This study is not yet accepting patients

Safety Profile of Psilocybin for Cocaine Use Disorder

a study on Cocaine Use Psilocybin

Summary

Eligibility
for people ages 21-55 (full criteria)
Healthy Volunteers
healthy people welcome
Location
at Los Angeles, California
Dates
study started
completion around
Principal Investigator
by Ziva D. Cooper, PhD
Headshot of Ziva D. Cooper
Ziva D. Cooper

Description

Summary

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

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

Keywords

Cocaine Use Disorder, Psilocybin

Eligibility

You can join if…

Open to people ages 21-55

  • Have a Body Mass Index from 18.5 - 34kg/m2
  • 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

You CAN'T join if...

  • 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

Location

  • University of California, Los Angeles
    Los Angeles California 90095 United States

Lead Scientist at UCLA

  • Ziva D. Cooper, PhD
    Dr. Ziva Cooper, Ph.D. is the Director of the UCLA Center for Cannabis and Cannabinoids in the Jane and Terry Semel Institute for Neuroscience and Human Behavior and Professor in the UCLA Departments of Psychiatry and Biobehavioral Sciences and Anesthesiology.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Los Angeles
ID
NCT06102434
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 10 study participants
Last Updated