Cannabidiol as an Adjunctive to Prolonged Exposure for the Treatment of PTSD

拟议的CDA-2将包括一项随机对照试验，以评估使用 大麻二酚（CBD），一种非中毒性植物大麻素，作为暴露疗法的辅助剂。的 一项试验将在VASDHS的136名患有PTSD的退伍军人中比较PE+CBD与PE+安慰剂。 拟定RCT的依据来自神经生物学、临床前和临床研究 创伤后应激障碍和大麻素这项研究代表了逻辑和创新的下一步， 现有的治疗方法和开发新的药物治疗创伤后应激障碍。此外，建议：1） 符合退伍军人事务部的病人护理使命，其目的是改善退伍军人创伤后应激障碍的治疗，2） 直接解决了退伍军人事务部的创伤后应激障碍精神药理学倡议，3）解决了一个研究领域 这在很大程度上被VA忽视，但与多个VA利益相关者直接相关（即， 研究大麻素治疗的功效）。拟议RCT的结果将告知 临床实践和政策，通过调查是否在PE的背景下管理CBD 治疗将改善创伤后应激障碍退伍军人的治疗结果。 拟议的CDA-2将为候选人提供一个重要的培训机会， 主要研究兴趣（大麻素治疗和PTSD RCT），并发展专业技能 在RCT执行中，涉及行为和新型精神药理学。候选人将是 由专注于PTSD治疗，精神药理学，RCT设计， 大麻素给药试验和生物统计学。拟议的工作将在一个 领先的VA研究中心（VASDHS）和世界知名的研究机构（UCSD School of 医学）。 拟议的试验还将允许候选人进行必要的培训，以实现她的长期目标。 我的目标是成为一名独立的研究员。RCT中的支架式培训和指导 设计，大麻精神药理学，生物统计学和赠款写作将有助于推动 在前沿研究领域独立的候选人。最后，审判结果将奠定 为今后的执行情况研究奠定基础， CBD跨VA诊所，并确定实施是否会导致减少PE会话， 更高的患者和治疗师满意度，以及更低的VA成本。

The proposed CDA-2 will include a randomized control trial to evaluate the efficacy of using Cannabidiol (CBD), a non-intoxicating phytocannabinoid, as an adjunctive to exposure therapy. The trial will compare PE+CBD to PE+placebo in a sample of 136 Veterans with PTSD at the VASDHS. The rationale for the proposed RCT is informed by neurobiological, preclinical, and clinical research on PTSD and cannabinoids. The study represents the logical and innovative next step for augmenting existing treatments and developing novel pharmacotherapy for PTSD. Moreover, the proposal: 1) aligns with the VA's patient care mission in its aim to improve treatment for Veterans with PTSD, 2) directly addresses the VA's PTSD Psychopharmacology Initiative, and 3) addresses an area of research that has largely been ignored by VA but is of direct relevance to multiple VA stakeholders (i.e., investigating the efficacy of cannabinoid treatments). Findings from the proposed RCT will inform clinical practice and policy by investigating whether administration of CBD in the context of PE therapy will improve treatment outcomes for Veterans with PTSD. The proposed CDA-2 will provide the candidate with an important training opportunity to merge her primary research interests (cannabinoid therapeutics and PTSD RCTs) and to develop specialized skill in RCT execution that involves both behavioral and novel psychopharmacology. The candidate will be mentored by leading experts who specialize in: PTSD treatment, psychopharmacology, RCT design, cannabinoid administration trials, and biostatistics. The proposed work will be conducted within a leading VA research center (VASDHS) and world-renowned research institution (UCSD School of Medicine). The proposed trial will also allow the candidate necessary training for achievement of her long-term goal to become an independent researcher within VA. Scaffolded training and mentorship in RCT design, cannabinoid psychopharmacology, biostatistics and grant writing will help propel the candidate to independence in a cutting-edge research area. Finally, results of the trial will lay the groundwork for future implementation studies that would attempt to determine feasibility of use of CBD across VA clinics and determine whether implementation leads to reduced sessions of PE, greater patient and therapist satisfaction, and lower costs to VA.