And it’s no surprise! A number of psychedelic drugs are beginning to show promise in their ability to treat a wide range of symptoms and conditions. The attraction of mainstream publications to the subject also increasingly points towards the mainstreaming of psychedelic therapeutics. So, could 2023 be the year of the psychedelic? Let’s take a look…
What to watch out for in 2023
The coming year is set to bring some interesting advancements in the world of psychedelic research, from studies into DMT and anxiety, to the efficacy of ketamine-assisted therapy for alcohol use disorder (AUD). Here are some of our ‘ones to watch’ for 2023:
MAPS PBC announcing positive results from a phase 3 trial of MDMA-assisted therapy for the treatment of PTSD
Talk about starting the new year right! In the first week of January California-based biopharmaceutical company MAPS Public Benefit Corporation (MAPS PBC) announced positive results regarding their phase 3 trial of MDMA-assisted therapy for the treatment of PTSD.
The trial treated 104 participants living with PTSD with either MDMA-assisted therapy or a placebo and reported improvements in functional impairments associated with PTSD compared to baseline and no serious adverse events. This becomes the company’s second positive phase 3 trial, lending greater support and credibility to MDMA-assisted therapy as a ‘breakthrough therapy’.
With these new results, MAPS PBC are planning to collate evidence to support the new drug application submission to the FDA in the third quarter of 2023. If approved, the company’s MDMA-assisted therapy will become the first psychedelic therapy used to treat a mental health condition.
Funding announced for Phase 3 Ketamine for the Reduction of Alcohol Relapse (KARE) trial
Building on the positive results of an earlier phase 2 trial, it was announced in December that a phase 3 trial into ketamine-assisted therapy and alcohol use disorder (AUD) was set to receive £2.4m of funding from the Medical Research Council and the National Institute for Health and Care Research, assisted by Awakn Life Sciences.
The trial will be led by the University of Exeter in conjunction with the NHS and will be delivered across 7 NHS sites. Researchers are aiming to recruit 280 participants with AUD, with half given ketamine at the dose used in the previous trial and psychological therapy, and the other half given a much lower dose of ketamine accompanied by a 7-session education package designed to inform participants about the dangerous effects of alcohol. The study is hoping to explore whether the low dose and education package combination helps to reduce harmful drinking.
If further positive results are found, it is hoped an NHS rollout can commence. This is vital considering there is an urgent need for new treatments for AUD. Recruitment for the study is set to take place mid-way through the year, although hopeful participants can pre-register their interest. It is of particular interest to see the NHS looking into the potential use of psychedelics, perhaps pointing to the mainstreaming of psychedelics in the UK, as official channels have historically adopted a hard line on this topic.
Small Pharma announces that the first patient has been dosed in its Phase 1 trial
Having launched the world’s first clinical trial for DMT-assisted therapy for the treatment of major depressive disorder (MDD) in February of last year, Small Pharma recently announced that the first patient had been dosed in its latest Phase 1 trial of intramuscular and intravenous administrations of DMT.
The trial is set to involve 14 participants allocated to two experimental arms. Psychedelic experienced participants will first receive a dose of DMT intramuscularly, followed by an intravenous dose 2-3 months later. Psychedelic naive participants will receive one intramuscular dose.
It is hoped that the trial will help to guide further research and development for Small Pharma. The intramuscular dose of DMT may provide greater convenience for clinicians administering treatment, and may improve the treatment experience for patients. Researchers are aiming to identify a target dose of their DMT compound that is well tolerated and offers patients a consistent breakthrough psychedelic experience.
The biotechnology company is also awaiting the results of their Phase 2a study of intravenous DMT administration in MDD. Therefore, it is hoped that these two trials will help to guide future clinical development and commercialisation.
Cybin announce Generalised Anxiety Disorder (GAD) as a target indication for DMT-assisted therapy
Continuing with the theme of DMT-assisted therapy, at the start of January biotechnology company Cybin announced they were turning their focus to GAD as a target indication for its DMT molecule, CYB004. Preclinical data has shown promise in CYB004’s ability to treat GAD, an indication that is in urgent need of more effective treatment options.
Cybin are currently conducting an exploratory Phase 1 trial to gain essential safety and dosing optimisation data for the future development of its CYB004 molecule. The company expects the trial to be complete in the first half of 2023, so keep your eyes peeled for further information!
Importantly these are just a handful of some of the interesting psychedelic trials and updates set to take place in 2023. With the global psychedelic industry predicted to grow to nearly $12bn a year by 2029, it’s no surprise that companies are making new announcements nearly everyday. With all this movement less than a month into the year, 2023 truly could become the year of the psychedelic.
This piece was written by Volteface Intern Megan Townsend. Megan is a current MA Criminology student at Birmingham City University. Tweets @megant2799.