Safety Profile of Psilocybin for Cocaine Use Disorder

This early-Phase I interventional trial (n=10) aims to assess the safety profile of psilocybin (25mg) in individuals with cocaine use disorder (CUD).

The University of California, Los Angeles, is conducting this study to determine the cardiovascular and subjective effects of psilocybin in individuals with cocaine use disorder who wish to stop using cocaine.

Participants, aged 21 to 55, will receive a single oral dose of 25 mg psilocybin during a laboratory visit lasting from 9 am to 3 pm in a comfortable environment. Two clinicians will be present during the session, where participants will ingest the psilocybin capsule and then lie down on a couch to reflect on their experience. Changes in heart rate, blood pressure, and subjective effects will be measured at one-hour intervals post-ingestion. No blood draws, behavioural assessments, or neuroimaging are included.

Follow-up check-ins will occur remotely at 48 hours, and 10, 50, and 90 days post-session. The study is estimated to start in February 2024 and conclude by December 2024.

Topic Opioid Use Disorder Addiction
Compound Psilocybin
Country United States of America
Visit trial
Status Not yet recruiting
Results Published No
Start date 01 February 2024
End date 31 December 2024
Phase Phase I
Design Open
Type Interventional
Generation First
Participants 10
Sex All
Age 21- 55
Therapy No

Trial Details

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.

NCT Number NCT06102434

Data attribution

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