Clinical TrialSubstance Use Disorders (SUD)PsilocybinRecruiting

Safety Profile of Psilocybin for Cocaine Use Disorder

This early-Phase I interventional trial (n=10) aims to assess the safety profile of psilocybin (25mg) in individuals with cocaine use disorder (CUD).

Target Enrollment
10 participants
Study Type
Phase I interventional
Design
Non-randomized

Detailed Description

The purpose of this single-group study is to establish the safe administration of 25 mg oral psilocybin in individuals with cocaine use disorder by assessing cardiovascular (heart rate, blood pressure) and subjective effects.

Ten participants attend a single 6-hour laboratory session (09:00–15:00) in a living-room-like environment with two clinicians present; psilocybin is given as five 5 mg capsules and measures are taken at 1-hour intervals.

No blood draws or neuroimaging are conducted; remote check-ins occur at 48 hours and at days 10, 50, and 90 post-session to monitor safety and wellbeing.

Study Protocol

Preparation

sessions

Dosing

1 sessions
360 min each

Integration

sessions

Study Arms & Interventions

Psilocybin

experimental

25 mg oral psilocybin

Interventions

  • Psilocybin25 mg
    via Oral• single dose• 1 doses total

    Five 5 mg capsules

Participants

Ages
21 – 55
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • Have a Body Mass Index from 18.5 - 34 kg/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

  • 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 Details

Locations

University of California, Los Angeles — Los Angeles, California, United States

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