RecruitingPhase 2NCT06518720

Treatment With Psilocybin for Chronic Neuropathic Pain and Depression (TRANSCEND)

Treatment With Psilocybin for Chronic Neuropathic Pain and Depression (TRANSCEND): An Open-Label Clinical Trial


Sponsor

Centre for Addiction and Mental Health

Enrollment

16 participants

Start Date

Apr 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study (TRANSCEND) is testing whether a single guided session with psilocybin — the active compound found in "magic mushrooms" — combined with psychological support, can reduce chronic neuropathic pain (nerve pain lasting months or years) and depression in adults. The treatment is given in a supervised clinical setting. **You may be eligible if...** - You are 18–65 years old - You have chronic neuropathic pain (ongoing nerve pain) and depression - You are an outpatient (not currently hospitalized) - You can read and communicate in English well enough to understand consent forms and study questions - You are deemed capable of giving informed consent **You may NOT be eligible if...** - You have a personal or family history of psychosis, schizophrenia, or bipolar disorder with psychotic features - You are taking medications that interact with psilocybin (such as lithium or certain antidepressants) - You have active suicidal thoughts or intent - You are pregnant or breastfeeding - You have significant heart disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPsilocybin 25 mg

The psilocybin used in this study meets quality specifications suitable for human research use. The active drug is encapsulated using a hydroxypropyl methylcellulose (HPMC) capsule and contains 25 mg of psilocybin. The psilocybin will be administered once during the trial in combination with supportive therapy.


Locations(1)

Centre for Addiction and Mental Health

Toronto, Ontario, Canada

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NCT06518720


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