The Bristol Cable

Approval for world-first trial marks massive step forward for research into psychedelics as medicine.

The UK’s first ever clinical study using MDMA has started in Bristol, in a landmark moment for the use of psychedelic drugs in psychotherapy.

After years of work to get the go-ahead, the trial is offering a small group of dependent drinkers from Bristol an eight-week therapy course including small doses of MDMA – the class A drug often known as ecstasy.

“MDMA represents the greatest, most innovative advance in psychiatric prescribing in the last 75 years”

Research has already been done in the US into using MDMA to treat post-traumatic stress disorder (PTSD) with the aim to get the drug licensed as therapeutic medicine by 2021.

However, this is the world’s first ever study looking at if the drug is similarly beneficial for treating addiction. Candidates in contact with Bristol’s drug services are going on a detox and receiving a course of MDMA-assisted therapy.

Dr Ben Sessa, a consultant child and adolescent psychiatrist and senior research fellow at Imperial College London, who specialises in mental health and addiction, is leading the study.

“MDMA represents the greatest, most innovative advance in psychiatric prescribing in the last 75 years, and it’s an opportunity not be missed in terms of developing this as a clinical tool,” he tells the Cable.

MDMA has successfully been tested to treat PTSD, because the drug removes the patient’s fear response while leaving other faculties intact. This enables the patient to talk to a therapist about their trauma without fear, for possibly the first time in their life.

“If you are carrying around memories in your head of painful trauma that goes back to childhood, you often spend your whole life going there and avoiding it at all costs, whether that means becoming a heroin addict or an alcoholic or self-harming,” Sessa says.

“The rationale behind this study is that we know MDMA works with trauma and that people with alcohol dependence have high levels of trauma in almost all cases, so we’re putting two and two together here.”

The study, which is sponsored by Imperial College London and being run at a facility in the University of Bristol, has recruited daily dependent drinkers from Bristol drug services, who experience withdrawal when they stop drinking. After a detox of seven to ten days, instead of going into typical treatment like individual therapy or Alcoholics Anonymous (AA), they start an eight-week MDMA therapy course.

Eligible participants receive weekly sessions of psychotherapy, including two day-long sessions with MDMA, after which they stay in the treatment centre overnight and are closely monitored. Follow-ups at three, six and nine months will continue to assess the safety and tolerability of the drug, but also if the patients have relapsed or stayed dry.

If this initial ‘open-label’ study goes well, the next stage will be a further ‘double-blind’ study alongside placebos in a few years.

Addiction treatment ‘crying out for something new’

Sessa says he was driven towards studying MDMA after seeing how ineffective traditional psychiatric methods are for a large group of people and “particularly those whose mental health problems are due to trauma or childhood abuse”.

“Treatment papers over the cracks by treating the symptoms but doesn’t get to the heart of the patients’ problem, which is often trauma”

Currently, the rate of success for alcohol addiction treatment is extremely low. “We chose alcohol addiction because the current treatments for alcohol misuse disorder are very poor – the four-year relapse rate post detox is 80-90%, which is awful. After 100 years of modern psychiatry, is that the best we can do?” he asks.

“People stay in treatment for years and it papers over the cracks by treating the symptoms but doesn’t get to the heart of the patients’ problem, which is often trauma. This diagnosis is crying out for something new.”

However, therapeutic MDMA use isn’t totally new. In fact, its history goes as far back as the mid-70s, as therapists who had been using LSD in psychiatry moved onto MDMA, which, unlike LSD, was still legal.

“Some interesting research was done on trauma therapy in the early 80s, but then MDMA was banned,” Sessa says. “Of course banning drugs is a terrible way of managing them. The whole rave thing happened, MDMA became a recreational drug. All research stopped for 30 years.”

Only recently has research recommenced. “There really has been a reawakening in the last 10 years. People are calling it the psychedelic renaissance,” he says.

Examples of this renaissance are studies at Imperial looking at treating depression with psilocybin, which is found in magic mushrooms, and US scientists considering future research into using MDMA to treat eating disorders.

Restrictive drug laws

Even with this renewed momentum, the legal status of MDMA in the UK has made it difficult to get the study approved, which has taken three years.

“Once all the data is in, it will be impossible not to license this drug, because the medical profession won’t stand for it not to be”

“This is the UK’s first ever clinical study using MDMA. It’s been incredibly difficult, very expensive and has taken a lot of time and effort,” Sessa says.

“We had delays when having the drug manufactured and adequately tested to meet all the right standards, as well as in getting the necessary regulatory approval and getting a Home Office license.”

MDMA is a ‘schedule one’ drug – a regulatory category for substances that aren’t used as medicines – so it has to be tracked by the Home Office. Each site has to be inspected to acquire a license – from where it’s made, analysed and tested to where it’s encapsulated, administered and stored.

“There’s no doubt that schedule one drugs are much harder to study,” Sessa says, who is highly critical of the UK’s drug laws.

MDMA, also known as ecstasy, is officially a class A drug under the Misuse of Drugs Act – the most serious classification that also includes heroin.

However, Sessa describes MDMA as a “staggeringly safe” clinical medicine as opposed to the ecstasy tablets that are taken recreationally. Even the concerns about that is overplayed, Sessa says, because the number of deaths is very low considering the huge amount of use – 750,000 doses every weekend.

From edition 15, OUT NOW! Read more from this edition.

The difficulties in getting this study up and running now mean future studies won’t have to jump through all the same hoops: “We’re trailblazing here and setting things up. I hope future studies will be much easier than this one.”

US researchers from the Multidisciplinary Association for Psychedelic Studies (MAPS) are aiming to get MDMA licensed for psychotherapy for PTSD by 2021.

The drug is currently in the final stages of trials and was recently granted ‘breakthrough therapy designation’, by the US’ Federal Drug Agency (FDA), meaning it has a meaningful advantage over existing treatments for PTSD.

If a license is awarded for PTSD, MDMA could be used ‘off-license’ to treat other diagnoses in the UK, including addiction.

Sessa is optimistic. “Once all the data is in, it will be impossible not to license this drug, because the medical profession won’t stand for it not to be.”