Psilocybin for Methamphetamine Addiction

Overseen By Protea Research

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: University of Wisconsin, Madison

Must not be taking: Psilocybin interactors

Disqualifiers: Pregnancy, Hypertension, Coronary syndrome, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether psilocybin, a compound found in certain mushrooms, can safely assist people with methamphetamine addiction when combined with behavioral support. Participants will take two doses of psilocybin in capsule form, approximately four weeks apart. Researchers aim to determine if this approach can be a feasible option for treating methamphetamine use disorder (MUD). It suits individuals diagnosed with MUD who do not have certain health issues, such as untreated high blood pressure or current heart problems. Participants will engage in the study for up to 26 weeks. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to receive this innovative treatment.

Will I have to stop taking my current medications?

You may need to stop taking certain medications if they interact with psilocybin. If you are currently using such medications and cannot or do not want to stop, you may not be eligible for the trial.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that psilocybin, the treatment under study for methamphetamine addiction, has been safe in other clinical trials. For instance, studies on psilocybin-assisted therapy for alcohol dependence found it to be both safe and effective, indicating that psilocybin can be well-tolerated with appropriate support.

Psilocybin can cause hallucinations, which are carefully managed in clinical settings to ensure safety. Potential risks include dangerous behavior if someone is unprepared or unsupervised, and it might worsen mental illness in individuals with certain conditions. However, proper supervision minimizes these risks.

Overall, psilocybin has been tested in other contexts and shown to be safe when used correctly. This trial aims to gather more specific information about its safety for methamphetamine addiction. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for methamphetamine addiction, which often rely on behavioral therapy and medications like bupropion or naltrexone, psilocybin offers a unique approach by using a psychedelic compound. Psilocybin targets the brain's serotonin receptors, potentially altering perception and cognition in a way that could help break addiction patterns. Researchers are excited about psilocybin because it might facilitate profound psychological insights and emotional breakthroughs during therapy sessions, possibly leading to more effective results in a shorter time frame compared to traditional methods.

What evidence suggests that psilocybin might be an effective treatment for methamphetamine use disorder?

Research has shown that psilocybin, when combined with therapy, may help treat substance use disorders. Early studies suggest that psilocybin can boost mood, improve social interactions, and reduce drug use in people with methamphetamine addiction. In this trial, participants will receive oral psilocybin with psychological support. One study found this method might be safe, effective, and easy to expand after initial withdrawal treatment. Another study supports the idea that psilocybin-assisted therapy can help people stay off methamphetamine. These findings make psilocybin a promising option for those wanting to reduce methamphetamine use. ^{3 6 7 8 9}

Who Is on the Research Team?

Christopher Nicholas, PhD

Principal Investigator

University of Wisconsin, Madison

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have been diagnosed with mild or moderate meth use disorder, using it less than 16 days last month.

Diagnosis of methamphetamine use disorder with meth use reported for less than 16 days in the past month

Exclusion Criteria

I have had a heart transplant or a stroke.

I am using medications that cannot be mixed with psilocybin and cannot stop.

I am currently experiencing heart-related chest pain.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preparation and Psychological Support

Participants receive at least 6 hours of psychological support in preparation for psilocybin dosing

1-2 weeks

First Psilocybin Dosing

Participants ingest the first oral dose of psilocybin, followed by 8 hours of observation and an overnight stay

1 day

1 visit (in-person)

Second Psilocybin Dosing

Approximately 4 weeks after the first dose, participants receive a second oral dose of psilocybin with the same observation protocol

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including integration sessions and study measures

Up to 26 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Psilocybin

Trial Overview

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.

How Is the Trial Designed?

Group I: Oral Psilocybin Experimental Treatment 1 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.

Psilocybin is already approved in United States, European Union for the following indications:

Approved in United States as Psilocybin for:

• Treatment-resistant depression (TRD) under Breakthrough Therapy designation

Approved in European Union as Psilocybin for:

• Treatment-resistant depression (TRD) under PRIME designation

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

Revive Therapeutics, Ltd.

Industry Sponsor

Trials

4

Recruited

820+

Published Research Related to This Trial

Psilocybin, a compound found in 'magic mushrooms', has shown potential in recent studies for treating various mental health conditions, including obsessive-compulsive disorder, alcohol and tobacco addiction, and major depressive disorder, particularly in terminally ill cancer patients.

Despite its classification as a Schedule I drug in 1970, which halted much research, there is a renewed interest in psilocybin's therapeutic effects, highlighting its importance in both historical and contemporary neuroscience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

DARK Classics in Chemical Neuroscience: Psilocybin. Geiger, HA., Wurst, MG., Daniels, RN.[2019]

Psilocybin, a hallucinogenic compound found in certain mushrooms, has been associated with increasing rates of drug abuse, highlighting the need for comprehensive pharmacological understanding.

Despite its historical use in the 1960s for experimental medical purposes, recent research has only begun to uncover the pharmacological properties of psilocybin, indicating a gap in knowledge that needs to be addressed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The pharmacology of psilocybin. Passie, T., Seifert, J., Schneider, U., et al.[2016]

Psilocybin, a prodrug for psilocin, shows strong agonist activity at the serotonin 5-HT2A receptor, which is responsible for its psychedelic effects, and has been shown to have nanomolar affinity for various serotonin receptor subtypes in both in vitro and in vivo studies.

In mouse experiments, psilocybin and related compounds induced head twitch responses, a sign of psychedelic activity, which were blocked by a 5-HT2A antagonist, confirming the involvement of this receptor in their effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Structure-Activity Relationships for Psilocybin, Baeocystin, Aeruginascin, and Related Analogues to Produce Pharmacological Effects in Mice. Glatfelter, GC., Pottie, E., Partilla, JS., et al.[2023]

In a study examining the effects of Psilocybe cubensis and Panaeolus cyanescens mushrooms on heart cells, the extracts did not worsen hypertrophy caused by endothelin-1 and provided protection against TNF-α-induced cell injury.

The findings suggest that these mushroom extracts can be safely used in controlled conditions for potential therapeutic benefits in heart disease, although caution is advised with higher concentrations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects and safety of Psilocybe cubensis and Panaeolus cyanescens magic mushroom extracts on endothelin-1-induced hypertrophy and cell injury in cardiomyocytes. Nkadimeng, SM., Steinmann, CML., Eloff, JN.[2021]

Methamphetamine use disorder is a serious condition with high relapse rates and limited effectiveness of current treatments, highlighting the need for new therapeutic options.

Psilocybin-assisted psychotherapy shows promise as a potential treatment for methamphetamine use disorder, based on early experiences from four clinical trials, although no published studies currently exist on this specific application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring psilocybin-assisted psychotherapy in the treatment of methamphetamine use disorder. Brett, J., Knock, E., Korthuis, PT., et al.[2023]

Psilocybin is primarily a pro-drug that converts to the active compound psilocin in the body, which then interacts with serotonin receptors to produce its hallucinogenic effects.

The metabolism of psilocybin and psilocin varies significantly among individuals, affecting their dose-response and potential toxicity, highlighting the need for personalized approaches in therapeutic settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metabolism of psilocybin and psilocin: clinical and forensic toxicological relevance. Dinis-Oliveira, RJ.[2018]

Psilocybin-containing mushrooms, commonly known as hallucinogenic or 'magic' mushrooms, rapidly affect the central nervous system within 0.5-1 hour of ingestion, leading to effects such as ataxia, hyperkinesis, and hallucinations.

The review discusses the significant toxicity associated with these mushrooms, highlighting the need for awareness and understanding of their pharmacology, clinical effects, and potential treatment for adverse reactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Hallucinogenic mushrooms]. Reingardiene, D., Vilcinskaite, J., Lazauskas, R.[2018]

This study identified phenylethylamine in Psilocybe semilanceata mushrooms, which may contribute to adverse reactions during psilocybin intoxication, as evidenced by a case involving three young men who experienced severe symptoms.

The levels of phenylethylamine in these mushrooms can vary significantly, with the highest concentration found in the case of hospitalization, suggesting that this compound could play a role in the tachycardia and other symptoms not directly linked to psilocybin.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Presence of phenylethylamine in hallucinogenic Psilocybe mushroom: possible role in adverse reactions. Beck, O., Helander, A., Karlson-Stiber, C., et al.[2019]

Psilocybin, a compound found in certain mushrooms, is being studied for its potential therapeutic effects in treating conditions like addiction, anxiety, and depression, primarily through its active metabolite psilocin, which interacts with the 5HT2A receptor.

While psilocybin shows promise as a treatment agent in neuropsychiatry, careful consideration of its safety and potential for harm is necessary to determine its clinical use, highlighting the need for a responsible approach in this research area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psilocybin in neuropsychiatry: a review of its pharmacology, safety, and efficacy. Dodd, S., Norman, TR., Eyre, HA., et al.[2022]

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