Department of Psychiatry, Yale School of Medicine, New Haven, CT, USA.
Department of Psychological Sciences, University of Connecticut, Mansfield, CT, USA.
J Psychopharmacol. 2022 Aug;36(8):974-986. doi: 10.1177/02698811221104052. Epub 2022 Jun 21.
Limited ethnoracial diversity in previous ±3,4-methylenedioxymethamphetamine-assisted therapy (MDMA-AT) trials for posttraumatic stress disorder (PTSD) has prompted questions concerning whether Black, Indigenous, and People of Color (BIPOC) also benefit from this treatment.
Secondary analysis was conducted using a modified intent-to-treat sample pooled from two Phase 2 open-label trials and a Phase 3 randomized, blinded placebo-controlled trial to compare efficacy and safety of MDMA-AT for PTSD between BIPOC and non-Hispanic White participants. Four subgroups were of interest: MDMA-AT, BIPOC ( = 20); MDMA-AT, non-Hispanic White ( = 63); Placebo-assisted therapy (Placebo-AT), BIPOC ( = 17); and Placebo-AT, non-Hispanic White ( = 27). Planned comparisons tested subgroup differences in changes in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) scores from baseline to primary endpoint, controlling for study type and baseline scores. Adverse events (AEs) on the day of (day 0) to 2 days post-dosing were reported for each subgroup.
In the MDMA-AT group, no significant ethnoracial difference in CAPS-5 change scores was observed. In the Placebo-AT group, BIPOC participants trended toward greater reductions in CAPS-5 scores than non-Hispanic Whites. Among non-Hispanic Whites, MDMA-AT was accompanied by significantly greater reductions in CAPS-5 scores than Placebo-AT. No treatment difference emerged among BIPOC participants. AEs were mostly rated as mild or moderate across subgroups.
These findings provide preliminary support for the efficacy and safety of MDMA-AT for treating PTSD across ethnoracial groups. There was also a trend toward greater efficacy with Placebo-AT among BIPOC participants. There was an imbalance in subgroups, highlighting the need for culturally responsive recruitment strategies to diversify future studies.
先前的创伤后应激障碍（PTSD）±3,4-亚甲二氧基甲基苯丙胺辅助治疗（MDMA-AT）试验中，研究对象的种族和民族多样性有限，这引发了人们的疑问，即黑人、原住民和有色人种（BIPOC）是否也能从这种治疗中受益。
使用从两项 2 期开放标签试验和一项 3 期随机、双盲安慰剂对照试验中汇总的修改后的意向治疗样本进行二次分析，以比较 MDMA-AT 治疗 PTSD 在 BIPOC 和非西班牙裔白人参与者中的疗效和安全性。有四个感兴趣的亚组：MDMA-AT，BIPOC（ = 20）；MDMA-AT，非西班牙裔白人（ = 63）；安慰剂辅助治疗（Placebo-AT），BIPOC（ = 17）；和安慰剂辅助治疗，非西班牙裔白人（ = 27）。计划比较测试了从基线到主要终点时，各亚组在临床医生管理的创伤后应激障碍量表第五版（CAPS-5）评分变化上的差异，控制了研究类型和基线评分。报告了每个亚组在给药后第 0 天至第 2 天期间的不良事件（AE）。
在 MDMA-AT 组中，CAPS-5 变化评分没有观察到明显的种族差异。在安慰剂-AT 组中，BIPOC 参与者的 CAPS-5 评分降低趋势大于非西班牙裔白人。在非西班牙裔白人中，MDMA-AT 治疗后 CAPS-5 评分的降低明显大于安慰剂-AT。BIPOC 参与者中未出现治疗差异。各亚组的不良事件大多评为轻度或中度。
这些发现初步支持 MDMA-AT 治疗 PTSD 在种族和民族群体中的疗效和安全性。安慰剂-AT 在 BIPOC 参与者中也有更大疗效的趋势。亚组之间存在不平衡，突出了需要有文化响应的招募策略，以使未来的研究多样化。
