Department of Psychiatry and Neurosciences, Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin, Hindenburgdamm 30, 12203, Berlin, Germany.
Oberberg Fachkliniken for Psychiatry, Psychosomatics and Psychotherapy, Berlin and Brandenburg, Germany.
BMC Psychiatry. 2023 May 5;23(1):319. doi: 10.1186/s12888-023-04818-5.
Distressing nightmares are a core symptom of posttraumatic stress disorder (PTSD) and contribute to psychiatric comorbidity, impaired physical health and decreased social functioning. No specific pharmacological treatment for PTSD-related nightmares is yet approved. Preliminary clinical data indicate that cannabinoid agonists can improve nightmares and overall PTSD symptoms in patients with PTSD. The primary objective of the study is to examine the efficacy of oral dronabinol (BX-1) versus placebo in reducing nightmares in patients with PTSD. The secondary objectives of the study are to examine the efficacy of oral BX-1 in reducing other PTSD symptoms.
The study is designed as a multi-centric, double-blind, randomized (1:1), placebo-controlled, parallel group interventional trial. Eligible patients will be randomized to BX-1 or placebo, receiving a once-daily oral dose before bedtime for 10 weeks. Primary efficacy endpoint is the Clinician-Administered PTSD Scale (CAPS-IV) B2 score for the last week, measuring frequency and intensity of nightmares. Secondary efficacy endpoints are other disorder-specific symptoms in patients with PTSD. Further, tolerability and safety of dronabinol will be assessed.
This randomized controlled trial will provide evidence whether treating patients with PTSD and nightmares with dronabinol is safe and efficacious.
NCT04448808, EudraCT 2019-002211-25.
创伤后应激障碍（PTSD）的核心症状是令人痛苦的噩梦，会导致精神共病、身体健康受损和社交功能下降。目前尚无针对 PTSD 相关噩梦的特定药物治疗方法。初步临床数据表明，大麻素激动剂可以改善 PTSD 患者的噩梦和整体 PTSD 症状。本研究的主要目的是研究口服屈大麻酚（BX-1）与安慰剂在减少 PTSD 患者噩梦方面的疗效。该研究的次要目的是研究口服 BX-1 对减少其他 PTSD 症状的疗效。
该研究设计为多中心、双盲、随机（1:1）、安慰剂对照、平行组干预试验。符合条件的患者将被随机分配到 BX-1 或安慰剂组，在睡前每天口服一次，持续 10 周。主要疗效终点是最后一周的创伤后应激障碍检查表（CAPS-IV）B2 评分，用于测量噩梦的频率和强度。次要疗效终点是 PTSD 患者的其他特定疾病症状。此外，还将评估屈大麻酚的耐受性和安全性。
这项随机对照试验将提供关于使用屈大麻酚治疗 PTSD 和噩梦患者是否安全有效的证据。
NCT04448808，EudraCT 2019-002211-25。
