UW Psilocybin Pharmacokinetics Study

NCT02163707 | Completed Phase 1 DMC

• 3 other identifiers: 2013-0998A561000PHARM\PHARMACY\PHARMACY
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Psilocybin is a naturally occurring psychedelic compound produced by more than 200 species of mushrooms, collectively known as psilocybin mushrooms. Psilocybin (4-phosphoroyloxy-N,N-dimethyltryptamine) is a hallucinogenic tryptamine that was first isolated from Psilocybe mushrooms in 1957. The objective of this Phase I clinical trial is to determine the pharmacokinetics of oral doses of psilocybin in normal, healthy adults. The study is performed in support of Phase II and Phase III studies of psilocybin for the treatment of refractory anxiety associated with incurable cancer, as well as other possible indications. Psilocybin is at present not an FDA-approved drug.

Conditions

Healthy

Keywords

Psilocybin; Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• Determine the concentrations of psilocin following escalating doses of psilocybin

  Determine the AUC of psilocin in plasma following single doses of 0.3, 0.45, and 0.6 mg/lg psilocybin, the precursor to psilocin.

  12 months

Secondary Outcomes (3)

• Characterize any non-linearity in the pharmacokinetics of psilocybin and psilocin.

  12 months

• Determine the effect of kidney function on psilocin pharmacokinetics.

  12 months

• Characterize the incidence and severity of adverse events associated with escalating doses of psilocybin in normal adults.

  12 months

Study Arms (3)

Psilocybin Dose 1

OTHER

0.3 mg/kg (approximately 20mg/70kg)

Drug: Psilocybin

Psilocybin Dose 2

OTHER

0.45 mg/kg (approximately 30 mg/70 kg)

Drug: Psilocybin

Psilocybin Dose 3

OTHER

0.6 mg/kg (approximately 40 mg/70 kg)

Drug: Psilocybin

Interventions

Psilocybin DRUG

Dose 1: 0.3 mg/kg (approximately 20mg/70kg) Dose 2: 0.45 mg/kg (approximately 30 mg/70 kg) Dose 3: 0.6 mg/kg (approximately 40 mg/70 kg)

Psilocybin Dose 1; Psilocybin Dose 2; Psilocybin Dose 3

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 21 - 80 years
• Able to read, speak, and understand spoken English
• Self-report of at least one prior positive hallucinogen drug experience that included a meaningful altered state of consciousness. Hallucinogenic substances can include psilocybin, LSD, or other classic hallucinogens.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 based upon CRU NP or study physician physical exam, which indicates a subject is fully functioning.
• A woman of childbearing potential must agree to practice an effective means of birth control during their participation in the clinical trial, up to and including the 90 day follow-up after their last psilocybin dose. Birth control method and written agreement to practice this method throughout the duration of the study will be documented on the Medical History Case Report Form. Effective contraception is defined as the regular use of one of the following:
• Established use of oral, injected, or implanted hormonal methods of contraception
• Placement of an intrauterine device (IUD) or intrauterine system (IUS)
• Barrier methods: Condom or Occlusive cap used with a spermicide
• female sterilization/hysterectomy (with documentation of surgery)
• post-menopausal (\>12 months since last menses at the time of screening)
• Male sterilization (with post-vasectomy documentation)
• True abstinence
• Ability and willingness to adhere to study requirements, including attending all study visits, preparatory and follow-up sessions, and completing all study evaluations.
• Agree to refrain from using any psychoactive drugs, including alcoholic beverages and tobacco, within 24 hours of each drug administration. The exception is caffeine.
• Participants will be required to be non-smokers.

You may not qualify if:

• Estimated creatinine clearance \<30 ml/min, using the Cockcroft Gault equation and actual body weight.
• Clinically significant abnormal chemistry or hematologic laboratory results (from a screen of Complete Blood Count with Differential and Comprehensive Metabolic Panel), using the UWHC core lab reference intervals.
• Females of childbearing potential with positive urine pregnancy at screening or the day of the first treatment.
• Clinically significant abnormalities in physical examination.
• Inadequately treated hypertension (systolic blood pressure \>140 mmHg or diastolic blood pressure \>90 mmHg).
• Personal history of primary psychotic disorder (unless substance-induced or due to a medical condition), bipolar affective disorder Type I or Type II, or schizophrenia.
• First or second-degree family history of primary psychotic disorder, bipolar affective disorder Type I, bipolar affective disorder Type II, or schizophrenia.
• Substance abuse or dependency within the past five years.
• Suicidal ideation or attempt within the past 30 days and/or any prior suicidal ideation/attempt that the study physician and PI feel makes the participant unsuitable for the study.
• Urine drug test containing non-prescribed drugs of abuse (non-prescribed opioids, benzodiazepines, amphetamines, phencyclidine, cocaine) at screening and day of first treatment. Urine cannabinoid concentrations \>50 ng/ml will suggest heavy marijuana use, and will be a threshold for excluding potential subjects.
• Current use of monoamine oxidase inhibitors or dopaminergic antagonists. Any prohibited agents must have been stopped at least 5x the elimination half-life of the specific drug.
• Subject does not have a local support person that is available during their 24 hour treatment and observation period.
• Concurrent or recent (within 5 years) history of major depression, obsessive-compulsive disorder, panic disorder, anorexia nervosa, or bulimia nervosa.
• Poor venous access.
• Known acute coronary syndrome or angina.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin, School of Pharmacy

Madison, Wisconsin, 53705, United States

Location

Related Publications (2)

• Brown RT, Nicholas CR, Cozzi NV, Gassman MC, Cooper KM, Muller D, Thomas CD, Hetzel SJ, Henriquez KM, Ribaudo AS, Hutson PR. Pharmacokinetics of Escalating Doses of Oral Psilocybin in Healthy Adults. Clin Pharmacokinet. 2017 Dec;56(12):1543-1554. doi: 10.1007/s40262-017-0540-6.

  PMID: 28353056 RESULT

• Nicholas CR, Henriquez KM, Gassman MC, Cooper KM, Muller D, Hetzel S, Brown RT, Cozzi NV, Thomas C, Hutson PR. High dose psilocybin is associated with positive subjective effects in healthy volunteers. J Psychopharmacol. 2018 Jul;32(7):770-778. doi: 10.1177/0269881118780713. Epub 2018 Jun 27.

  PMID: 29945469 RESULT

MeSH Terms

Interventions

Psilocybin

Intervention Hierarchy (Ancestors)

Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tryptamines; Indolizidines; Indolizines

Study Officials

• Paul Hutson, PharmD

  University of Wisconsin, School of Pharmacy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2014
• First Posted: June 16, 2014
• Study Start: June 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 15, 2020

Record last verified: 2020-04

Locations

US (1)