MDMA, also known as ecstasy, has been rejected by pharmaceutical company bosses as a treatment for post-traumatic stress disorder (PTSD), amid allegations of sexual assault levelled at those taking part in clinical trials.
Horrifying footage posted online shows a therapist involved in the trials telling a participant to spread her legs, pinning her down and laying her down beside him.
A Canadian patient who volunteered to participate in one of the pivotal studies later accused a researcher of sexual assault and took legal action.
A total of three clinical studies on MDMA conducted by the same research group have been retracted from the medical journal Psychopharmacology on grounds of “unethical conduct,” although no specific reference was made to the allegations.
This comes after the research group, pharmaceutical company Lykos Therapeutics, saw its MDMA therapy rejected by the US health watchdog, the FDA, due to a lack of evidence to demonstrate the “safety and efficacy” of the treatment.
Mental health researchers have been exploring the potential benefits of this class A drug for more than a decade.
The rush of feel-good hormones is thought to create an ideal environment 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 this field is Lykos Therapies, formerly 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, have 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 exploring the use of MDMA for post-traumatic stress disorder (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 calls himself a “psychedelic researcher” but is not a licensed therapist.
Footage of Ms Buisson’s sessions shows Mr Yensen telling her to spread her legs and then Dr Dryer having him spoon her on the bed.
In the footage, Mr Yensen is later seen holding her down as she struggles to free herself.
MDMA can cause users to experience a decrease in fear and an increase in confidence.
This lowering of inhibitions and building of confidence can leave those who use the drug, whether for therapeutic or recreational purposes, vulnerable to potential abuse.
It is for this reason that many trials involving psychedelics such as MDMA require the presence of two registered mental health professionals as supervisors, as a best practice.
However, this was not the case in the 2015 Lykos clinical trial.
It is also difficult to obtain patient consent during an MDMA-assisted trial.
For example, it may not be known whether a patient’s consent to unconventional behavior, such as being touched by a therapist, is genuine or the result of drug action.
According to manuals developed by Lykos, therapists are allowed to use “nurturing touch” or “focused bodywork” to interact with their patients.
These instructions give those carrying out the therapy a great deal of freedom to act as they wish, all for the apparent benefit of their patient.
Ms Buisson said at one point she tried to pass out during the sessions as a way to escape what was happening.
“I understand that in that seven-hour session… I was gagged and restrained and I screamed and struggled non-stop. And to the point where I tried to give myself a concussion to get out of that situation,” he said. ABC News.
Ms Buisson was hailed 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 this compared to before she started and detailed how there was little support offered to patients afterwards.
As part of the trial, she was paired with licensed therapist Dr. Donna Dryer and her husband, Richard Yensen, who calls himself a “psychedelic researcher” but is not a licensed therapist.
After the study, she moved to Cortes Island, British Columbia, where Mr. Yensen and Dr. Dryer lived, to continue therapy with them.
Mr Yensen is alleged to have made sexual advances towards Ms Buisson claiming it was part of therapy to help her recover from her sexual trauma.
Ms Buisson says that during that time she was given another drug, the tranquiliser ketamine, and while she was taking it, Mr Yensen demanded that she have sex.
She later reported Mr. Yensen to the police for sexual assault and “therapeutic abuse.”
In court documents, Mr Yensen claimed he had 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 doctor I spoke to afterwards summed up 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 its 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 in which Ms. Buisson participated.
In 2022, when Buisson’s story first broke, the company said Dr. Dryer and Mr. Yensen “substantially deviated” from the 2015 trial protocol and banned them from providing MDMA-assisted therapy.
The company’s trials have also been mired in controversy with allegations that doctors overseeing the study were holding “clandestine” MDMA sessions not authorized by the trial and, in essence, using the drugs illegally.
Lykos has also questioned Psychopharmacology’s decision to retract the studies.
“The papers remain scientifically sound and present important contributions to the study of potential treatments for PTSD,” he said in a statement to the The New York Times.
The company acknowledged that it did not notify the magazine about the violations, but said this should have been addressed through 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 had been sexually assaulted by those entrusted to carry them out.
Lykos also said that data from the retracted studies were not part of its recent FDA application.
MDMA provides an immediate pleasurable feeling by stimulating the release of neurotransmitters, such as dopamine, norepinephrine and serotonin, in the brain.
It is a combination of psychedelic and stimulant and often causes an explosion of energy as well as hallucinations.
Like many addictive drugs, MDMA causes a feeling of euphoria, but is often associated with its social effects, which make a person feel friendlier and closer to other people, and more affectionate. It is most common at music festivals and raves.
But it is not without significant drawbacks, which can include suicidal ideation.
Drug use alters a person’s brain chemistry. It can cause anxiety, increased depression and panic attacks, as well as nausea, diarrhea, headaches and insomnia.
It is thought to be due to the rush of feel-good neurochemicals that flood the brain during the high, followed by lower-than-average levels of those chemicals in the hours and days after the drug leaves the body.
This feeling may also encourage someone to go back on the medication and continue taking it to mitigate those effects.
An estimated one in 100 over-16s in England and Wales used MDMA, which is an illegal class A drug in the UK, last year, with this figure rising to one in 50 among 16-24 year olds.
Post-traumatic stress disorder (PTSD) affects 13 million Americans and is especially common among war veterans who are at high risk for suicide.
It involves symptoms such as flashbacks, nightmares, severe anxiety, overwhelming guilt or shame, and outbursts of anger or aggressive behavior.
There remains a large unmet need for new treatments for PTSD, as existing medications do not work for all patients.
There have already been calls for psychedelics to be made available to PTSD sufferers in the UK.
Charlotte Nichols, Labour MP for Warrington North in the House of Commons last year, gave a harrowing account of her own experience with post-traumatic stress disorder (PTSD) as a result of being the victim of crime.
In a discussion about psilocybin treatments, better known as magic mushrooms which belong to the same family of psychedelics as MDMA, he detailed some of the challenges of living with the disease.
She told parliament that at times her debilitating condition made her think ending her own life “would be an act of kindness” towards her loved ones, and listed the therapies and medications needed to help cope with the “living hell”.
