Psilocybin for Cocaine Addiction

Overseen By Conor H Murray, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of California, Los Angeles

Must not be taking: Antidepressants, Serotonergic substances

Disqualifiers: Hypertension, Cardiac conditions, Psychosis, 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: 49

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety of psilocybin, a compound found in certain mushrooms, for individuals with cocaine use disorder who want to quit. Participants will take a single dose of psilocybin in a comfortable setting while researchers monitor heart rate, blood pressure, and mood changes. The study seeks individuals who have regularly used cocaine, wish to stop, and have used psychedelics a few times in their life but not in the past year. As an Early Phase 1 trial, this research focuses on understanding how psilocybin works in people, offering participants a chance to contribute to groundbreaking research.

Will I have to stop taking my current medications?

The trial requires that you do not use antidepressants or other medications that affect serotonin. If you are on these medications, you would need to stop taking them to participate.

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

Research has shown that psilocybin, the treatment under study, has a good safety record in other studies. It has been used safely in individuals with various substance use issues, such as alcohol and smoking. These studies found that psilocybin is usually well-tolerated, with some individuals experiencing temporary mood or perception changes. These effects are generally mild and short-lived.

While data on psilocybin for cocaine addiction is limited, the treatment is currently in early phase studies. These studies primarily focus on safety, indicating that psilocybin has shown enough promise in earlier research to warrant further testing. Additionally, psilocybin has been studied in various settings for its therapeutic effects, enhancing understanding of its safety in humans.

Overall, while there are no guarantees, available data suggests that psilocybin is generally safe with manageable effects when used under controlled conditions. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for cocaine addiction, which often include behavioral therapies and medications like disulfiram or naltrexone, psilocybin offers a unique approach. Psilocybin is a psychedelic compound that works by interacting with serotonin receptors in the brain, potentially leading to transformative experiences and shifts in perception that could help break addiction patterns. Researchers are excited because psilocybin might offer rapid and enduring benefits after just a single or a few sessions, which is a stark contrast to the prolonged treatment courses typically needed with current options.

What evidence suggests that psilocybin might be an effective treatment for cocaine addiction?

Research has shown that psilocybin, the treatment under study in this trial, might help with addiction, including cocaine addiction. Some studies found that therapy using psilocybin can improve symptoms for people with substance use problems. Specifically, psilocybin may help reduce cravings and encourage positive changes in mood and behavior. While more research is needed to fully understand its effects, early results are promising. Psilocybin affects certain parts of the brain related to mood and perception, which might help break addictive habits. ^{3 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults aged 21-55 in Los Angeles with cocaine use disorder who want to stop using cocaine. They must have a healthy weight, limited experience with psychedelics, and no severe mental health or heart conditions. Pregnant women and those on antidepressants or with a history of adverse reactions to psychedelics cannot participate.

Inclusion Criteria

You have not consumed any classical psychedelic substances within the past twelve months.

You have a Body Mass Index within the healthy range of 18.5 to 34 kilograms per square metre.

You have had between one and ten experiences with a 5-HT2a agonist psychedelic.

Exclusion Criteria

You or someone in your immediate family has had mental health conditions like psychosis, bipolar disorder, or schizophrenia.

I have epilepsy or a history of seizures.

You have been diagnosed with anxiety or mood disorders according to a specific manual used by doctors.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

25 mg oral psilocybin is administered during a single laboratory visit, with monitoring of heart rate, blood pressure, and subjective effects

1 day

1 visit (in-person)

Follow-up

Participants are monitored remotely for safety and effectiveness after treatment

90 days

Remote check-ins at 48 hours, and 10, 50, and 90 days

What Are the Treatments Tested in This Trial?

Interventions

• Psilocybin

Trial Overview The study tests the safety of a single dose of psilocybin (25 mg) for treating cocaine addiction by monitoring heart rate, blood pressure, and mood changes hourly. Participants will spend one day in a comfortable setting under clinician supervision without invasive procedures like blood draws.

How Is the Trial Designed?

Group I: Psilocybin Experimental Treatment 1 Intervention

25 mg psilocybin

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 California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

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-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]

A 30-year-old man experienced severe symptoms, including vomiting and muscle pain, after receiving an intravenous injection of Psilocybe mushroom extract, highlighting the potential dangers of using hallucinogenic substances in non-traditional ways.

The patient showed rapid improvement with supportive care, suggesting that while the effects of Psilocybe mushrooms can be serious, timely medical intervention can effectively manage the symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravenous mushroom poisoning. Curry, SC., Rose, MC.[2019]

There is a growing trend among young people to consume wild Psilocybin mushrooms for their hallucinogenic effects, but this practice carries risks.

The report highlights seven cases of mushroom overdosage, stressing that while Psilocybin mushrooms are generally considered harmless, there is a significant danger of accidentally consuming toxic mushroom species that can cause serious harm.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The danger of hallucinogenic mushrooms. Mills, PR., Lesinskas, D., Watkinson, G.[2017]

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]

In a study of 27 patients with moderate to severe major depressive disorder, psilocybin-assisted treatment showed significant and lasting antidepressant effects, with 75% of participants experiencing a treatment response and 58% achieving remission after 12 months.

There were no serious adverse events related to psilocybin, indicating a favorable safety profile, and participants reported meaningful personal and spiritual experiences that correlated with increased well-being, although these did not directly predict improvements in depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of psilocybin-assisted treatment for major depressive disorder: Prospective 12-month follow-up. Gukasyan, N., Davis, AK., Barrett, FS., et al.[2022]

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 serotonergic psychedelic, has shown promise in treating various psychiatric disorders, including depression and substance use disorders, with 9 clinical trials conducted between 2000 and 2020.

The treatment is generally well tolerated with limited side effects, and some patients with treatment-resistant conditions have experienced significant long-term improvements after just a few sessions, indicating its potential efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Treatment with psilocybin: applications for patients with psychiatric disorders]. Breeksema, JJ., Koolen, MHB., Somers, M., et al.[2021]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8901083/

Analysis of Psilocybin-Assisted Therapy in Medicine This review analyzes the potential of psilocybin in the treatment of addiction, depression, and end-of-life mood disorders.

2. sciencedirect.com sciencedirect.com/science/article/pii/S0028390818302296

The abuse potential of medical psilocybin according to ... Psilocybin has been evaluated in a variety of preclinical models of physical dependence and abuse potential, yielding qualitatively generally similar findings ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02037126

Psilocybin-facilitated Treatment for Cocaine Use The primary purpose of this study is to evaluate the feasibility and estimate the efficacy of psilocybin-facilitated treatment for cocaine use.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9947277/

Therapeutic effect of psilocybin in addiction: A systematic ... All four clinical trials indicated a beneficial effect of psilocybin-assisted therapy on SUD symptoms. Larger RCTs in patients with SUDs need to evaluate ...

5. medrxiv.org medrxiv.org/content/10.1101/2025.04.04.25324315v1.full.pdf

a scoping review on clinical trials and perspectives on under In the present review, we describe ongoing clinical trials investigating the effectiveness of psychedelic drugs in treating symptoms associated ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06102434

Safety Profile of Psilocybin for Cocaine Use Disorder Study Overview. The purpose of this study is to establish the safe administration of psilocybin in individuals with cocaine use disorder in terms of ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40245969/

Efficacy and safety of psilocybin for the treatment ... PAP was associated with significant reductions in alcohol consumption, smoking cessation, and related psychological improvements. AUD studies ...

8. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT06102434?keyword=%22Cocaine%20Use%20Disorder%22

Safety Profile of Psilocybin for Cocaine Use Disorder The purpose of this study is to establish the safe administration of psilocybin in individuals with cocaine use disorder in terms of cardiovascular (e.g., ...