Data_sheet_1_Therapeutic effect of psilocybin in addiction: A systematic review.docx

BackgroundPsychedelic-assisted therapy [e.g., with lysergic acid diethylamide (LSD)] has shown promising results as treatment for substance use disorders (SUDs). Previous systematic reviews assessing the efficacy of psilocybin in SUDs only included clinical trials conducted in the last 25 years, but they may have missed clinical trials assessing the efficacy of psilocybin that were conducted before the 1980s, given much research has been done with psychedelics in the mid-20th century. In this systematic review, we specifically assessed the efficacy of psilocybin in patients with a SUD or non-substance-related disorder with no publication date restrictions in our search strategy.MethodsA systematic literature search was performed according to Preferred Reporting Items for Systematic reviews and Meta-Analysis (PRISMA) guidelines from the earliest published manuscript up to September 2, 2022, in seven electronic databases, including clinical trials in patients with a SUD or non-substance-related disorder evaluating the efficacy of psilocybin.ResultsA total of four studies (six articles, of which two articles were long-term follow-up results from the same trial) were included in this systematic review. Psilocybin-assisted therapy was administered to n = 151 patients in a dose ranging from 6 to 40 mg. Three studies focused on alcohol use disorder, and one study on tobacco use disorder. In a pilot study (n = 10), the percentage of heavy drinking days decreased significantly between baseline and weeks 5–12 (mean difference of 26.0, 95% CI = 8.7–43.2, p = 0.008). In another single-arm study (n = 31), 32% (10/31) became completely abstinent from alcohol (mean duration of follow-up 6 years). In a double-blind, placebo-controlled randomized controlled trial (RCT, n = 95), the percentage of heavy drinking days during the 32-week double-blind period was significantly lower for psilocybin compared to placebo (mean difference of 13.9, 95% CI = 3.0–24.7, p = 0.01). In a pilot study (n = 15), the 7-day point prevalence of smoking abstinence at 26 weeks was 80% (12/15), and at 52 weeks 67% (10/15).ConclusionOnly one RCT and three small clinical trials were identified assessing the efficacy of psilocybin combined with some form of psychotherapy in patients with alcohol and tobacco use disorder. All four clinical trials indicated a beneficial effect of psilocybin-assisted therapy on SUD symptoms. Larger RCTs in patients with SUDs need to evaluate whether psilocybin-assisted therapy is effective in patients with SUD.

背景：迷幻药物辅助治疗（例如，使用麦角酸二乙基酰胺（LSD））在物质使用障碍（SUDs）的治疗中已显示出有前景的结果。先前评估迷幻剂在SUDs中疗效的系统评价仅纳入了过去25年内进行的临床试验，但它们可能遗漏了在20世纪80年代之前评估迷幻剂疗效的临床试验，因为在中世纪20世纪，大量关于迷幻药物的研究已被进行。在本系统评价中，我们特别评估了在无出版日期限制的搜索策略中，迷幻剂在患有SUD或与物质无关的疾病患者中的疗效。方法：根据系统评价和荟萃分析优先报告项目（PRISMA）指南，从最早发表的稿件起至2022年9月2日，在七个电子数据库中进行了系统文献检索，包括评估迷幻剂在患有SUD或与物质无关的疾病患者中疗效的临床试验。结果：本系统评价纳入了四项研究（六篇文章，其中两篇文章来自同一试验的长期随访结果），共151名患者接受了从6至40毫克的剂量治疗。三项研究专注于酒精使用障碍，一项研究关注烟草使用障碍。在一项试点研究中（n = 10），与基线相比，在第5至12周之间重度饮酒的天数显著减少（平均差异为26.0，95%置信区间为8.7–43.2，p = 0.008）。在另一项单臂研究中（n = 31），32%（10/31）的患者在平均随访6年后完全戒酒。在一项双盲、安慰剂对照的随机对照试验（RCT，n = 95）中，与安慰剂相比，在32周的双盲期间重度饮酒的天数显著降低（平均差异为13.9，95%置信区间为3.0–24.7，p = 0.01）。在一项试点研究中（n = 15），在26周时7天的吸烟戒断点现患率为80%（12/15），在52周时为67%（10/15）。结论：仅识别出一种随机对照试验和三项小型临床试验，评估了将迷幻剂与某种形式的心理治疗相结合在患有酒精和烟草使用障碍患者中的疗效。所有四项临床试验均表明，迷幻剂辅助治疗对SUD症状具有有益作用。需要更大规模的RCT来评估迷幻剂辅助治疗是否对SUD患者有效。