Peter Hendricks, Ph.D.The University of Alabama at Birmingham and Diamond Therapeutics, Inc., have announced a research collaboration on a clinical trial of low-dose psilocybin. The study will be conducted at UAB and will evaluate the effects of low doses of psilocybin in patients with demoralization, defined as a sense of helplessness, hopelessness, and a loss of meaning or purpose in life.
Most research studies on demoralization have been conducted among those with a medical diagnosis, most notably those with cancer or in palliative care. In the wake of the COVID-19 pandemic, demoralization has been studied in a variety of demographics, including younger populations, college students, people with comorbid mental health conditions, pre- and post-natal mothers, medical and clinical staff, people in the criminal justice system, police officers, and teachers.
“Recent studies suggest that larger doses of psilocybin have the potential to treat demoralization among those with advanced-stage cancer and among people living with HIV,” said Peter Hendricks, Ph.D., professor in the UAB School of Public Health and principal investigator. “This study aims to see if lower doses of psilocybin might treat demoralization in a broader population, that is, among those who might be experiencing demoralization for a variety of reasons, not just due to a medical condition.”
The trial will be a five-week, randomized, double-blind, placebo-controlled study. It will evaluate the feasibility, efficacy and mechanisms of action of low doses of psilocybin on patients with moderate to severe demoralization. Doses will be administered in a low range that is not thought to produce mystical, transcendent or hallucinogenic effects in subjects. Around 60 patients will be enrolled.
“Dr. Hendricks is an internationally renowned researcher,” said Judith Blumstock, chief executive officer of Diamond Therapeutics. “This trial is a key milestone in Diamond’s pursuit of low-dose, sub-perceptual, psychedelic-derived medicines that are safer and more effective for patients than the current first-line treatments.”
The study builds on the results of Diamond’s completed Phase I clinical trial, which was conducted under Health Canada regulations and established a safe, tolerable, non-hallucinogenic dose range for the use of low doses of psilocybin on an outpatient basis.
Further study details are listed on clinicaltrials.gov.