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Psychedelic

Psilocybin for Methamphetamine Addiction

Phase 1
Recruiting
Led By Christopher Nicholas, PhD
Research Sponsored by University of Wisconsin, Madison
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of methamphetamine use disorder with meth use reported for less than 16 days in the past month
Be older than 18 years old
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upup to 26 weeks
Awards & highlights
No Placebo-Only Group

Study Summary

This trial is testing whether psilocybin can help with meth addiction and will last 26 weeks.

Eligible Conditions
  • Methamphetamine Addiction
  • Substance Use Disorders
  • Chemically-Induced Disorders
  • Substance Use Disorder
  • Stimulant Use Disorder

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 26 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 26 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of serious adverse events associated with oral psilocybin
Secondary outcome measures
Changes in substance use
Functional changes in psychedelic and addiction-related neurocircuitry using functional magnetic resonance imaging.
Number of participants who complete at least one dose of psilocybin
+1 more
Other outcome measures
Changes in addiction-related constructs

Side effects data

From 2021 Phase 2 trial • 95 Patients • NCT02061293
44%
Headache
21%
Nausea
15%
Anxiety
8%
Suicidal Ideation
6%
Insomnia
6%
Depressed mood
4%
Abdominal pain upper
4%
Vomiting
4%
Corona virus infection
4%
Upper respiratory tract infection
4%
Viral upper resp. tract infection
4%
Alcohol poisoning
4%
Depression
4%
Pneumonia
2%
Illusion
2%
Urinary incontinence
2%
Biopsy cervix
2%
Palpitations
2%
Cataract
2%
Abdominal pain
2%
Toothache
2%
Pain
2%
Limb injury
2%
Muscle strain
2%
Blood pressure diastolic increased
2%
Blood pressure increased
2%
Back pain
2%
Musculoskeletal pain
2%
Myalgia
2%
Dizziness
2%
Psychomotor hyperactivity
2%
Alcohol withdrawal syndrome
2%
Dysphoria
2%
Testicular pain
2%
Hyperventilation
2%
Food poisoning
2%
Food allergy
2%
Dyspepsia
2%
Influenza
2%
Nasal congestion
2%
Skin cosmetic procedure
2%
Photopsia
2%
Diverticulitis
2%
Asthenia
2%
Fatigue
2%
Gingivitis
2%
Dyspnea
2%
Oropharyngeal pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Psilocybin
Diphenhydramine

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Oral PsilocybinExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Psilocybin
2021
Completed Phase 2
~720

Find a Location

Who is running the clinical trial?

University of Wisconsin, MadisonLead Sponsor
1,140 Previous Clinical Trials
2,946,031 Total Patients Enrolled
Revive Therapeutics, Ltd.Industry Sponsor
3 Previous Clinical Trials
809 Total Patients Enrolled
Christopher Nicholas, PhDPrincipal InvestigatorUniversity of Wisconsin, Madison
1 Previous Clinical Trials

Media Library

Psilocybin (Psychedelic) Clinical Trial Eligibility Overview. Trial Name: NCT05322954 — Phase 1
Methamphetamine Addiction Research Study Groups: Oral Psilocybin
Methamphetamine Addiction Clinical Trial 2023: Psilocybin Highlights & Side Effects. Trial Name: NCT05322954 — Phase 1
Psilocybin (Psychedelic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05322954 — Phase 1
Methamphetamine Addiction Patient Testimony for trial: Trial Name: NCT05322954 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment phase of this research endeavor still open?

"Reports on clinicaltrials.gov indicate that this specific trial, which had its first post date of December 1st 2022 and final edit as November 8th 202 is no longer enrolling patients. However, there are 1190 other trials in search for participants at the present moment."

Answered by AI

Who meets the requirements for inclusion in this experiment?

"To be eligible for this medical trial, individuals must have a documented history of substance abuse and fall within the required age-range (25 to 65). The research team is seeking approximately 12 participants."

Answered by AI

How reliable is Psilocybin in protecting people from harm?

"The safety of Psilocybin is rated 1 on a scale from 1 to 3 due to the fact that this is only in its first phase of testing with limited data available for efficacy and safety."

Answered by AI

Is the minimum age requirement for this research 18 years or older?

"The criteria for this medical trial mandates that applicants be between 25 and 65 years of age. For those under 18 or over 65, there are 314 studies and 797 studies respectively catered towards them."

Answered by AI

Who else is applying?

What state do they live in?
Colorado
Wisconsin
California
Other
How old are they?
65+
18 - 65
What site did they apply to?
University of Wisconsin
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
0
2
3+

Why did patients apply to this trial?

I want to quit. Used meth for most adult life would like to quit and help others quit.
PatientReceived no prior treatments
I have tried countless rehabs treatments medications etc to help my substance use to no avail.
PatientReceived 2+ prior treatments
Seen a YouTube video about psilocybin treating addiction did some digging and came across this study. Please help me.
PatientReceived 1 prior treatment
Because I just want to be sober I haven’t done many other drugs and I’ve tried everything to get sober it works until it doesn’t and I want to be happy sober.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

When can I start?
PatientReceived no prior treatments

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. University of Wisconsin: < 24 hours
Average response time
  • < 1 Day
Recent research and studies
clinicaltrials.govStudy
Study of the Safety and Feasibility of Psilocybin in Adults With Methamphetamine Use Disorder
2023. "Study of the Safety and Feasibility of Psilocybin in Adults With Methamphetamine Use Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05322954.
All > Substance Abuse > Psilocybin
~5 spots leftby May 2024
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