Study of the Safety and Feasibility of Psilocybin in Adults With Methamphetamine Use Disorder
NCT ID: NCT05322954
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
PHASE1
12 participants
INTERVENTIONAL
2023-03-03
2026-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Psilocybin
25mg orally followed by 25 mg or 50 mg orally
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Psilocybin
25mg orally followed by 25 mg or 50 mg orally
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* 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
25 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Revive Therapeutics, Ltd.
INDUSTRY
University of Wisconsin, Madison
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Christopher Nicholas, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Wisconsin, Madison
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Wisconsin
Madison, Wisconsin, United States
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Click this link to contact us to see if you qualify
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2021-1087
Identifier Type: OTHER
Identifier Source: secondary_id
A532017
Identifier Type: OTHER
Identifier Source: secondary_id
SMPH/FAMILYMEDICINE/FAMILYMED
Identifier Type: OTHER
Identifier Source: secondary_id
Protocol Version 7/11/2023
Identifier Type: OTHER
Identifier Source: secondary_id
2021-1087
Identifier Type: -
Identifier Source: org_study_id