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Pharma & Biotech

MindMed announces start of first-ever clinical trial evaluating the combination of MDMA and LSD in humans

If administered in combination with LSD, the company said MDMA may increase positive subjective drug effects, including positive mood and empathy, and reduce the negative emotions and anxiety sometimes associated with LSD

Mind Medicine (MindMed) Inc (NEO:MMED) (OTCQB:MMEDF) (FRA:MMQ) announced Wednesday the start of the first-ever clinical trial measuring and evaluating MDMA and LSD used in combination in the human body.

The trial will be conducted at the University Hospital Basel Liechti Lab in Basel, Switzerland.

If administered in combination with LSD, MindMed said that MDMA may increase positive subjective drug effects, including positive mood and empathy, and reduce the negative emotions and anxiety that are sometimes associated with LSD - producing an overall more positive experience.

READ: MindMed announces study to evaluate the effects of daytime and evening administration of low doses of LSD

MindMed is undertaking a Phase 1 clinical trial to evaluate if MDMA, when balanced and used in combination with LSD, can help offset some of the known potential unpleasant effects of LSD that occur in therapy or clinical settings.

The company said it is interested in understanding how to balance both MDMA and LSD in a cohesive way to create better patient outcomes, and develop more advanced psychedelic-assisted therapies, as MindMed expands both its R&D and commercial drug development pipeline. The study is anticipated to take around one year to complete.

"I believe that when LSD and MDMA are taken together they have exceptional potential to open a window into our mind which will awaken it to new levels of awareness by changing the fluidity of the ‌state‌ ‌of‌ ‌consciousness, amplifying‌ ‌changed‌ ‌perceptions,‌ ‌intensifying ‌emotions‌, ‌and‌ stimulating ‌novel‌ ‌thoughts,” said MindMed president Dr Miri Halperin Wernli in a statement. “It is like a gateway to a multidimensional universe.‌"

The Phase 1 double-blind, placebo-controlled, four-period crossover design study officially began this week and will assess subjective and autonomic effects aiming to determine the qualitative emotional differences between a combined MDMA and LSD experience, a pure LSD experience and a pure MDMA experience, versus a placebo.

LSD in other trials

MindMed noted that LSD in other Phase 1 clinical trials has demonstrated an acute subjective effect on the serotonin 5-HT2A receptor stimulation, leading to ego dissolution and neuroplasticity. These properties of LSD are thought to have therapeutic effects on patients suffering from mental disorders.

However, in some instances unpleasant effects can occur in therapy, causing distress to the subject through acute anxiety.

If MindMed finds the Phase 1 trial results promising, it will work with expert clinicians to undertake patient studies with treatments combining MDMA and LSD for various potential indications and mental disorders.

With its recent capital raise resulting in a total of C$237.2 million (US$183.8 million) raised to date and the essential addition of Robert Barrow as chief development officer, MindMed said it is well-positioned to capitalize on research advancements resulting from groundbreaking studies.

Contact the author: patrick@proactiveinvestors.com

Follow him on Twitter @PatrickMGraham

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