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

University of Wisconsin (UW)

Status and phase: Active, not recruiting; Phase 1

Conditions: Stimulant-Use Disorder; Methamphetamine Use Disorder; Substance Use Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Treatments: Drug: Psilocybin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05322954

Protocol Version 7/11/2023 (Other Identifier)

2021-1087 (Other Identifier)

A532017 (Other Identifier)

SMPH/FAMILYMEDICINE/FAMILYMED (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 estimated patients

Sex: All

Ages: 25 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of methamphetamine use disorder

Exclusion criteria

• Positive urine pregnancy at any time point during screening or study participation
• Inadequately treated hypertension, defined as 2 blood pressure readings, 10 minutes apart, of greater than 140/90 mmHg systolic/diastolic
• Current acute coronary syndrome or angina
• History of heart transplant or stroke
• Current use of and inability or unwillingness to taper off of medications that may interact with psilocybin
• Current insulin dependence, due to Type I or Type II diabetes

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Oral Psilocybin

Experimental group

Description:

Psilocybin with psychological support: Psilocybin will be administered in the form of capsules, taken orally with water. Each participant will receive 2 doses, approximately 4 weeks apart.

Treatment:

Drug: Psilocybin