Safety Profile of Psilocybin for Cocaine Use Disorder

Launched by UNIVERSITY OF CALIFORNIA, LOS ANGELES · Oct 20, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the safety of a substance called psilocybin for people who have a cocaine use disorder. The goal is to see how psilocybin affects the heart and mood when taken by individuals who want to stop using cocaine. The study will involve men and women aged 21 to 55 from the Los Angeles area who meet certain criteria, such as having a desire to quit cocaine and a history of using psychedelics, but not in the past year.

Participants in this trial will take a single dose of 25 mg of psilocybin in a comfortable setting, where they will lie down and reflect on their experience. Throughout the day, healthcare providers will monitor their heart rate and blood pressure to ensure their safety. After the session, researchers will check in with participants remotely at various times over the next few months to see how they are doing. It’s important to note that there are specific health criteria that must be met to participate, such as not having certain heart conditions or mental health issues.

Gender

ALL

Eligibility criteria

• 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