Status:
RECRUITING
Safety Profile of Psilocybin for Cocaine Use Disorder
Lead Sponsor:
University of California, Los Angeles
Conditions:
Cocaine Use Disorder
Eligibility:
All Genders
21-55 years
Phase:
EARLY_PHASE1
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) effec...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06102434
Start Date
February 1 2026
End Date
June 1 2026
Last Update
December 22 2025
Active Locations (1)
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1
University of California, Los Angeles
Los Angeles, California, United States, 90095