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FelfüggesztveKorai 1. fázis

Safety Profile of Psilocybin for Cocaine Use Disorder

A legfontosabb adatok

Ki végzi
University of California, Los Angeles
Hol
Los Angeles (Egyesült Államok)A helyszín megnézése
Azonosító
Állapot
Felfüggesztve
Fázis
Korai 1. fázis
Résztvevők
10 fő, tervezett
Kezdés
2029. febr. 1.
Várható befejezés
2029. jún.
A vizsgálat típusa
Beavatkozással járó
A vizsgált kezelések
  • Psilocybin
A regiszteradat frissítve
2026. április 7.
Miért állt le
Departmental support

Ki vehet részt

Életkor
21 év – 55 év
Nem
Nők és férfiak
Egészséges önkéntesek
Részt vehetnek

A regiszter feltételei, szó szerint

Mind a 22 feltétel megnézéseKevesebb

Ki vehet részt

  • 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

Ki nem vehet részt

  • History of serious adverse events in response to classical psychedelics including history of Hallucinogen Persisting Perceptive Disorder
  • A resting heart rate greater than 90 bpm
  • Current hypertension (exceeding 140 systolic and 90 diastolic at resting)
  • 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
  • Any clinical condition, history of illness, or laboratory results that may place participants at greater risk as judged by the study physician
  • Abnormal electrocardiogram based on testing at study entrance
  • Current use of antidepressants or other serotonergic-affecting substances
  • Arrest for a violent offense
  • Women will not be eligible if trying to get pregnant, pregnant, or lactating

Helyszínek itt: Egyesült Államok

  • University of California, Los AngelesLos Angeles, Egyesült Államok

A vizsgálatról

Mit akar kideríteni a vizsgálat

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.

A vizsgálat csoportja

  • PsilocybinA vizsgált kezelés

    25 mg psilocybin

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on.
Hivatalos cím
Safety Profile of 25 mg Psilocybin in Individuals With Cocaine Use Disorder
A regiszteradat frissítve
2026. április 7.