PsilWell: Join A Psilocybin Wellness Study

This trial is designed to investigate the effects of psilocybin-assisted group therapy in well and unwell adults. The ideal trial participant is in overall good health, between 18–65 years old, without cardiovascular conditions, severe PTSD and/or not taking antidepressants (ex. SSRIs, SNRIs, TCAs, Ketamine) and has not used any psychedelic/hallucinogenic (ex., Psilocybin, cannabis, LSD, MDMA) or illicit substances (ex. Heroin, cocaine, opioids/opiates) in the past 2 months.

Psilocybin has been clinically studied within mental health conditions such as depression, anxiety and post-traumatic stress disorder and has shown promising results in reducing symptoms associated with these conditions. PsilWell seeks to determine if psilocybin-assisted group therapy affects people's wellness without focusing on mental health diagnoses.

Psilocybin has been used traditionally by Indigenous peoples for centuries as part of healing ceremonies to improve aspects of wellness. The PsilWell trial investigates if psilocybin-assisted group therapy can help people feel better in ways that go beyond diagnostic criteria. In de-centering diagnoses, we can prioritize questions that focus on participants' feelings and experiences with the treatment.

Participants in the PsilWell clinical trial undergo a 3-step screening process (Self-screen, Phone Screen, Onsite Screen) before enrolling. Once enrolled, participants are assigned to a group of 6 who will undergo 3 preparatory group therapy sessions, 1 dosing day and 3 integration group therapy sessions together, guided by licensed therapists and medical supervision. Participants will complete questionnaires related to their quality of life and well-being throughout the course of the study. The total length of participation from enrollment to final visit is 7 weeks.

The trial will be active for 1–1.5 years, with recruitment anticipated to end June 2027. This date may be earlier if recruitment is successful.

For participants, the length of trial participation is 7 weeks following enrollment. Once enrolled, you will begin group therapy the following week.

The PsilWell clinical trial is community-funded, meaning participants pay the Sponsor (Hippo Science) to participate. Hippo Science has pioneered a model whereby participants pay to participate in its clinical trials. The cost of participation varies by trial but is kept as low as possible.

The average cost of a clinical trial can run between $20,000–$100,000 USD per participant. This cost is typically covered by large pharmaceutical companies who view the clinical trial as an investment into the development of their drug product, or one of few government grants. There is little to no financial incentive for investors to invest in clinical research outside of drug development. We believe this paradigm stunts the development of novel research and have worked tirelessly to reduce this cost to $4,500 per participant.

We believe that people should get a say in the research being performed and what investigational products are brought to market. By voting with their dollar, participants can choose to further the research that answers the questions they're personally curious about and gain access to treatments that are otherwise inaccessible. This model allows us to ask novel questions that people want answered, not shareholders. Data collected from our trials will be made publicly available (i.e., published in academic journals, presented at conferences) and contribute to scholarly literature.

Hippo Life Science (Hippo) is a grassroots clinical research company founded to assist clinicians and investigators in conducting clinical research.

The current clinical research landscape greatly favours large pharmaceutical companies who are financially motivated to progress drug development. At Hippo, we believe in science that centers people's (i.e., stakeholders') health and their experiences: Not shareholder interests. Hippo unites clinicians and investigators who otherwise would not be able to perform research given the magnitude of resources required to execute novel and ethical clinical trials.

• →People-First: We engage the real people at the center of our research to inform, guide and support our strategy and goals. Hippo aims to produce clinical data that tells the story of its participants.
• →Democratizing research: We provide a pathway for independent clinicians and investigators to produce high quality clinical research and for prospective participants to access investigational products that are unsupported by pharmaceutical companies.
• →De-centering drug development: We investigate topics and investigational products that interest and may improve the lives of its participants: Not shareholder interests.