MDMA, also known as ecstasy, has been rejected by drug bosses as a treatment for post-traumatic stress disorder (PTSD) – amid allegations of sexual abuse against those involved in clinical trials.
Gruesome footage posted online shows a therapist involved in the trials asking a participant to spread her legs, pinning her down and lying down next to her.
A Canadian patient who volunteered for one of the major studies subsequently accused a researcher of sexual abuse and initiated legal action.
A total of three clinical studies on MDMA by the same research group have now been retracted from the medical journal Psychopharmacology due to “unethical conduct,” although no specific reference was made to the allegations.
This comes after the research group, pharmaceutical company Lykos Therapeutics, had its MDMA therapy rejected by the US health authority FDA, due to a lack of evidence of the treatment’s “safety and efficacy”.
Mental health researchers have been investigating the potential benefits of the Class A drug for more than a decade.
The flood of feel-good hormones is thought to create an ideal environment for people with post-traumatic stress disorder (PTSD) to relive painful and difficult memories, which they may need to work through with the help of a psychotherapist.
One of the biggest players in this space is Lykos Therapies, formerly known as MAPS. It is 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 participate in a Lykos study investigating the use of MDMA for PTSD. Ms. Buisson had developed PTSD as a result of a previous sexual assault.
As part of the process, 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 from Ms Buisson’s sessions shows Mr Yensen asking her to spread her legs and Dr Dryer then lying on the bed with her.
The footage later shows Mr. Yensen holding her down as she tries to break free.
MDMA can help people who use it experience less anxiety and more confidence.
This lowering of inhibitions and development of trust can leave those who use the drug, therapeutically or recreationally, vulnerable to potential abuse.
For this reason, many studies involving psychedelics such as MDMA have two registered mental health professionals present as supervisors.
However, this was not the case in the 2015 Lykos clinical trial.
Moreover, it is difficult to obtain patient consent during a trial with MDMA.
For example, it may be unknown whether a patient’s consent to unconventional behavior, such as being touched by a therapist, is genuine or a result of the effects of the drug.
According to Lykos’ manuals, therapists may use a “nurturing touch” or “focused body treatment” when interacting with their patients.
These instructions give practitioners a great deal of freedom to act as they wish, all in the interest of their patient.
Ms Buisson said that at one point during the sessions she tried to knock herself unconscious to escape what was happening.
“I understand that in that seven-hour session… I was bound and pinned down and I was screaming and fighting non-stop. And to the point where I was trying to concuss myself to get out of that situation,” she said. ABC News.
Ms Buisson was identified as a success story in the research, the results of which were published as part of the now-retracted study.
However, she said she actually felt worse afterwards than before she started, and she also reported that there was little support offered to patients afterwards.
As part of the process, 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 her studies, she moved to Cortes Island in British Columbia, where Mr. Yensen and Dr. Dryer lived, to continue therapy there.
Mr Yensen allegedly made sexual advances towards Ms Buisson, claiming that this was part of therapy to help her recover from her sexual trauma.
Ms Buisson says she was given another drug at the time, the sedative ketamine, and that Mr Yensen demanded sex with her during her treatment.
She would later report Mr. Yensen to the police for sexual abuse and “therapy abuse.”
In court documents, Mr. Yensen alleged he had a consensual “intimate and sexual relationship” with her.
But Mrs Buisson describes the experience as being a ‘sex slave’.
“The first clinician I actually spoke to afterward summed up my experiences: I was seduced, drugged, raped, accused and held as a sex slave for almost two years,” she said.
Meanwhile, the Food and Drug Administration (FDA) has asked Lykos to conduct another clinical trial to confirm the reliability of their previous findings.
Lykos has indicated that it will appeal the decision.
The company was formerly known as the Multidisciplinary Association for Psychedelic Studies (MAPS) when it oversaw the 2015 trial involving Ms. Buisson.
When Ms Buisson’s story first came to light in 2022, the company said Dr Dryer and Mr Yensen had “materially deviated” from the 2015 trial protocol. The company banned them from providing MDMA-assisted therapy.
The company’s trials have also been surrounded by allegations that doctors overseeing the study were holding “underground” MDMA sessions that were not approved by the trial and were actually using the drugs illegally.
Lykos also disputes Psychopharmacology’s decision to retract the studies.
“The articles are still scientifically sound and make an important contribution to research into possible treatments for PTSD,” a statement to the New York Times.
The company has acknowledged that it failed to notify the magazine of violations, but says this should have been done through a correction rather than a recantation.
Three clinical trials that published results on MDMA in psychotherapy have now been retracted after a patient said she was sexually abused by those in charge of the studies.
Lykos also said that data from the retracted studies were not part of the recent FDA filing.
MDMA provides an immediate feeling of well-being by stimulating the release of neurotransmitters in the brain, such as dopamine, norepinephrine and serotonin.
It is a combination of psychedelic and stimulant drugs and often causes an energy boost and hallucinations.
Like many addictive drugs, MDMA produces a sense of euphoria, but is most often associated with its social effects, making a person feel friendlier, closer to other people, and more loving. It is most common at music festivals and raves.
But it also comes with major downsides, including suicidal thoughts.
Using drugs changes a person’s brain chemistry. It can lead to anxiety, increased depression and panic attacks, as well as nausea, diarrhea, headaches and insomnia.
This is thought to be because during the high, a flood of feel-good neurochemicals rushes through the brain, with levels of these chemicals remaining lower than average in the hours and days after the drug leaves your body.
This feeling can also prompt a person to retake and continue taking the drug to mitigate the effects.
It is estimated that one in 100 young people aged 16 and over in England and Wales used MDMA, an illegal class A drug in the UK, last year. Among 16- to 24-year-olds, the figure is one in 50.
PTSD affects 13 million Americans and is especially common among war veterans, who are at high risk for suicide.
Symptoms include flashbacks, nightmares, intense anxiety, overwhelming feelings of guilt or shame, and outbursts of anger or aggressive behavior.
There is still a large unmet need for new treatments for PTSD, because existing drugs do not work for all patients.
There have been previous calls for psychedelics to be made available to patients with PTSD in the UK.
Charlotte Nichols, the Labour MP for Warrington North in the House of Commons, gave a heartbreaking account last year of her own experiences with PTSD, suffered as a victim of crime.
In a debate about treatments using psilocybin, better known as magic mushrooms that belong to the same family of psychedelics as MDMA, she described some of the challenges that come with living with the condition.
She told parliament that her debilitating condition sometimes made her think ending her own life would be “a gesture of kindness” to her loved ones, and listed the therapies and medications she needed to endure the “living hell”.
