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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05322954
Recruitment Status : Not yet recruiting
First Posted : April 12, 2022
Last Update Posted : May 25, 2022
Sponsor:
Collaborator:
Revive Therapeutics, Ltd.
Information provided by (Responsible Party):
University of Wisconsin, Madison

Tracking Information
First Submitted Date  ICMJE April 4, 2022
First Posted Date  ICMJE April 12, 2022
Last Update Posted Date May 25, 2022
Estimated Study Start Date  ICMJE July 2022
Estimated Primary Completion Date April 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 4, 2022)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 20, 2022)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 4, 2022)
  • 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.
  • Change in Timeline Follow Back [ Time Frame: Up to 26 weeks ]
    Methamphetamine use will be evaluated using a self-report, timeline follow-back method 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 determined by seed and independent component-based neuroimaging analysis. Participants will undergo a 15-minute resting-state fMRI scanning sequence in which they will be instructed to clear their mind and remain passively awake.
Current Other Pre-specified Outcome Measures
 (submitted: April 4, 2022)
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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Study of the Safety and Feasibility of Psilocybin in Adults With Methamphetamine Use Disorder
Official Title  ICMJE Safety and Feasibility of Psilocybin in Methamphetamine Use Disorder in a Community-Based Sample
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Methamphetamine Use Disorder
  • Substance-Related Disorders
  • Chemically-Induced Disorders
  • Substance Use Disorders
  • Stimulant-Use Disorder
Intervention  ICMJE Drug: Psilocybin
25mg orally followed by 25 mg or 50 mg orally
Study Arms  ICMJE 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.
Intervention: Drug: Psilocybin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: April 4, 2022)
12
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2023
Estimated Primary Completion Date April 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Protea Research 608-225-0718 protea.research@mailplus.wisc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05322954
Other Study ID Numbers  ICMJE 2021-1087
2021-1087 ( Other Identifier: UW Madison )
A532017 ( Other Identifier: UW Madison )
SMPH/FAMILYMEDICINE/FAMILYMED ( Other Identifier: UW Madison )
5/23/2022 ( Other Identifier: UW Madison )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party University of Wisconsin, Madison
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Wisconsin, Madison
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Revive Therapeutics, Ltd.
Investigators  ICMJE
Principal Investigator: Christopher Nicholas, PhD University of Wisconsin, Madison
PRS Account University of Wisconsin, Madison
Verification Date May 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP