Clinical trial NCT05322954: Study of the Safety and Feasibility of Psilocybin in Adults With Methamphetamine Use Disorder
Official title: Safety and Feasibility of Psilocybin in Methamphetamine Use Disorder in a Community-Based Sample
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Methamphetamine Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Substance Use Disorders
Stimulant-Use Disorder
Keywords: methamphetamine
psilocybin
psychedelics
stimulants
substance use
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: Revive Therapeutics, Ltd.
First posted: 2022-04-12
Enrollment: 12
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of serious adverse events associated with oral psilocybin
timeFrame: Up to 26 weeks
Secondary outcomes:
measure: Number of participants who complete at least one dose of psilocybin
timeFrame: Up to 26 weeks
measure: Number of participants who complete two-month follow-up visit
timeFrame: Up to 26 weeks
measure: Changes in substance use
timeFrame: Up to 26 weeks
measure: Functional changes in psychedelic and addiction-related neurocircuitry using functional magnetic resonance imaging.
timeFrame: Up to 26 weeks
Other outcomes:
measure: Changes in addiction-related constructs
timeFrame: Up to 26 weeks
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Christopher Nicholas, PhD
role: PRINCIPAL_INVESTIGATOR
References: