Abstract：
BACKGROUND: Ayahuasca is a South American plant hallucinogen rich in the psychedelic N,N-dimethyltryptamine and β-carbolines (mainly harmine). Preclinical and observational studies suggest that ayahuasca exerts beneficial effects in substance use disorders, but these potentials were never assessed in a clinical trial.
METHODS: Single-center, single-blind, feasibility, proof-of-concept study, assessing the effects of one dose of ayahuasca accompanied by psychological support (without psychotherapy) on the drinking patterns (primary variable) of 11 college students with harmful alcohol consumption. Secondary variables included safety and tolerability, craving, personality, anxiety, impulsivity, self-esteem, and social cognition.
RESULTS: Ayahuasca was well tolerated (no serious adverse reactions were observed), while producing significant psychoactive effects. Significant reductions in days per week of alcohol consumption were found between weeks 2 and 3 (2.90 ± 0.28 vs 2.09 ± 0.41; P < 0.05, uncorrected), which were not statistically significant after Bonferroni correction. There were no statistically significant effects for other variables, except for a significant reduction in reaction time in an empathy task.
CONCLUSIONS: A significant reduction in days of alcohol consumption was observed 2-3 weeks after ayahuasca intake, but this effect did not survive after Bonferroni correction. The lack of significant effects in alcohol use and other variables may be related to the small sample size and mild/moderate alcohol use at baseline. The present study shows the feasibility of our protocol, paving the way for future larger, controlled studies.
METHODS: Single-center, single-blind, feasibility, proof-of-concept study, assessing the effects of one dose of ayahuasca accompanied by psychological support (without psychotherapy) on the drinking patterns (primary variable) of 11 college students with harmful alcohol consumption. Secondary variables included safety and tolerability, craving, personality, anxiety, impulsivity, self-esteem, and social cognition.
RESULTS: Ayahuasca was well tolerated (no serious adverse reactions were observed), while producing significant psychoactive effects. Significant reductions in days per week of alcohol consumption were found between weeks 2 and 3 (2.90 ± 0.28 vs 2.09 ± 0.41; P < 0.05, uncorrected), which were not statistically significant after Bonferroni correction. There were no statistically significant effects for other variables, except for a significant reduction in reaction time in an empathy task.
CONCLUSIONS: A significant reduction in days of alcohol consumption was observed 2-3 weeks after ayahuasca intake, but this effect did not survive after Bonferroni correction. The lack of significant effects in alcohol use and other variables may be related to the small sample size and mild/moderate alcohol use at baseline. The present study shows the feasibility of our protocol, paving the way for future larger, controlled studies.
摘要：
背景：Ayahuasca是一种富含迷幻N的南美植物致幻剂，N-二甲基色胺和β-咔啉类（主要是harmine）。临床前和观察性研究表明，ayahuasca在物质使用障碍中发挥有益作用，但这些潜能从未在临床试验中进行过评估.
方法：单中心，单盲,可行性,概念验证研究，评估一剂ayahuasca伴随着心理支持（无心理治疗）对11名有害饮酒大学生饮酒模式（主要变量）的影响。次要变量包括安全性和耐受性，渴望,个性,焦虑,冲动,自尊,和社会认知。
结果：Ayahuasca耐受性良好（未观察到严重不良反应），同时产生显著的精神作用。在第2周和第3周之间，每周饮酒天数显着减少（2.90±0.28vs2.09±0.41；P<0.05，未校正），Bonferroni校正后无统计学意义。对其他变量没有统计学意义的影响，除了移情任务的反应时间显着减少。
结论：摄入ayahuasca后2-3周观察到饮酒天数显着减少，但是Bonferroni校正后这种效果无法存活。在酒精使用和其他变量中缺乏显着影响可能与基线时样本量小和轻度/中度酒精使用有关。本研究表明了我们协议的可行性，为未来更大的道路铺平道路，对照研究。
方法：单中心，单盲,可行性,概念验证研究，评估一剂ayahuasca伴随着心理支持（无心理治疗）对11名有害饮酒大学生饮酒模式（主要变量）的影响。次要变量包括安全性和耐受性，渴望,个性,焦虑,冲动,自尊,和社会认知。
结果：Ayahuasca耐受性良好（未观察到严重不良反应），同时产生显著的精神作用。在第2周和第3周之间，每周饮酒天数显着减少（2.90±0.28vs2.09±0.41；P<0.05，未校正），Bonferroni校正后无统计学意义。对其他变量没有统计学意义的影响，除了移情任务的反应时间显着减少。
结论：摄入ayahuasca后2-3周观察到饮酒天数显着减少，但是Bonferroni校正后这种效果无法存活。在酒精使用和其他变量中缺乏显着影响可能与基线时样本量小和轻度/中度酒精使用有关。本研究表明了我们协议的可行性，为未来更大的道路铺平道路，对照研究。
