Imperial College London, Centre for Neuropsychopharmacology, Division of Brain Sciences, Faculty of Medicine, London, UK.
Drug Science, London, UK.
J Psychopharmacol. 2021 Apr;35(4):375-383. doi: 10.1177/0269881121991792. Epub 2021 Feb 18.
3,4-methylenedioxymethamphetamine (MDMA) therapy has qualities that make it potentially well suited for patients with addictions, but this has never been explored in a research study. We present data from the Bristol Imperial MDMA in Alcoholism (BIMA) study. This is the first MDMA addiction study, an open-label safety and tolerability proof-of-concept study investigating the potential role for MDMA therapy in treating patients with alcohol use disorder (AUD).
This study aimed to assess if MDMA-assisted psychotherapy can be delivered safely and can be tolerated by patients with AUD post detoxification. Outcomes regarding drinking behaviour, quality of life and psychosocial functioning were evaluated.
Fourteen patients with AUD completed a community alcohol detoxification and received an eight-week course of recovery-based therapy. Participants received two sessions with MDMA (187.5 mg each session). Psychological support was provided before, during and after each session. Safety and tolerability were assessed alongside psychological and physiological outcome measures. Alcohol use behaviour, mental well-being and functioning data were collected for nine months after alcohol detoxification.
MDMA treatment was well tolerated by all participants. No unexpected adverse events were observed. Psychosocial functioning improved across the cohort. Regarding alcohol use, at nine months post detox, the average units of alcohol consumption by participants was 18.7 units per week compared to 130.6 units per week before the detox. This compares favourably to a previous observational study (the 'Outcomes' study) by the same team with a similar population of people with AUD.
This study provides preliminary support for the safety and tolerability of a novel intervention for AUD post detox. Further trials to examine better the therapeutic potential of this approach are now indicated.
3,4-亚甲二氧基甲基苯丙胺（MDMA）治疗具有使其非常适合治疗成瘾患者的特质，但这从未在研究中得到探索。我们展示了来自布里斯托尔帝国 MDMA 治疗酒精中毒（BIMA）研究的数据。这是第一项 MDMA 成瘾研究，一项开放标签的安全性和耐受性概念验证研究，旨在调查 MDMA 治疗在治疗酒精使用障碍（AUD）患者中的潜在作用。
本研究旨在评估 MDMA 辅助心理治疗是否可以安全地提供给戒毒后的 AUD 患者，并且患者可以耐受。评估了与饮酒行为、生活质量和心理社会功能相关的结果。
14 名 AUD 患者完成了社区酒精戒毒，并接受了为期八周的康复治疗课程。参与者接受了两次 MDMA 治疗（每次 187.5 毫克）。在每次治疗前后提供心理支持。评估安全性和耐受性以及心理和生理结果测量。在酒精戒毒后九个月收集酒精使用行为、心理健康和功能数据。
所有参与者均耐受 MDMA 治疗。未观察到意外的不良事件。心理社会功能在整个队列中均有所改善。关于饮酒，在戒毒后九个月，参与者的平均饮酒量为每周 18.7 单位，而戒毒前为每周 130.6 单位。这与同一团队的先前观察性研究（“结果”研究）中具有相似 AUD 人群的情况相比表现良好。
本研究为戒毒后 AUD 的新型干预措施的安全性和耐受性提供了初步支持。现在需要进一步的试验来更好地研究这种方法的治疗潜力。
