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

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.

Study Overview

• Status: Recruiting
• Conditions: Substance-Related Disorders; Chemically-Induced Disorders; Substance Use Disorders; Methamphetamine Use Disorder; Stimulant-Use Disorder
• Intervention / Treatment: Drug: Psilocybin

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.

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Protea Research; Phone Number: 608-225-0718; Email: protea.research@mailplus.wisc.edu

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53705
      • Recruiting
      • University of Wisconsin
      • Contact: Protea Research; Phone Number: 608-225-0718; Email: protea.research@mailplus.wisc.edu
      • Principal Investigator: Christopher Nicholas, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oral Psilocybin; 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.	Drug: Psilocybin; 25mg orally followed by 25 mg or 50 mg orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of serious adverse events associated with oral psilocybin	Incidence of serious adverse events attributable to psilocybin as categorized according to NCI Common Toxicity Criteria version 4.0. and assigned attribution (probably, possibly, and not related).	Up to 26 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants who complete at least one dose of psilocybin	Study protocol retention and adherence for preparation, dosing and follow-up visits determined by adherence and retention rates, number of visits attended throughout the duration of the study.	Up to 26 weeks
Number of participants who complete two-month follow-up visit	Study protocol adherence for preparation, dosing and follow-up visits determined by adherence and retention rates, number of visits attended throughout the duration of the study.	Up to 26 weeks
Changes in substance use	Frequency of use of methamphetamine and other substances will be evaluated and tracked based on participant self-reported use at each visit.	Up to 26 weeks
Functional changes in psychedelic and addiction-related neurocircuitry using functional magnetic resonance imaging.	Changes in functional connectivity (FC). Participants will undergo a 15-minute resting-state fMRI scanning sequence to measure changes in FC at rest pre- and post-dose.	Up to 26 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in addiction-related constructs	Changes in psychological, affective, and behavioral addiction-related constructs (e.g. craving, motivation, self-efficacy, self-compassion, mindfulness, experiential avoidance, etc.) measured by brief questionnaires prior to and following each psilocybin dosing session	Up to 26 weeks

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: Revive Therapeutics, Ltd.
• Investigators: Principal Investigator: Christopher Nicholas, PhD, University of Wisconsin, Madison

Publications and helpful links

Helpful Links

• Click this link to contact us to see if you qualify

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2023
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: April 4, 2022
• First Submitted That Met QC Criteria: April 4, 2022
• First Posted (Actual): April 12, 2022

Study Record Updates

• Last Update Posted (Actual): July 18, 2023
• Last Update Submitted That Met QC Criteria: July 13, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: psilocybin; methamphetamine; substance use; psychedelics; stimulants
• Additional Relevant MeSH Terms: Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Physiological Effects of Drugs; Psychotropic Drugs; Hallucinogens; Psilocybin
• Other Study ID Numbers: 2021-1087 (Other Identifier: UW Madison); A532017 (Other Identifier: UW Madison); SMPH/FAMILYMEDICINE/FAMILYMED (Other Identifier: UW Madison); Protocol Version 7/11/2023 (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No