Study of the Safety and Feasibility of Psilocybin in Adults With Methamphetamine Use Disorder
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|ClinicalTrials.gov Identifier: NCT05322954
Recruitment Status : Recruiting
First Posted : April 12, 2022
Last Update Posted : July 18, 2023
|Condition or disease
|Methamphetamine Use Disorder Substance-Related Disorders Chemically-Induced Disorders Substance Use Disorders Stimulant-Use Disorder
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 :
|Interventional (Clinical Trial)
|Estimated Enrollment :
|Single Group Assignment
|None (Open Label)
|Health Services Research
|Safety and Feasibility of Psilocybin in Methamphetamine Use Disorder in a Community-Based Sample
|Actual Study Start Date :
|March 3, 2023
|Estimated Primary Completion Date :
|Estimated Study Completion Date :
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.
25mg orally followed by 25 mg or 50 mg orally
- 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).
- Number of participants who complete at least one dose of psilocybin [ Time Frame: Up to 26 weeks ]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.
- Number of participants who complete two-month follow-up visit [ Time Frame: Up to 26 weeks ]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.
- Changes in substance use [ Time Frame: Up to 26 weeks ]Frequency of use of methamphetamine and other substances will be evaluated and tracked based on participant self-reported use at each visit.
- Functional changes in psychedelic and addiction-related neurocircuitry using functional magnetic resonance imaging. [ Time Frame: Up to 26 weeks ]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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05322954
|Contact: Protea Research
|United States, Wisconsin
|University of Wisconsin
|Madison, Wisconsin, United States, 53705
|Contact: Protea Research 608-225-0718 email@example.com
|Principal Investigator: Christopher Nicholas, PhD
|Christopher Nicholas, PhD
|University of Wisconsin, Madison