MDMA, also known as ecstasy, has been rejected by drug chiefs as a treatment for post traumatic stress disorder (PTSD) — amid accusations of sexual assault levelled at those involved in clinical trials.
Horrific footage published online shows a therapist involved in the trials telling a participant to spread her legs, pinning her down and lying beside her.
A Canadian patient who volunteered to participate in one of the pivotal studies has subsequently accused an investigator of sexual assault, and pursued legal action.
A total of three clinical studies on MDMA by the same research group have now been retracted from the medical journal Psychopharmacology on the grounds of ‘unethical conduct’ — although no specific reference was made to the allegations.
It comes as the research group —drug firm Lykos Therapeutics — has its MDMA therapy rejected by US health watchdog the FDA due to a lack of evidence to prove the treatment’s ‘safety and efficacy’.
Mental health researchers have been exploring the potential benefits of the Class A drug for over a decade.
It is thought the flood of feel-good hormones creates an ideal setting for people with post traumatic stress disorder (PTSD) to revisit painful and difficult memories that they may need to process with the help of a psychotherapist.
One of the biggest players in the field is Lykos Therapies — previously known as MAPS — a California-based company that has led several influential studies.
However, disturbing details about one of Lykos’ clinical trials, conducted in 2015, has come to light thanks to the testimony of a volunteer named Meaghan Buisson, now 44.
In 2015 she volunteered to take part in a Lykos trial that explored using MDMA for PTSD. Ms Buisson had developed PTSD as a result of a previous sexual assault.
As part of the trial, she was paired with licensed therapist Dr Donna Dryer and her husband, Richard Yensen, who bills himself as a ‘psychedelic researcher’ but isn’t a licensed therapist.
Footage of Ms Buisson’s sessions show Mr Yensen telling her to spread her legs with himself and Dr Dryer then seen spooning her in bed.
In the footage, Mr Yensen is later seen pinning her down as she struggles to get free.
MDMA can lead those who take it to experience a decrease in fear and increase in trust.
This decrease in inhibitions, and fostering of trust, can leave those who take the drug, either therapeutically or recreationally, vulnerable to potential abuse.
It’s for this reason that many trials involving psychedelics like MDMA require the presence of two registered mental health professionals as supervisors as best practise.
However, this wasn’t the case in the Lykos 2015 clinical trial.
It’s also difficult to accertain patient consent during an MDMA-assisted trial.
For example, it can be unknown if a patient’s consent to unconventional behaviour, such as a therapist touching them, is genuine, or the result of the effect of the drug.
According to manuals produced by Lykos, therapists are permitted to use a ‘nurturing touch’ or ‘focused bodywork’ to interact with their patients.
These instructions give those carrying out therapy a great degree of freedom to act how they please, all for the apparent benefit of their patient.
Ms Buisson said at one point she tried to knock herself out during the sessions as a way to escape what was happening.
‘I understand in that seven-hour session … that I was gagged and pinned down and that I screamed and fought non-stop. And to the point where I tried to concuss myself to get out of that situation,’ she told ABC News.
Ms Buisson was marked as a success story in the trial, the results of which were published as part of the now retracted study.
But she said she actually felt worse after it compared to before she started and has detailed how there was little support offered to patients in the aftermath.
As part of the trial, she was paired with licensed therapist Dr Donna Dryer, and her husband, Richard Yensen, who bills himself as a ‘psychedelic researcher’ but isn’t a licensed therapist
After the study, she moved to Cortes Island, in British Columbia, where Mr Yensen and and Dr Dryer lived, to continue to have therapy with them.
Mr Yensen is alleged to have made sexual advances towards Ms Buisson claiming it was part of a therapy to help her recover from her sexual trauma.
Ms Buisson says during this time she was given another drug, the tranquilizer ketamine, and while she was on it Mr Yensen would demand sex.
She would later report Mr Yensen to the police for sexual assault and ‘therapy abuse’.
In court documents Mr Yensen claimed he had a consensual ‘intimate and sexual relationship’ with her.
But Ms Buisson has described the experience as akin to being a ‘sex slave’.
‘The first clinician I really spoke to afterwards summarised my experiences…as being seduced, drugged, raped, blamed and held as a sex slave for nearly two years,’ she said.
Meanwhile, the Food and Drug Administration (FDA) has asked Lykos to complete another clinical trial to confirm the reliability of their previous findings.
Lykos has said it will appeal the decision.
The company was previously known as the Multidisciplinary Association for Psychedelic Studies (MAPS) when it oversaw the 2015 trial Ms Buisson was involved in.
In 2022, when Ms Buisson’s story first came to light, the company said Dr Dryer and Mr Yensen ‘substantially deviated’ from the 2015 trial protocol and has barred them from providing MDMA-assisted therapy.
The company’s trials have also come under a cloud with allegations of doctors overseeing the study of holding ‘underground’ MDMA sessions not sanctioned by the trial, and essentially using the drugs illegally.
Lykos has also disputed Psychopharmacology’s decision to retract the studies.
‘The articles remain scientifically sound and present important contributions to the study of potential treatments for PTSD,’ it said in a statement to the New York Times.
The company has acknowledged it failed to notify the journal about violations but said this should have been addressed via a correction rather than a retraction.
Three clinical studies that published results on MDMA in psychotherapy have now been retracted after a patient said she was sexually assaulted by those trusted with conducting them
Lykos has also said the data from the retracted studies didn’t form part of its recent FDA application.
MDMA provides an immediate enjoyable feeling by stimulating the release of neurotransmitters, such as dopamine, norepinephrine, and serotonin, in the brain.
It’s a combination of psychedelic and stimulant and often causes a burst in energy as well as hallucinations.
Like many addictive drugs, MDMA causes a sense of euphoria, but is most often associated with its social effects, causing someone to feel friendlier and closer to other people, and more loving. It’s most common at music festivals and raves.
But it’s not without its major downsides, which can include suicidal ideation.
Taking drugs alters a person’s brain chemistry. It can lead to anxiety, greater depression, and panic attacks, as well as nausea, diarrhoea, headaches, and insomnia.
It’s believed to be due to the rush of feel-good neurochemicals flooding the brain during the high, followed by lower-than-average levels of those chemicals in the hours and days after the drug leaves one’s system.
This feeling may also encourage someone to take the drug again and to keep taking it to mitigate those effects.
An estimated one in 100 over the age of 16 in England and Wales used MDMA, which is a Class A illegal drug in the UK, last year, those this rose to one in 50 among those aged 16 to 24.
PTSD affects 13 million Americans and is especially common among war veterans who are at high risk of suicide.
It involves symptoms such as flashbacks, nightmares, severe anxiety, overwhelming guilt or shame and angry outbursts or aggressive behavior.
There remains a large unmet need for new treatments for PTSD as existing drugs do not work on all patients.
Calls for psychedelics to be made available to patients in the UK with PTSD have been made before.
Charlotte Nichols, the Labour MP for Warrington North in the House of Commons last year gave a heartrending account of how her own experience with PTSD which she has as result of being victim of crime.
In a debate on psilocybin treatments, better known as magic mushrooms which belong to same family of psychedelics as MDMA, she detailed some of the the challenges of living with the condition.
She told Parliament she that at times the debilitating condition made her think that ending her own life ‘would be a kindness’ to her loved ones, and listed the therapies and medications needed to help deal with the ‘living hell’.
