兰试验注册 NTR5100。于 2015 年 3 月 13 日注册。方案版本：发布日期 2018 年 1 月 17 日，方案修订号 7。
