Issue link: https://www.e-digitaleditions.com/i/1470128
13 clinical trial / feature cannabissciencetech.com Psychedelics: New Frontiers in Alternative Medicine Q: Can you tell us more about your work at Cannsun Group PLC? A: Donaghue Woodman: As Head of Research and Develop- ment, I'm responsible for investigating and initiating novel active pharmaceu- tical ingredients (APIs), research, and trials, respectively, that will make a positive lasting change on diseases that impact populations, especially women, within developing countries. I assist in navigation of the regulatory environment to ensure that we not only remain compliant, but also contribute to new laws and regulations around cannabis and psychedelic therapies in southern Africa. As Chief Medical Information Of- ficer of CannhealthMD, Cannsun's Clinical Education arm, I am respon- sible for data analysis on current med- ical needs and market gaps relating to medical cannabis and psychedelics; the creation of educational content and forums; training of medical doctors, nurses, and pharmacist on medical cannabis and psychedelics in South Af- rica; and lastly forming valuable part- nerships and collaborations for ver- tical integration of our operations in sub-Saharan Africa. Q: What prompted Cannsun to conduct a study on the effects of psilocybin on major depressive disorder (MDD)? A: Woodman: Major depressive disorder (MDD) impacts more than 300 million people globally and has led to rising healthcare expenditures in both private and public sectors. Mental health conditions such as depression and anxiety cost the South African economy more than $12.5 billion because of mental ill health. Patients suffering from MDD are at higher risk of mortality than those who aren't; in sub-Saharan Africa, where an estimated 8.2 million people are living with HIV, MDD is one of the more prevalent co-morbidities in human immunodefi- ciency virus (HIV) and in women. Data presented by the South African College of Applied Psychology in 2018 (2) suggest that one in six South Africans suffers from anxiety, depression, or a substance use disorder. According to the data, 40% of South Africans living with HIV have a comorbid mental disorder, 41% of pregnant women are depressed, and about 60% of South Africans could be suffering from post-traumatic stress. Due to the high rate of relapse, which could be as much as 40-60%, new therapies and treatment modalities are urgently needed. Q: Can you share more details about the clinical trial? What are you hoping to learn? A: Woodman: The trial is a double-blind, randomized, phase 2 feasibility study of psilocy- bin-assisted brief supportive psycho- therapy in an HIV positive all female group with major depressive disorder. The trial will comprise of 30 partici- pants and each participant will be inducted into the trial for three months in total. The trial will be conducted at TASK facilities in Cape Town, South Africa. The aim of the study is not only to assess safety and efficacy of psilocy- bin in HIV positive individuals, but to also assess the entourage effect of es- trogen and psilocybin in treatment of MDD in women. Q: Why is it important that the participants in this study are both women and HIV positive? A: Woodman: Women are twice as likely to contract HIV than men in sub-Saharan Africa. In these regions, women between the ages of 15–19 years account for 6 in 7 new HIV infections, contributing to 63% of all new infections. In 2020, an estimated 4200 women between the ages of 15–24 years became infected weekly. Serious mental illness is associated with harder-to-treat progression of HIV disease. Depression has been associat- ed with lack of medication adherence among HIV positive infected individu- als. Treatment with antidepressant medication has shown to assist in improving antiretroviral adherence among those suffering from mental health issues. Comorbid psychiatric diseases linked to HIV, such as major depressive disorder and substance abuse, have been shown to be predic- tive precursors of suicidal ideation in HIV positive individuals. A recent study conducted in HIV positive individuals discovered that persons with a history of suicidal ideation reported signifi- cantly higher degrees of current depressive symptoms and had a greater