The world’s first trial investigating the role of MDMA therapy for the treatment of alcohol use disorder has shown positive results, reports Health Europa. The study led by Imperial College London has been published in the Journal of Psychopharmacology.
The Awakn Life Sciences Bristol Imperial MDMA in Alcoholism (BIMA) trial, an open-label safety, tolerability and proof-of-concept study investigating the potential role for MDMA therapy in treating patients with alcohol use disorder (AUD), has provided preliminary support for the safety and tolerability of MDMA post-detox.
According to the report in Health Europa, published on 22 February 2021:
Alcohol use disorder is the most prevalent substance use disorder, with alcohol use as one of the top five causes of disease and disability in almost all countries throughout Europe.
In the UK, alcohol and related diseases are the leading cause of death in men aged between 16 and 54, accounting for over 20% of the total UK adult population. These figures are also predicted to rise as a result of the COVID-19 pandemic.
While there are current treatment methods available that are effective for some segments of the population, relapse rates are high.
Potential treatment for alcohol use disorder
The results show that MDMA treatment 3,4-methylenedioxymethamphetamine [also known as the recreational drug ecstasy or molly] was well tolerated by all participants and no unexpected adverse events were observed, as well as improved psychosocial functioning across the cohort.
Over 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.
Significantly, at nine months post detox, the average units of alcohol consumption by participants were 18.7 units per week compared to 130.6 units per week before the detox. This compares favourably to a previous observational study by the same team with a similar population of people with AUD.
Dr Ben Sessa, Awakn’s Chief Medical Officer, said: “This is the first clinical study into the potential effectiveness of MDMA-Assisted Psychotherapy as a treatment for alcohol use disorder. It provides preliminary support for the safety and tolerability of MDMA post-detox.
“Awakn is now designing further trials to examine better the therapeutic potential of MDMA. I am very grateful for the inspirational work of my research colleagues, Dr Laurie Higbed, Professor David Nutt and Steven O’Brien.”
The study team was chaired by Awakn’s chief scientific advisor Professor David Nutt, of the Department of Medicine at Imperial College London. He added: “This clinical study supports the practical experience of many thought leaders in psychiatry that psychedelic-assisted treatments, including MDMA for mental health disorders, have the potential to deliver significantly better outcomes for many patient groups.”
Awakn is now preparing to bring this research forward into a Phase IIb study which will take place in the United Kingdom and will be a double-blind, placebo-controlled clinical trial designed to investigate further the safety and efficacy of MDMA for alcohol use disorder.
Study details
First study of safety and tolerability of 3,4-methylenedioxymethamphetamine-assisted psychotherapy in patients with alcohol use disorder
Ben Sessa, Laurie Higbed, Steve O’Brien, Claire Durant, Chloe Sakal, Daniel Titheradge, Tim M Williams, Anna Rose-Morris, Elsa Brew-Girard, Sam Burrows, Chantelle Wiseman, Sue Wilson, James Rickard and David J Nutt
Author affiliations: Imperial College London; Drug Science, London; University of Bristol; Avon and Wiltshire NHS Foundation Trust; and Biotherapy Services, London.
Published in the Journal of Pschopharmacology on 18 February 2021.
Abstract
Background
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).
Aims
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.
Methods
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.
Results
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.
Conclusions
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.
[link url="https://www.healtheuropa.eu/results-from-worlds-first-mdma-alcohol-use-disorder-trial/106043/"]Health Europa report – Results from world’s first MDMA alcohol use disorder trial (Open access)[/link]
[link url="https://journals.sagepub.com/doi/full/10.1177/0269881121991792"]Journal of Psychopharmacology article – First study of safety and tolerability of 3,4-methylenedioxymethamphetamine-assisted psychotherapy in patients with alcohol use disorder (Restricted access)[/link]
[link url="https://www.hra.nhs.uk/planning-and-improving-research/application-summaries/research-summaries/bristol-imperial-mdma-in-alcoholism-study-bima/"]NHS study details – Bristol Imperial MDMA in Alcoholism Study (BIMA) (Open access0[/link]
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