Study of the Safety and Feasibility of Psilocybin in Adults With Methamphetamine Use Disorder

The purpose of this research study is to investigate the safety and feasibility of two (2) oral doses of psilocybin when combined with behavioural support for methamphetamine use disorder (MUD). Participants have a diagnosis of mild or moderate methamphetamine use disorder (MUD). Participants can expect to be actively engaged in the study for up to 26 weeks.

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Status Planned
Start date 18 April 2022
End date 18 April 2022
Chance of happening 79%
Phase Phase I
Design Open
Type Interventional
Generation First
Participants 12
Sex All
Age 25- 65
Therapy Yes

Trial Details

The objective of this study is to determine the safety of psilocybin in adult participants with mild - to - moderate MUD. Eligible participants will be adults with methamphetamine use disorder recruited from the community. After the physical and psychological screening and at least 6 hours of psychological support for the psilocybin dosing, each participant will ingest 1 oral dose of psilocybin. All dosing sessions will be attended by 2 specially trained facilitators, in a dedicated Session Room at the University of Wisconsin School of Pharmacy. After eight hours of observation in the dosing room, the participant will stay overnight in the hospital Clinical Research Unit, and complete an integration session with at least one of the session facilitators before being discharged to home. Approximately 4 weeks after the first dose, the participant will receive a second oral dose of psilocybin, with the same length of observation. Participants who decide not to proceed to the second dose will complete two additional integration sessions and study measures through the two-month follow-up.

NCT Number NCT05322954

Sponsors & Collaborators

University of Wisconsin-Madison
The Transdisciplinary Center for Research in Psychoactive Substances (TCRPS) was launched at the University of Wisconsin-Madison in 2021.

Revive Therapeutics
Revive Therapeutics is a life sciences company that aims to develop psychedelics and cannabinoids for rare disorders and infectious diseases.

Data attribution

A large set of the trials in our database are sourced from ClinicalTrials.gov (CTG). We have modified these post to display the information in a more clear format or to correct spelling mistakes. Our database in actively updated and may show a different status (e.g. completed) if we have knowledge of this update (e.g. a published paper on the study) which isn't reflected yet on CTG. If a trial is not sourced from CTG, this is indicated on this page and you can follow the link to the alternative source of information.
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