Holding company Blackhawk Growth Corp.(OTC:BLRZF)'s subsidiary company MindBio Therapeutics Pty Ltd shared the positive data gathered from its Phase 1 clinical trials microdosing LSD formulation in 80 healthy participants.
A practical summary of the outcomes collected at this stage: microdoses of LSD have not shown severe adverse effects -though jitteriness can emerge in some patients- and increases in energy, wellness, happiness, creativity and connectedness suggest anti-anhedonic properties to improve treatment of patients with depression, home-based microdosing studies seem to be feasible and practical, and a subtle dose measuring and adjustment could optimize the treatment regimen.
MindBio co-founder Justin Hanka explained these Phase 1 clinical trials’ positive data is a confirmation of the company’s investment in the continuation of the proprietary LSD development into Phase 2 clinical trials.
These following studies will assess the compound’s efficacy to treat patients with Major Depressive Disorder (MDD) along with late-stage cancer patients suffering existential distress.
“We are pleased to report positive outcomes in our clinical trials and we are excited about the progress we are making towards the commercialization of psychedelic medicines and finding more effective medical treatments for mental health conditions,” said Blackhawk, CEO Fred Pels.
The Study And Outcomes
Of the total 136 participants screened for the study, 80 were randomized. Specifically, healthy male volunteers were randomized into even 10 μg (0.01 mg) LSD and placebo groups and received 14 doses of either every three days for six weeks.
A total 1102 microdoses (LSD/placebo) were administered with 100% adherence to regimen and no diversion of substances. The first doses were given under supervision while the remaining doses were self-administered.
Safety data, blinding, daily questionnaires, expectancy, and pre- and post-intervention psychometrics and cognitive tasks were measured and recorded.
Participants reported increased ratings of energy, wellness, creativity, happiness and connectedness on dose days compared to non-dose days, all which persisted when controlling for pre-trial expectancy.
Angry, connected, creative, energy, happy, irritable and well states showed significant interaction effects.
As for adverse effects, while most of the participants in both groups experienced one, that number was not statistically significant: only “jitteriness” arose as a repeated event, present in 32.5% of LSD patients and 7.5% in placebo participants.
Median severity events were mild in both groups, with four volunteers suffering from mild anxiety being removed from the LSD group. No deaths nor severe events occurred in the study.
Photo by Yoann Boyer on Unsplash
