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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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 26 weeks
Awards & highlights

Study Summary

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

Who is the study for?
This trial is for adults with methamphetamine use disorder who've used meth less than 16 days in the past month. It's not for those with insulin-dependent diabetes, pregnant individuals, untreated high blood pressure, a history of heart transplant or stroke, current severe heart issues, or those on certain medications.Check my eligibility
What is being tested?
The study tests the safety and practicality of two oral doses of psilocybin alongside behavioral support over approximately six months. Psilocybin is given to see if it can help people with methamphetamine addiction.See study design
What are the potential side effects?
Psilocybin may cause psychological effects like changes in perception, mood swings, and altered sense of time. Physical side effects could include headaches, dizziness, nausea or increased heart rate.

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
9%
Nausea
7%
Pain
7%
Viral upper resp. tract infection
7%
Back pain
7%
Bronchitis
4%
Insomnia
4%
Suicidal Ideation
4%
Diarrhea
4%
Influenza
4%
Headache
4%
Sinus headache
4%
Depressed mood
4%
Depression
4%
Lower resp. tract congestion
4%
Oropharyngeal pain
4%
Alcohol withdrawal syndrome
2%
Peripheral swelling
2%
Pyrexia
2%
Thrombocytosis
2%
Constipation
2%
Oedema
2%
Dermatitis contact
2%
Bronchitis bacterial
2%
Eye infection
2%
Fungal infection
2%
Traumatic lung injury
2%
Hyponatremia
2%
Arthralgia
2%
Musculoskeletal pain
2%
Pain in extremity
2%
Dizziness
2%
Hypoesthesia
2%
Migraine
2%
Sedation
2%
Anger
2%
Anxiety
2%
Cough
2%
Rhinorrhea
2%
Sexual abuse
2%
Sinus congestion
2%
Malignant melanoma
2%
Endodontic procedure
2%
Mallory-Weiss Syndrom
2%
Anemia
2%
Vomiting
2%
Influenza like Illness
2%
Gingivitis
2%
Restlessness
2%
Arthoscopic surgery
100%
80%
60%
40%
20%
0%
Study treatment Arm
Diphenhydramine
Psilocybin

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
~730

Find a Location

Who is running the clinical trial?

University of Wisconsin, MadisonLead Sponsor
1,177 Previous Clinical Trials
2,742,150 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. I just wanna stop the craving and be some what normal. All I want is to break free of meth addiction, I hate it.
PatientReceived no prior treatments
Lost custody and I'm homeless out of my mind in Albuquerque. This is one avenue I have never tried and feel could change my life.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

When can I start? Do you pay for my travel?
PatientReceived 2+ prior treatments

How responsive is this trial?

Average response time
  • < 1 Day
Typically responds via
Phone Call
Most responsive sites:
  1. University of Wisconsin: < 24 hours
~1 spots leftby May 2024