Study of the Safety and Feasibility of Psilocybin in Adults With Methamphetamine Use Disorder

Substance Use Disorders Clinical Trial

Official title:

Safety and Feasibility of Psilocybin in Methamphetamine Use Disorder in a Community-Based Sample

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05322954
• Other study ID #: 2021-1087
• Secondary ID: 2021-1087A532017
• Status: Recruiting
• Phase: Phase 1
• Start date: March 3, 2023
• Est. completion date: May 2025

Study information

• Verified date: May 2024
• Source: University of Wisconsin, Madison
• Contact: Protea Research
• Phone: 608-225-0718
• Email: protea.research[@]mailplus.wisc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). Participants can expect to be actively engaged in the study for up to 26 weeks.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

Inclusion Criteria:

• Diagnosis of methamphetamine use disorder

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Chemically-Induced Disorders
• Methamphetamine Use Disorder
• Substance Use Disorders
• Substance-Related Disorders

Intervention

Drug:
• Psilocybin
25mg orally followed by 25 mg or 50 mg orally

Locations

Country	Name	City	State
United States	University of Wisconsin	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	Revive Therapeutics, Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Secondary	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
Secondary	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.	Up to 26 weeks
Secondary	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
Secondary	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

External Links

•   Click this link to contact us to see if you qualify