Awakn Life Sciences is using an Imperial study into MDMA-assisted psychotherapy to create a treatment for alcoholism that it aims to offer in clinics.

The academics behind the Bristol Imperial MDMA in Alcoholism Study, four of whom have taken senior roles at biotechnology company Awakn Life Sciences to help it develop the new treatment, say that psychotherapy under the influence of the drug MDMA could help patients process the traumatic experiences that are often the root cause of alcoholism.

While pharmaceuticals such as antidepressants are already used as a long-term treatment in combination with psychotherapies, the treatment under development could eventually be among the first approved treatments to use the acute effects of a pharmaceutical synergistically with psychotherapy to enhance its results.

Alcoholism and trauma

The researchers say that alcoholism is often the result of trauma. “There will be people who’ve experienced trauma and adversity perhaps in childhood or later life,” explains Dr Laurie Higbed, Honorary Research Officer in Imperial's Department of Brain Sciences and Lead Psychologist at Awakn.

There are people who’ve experienced trauma in childhood or later life. Sometimes they don’t seek support and they struggle in functioning in their relationships or other areas of their life. And sometimes they use alcohol or heroin to cope." Dr Laurie Higbed

“Sometimes they seek support via talking therapy or medication. Sometimes they don’t seek support and they struggle in functioning in their relationships or other areas of their life. And perhaps they use alcohol or heroin to cope.”

Psychotherapy can be beneficial for patients like these but has limitations because patients often do not feel comfortable talking about traumatic experiences. “If you have patients with long term mental health problems like alcoholism or PTSD [post-traumatic stress disorder], one problem is they hit a brick wall because they are experts at avoiding the difficult thing,” says Dr Ben Sessa, Honorary Senior Research Fellow in Imperial’s Department of Brain Sciences and Chief Medical Officer at Awakn. “They’ll talk about everything, but not that one traumatic experience. They’re taking antidepressants to paper over the cracks.”

Using MDMA to enhance psychotherapy

MDMA was originally developed by the pharmaceutical company Merck in 1912, but it has taken a long time to understand its effects and therapeutic potential due partly to its more recent status as a controlled drug, known as the main ingredient in ecstasy.

If you were inventing a drug to enhance trauma-focused psychotherapy, you'd invent MDMA. It reduces anxiety and depression. It has a stimulatory effect that motivates patients to engage. Dr Ben Sessa

“One of the reasons we had the confidence to begin new research into MDMA was that we had done the first proper brain imaging research, 12 years ago now, showing that it dampened down the parts of the brain active in PTSD. Getting the licence to do the research was about the fact that we are world-leaders in this field,” says Professor David Nutt, Director of Imperial's Neuropsychopharmacology Unit and Awakn’s Head of Research.

Dr Sessa argues that MDMA’s effects make it ideal for helping patients address trauma. “If you were going to invent a drug to enhance trauma focused psychotherapy, you would invent MDMA,” he says. “It has an effect at serotonin receptors to reduce anxiety and depression ­­– that’s very valuable in patients with a lifetime of trauma. It has a mild stimulatory effect via norepinephrine and dopamine, which motivates patients to engage in therapy. Paradoxically, MDMA also has a mild relaxation effect that takes the edge off hypervigilance, and it enhances  the release of the hormone oxytocin, which fosters attachment and bonding.”

Combined with psychotherapy, this could help patients overcome difficult emotions. “We’re using MDMA to allow people to relive the trauma and gain mastery over the emotions,” says Professor Nutt. “It's a form of extinction therapy. The memories come back, the emotions come back, but the MDMA helps them contain the emotions sufficiently so that eventually they extinguish. You never erase the memory of the event, but you stop the emotions coming back every time you think about the event.”

Early research

The team has established the safety of the treatment through an early-stage clinical trial carried out by Imperial in collaboration with the University of Bristol and funded by the Alexander Mosley Charitable Trust, in which patients with alcohol use disorder who had undergone detox were given a course of psychotherapy assisted in some sessions by MDMA.

While the trial was not designed to establish the treatment’s efficacy, a secondary outcome was that eight weeks after the course of treatment, only 21% of participants reported drinking over 14 units of alcohol per week. Later stage trials that incorporate blinding and a control group will be required to establish if the treatment is effective, but this secondary outcome was better than in an earlier trial the team carried out with similar patients using psychotherapy alone, in which 76% of participants had returned to drinking over 14 units of alcohol per week eight weeks after concluding psychotherapy.

Clinical development and delivery

Awakn has entered into a commercial agreement with Imperial to use the data from the team’s early-stage trial of MDMA-assisted psychotherapy and has engaged Dr Higbed, Professor Nutt, Dr Sessa, and Steve O’Brien, former research assistant and now Operations Manager at Awakn, in senior positions to take forward the development of the new therapeutic approach. Professor Nutt and Drs Higbed and Sessa maintain academic roles at Imperial.

We predict this will blow out of the water the idea of going into an expensive residential rehab to treat your alcoholism and then walking out into the pub, which we see so often. We believe we can deliver a community-based course that is more effective. Dr Ben Sessa

Awakn aims to clinically develop the new therapy via its active research programme, and privately deliver it via a network of high street psychedelic medicine clinics for mental health. But the team says they hope that the therapy will eventually be adopted by the NHS. “We would welcome this to move out of private medicine. We're a private clinic because the therapy is not yet NICE [National Institute of Health and Care Excellence]-recommended or available on the NHS, but we want it to be. And we're working with the NHS to try and achieve that,” says Dr Sessa.

 “The really interesting thing will be over the next five or ten years, when meaningful efficacy data comes in from widespread use,” he continues. “Our prediction is that this is going to blow out of the water the idea of going into very expensive six-month residential rehabs to treat your alcoholism and then walk out the next day into the pub, which we've seen so many times. We believe we can deliver a nine-week community-based course for treatment of addictions that is more effective. If that does turn out to be the case, it’s going to be a whole new paradigm.”

Translation and commercialisation at Imperial

Imperial uses licensing agreements such as the agreement with Awakn, industry research partnerships, consultancy services and startup companies to translate the academic insights of its community into innovations and technologies that make a positive difference to the world. More information about this activity is available from the College’s Enterprise Division.