Landmark clinical trial exploring LSD-MDMA combo to begin late 2020
Psychedelic pharmaceutical company MindMed is set to conduct a novel Phase 1 clinical trial exploring the subjective effects of combining LSD with MDMA. The primary goal of the prospective study is to investigate whether MDMA, a drug known to induce feelings of well-being, can reduce some acute negative mood effects seen with LSD and improve overall outcomes for psychedelic-assisted psychotherapy.
It is fair to say psychedelic science is booming at the moment. MDMA is on the cusp of being approved as a treatment for PTSD; psilocybin has been twice granted a Breakthrough Therapy designation by the FDA for depression; and LSD is being trialed for everything from Alzheimer’s disease to alcoholism.
MindMed, working with a psychedelic research lab headed by Matthias Liechti at the University of Basel in Switzerland, is building a strong resume of research projects that are certainly unique. Earlier this year the company revealed it is working on an LSD-neutralizing compound designed to function as an “off-switch” for any psychedelic experience that becomes too discomforting for patients. The company is also conducting a Phase 2 trial testing LSD microdoses for adult ADHD.
Discussing the genesis of this new clinical trial, Liechti hypothesizes the two drugs may synergistically function to deliver greater therapeutic outcomes than when administered alone.
"The potential of MDMA-LSD is to create a psychological state that may have the benefits of both substances and have longer lasting effects than standalone psilocybin or LSD,” says Liechti. “Inducing an overall primarily positive acute response during psychedelic assisted therapy is critical because several studies showed that a more positive acute experience is linked to a greater therapeutic long-term effect in patients."
The Phase 1 clinical trial, set to commence later this year, will initially enroll 24 healthy subjects. A four-stage cross-over design means each subject will blindly undertake four experimental sessions.
The four sessions will be: 100 micrograms of LSD + MDMA placebo; LSD placebo + 100mg of MDMA; 100 micrograms of LSD + 100 mg of MDMA; and LSD placebo + MDMA placebo. The primary outcome measures will evaluate the acute subjective effects of each combination, plus autonomic effects such as heart rate, blood pressure and body temperature.
This study will be the first robust clinical trial to investigate what happens when you combine these two well-known psychoactive drugs. However, recreational drug users and psychonauts do have a long anecdotal history of combining these two drugs.
Called “candyflipping”, one of the few published academic investigations into the practice suggested this combination of drugs do indeed seem to synergistically interact to result in a heightened experience, stronger than taking either substance alone. Of course, whether this translates into a greater therapeutic outcome within the context of psychedelic-assisted psychotherapy is unknown.
MindMed states the trial will begin late in 2020 and is expected to take up to a year to complete, so it's reasonable to assume any published results will not appear until early 2022.