Safety Profile of Psilocybin for Cocaine Use Disorder

NCT06102434 | Recruiting Early Phase 1 FDA Drug

• 1 other identifier: 21-002081
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cocaine Use Disorder

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Self-reported cocaine craving

  48 hours and 10, 50, and 90 days after psilocybin administration.

• Self-reported mood ratings

  48 hours and 10, 50, and 90 days after psilocybin administration.

Study Arms (1)

Psilocybin

EXPERIMENTAL

25 mg psilocybin

Drug: Psilocybin

Interventions

Psilocybin DRUG

Five oral capsules containing 5 mg of psilocybin each

Psilocybin

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)
• use of a classical psychedelic in the last year

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

University of California, Los Angeles

Los Angeles, California, 90095, United States

RECRUITING

MeSH Terms

Interventions

Psilocybin

Intervention Hierarchy (Ancestors)

Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tryptamines; Indolizidines; Indolizines

Central Study Contacts

Conor H Murray, PhD

CONTACT

3174374992; conormurray@mednet.ucla.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 17, 2023
• First Posted: October 26, 2023
• Study Start: February 1, 2026
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 26, 2026

Record last verified: 2026-01

Locations

US (1)