Safety Profile of Psilocybin for Cocaine Use Disorder
Key facts
- Who runs it
- University of California, Los Angeles
- Where
- Los Angeles, United StatesSee the site
- Trial code
- Status
- Suspended
- Phase
- Early phase 1
- People taking part
- 10 people, planned
- Starts
- 1 Feb 2029
- Expected to end
- Jun 2029
- Type of study
- Interventional
- Treatments tested
- Psilocybin
- Record updated
- 7 April 2026
- Why it stopped
- Departmental support
Who can take part
- Age
- 21 years to 55 years
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
Show all 22 criteriaShow less
Who can take part
- 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
Who cannot take part
- History of serious adverse events in response to classical psychedelics including history of Hallucinogen Persisting Perceptive Disorder
- A resting heart rate greater than 90 bpm
- Current hypertension (exceeding 140 systolic and 90 diastolic at resting)
- 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
- Any clinical condition, history of illness, or laboratory results that may place participants at greater risk as judged by the study physician
- Abnormal electrocardiogram based on testing at study entrance
- Current use of antidepressants or other serotonergic-affecting substances
- Arrest for a violent offense
- Women will not be eligible if trying to get pregnant, pregnant, or lactating
Where in United States
- University of California, Los AngelesLos Angeles, United States
About the trial
What the trial wants to find out
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.
The group in the trial
- PsilocybinTreatment being tested
25 mg psilocybin
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Safety Profile of 25 mg Psilocybin in Individuals With Cocaine Use Disorder
- Record updated
- 7 April 2026