WASHINGTON (AP) — LSD reduced symptoms of anxiety in a midstage study published Thursday, paving the way for additional testing and possible medical approval of a psychedelic drug that has been banned in the U.S. for more than a half century.
WASHINGTON (AP) — 瑞士制药公司MindMed的中期临床试验显示,LSD(麦角酸二乙酰胺)可显著减轻焦虑症症状,为这一已被美国禁止半个世纪的迷幻药物开辟了新的医学应用可能性。
The results from drugmaker Mindmed tested several doses of LSD in patients with moderate-to-severe generalized anxiety disorder, with the benefits lasting as long as three months. The company plans to conduct follow-up studies to confirm the results and then apply for Food and Drug Administration approval.
研究结果显示,MindMed公司对中度至重度广泛性焦虑症患者测试了不同剂量的LSD,其中疗效最长可持续三个月。公司计划进行后续研究以验证结果,并向美国食品药品监督管理局(FDA)提交审批申请。
Beginning in the 1950s, researchers published a flurry of papers exploring LSD's therapeutic uses, though most of them don't meet modern standards.
Frederick Barrett, who directs Johns Hopkins University’s psychedelic center and was not involved in the research, said: “I see this paper as a clear step in the direction of reviving that old research, applying our modern standards and determining what are the real costs and benefits of these compounds.”
自1950年代起,科学家曾发表大量论文探索LSD的治疗潜力,但多数研究未达到现代科学标准。约翰斯·霍普金斯大学迷幻研究中心主任Frederick Barrett(未参与该研究)表示:“这篇论文标志着用现代标准重启早期研究,明确这类化合物的真实风险与效益。”
Psychedelic research is rebounding. Psychedelics are in the midst of a popular and scientific comeback, with conferences, documentaries, books and medical journals exploring their potential for conditions like depression, anxiety and post-traumatic stress disorder. The FDA has designated psilocybin, MDMA and now LSD as potential “breakthrough” therapies based on early results.
迷幻药物研究正迎来复兴。这类物质正通过学术会议、纪录片、书籍和医学期刊被重新评估,其在抑郁症、焦虑症和创伤后应激障碍(PTSD)等领域的潜力备受关注。FDA已将裸盖菇素(psilocybin)、MDMA(摇头丸)和LSD列为潜在“突破性疗法”。
Still, the drugs have not had a glide path to the market. Last year, the FDA rejected MDMA as a treatment for PTSD, citing flawed study methods, potential research bias and other issues. The new LSD study, published by the Journal of the American Medical Association, addresses some of those problems.
然而,相关药物的商业化之路仍不平坦。去年,FDA因研究方法缺陷和潜在偏见否决了MDMA治疗PTSD的申请。此次发表于《美国医学会杂志》的LSD研究部分解决了这些问题。
MDMA, like many other psychedelics, was tested in combination with hours of talk therapy by trained health professionals. That approach proved problematic for FDA reviewers, who said it was difficult to separate the benefits of the drug from those of therapy. The LSD study took a simpler approach: Patients got a single dose of LSD — under professional supervision, but without therapy — and then were followed for about three months.
MDMA等药物常与数小时的心理治疗联合使用,但FDA审评认为难以区分药物与治疗的效果。本项LSD研究采用更简单设计:患者单次服药后在专业监督下观察三个月,不附加心理干预。
Barrett noted that the paper does not detail how patients were prepared for the experience or what sort of follow-up they received, which is crucial to understanding the research.
Barrett指出,论文未详细说明受试者的准备过程及后续支持,而这是理解研究结果的关键。他补充道:“这类主观体验可能需要心理专家解读才能产生意义。”
Anxiety eased but questions remain. For the study, researchers measured anxiety symptoms in nearly 200 patients who randomly received one of four doses of LSD or a placebo. The main aim was to find the optimal dose of the drug, which can cause intense visual hallucinations and occasionally feelings of panic or paranoia.
研究显示,近200名患者随机接受四种LSD剂量或安慰剂。最高剂量组在四周后焦虑评分显著下降,12周后65%的100毫克组患者持续改善,近50%达到缓解。常见副作用包括幻觉、恶心和头痛。
Patients who got dummy pills also improved — a common phenomenon in psychedelic and psychiatric studies — but their changes were less than half the size of those taking the real drug. The research was not immune to problems seen in similar studies.
安慰剂组也出现改善,但幅度不足真实药物组的一半。研究仍存在盲法失效(多数患者能分辨用药情况)和受试者脱落等局限性。
Mindmed is conducting two large, late-stage trials that will track patients over a longer period of time and, if successful, be submitted for FDA approval.
MindMed已启动两项大规模Ⅲ期试验,长期追踪疗效并提交审批。研究首席作者、马萨诸塞州总医院的Maurizio Fava表示:“部分患者可能需要重复治疗,但单次剂量的长效性已十分显著。”
The possibility of using LSD as a medical treatment isn’t new. In the 1950s and 1960s, over 1,000 papers documented LSD’s use treating alcohol addiction, depression and other conditions. However, a federal backlash in the late 1960s, linked to counterculture figures like Timothy Leary, led to a 1970 law classifying LSD as a Schedule 1 drug, halting U.S. research.
LSD的医学价值并非新发现。1950-60年代曾有超千篇论文记录其治疗酒精成瘾和抑郁症等效果,但因与反主流文化关联,1970年美国将其列为一级管制药物,研究全面停止。
When nonprofits began reassessing psychedelics in the 1980s-1990s, they focused on lesser-known hallucinogens like MDMA and psilocybin to avoid LSD’s controversies.
上世纪80-90年代,非营利机构重启研究时优先选择MDMA和裸盖菇素以避开LSD争议。Fava表示:“MindMed是首个系统评估LSD的企业。”
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