This open-label, Phase II trial (n=16) will assess the feasibility, tolerability, and preliminary efficacy of psilocybin (25mg) therapy for adults with chronic neuropathic pain and treatment-resistant depression (TRD).
The study, sponsored by the Centre for Addiction and Mental Health, aims to evaluate whether psilocybin can effectively alleviate both chronic pain and depression symptoms in individuals who have not responded well to other treatments.
Conducted by Dr. Muhammad Ishrat Husain, the trial will provide each participant with a single 25 mg dose of psilocybin, accompanied by supportive therapy.
Outcomes will be measured through various scales, including the Montgomery-Åsberg Depression Rating Scale and the Patient Reported Outcomes Measurement Information System for pain intensity and interference.
The trial is set to start in September 2024 and is expected to complete by September 2026.
Trial Details
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.Trial Number NCT06518720