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| ID | Type | Description | Link |
|---|---|---|---|
| 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 |
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| Name | Class |
|---|---|
| Revive Therapeutics, Ltd. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psilocybin | Drug | 25mg orally followed by 25 mg or 50 mg orally |
|
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher Nicholas, PhD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin | Madison | Wisconsin | 53705 | United States |
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| Label | URL |
|---|---|
| Click this link to contact us to see if you qualify | View source |
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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 |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D011562 | Psilocybin |
| ID | Term |
|---|---|
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D014363 | Tryptamines |
| D054836 | Indolizidines |
| D007212 | Indolizines |
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