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.
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 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.