Psilocybin for Chronic Pain and Depression
(TRANSCEND Trial)
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
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single dose of 25 mg psilocybin orally with psychotherapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term follow-up
Participants are monitored for adverse events and retention over 24 months
Treatment Details
Interventions
- Psilocybin
Psilocybin is already approved in United States, European Union for the following indications:
- Treatment-resistant depression (TRD) under Breakthrough Therapy designation
- 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