Initial studies have found that certain psychedelics have plenty of potential as treatments for mental health conditions such as post-traumatic stress disorder (PTSD) and major depressive disorder. Furthermore, activists across the country have put forth a variety of measures to decriminalize psychedelics, with cities such as Denver moving to decriminalize all psychedelics.
But before psychedelics can be approved for widespread medical use, they will have to go through the clinical trial system successfully. This process involves three phases: phase I trials where animals are used to test the efficacy and safety of drugs; phase 2 trials involving several dozen patients with a specific condition such as PTSD; phase 3 trials where the safety and efficacy of the drug are tested in a large group of people, usually more than 100 patients.
Once a psychedelic has successfully advanced past the third phase of clinical trials, it will be well on its way to receiving approval from the U.S. Food and Drugs Administration (FDA). At the moment, there are three pivotal phase 3 clinical trials that could significantly speed up the legalization of psychedelics in the United States.
MDMA-assisted therapy to treat PTSD. Funded by the nonprofit MAPS, this clinical trial is currently in its second phase 3 trial; 88% of the participants involved in the first phase 3 trial reported a 50% or more reduction in their PTSD symptoms while 66% said their symptoms had improved so much that they technically didn’t qualify for a PTSD diagnosis.
The second phase 3 trial will involve 100 participants, with half of them receiving a placebo and the other half getting a dose of between 80–180 mg of MDMA three times over a 12-week period.
Psilocybin-assisted therapy to treat depression. Psilocybin is the main psychoactive ingredient in magic mushrooms. Psychedelics company Compass Pathways will soon launch a phase 3 clinical trial to determine if psilocybin can be an effective treatment for treatment-resistant depression. The company’s preceding phase 2b trial was the largest psychedelic clinical trial, involving 233 patients who were divvied into groups that received either a placebo or 25mg of psilocybin.
During that test, 36.7% of the patients saw a 50% reduction in depression levels after three weeks of treatment. Depression levels had fallen by 24.1% after 12 weeks of treatment.
Ketamine therapy to treat alcohol use disorder. A phase 3 trial funded by Awakn Life Sciences will aim to see if ketamine-assisted therapy can be effective at treating alcohol-use disorder. Beginning in early 2023, the test will involve an estimated 280 patients and will follow up with the patients 6 and 12 months after the ketamine therapy.
The phase 2 trial delivered encouraging results, with 86% of the patients remaining alcohol-free six months after the trial. Researchers also found that patients who went through the therapy were 2.7 times less likely to relapse.
This particular ketamine study could take the activities of companies such as Delic Holdings Corp. (CSE: DELC) (OTCQB: DELCF) in an additional direction once the trial yields positive results for the treatment of AUD.
NOTE TO INVESTORS: The latest news and updates relating to Delic Holdings Corp. (CSE: DELC) (OTCQB: DELCF) are available in the company’s newsroom at https://ibn.fm/DELCF
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