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Trial record 1 of 2 for:    psilocybin | methamphetamine
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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
Sponsor:
Collaborator:
Revive Therapeutics, Ltd.
Information provided by (Responsible Party):
University of Wisconsin, Madison

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.

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 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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Actual Study Start Date : March 3, 2023
Estimated Primary Completion Date : May 2024
Estimated Study Completion Date : August 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Methamphetamine

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




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Other Outcome Measures:
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
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Contact: Protea Research 608-225-0718 protea.research@mailplus.wisc.edu

Locations
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United States, Wisconsin
University of Wisconsin Recruiting
Madison, Wisconsin, United States, 53705
Contact: Protea Research    608-225-0718    protea.research@mailplus.wisc.edu   
Principal Investigator: Christopher Nicholas, PhD         
Sponsors and Collaborators
University of Wisconsin, Madison
Revive Therapeutics, Ltd.
Investigators
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Principal Investigator: Christopher Nicholas, PhD University of Wisconsin, Madison
Additional Information:
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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT05322954    
Other Study ID Numbers: 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 )
First Posted: April 12, 2022    Key Record Dates
Last Update Posted: July 18, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Wisconsin, Madison:
methamphetamine
psilocybin
psychedelics
stimulants
substance use
Additional relevant MeSH terms:
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Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Psilocybin
Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs