Safety Profile of Psilocybin for Cocaine Use Disorder

Safety Profile of 25 mg Psilocybin in Individuals With Cocaine Use Disorder

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.

Study Overview

• Status: Suspended
• Conditions: Cocaine Use Disorder
• Intervention / Treatment: Drug: Psilocybin

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • University of California, Los Angeles

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Have a Body Mass Index from 18.5 - 34kg/m^2
• Score of at least 3 on the Severity of Dependence Scale
• Desire to cease cocaine use as indicated by a goal of complete cocaine abstinence on the Thoughts about Abstinence Questionnaire
• At least 1, but not more than 10 total lifetime use of a classical psychedelic (5-HT2a agonist)
• 0 use of a classical psychedelic in the last year

Exclusion Criteria:

• History of serious adverse events in response to classical psychedelics including history of Hallucinogen Persisting Perceptive Disorder
• Abnormal electrocardiogram based on testing at study entrance
• A resting heart rate greater than 90 bpm
• Current hypertension (exceeding 140 systolic and 90 diastolic at resting)
• Current use of antidepressants or other serotonergic-affecting substances
• History of cardiac conditions
• History of hepatic or renal impairments
• History of stroke or Transient Ischemic Attack
• Epilepsy or history of seizures
• Immediate family or personal history of psychosis, bipolar disorder, or schizophrenia
• Anxiety or mood disorders determined by the Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-V)
• Must not meet DSM-V criteria for any substance use disorders other than cocaine, caffeine, or nicotine
• Must not meet DSM-V criteria for borderline personality or dissociative disorders
• Current suicidal ideation or lifetime history of suicide attempts
• Arrest for a violent offense
• Any clinical condition, history of illness, or laboratory results that may place participants at greater risk as judged by the study physician
• Women will not be eligible if trying to get pregnant, pregnant, or lactating

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Psilocybin; 25 mg psilocybin	Drug: Psilocybin; Five oral capsules containing 5 mg of psilocybin each

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate	Beats per minute measured with blood pressure monitor.	From pre-dose through one-hour intervals post-dose until heart rate has returned to within 20% of the pre-dose measure, or after a minimum of 6 hours.
Blood pressure	Systolic and diastolic blood pressure measured with blood pressure monitor.	From pre-dose through one-hour intervals post-dose until blood pressure has returned to within 20% of the pre-dose measure, or after a minimum of 6 hours
Self-reported drug effects	Average and peak subjective ratings of drug effects associated with mood measured using visual analogue scales (VAS; 1-100 mm).	From pre-dose through one-hour intervals post-dose over a 6-bour period.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported cocaine craving	Average subjective ratings of cocaine craving measured using Cocaine Craving Questionnaire-Brief. Each item on the 10 item questionnaire is scored on a scale ranging from 1 for "Strongly Disagree" to 7 for "Strongly Agree," with higher scores indicating greater cocaine craving.	48 hours and 10, 50, and 90 days after psilocybin administration.
Self-reported mood ratings	Average subjective ratings of Depression, Anxiety, Stress measured using Depression, Anxiety and Stress scales of the Depression Anxiety Stress Scale (DASS-21). Each scale consists of 7 items rated from 0 to 3, with higher scores indicating greater Depression, Anxiety, or Stress.	48 hours and 10, 50, and 90 days after psilocybin administration.

Collaborators and Investigators

• Sponsor: University of California, Los Angeles

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2029
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): June 1, 2029

Study Registration Dates

• First Submitted: October 17, 2023
• First Submitted That Met QC Criteria: October 20, 2023
• First Posted (Actual): October 26, 2023

Study Record Updates

• Last Update Posted (Actual): April 7, 2026
• Last Update Submitted That Met QC Criteria: April 1, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Alkaloids; Indoles; Indole Alkaloids; Indolizidines; Indolizines; Tryptamines; Psilocybin
• Other Study ID Numbers: 21-002081

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No