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

Psilocybin

Brief Summary

The purpose of this research study is to investigate the safety and feasibility of two (2) oral doses of psilocybin when combined with behavioral 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.

Intervention / Treatment

  • Drug: Psilocybin

Condition or Disease

  • Methamphetamine Use Disorder
  • Substance-Related Disorders
  • Chemically-Induced Disorders
  • Substance Use Disorders
  • Stimulant-Use Disorder

Phase

Study Design

Study type: Interventional
Status: Not yet recruiting
Study results: No Results Available
Age: 25 Years to 65 Years   (Adult, Older Adult)
Enrollment: 12 ()
Funded by: Other|Industry

Masking

Clinical Trial Dates

Start date: Jul 01, 2022
Primary Completion: Apr 01, 2023
Completion Date: Jul 01, 2023
Study First Posted: Apr 12, 2022
Last Updated: May 25, 2022

Sponsors / Collaborators

Lead Sponsor: N/A
Responsible Party: N/A

Location

Madison, Wisconsin, USA

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 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 discharge 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.

Eligibility Criteria

Sex: All

More Details

NCT Number: NCT05322954
Other IDs: 2021-1087|A532017|SMPH/FAMILYMEDICINE/FAMILYMED|5/23/2022
Study URL: https://ClinicalTrials.gov/show/NCT05322954
Last updated: Jun 17, 2022