Methamphetamine Use DisorderPhase 1NCT05322954
Study of the Safety and Feasibility of Psilocybin in Adults With Methamphetamine Use Disorder
A Phase 1 study testing Psilocybin in people with Methamphetamine Use Disorder and Substance-Related Disorders, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Methamphetamine Use Disorder, Substance-Related Disorders, Chemically-Induced Disorders
- What is being tested?
- Psilocybin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Mar 2023to 7 Mar 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of methamphetamine use disorder
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Psilocybin
- Keywords
- methamphetamine, psilocybin, psychedelics, stimulants, substance use
- Medical subject headings
- Substance-Related Disorders, Chemically-Induced Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsilocybinDrug
25mg orally followed by 25 mg or 50 mg orally
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Psilocybin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Up to 26 weeks
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2022
- Study start3 Mar 2023
- Primary completion7 Mar 2024
- Study completion7 Mar 2024
Why it stopped: due to sponsor financial constraints
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Methamphetamine Use DisorderStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Revive Therapeutics, Ltd.
- Responsible party
- Sponsor
- Investigators
- Christopher Nicholas, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05322954
- Sponsor's protocol ID
- 2021-1087
- Other IDs
- 2021-1087, A532017, SMPH/FAMILYMEDICINE/FAMILYMED, Protocol Version 7/11/2023
- Status last verified
- May 2026
- First submitted
- 4 Apr 2022
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Feasibility of Psilocybin in Methamphetamine Use Disorder in a Community-Based Sample
- ClinicalTrials.gov ID
- NCT05322954
- Acronym / sponsor ID
- 2021-1087
- Conditions
- Methamphetamine Use Disorder, Substance-Related Disorders, Chemically-Induced Disorders, Substance Use Disorders, Stimulant-Use Disorder
- Keywords
- methamphetamine, psilocybin, psychedelics, stimulants, substance use
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: due to sponsor financial constraints
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Revive Therapeutics, Ltd.
- Study start
- 3 Mar 2023 (actual)
- Primary completion
- 7 Mar 2024 (actual)
- Study completion
- 7 Mar 2024 (actual)
- First posted
- 12 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oral Psilocybin | Experimental | Drug: PsilocybinPsilocybin 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. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of methamphetamine use disorder
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psilocybin25mg orally followed by 25 mg or 50 mg orally | Drug | Oral Psilocybin |
Primary outcome
Incidence of serious adverse events associated with oral psilocybin
Time frame: Up to 26 weeks
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).
4 secondary outcomes
Number of participants who complete at least one dose of psilocybin
Time frame: Up to 26 weeks
Number of participants who complete two-month follow-up visit
Time frame: Up to 26 weeks
Changes in substance use
Time frame: Up to 26 weeks
Functional changes in psychedelic and addiction-related neurocircuitry using functional magnetic resonance imaging.
Time frame: Up to 26 weeks
Results and safety
The study was stopped early (reason given: due to sponsor financial constraints). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Click this link to contact us to see if you qualifyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Nicholas, PhD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Psilocybin in people with Methamphetamine Use Disorder and Substance-Related Disorders, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: due to sponsor financial constraints). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of serious adverse events associated with oral psilocybin (time frame: Up to 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.