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

NCT05322954 | Active Not Recruiting Phase 1 DMC FDA Drug

• 4 other identifiers: 2021-1087A532017SMPH/FAMILYMEDICINE/FAMILYMEDProtocol Version 7/11/2023
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

methamphetamine; psilocybin; psychedelics; stimulants; substance use

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Number of participants who complete at least one dose of psilocybin

  Up to 26 weeks

• Number of participants who complete two-month follow-up visit

  Up to 26 weeks

• Changes in substance use

  Up to 26 weeks

• Functional changes in psychedelic and addiction-related neurocircuitry using functional magnetic resonance imaging.

  Up to 26 weeks

Other Outcomes (1)

• Changes in addiction-related constructs

  Up to 26 weeks

Study Arms (1)

Oral Psilocybin

EXPERIMENTAL

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

Interventions

Psilocybin DRUG

25mg orally followed by 25 mg or 50 mg orally

Oral Psilocybin

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of methamphetamine use disorder

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• Revive Therapeutics, Ltd.: collaborator

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53705, United States

Location

Related Links

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

MeSH Terms

Conditions

Substance-Related Disorders; Chemically-Induced Disorders

Interventions

Psilocybin

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tryptamines; Indolizidines; Indolizines

Study Officials

• Christopher Nicholas, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2022
• First Posted: April 12, 2022
• Study Start: March 3, 2023
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2026
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)