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BrandsDr. Ben Sessa's Bristol Imperial MDMA in Alcoholism (BIMA) trial
10.12.2022
Awakn announces today the publication of results from its CMO Dr. Ben Sessa's Bristol Imperial MDMA in Alcoholism (BIMA) trial, an open-label safety, tolerability and proof-of-concept study investigating the potential role for MDMA-Assisted Psychotherapy in treating patients with alcohol use disorder (AUD).
Results published today in the Journal of Psychopharmacology, show that MDMA-Assisted Psychotherapy (3,4-methylenedioxymethamphetamine) was well tolerated by all participants. No unexpected adverse events were observed, and psychosocial functioning improved across the cohort.
Over an eight-week course of 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 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.
Dr Ben Sessa, Awakn's Chief Medical Officer, commented, "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, Prof. David Nutt, and Steven O'Brien."
Alcohol use disorder is the most prevalent substance use disorder, with alcohol use one of the top five causes of disease and disability in almost all countries throughout Europe [i]. In the UK, alcohol and related diseases are the leading cause of death in men aged between 16 and 54 years, accounting for over 20% of the total UK adult population [ii]. These figures are also predicted to rise as a result of the COVID pandemic. While there are current treatment methods available, which are effective for some segments of the population, relapse rates are high.
The study team was chaired by Awakn's Chair of the Scientific Advisory Board, Prof. David Nutt, Dept of Medicine, 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 bringing this research forward into a Phase IIb study in the United Kingdom and will be a double-blind, placebo-controlled clinical trial designed to investigate further, the safety and efficacy of MDMA-assisted psychotherapy for Alcohol Use Disorder.
Awakn's CEO Anthony Tennyson said, "Today's publication of our CMO's BIMA study is an important milestone. This was the world's first clinical research study exploring MDMA-Assisted Psychotherapy as a treatment for any addiction, and the results are promising. We look forward to advancing this research into Phase IIb in 2021 with our goal being MDMA-Assisted Psychotherapy approved as a treatment for AUD."
Dr Ben Sessa
A day in the life of a consultant psychiatrist and psychedelic drug researcher
Drugs are central to my life. Just like you, I was born to a drugged mother, injected minutes after birth and repeatedly dosed throughout my childhood.
My patients are simply self-medicating. And who can blame them? Their medicines (heroin, crack and alcohol) work better than mine (Prozac) at blunting life's sharp edgesDr Ben Sessa
Drugs help me get up and go to work, sustain me throughout the day and relax me in the evenings. I am a regular consumer of legal highs. Almost all of us are.
I work with children in a secure custodial setting, most of whom have used drugs before incarceration to have fun. I also work in an adult addictions service with people whose drug use is mistaken for the cause of their problems. It is not. Addiction is not about drugs. Rather, drugs slot neatly into a pre-drug maladaptive profile of failed opportunities and chronic exclusion of hope.
My patients are simply self-medicating. And who can blame them? Their medicines (heroin, crack and alcohol) work better than mine (Prozac) at blunting life's sharp edges. Nevertheless, I give them my drugs and help them off theirs. But in my clinical experience no drugs in isolation will eradicate mental disorder. Most psychiatric prescribing merely papers over the cracks of patients' symptoms with maintenance therapies that do not cure them. The core of their distress (childhood trauma, social exclusion, lack of education and opportunities) is hard and expensive to resolve. Prozac is cheaper and faster.
And I also work for the family law courts, assessing parents and children whose prospects are judged by court decisions based on their past or potential future drug use. But drug use and misuse are different. Most people take most drugs, most of the time relatively benignly. Drug misuse and addiction is not the drugs' fault. Simply prohibiting drugs and criminalising users is a grossly simplistic and dangerous folly. Our system for classifying drugs is unscientific, socially irresponsible and morally reprehensible. Our drug laws increase the harms, deaths, associated crime and even the usage of drugs. There is more scientific validity for homeopathy than prohibition. The arbitrary assignment of substances into classes A, B and C has no pharmacological validity, is patronising, dangerous and sends the wrong public health message. Drugs don't kill people. Prohibition does.
Yet our drug laws have persisted, unaudited and unaltered for 50 years despite clear evidence of their lack of efficacy. Why? This is a complex question that often leads towards unhelpful conspiracy theories. In wishing to avoid this, I can only assume successive governments sustain the destructive policy with my best interests at heart. It's enough to turn one to drugs.
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