SuspendedEarly Phase 1

Safety Profile of Psilocybin for Cocaine Use Disorder

NCT06102434 · University of California, Los Angeles

Closed to entry

Status

Not accepting participants

Early Phase 1

Phase

Target enrolment

Study sites

1 US states

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

Heart rate
Measured over 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
Measured over 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
Measured over From pre-dose through one-hour intervals post-dose over a 6-bour period.

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

21 Years to 55 Years

Ages

All

Sex

Accepted

Healthy volunteers

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

Where

1 study site

Facility	City	Region	Country
University of California, Los Angeles	Los Angeles	California	United States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

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NCT06102434 on ClinicalTrials.gov →

Last updated in the registry 2026-04-07. Registry records change; this page reflects the data build of 2026-08-25.

Where this trial sits

Substance

Psilocybin

Recruiting in

California115

All 6 trials from University of California, Los Angeles →