16 Participants Needed

Psilocybin for Chronic Pain and Depression

(TRANSCEND Trial)

AC
MI
Overseen ByMuhammad Ishrat Husain, MBBS, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

Yes, you will need to taper off your current antidepressant and antipsychotic medications for at least 2 weeks before starting the trial and for the duration of the study, if your doctor confirms it's safe.

What evidence supports the effectiveness of the drug psilocybin for treating chronic pain and depression?

Preliminary studies suggest that psilocybin may help with major depressive disorder and depression in terminally ill cancer patients, showing promise for its potential use in treating depression. However, more research is needed to confirm its effectiveness specifically for chronic pain and depression.12345

Is psilocybin generally safe for human use?

Psilocybin is generally considered safe when used in controlled settings with proper screening and support, although it can cause challenging psychological experiences and, in rare cases, lead to risky behavior or enduring psychological distress. It is important to use it under medical supervision, especially for individuals with pre-existing mental health conditions.13678

How is the drug psilocybin unique in treating chronic pain and depression?

Psilocybin is unique because it can provide rapid and long-lasting relief from chronic pain and depression, even at low doses that do not cause a psychedelic experience. It works differently from traditional treatments by potentially modulating the immune system and promoting long-term changes in brain function, offering new hope for patients who have not found relief with other therapies.3491011

What is the purpose of this trial?

Psilocybin, the chemical component of "magic mushrooms", has been administered with psychotherapy in several randomized clinical trials (RCTs) showing large and sustained antidepressant effects.The purpose of this study is to assess the feasibility, tolerability, and preliminary efficacy of psilocybin therapy for adults with chronic neuropathic pain and co-morbid treatment resistant depression.

Research Team

MI

Muhammad Ishrat Husain, MBBS, MD

Principal Investigator

Centre for Addiction and Mental Health

Eligibility Criteria

This trial is for adults with chronic nerve pain and depression that hasn't improved with standard treatments. Participants must be able to undergo psychotherapy sessions and take psilocybin safely.

Inclusion Criteria

I am willing to gradually stop taking my current antidepressant and antipsychotic medications under a doctor's care.
I have been diagnosed with major depression without psychosis.
Must be willing to comply with all study procedures
See 10 more

Exclusion Criteria

I have been diagnosed with a psychiatric disorder defined in the DSM-5.
I do not have any other serious health conditions that could affect the study or my safety.
I cannot take psilocybin due to health risks.
See 8 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of 25 mg psilocybin orally with psychotherapy

1 week
2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week
1 visit (in-person)

Long-term follow-up

Participants are monitored for adverse events and retention over 24 months

24 months

Treatment Details

Interventions

  • Psilocybin
Trial Overview The study tests the effects of a single dose of Psilocybin (25 mg), combined with psychotherapy, on individuals suffering from long-term neuropathic pain and depression resistant to usual treatments.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Psilocybin (25 mg)Experimental Treatment1 Intervention
One capsule of psilocybin 25 mg will be taken orally with a glass of water.

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

Find a Clinic Near You

Who Is Running the Clinical Trial?

Centre for Addiction and Mental Health

Lead Sponsor

Trials
388
Recruited
84,200+

Findings from Research

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.
[Hallucinogenic mushrooms].Reingardiene, D., Vilcinskaite, J., Lazauskas, R.[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.
[Treatment with psilocybin: applications for patients with psychiatric disorders].Breeksema, JJ., Koolen, MHB., Somers, M., et al.[2021]
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.
The pharmacology of psilocybin.Passie, T., Seifert, J., Schneider, U., et al.[2016]

References

[Hallucinogenic mushrooms]. [2018]
[Treatment with psilocybin: applications for patients with psychiatric disorders]. [2021]
The pharmacology of psilocybin. [2016]
Psilocybin in Palliative Care: An Update. [2023]
DARK Classics in Chemical Neuroscience: Psilocybin. [2019]
Intravenous mushroom poisoning. [2019]
Effects and safety of Psilocybe cubensis and Panaeolus cyanescens magic mushroom extracts on endothelin-1-induced hypertrophy and cell injury in cardiomyocytes. [2021]
Survey study of challenging experiences after ingesting psilocybin mushrooms: Acute and enduring positive and negative consequences. [2018]
Mycotherapy: Potential of Fungal Bioactives for the Treatment of Mental Health Disorders and Morbidities of Chronic Pain. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Are psychedelics the answer to chronic pain: A review of current literature. [2023]
11.United Statespubmed.ncbi.nlm.nih.gov
Microdosing psilocybin for chronic pain: a case series. [2023]
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