Safety Profile of Psilocybin for Cocaine Use Disorder
Status:
Not yet recruiting
Trial end date:
2025-12-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to establish the safe administration of psilocybin in
individuals with cocaine use disorder in terms of cardiovascular (e.g., heart rate) and
subjective (e.g., mood) effects. The study's subject population consists of men and women
between the ages of 21 and 55 from the Los Angeles area that meet criteria for cocaine use
disorder and express an interest in ceasing cocaine use. 25 mg oral psilocybin will be
administered to 10 individuals (separately) during a single laboratory visit. The laboratory
visit will take place from 9 am until 3 pm within a comfortable, living room like
environment. Within this study session room, participants will be accompanied by two
clinicians. Participants will then consume the psilocybin capsule, and thereafter will be
encouraged to lie down on a couch and introspect on the experience. At one-hour intervals
following ingestion, participants will be tested briefly for changes in heart rate, blood
pressure, and subjective effects. No blood draws, behavioral assessments, or neuroimaging is
included in the study. Following the laboratory visit, investigators will check-in on
participants remotely, after 48 hours, and 10, 50, and 90 days from the psilocybin session.