drugset / Trial / NCT02163707
UW Psilocybin Pharmacokinetics Study
Non-randomizedSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2014-06
- Primary completion
- 2015-12
- Completion
- 2015-12
Publications
- Results 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.
- Results 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Psilocybin | Other / unclassified | 0.3 mg/kg | Oral |
| Subject | Psilocybin | Other / unclassified | 0.45 mg/kg | Oral |
| Subject | Psilocybin | Other / unclassified | 0.6 mg/kg | Oral |
Indications
No indication recorded.