Study of the Safety and Feasibility of Psilocybin in Adults With Methamphetamine Use Disorder
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT05322954 |
Recruitment Status :
Recruiting
First Posted : April 12, 2022
Last Update Posted : May 14, 2024
|
Tracking Information | |||||
---|---|---|---|---|---|
First Submitted Date ICMJE | April 4, 2022 | ||||
First Posted Date ICMJE | April 12, 2022 | ||||
Last Update Posted Date | May 14, 2024 | ||||
Actual Study Start Date ICMJE | March 3, 2023 | ||||
Estimated Primary Completion Date | May 2025 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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).
|
||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
|
||||
Original Secondary Outcome Measures ICMJE |
|
||||
Current Other Pre-specified Outcome Measures |
Changes in addiction-related constructs [ Time Frame: Up to 26 weeks ] 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
|
||||
Original Other Pre-specified Outcome Measures | Same as current | ||||
Descriptive Information | |||||
Brief Title ICMJE | Study of the Safety and Feasibility of Psilocybin in Adults With Methamphetamine Use Disorder | ||||
Official Title ICMJE | Safety and Feasibility of Psilocybin in Methamphetamine Use Disorder in a Community-Based Sample | ||||
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. | ||||
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 ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Health Services Research |
||||
Condition ICMJE |
|
||||
Intervention ICMJE | Drug: Psilocybin
25mg orally followed by 25 mg or 50 mg orally
|
||||
Study Arms ICMJE | 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.
Intervention: Drug: Psilocybin
|
||||
Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
12 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | May 2025 | ||||
Estimated Primary Completion Date | May 2025 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
Sex/Gender ICMJE |
|
||||
Ages ICMJE | 25 Years to 65 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
|
||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT05322954 | ||||
Other Study ID Numbers ICMJE | 2021-1087 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 ) |
||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
|
||||
IPD Sharing Statement ICMJE |
|
||||
Current Responsible Party | University of Wisconsin, Madison | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | University of Wisconsin, Madison | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Revive Therapeutics, Ltd. | ||||
Investigators ICMJE |
|
||||
PRS Account | University of Wisconsin, Madison | ||||
Verification Date | May 2024 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |