Safety Profile of Psilocybin for Cocaine Use Disorder

Study Overview
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Brief Summary
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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.

Official Title
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Safety Profile of 25 mg Psilocybin in Individuals With Cocaine Use Disorder

Conditions
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Cocaine Use Disorder

Intervention / Treatment
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* Drug: Psilocybin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Psilocybin<br>25 mg psilocybin | Drug: Psilocybin<br>* Five oral capsules containing 5 mg of psilocybin each<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate | Beats per minute measured with blood pressure monitor. | 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 | Systolic and diastolic blood pressure measured with blood pressure monitor. | 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 | Average and peak subjective ratings of drug effects associated with mood measured using visual analogue scales (VAS; 1-100 mm). | From pre-dose through one-hour intervals post-dose over a 6-bour period. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported cocaine craving | Average subjective ratings of cocaine craving measured using Cocaine Craving Questionnaire-Brief. Each item on the 10 item questionnaire is scored on a scale ranging from 1 for Strongly Disagree to 7 for Strongly Agree, with higher scores indicating greater cocaine craving. | 48 hours and 10, 50, and 90 days after psilocybin administration. | 
| Self-reported mood ratings | Average subjective ratings of Depression, Anxiety, Stress measured using Depression, Anxiety and Stress scales of the Depression Anxiety Stress Scale (DASS-21). Each scale consists of 7 items rated from 0 to 3, with higher scores indicating greater Depression, Anxiety, or Stress. | 48 hours and 10, 50, and 90 days after psilocybin administration. |