Safety Profile of Psilocybin for Cocaine Use Disorder

University of California, Los Angeles (UCLA)

Status and phase

Enrolling

Early Phase 1

Conditions

Cocaine Use Disorder

Treatments

Drug: Psilocybin

Study type

Interventional

Funder types

Other

Identifiers

NCT06102434

21-002081

Details and patient eligibility

About

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.

Enrollment

10 estimated patients

Sex

All

Ages

21 to 55 years old

Volunteers

Accepts Healthy Volunteers

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