Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, United States of America.
Scottsdale Research Institute, Scottsdale, Arizona, United States of America.
PLoS One. 2021 Mar 17;16(3):e0246990. doi: 10.1371/journal.pone.0246990. eCollection 2021.
There is a pressing need for development of novel pharmacology for the treatment of Posttraumatic Stress Disorder (PTSD). Given increasing use of medical cannabis among US military veterans to self-treat PTSD, there is strong public interest in whether cannabis may be a safe and effective treatment for PTSD.
The aim of the present study was to collect preliminary data on the safety and potential efficacy of three active concentrations of smoked cannabis (i.e., High THC = approximately 12% THC and < 0.05% CBD; High CBD = 11% CBD and 0.50% THC; THC+CBD = approximately 7.9% THC and 8.1% CBD, and placebo = < 0.03% THC and < 0.01% CBD) compared to placebo in the treatment of PTSD among military veterans.
The study used a double-blind, cross-over design, where participants were randomly assigned to receive three weeks of either active treatment or placebo in Stage 1 (N = 80), and then were re-randomized after a 2-week washout period to receive one of the other three active treatments in Stage 2 (N = 74). The primary outcome measure was change in PTSD symptom severity from baseline to end of treatment in Stage 1.
The study did not find a significant difference in change in PTSD symptom severity between the active cannabis concentrations and placebo by the end of Stage 1. All three active concentrations of smoked cannabis were generally well tolerated.
The present study is the first randomized placebo-controlled trial of smoked cannabis for PTSD. All treatment groups, including placebo, showed good tolerability and significant improvements in PTSD symptoms during three weeks of treatment, but no active treatment statistically outperformed placebo in this brief, preliminary trial. Additional well-controlled and adequately powered studies with cannabis suitable for FDA drug development are needed to determine whether smoked cannabis improves symptoms of PTSD.
Identifier: NCT02759185; ClinicalTrials.gov.
对于创伤后应激障碍（PTSD）的治疗，迫切需要开发新的药理学。鉴于美国退伍军人越来越多地使用医用大麻来自我治疗 PTSD，公众强烈关注大麻是否可能是一种安全有效的 PTSD 治疗方法。
本研究旨在收集关于三种不同浓度吸食大麻（即高 THC=约 12% THC 和 <0.05% CBD；高 CBD=11% CBD 和 0.50% THC；THC+CBD=约 7.9% THC 和 8.1% CBD，安慰剂=<0.03% THC 和 <0.01% CBD）与安慰剂相比在治疗退伍军人 PTSD 方面的安全性和潜在疗效的初步数据。
该研究采用双盲、交叉设计，参与者在第一阶段（N=80）中随机分配接受三种治疗方案（活性治疗或安慰剂），然后在 2 周洗脱期后重新随机分配接受第二阶段的其他三种活性治疗中的一种（N=74）。主要观察指标是第一阶段从基线到治疗结束时 PTSD 症状严重程度的变化。
本研究未发现第一阶段结束时，活性大麻浓度与安慰剂之间 PTSD 症状严重程度的变化有显著差异。所有三种吸食大麻的活性浓度通常都具有良好的耐受性。
本研究是第一项关于 PTSD 吸食大麻的随机安慰剂对照试验。所有治疗组，包括安慰剂组，在三周的治疗期间都表现出良好的耐受性和 PTSD 症状的显著改善，但在这项短暂的初步试验中，没有一种活性治疗在统计学上优于安慰剂。需要进行更多的、适合 FDA 药物开发的大麻的、充分的、对照良好的研究，以确定吸食大麻是否能改善 PTSD 症状。
标识符：NCT02759185；ClinicalTrials.gov。
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