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

12 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests if psilocybin pills, combined with counseling, are safe for adults addicted to methamphetamine. Psilocybin can change brain function temporarily, helping people see their addiction differently. Counseling supports participants in understanding and using these new insights to aid their recovery. Psilocybin has shown potential in treating addiction, including nicotine and alcohol addiction, and has been studied for its effects on depression and anxiety.

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.

What data supports the effectiveness of the drug psilocybin for methamphetamine addiction?

While there are no published studies specifically on psilocybin for methamphetamine addiction, psilocybin has shown promise in treating other substance use disorders, such as alcohol and tobacco addiction, and difficult-to-treat conditions like major depressive disorder. This suggests potential for its use in methamphetamine addiction treatment. ^{1 2 3 4 5}

Is psilocybin safe for human use?

Psilocybin, found in magic mushrooms, has been used historically and in recent studies for various conditions, showing promise in treating disorders like depression and addiction. While generally considered safe under controlled conditions, it can cause rapid effects on the nervous system, and adverse reactions may occur, especially if other substances like phenylethylamine are present. Caution is advised, particularly for individuals with heart conditions. ^{3 5 6 7 8}

How is psilocybin different from other drugs for methamphetamine addiction?

Psilocybin is unique because it is a psychedelic drug that works by affecting serotonin receptors in the brain, which is different from traditional treatments like contingency management and psychotherapy that have limited success. Unlike other drugs, psilocybin is being explored for its potential to assist in psychotherapy, offering a novel approach to treating methamphetamine addiction. ^{2 3 5 6 9}

Research Team

Christopher Nicholas, PhD

Principal Investigator

University of Wisconsin, Madison

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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, 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 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, 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-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]

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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Psilocybin in neuropsychiatry: a review of its pharmacology, safety, and efficacy. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Exploring psilocybin-assisted psychotherapy in the treatment of methamphetamine use disorder. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

The pharmacology of psilocybin. [2016]

4. England pubmed.ncbi.nlm.nih.gov

Metabolism of psilocybin and psilocin: clinical and forensic toxicological relevance. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

DARK Classics in Chemical Neuroscience: Psilocybin. [2019]

6. Switzerland pubmed.ncbi.nlm.nih.gov

[Hallucinogenic mushrooms]. [2018]

7. England 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. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Presence of phenylethylamine in hallucinogenic Psilocybe mushroom: possible role in adverse reactions. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Structure-Activity Relationships for Psilocybin, Baeocystin, Aeruginascin, and Related Analogues to Produce Pharmacological Effects in Mice. [2023]