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

大麻二酚作为长期暴露治疗 PTSD 的辅助药物

• 批准号: 10595486
• 负责人: Catherine Ayers
• 金额: --
• 依托单位: VA SAN DIEGO HEALTHCARE SYSTEM
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-10-01 至 2024-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10595486
• 关键词: Address; Aftercare; Anxiety; Area; Behavioral; Biometry; Cannabidiol; Cannabinoids; Caring; Clinic; Clinical; Clinical Research; Clinical Trials; Cognition; Combination Medication; Data; Development; Distress; Double-Blind Method; Dropout; Educational Status; Effectiveness; Exposure to; Extinction; Female; Future; Goals; Grant; Impairment; Institution; Lead; Mediating; Mediation; Mental Depression; Mental Health Services; Mentors; Mentorship; Mission; Moods; Neurobiology; Participant; Patient Care; Patients; Pharmacotherapy; Placebos; Policies; Post-Traumatic Stress Disorders; Psychopharmacology; Psychotherapy; Randomized; Randomized, Controlled Trials; Research; Research Personnel; Sampling; Services; Sleeplessness; Speed; Symptoms; Testing; Training; Trauma; Treatment outcome; Veterans; Work; Writing; cannabinoid administration; cannabinoid treatment; clinical implementation; clinical practice; clinically significant; cost; design; efficacious treatment; efficacy evaluation; efficacy testing; follow-up; future implementation; implementation study; improved; innovation; interest; learning extinction; male; medical schools; military veteran; novel; phytocannabinoid; pre-clinical research; psychosocial; reduce symptoms; response; satisfaction; scaffold; skills; sleep quality; training opportunity; treatment comparison; treatment effect; treatment group; treatment response

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.

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)，一种非醉人的植物大麻素，作为暴露疗法的辅助。这个 试验将在VASDHS对136名患有创伤后应激障碍的退伍军人样本进行PE+CBD和PE+安慰剂的比较。 神经生物学研究、临床前研究和临床研究为建议的随机对照试验提供了依据。 创伤后应激障碍和大麻素。这项研究代表了增强的合乎逻辑和创新的下一步 创伤后应激障碍的现有治疗方法和开发新的药物疗法。此外，建议：1) 与退伍军人管理局的病人护理使命保持一致，其目标是改善患有创伤后应激障碍的退伍军人的治疗，2) 直接解决退伍军人事务部的创伤后应激障碍精神药理学倡议，并3)解决一个研究领域 这在很大程度上被退伍军人管理局忽视了，但与退伍军人管理局的多个利益相关者直接相关(即， 调查大麻素治疗的效果)。拟议的随机对照试验的结果将为 通过调查是否在PE环境下应用CBD的临床实践和政策 治疗将改善患有创伤后应激障碍的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，使其能够合并HERE 主要研究兴趣(大麻素疗法和创伤后应激障碍随机对照试验)和发展专门技能 在随机对照试验的执行中，这涉及到行为和新的精神药理学。候选人将是 由以下领域的领先专家指导：创伤后应激障碍治疗、精神药理学、随机对照试验设计、 大麻素给药试验和生物统计学。拟议的工作将在 领先的退伍军人研究中心(VASDHS)和世界著名的研究机构(UCSD School of 医学)。 拟议的审判还将允许候选人接受必要的培训，以实现她的长期目标。 目标是成为退伍军人事务部的一名独立研究员。RCT中的支架式培训和指导 设计、大麻素精神药理学、生物统计学和拨款申请将有助于推动 在尖端研究领域获得独立的候选人。最后，审判的结果将为 为今后的执行研究奠定基础，这些研究将试图确定使用 跨退伍军人管理局诊所的CBD，并确定实施是否会导致PE会话减少， 更高的患者和治疗师满意度，以及更低的退伍军人事务部成本。