Issue link: https://www.e-digitaleditions.com/i/1470128
14 feature / clinical trial Psychedelics: New Frontiers in Alternative Medicine cannabissciencetech.com prevalence of not only major depressive disorder but showed higher levels of plasma HIV RNA (3). Women have previously been un- der-represented in clinical trials relat- ed to mental health, and in trials where women were included, the published results were not always gender specif- ic. In addition, post puberty, women have a 2:1 increased prevalence of ma- jor depression compared to men. Cur- rent treatment for depression is subop- timal or ineffective in approximately 50% of patients. It is vitally important to have a deeper understanding of how wom- en respond to medical treatment for major depression versus men in order to develop psychedelic therapies and treatment protocols for women that have clinically significant outcomes that are safe and effective. Q: Can you tell us about the partnerships you have formed for conducting this study, such as with TASK and with Professor Soraya Seedat? A: Woodman: Established in 2005, TASK is a renowned research specialist organization in infectious diseases, most notably in tuberculosis (TB), COVID-19 treat- ment, and vaccines. TASK's founder, Professor Andreas Diacon, has been celebrated by the Bill and Melinda Gates Foundation as a "hero in the field" for his contribution to TB drug development. The TASK clinical research organi- zation (CRO) will work in conjunction with Soraya Seedat, a distinguished Professor of Psychiatr y and Executive Head of the Department of Psychiatr y at Stellenbosch University in South Africa. She has more than 20 years of clinical, epidemiological, and basic neuroscience research experience as a psychiatrist. She has also been the recipient of several awards includ- ing the World Federation of the Socie- ty of Biological Psychiatr y Fellowship, the Anxiety Disorders Association of America Career Development Award, the Humboldt Research Award, and many others. Q: When do you hope to have results published? A: Woodman: Each patient will be enlisted into the trial for at least three months, and due to the high rate of HIV in South Africa and emphasis being placed on mental health and major depressive disorder, we foresee trial completion in about eight months from our start date in July. The results of the trial will most likely be published by April or May 2023 by Professor Seedat from USB post completion. Q: What have other studies suggested so far about the effect of psilocybin on treating mental health conditions? A: Woodman: A recent study published by Roland Griffiths and colleagues (2022) examining the safety and efficacy of psilocybin over a 12 month period in a patient group suffering from moderate to severe MDD showed that the substantial antidepressant effects of psilocybin-as- sisted therapy may last 12 months following acute intervention in certain patients (4). This data serves as a valuable tool for future research and development and government planning of mental healthcare policies and healthcare expenditure in combating major depression in countries like South Africa. Q: What sorts of research has Cannsun conducted with cannabis? Have you conduct- ed any studies on the use of cannabis as a treatment in conjunction with psilocybin? A: Woodman: Cannsun Group PLC, founded by David Parry and managed by our Canadian-based COO Aaron Katerenchuk, is a bio-pharmaceutical company focused on developing and commercializing new medicines to optimize human potential with operations in South Africa and Thailand. Cannsun Medicinal Global has a strong focus on research and development in both women's health and mental health. We are in the process of finalizing a clinical trial proposal for submission to the regulatory authority for research in schizophrenia (phase 1 trial). No combination therapy trial using both cannabis and psilocybin as a treatment modality has been done in South Africa to date due to the sensitive nature of these molecules in South Africa and their regulatory status. Although Cannsun has been awarded the first psilocybin trial and is cultivating medicinal cannabis in Atlantis, South Africa both of these modalities are still classed under a Schedule 7 substance in terms of the Medicines and Related Substances Act 101 of 1965. Q: Where do you hope to see more research in the future? A: Woodman: I wish to see more research done on and documented scientific data present- ed on whole psilocybin mushroom extract used to treat mental health disorders versus single molecule API. I wish to see more integrative CONTINUED ON PAGE 18