NCT05322954

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

Safety and Feasibility of Psilocybin in Methamphetamine Use Disorder in a Community-Based Sample

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 25 Years – 65 Years
• Healthy volunteers: Not accepted

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 methamphetamine use disorder (MUD). Participants can expect to be actively engaged in the study for up to 26 weeks.

Detailed description

The objective of this study is to determine the safety of psilocybin in adult participants with 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. If you are interested in participating in this study, please fill out a brief 1-minute survey at the link in the "More Information" section at the bottom of this record.

Conditions

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

Interventions

Type	Name	Description
DRUG	Psilocybin	25mg orally followed by 25 mg or 50 mg orally

Timeline

• Start date: 2023-03-03
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2022-04-12
• Last updated: 2025-12-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study