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

Sponsor

University of Wisconsin, Madison (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05322954

Collaborator

Revive Therapeutics, Ltd. (Industry)

Enrollment

Location

Arm

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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 mild or moderate methamphetamine use disorder (MUD). Participants can expect to be actively engaged in the study for up to 26 weeks.

Condition or Disease	Intervention/Treatment	Phase
Methamphetamine Use Disorder Substance-Related Disorders Chemically-Induced Disorders Substance Use Disorders Stimulant-Use Disorder	Drug: Psilocybin	Phase 1

Detailed Description

The objective of this study is to determine the safety of psilocybin in adult participants with mild - to - moderate 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

12 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Apr 1, 2023

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
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.	Drug: Psilocybin 25mg orally followed by 25 mg or 50 mg orally

Arm

Intervention/Treatment

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.

Drug: Psilocybin

25mg orally followed by 25 mg or 50 mg orally

Outcome Measures

Primary Outcome Measures

Incidence of serious adverse events associated with oral psilocybin [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).

Secondary Outcome Measures

Number of participants who complete at least one dose of psilocybin [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 [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 [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. [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.

Other Outcome Measures

Changes in addiction-related constructs [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Diagnosis of mild or moderate methamphetamine use disorder with meth use reported for less than 16 days in the past month

Exclusion Criteria:

Females with 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
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