Psilocybin for Chronic Pain and Depression
(TRANSCEND Trial)

Recruiting in Palo Alto (17 mi)

Overseen byMuhammad Ishrat Husain, MBBS, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Centre for Addiction and Mental Health

No Placebo Group

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

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.

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 am between 18 and 65 years old and not hospitalized.

I have been diagnosed with major depression without psychosis.

+11 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.

+8 more

Participant Groups

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.

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: