Backed by Science and Tradition
Human beings have used psychedelics for thousands of years. Modern research on these substances began in the 1950s and has seen a resurgence in recent years. Psilocybin and MDMA are now being used to treat a broad range of mental and physical health issues, reshaping the future of mental health care and offering new hope to many patients.
Expanding Horizons with Health Canada
Health Canada currently restricts legal access to psychedelics under the Special Access Program (SAP) to a limited range of conditions:
* Psilocybin: Major depressive disorder, treatment-resistant depression and terminal illness/end-of-life anxiety.
* MDMA: PTSD.
The ongoing tension between scientific progress and bureaucratic constraints often limits access to these life-changing therapies. For example, current Health Canada excludes conditions like cluster headaches and substance use disorder, despite evidence of psilocybin’s benefits.
Explore Key Research
Explore some of the leading clinical studies on psilocybin and MDMA, highlighting their applications for conditions currently approved for treatment under Health Canada’s Special Access Program (SAP).
Psilocybin Research
DEPRESSION:
This systematic review analyzed the effects of psilocybin on depressive symptoms in patients diagnosed with life-threatening illnesses or major depressive disorder. The review included 13 studies with a total of 686 participants, and the meta-analysis of 9 studies (596 participants) found a significant and large effect in favor of psilocybin (SMD = -0.78; p<0.001) for reducing depressive symptoms. The review suggests preliminary evidence supporting the antidepressant efficacy of psilocybin-assisted psychotherapy but calls for further studies to assess safety, efficacy, and treatment optimization. October 2023
This is the first modern study (n=12) on psilocybin and its effects on treatment-resistant depression (TRD). It shows that two sessions with psilocybin (10mg and 25mg) in combination with psychological support can reduce depressive symptoms over periods of one week to three months after treatment. Psilocybin was well tolerated by all of the patients, and no serious or unexpected adverse events occurred. May 2016
This randomized open-label study (n=24) found that two sessions with psilocybin (20 and 30mg/70kg) significantly improved depression scores for a population with major depressive disorder (MDD) up to 8 weeks later. November 2020
END OF LIFE:
This study (n=51) investigated the effects of a high dose of psilocybin (22 or 30mg/70kg) on depression and anxiety in patients with life-threatening cancer. It found significant improvements in clinician- and self-administered measures of depression and anxiety, even without psychotherapy (as many other studies provide). At 6-month follow-up, these changes were sustained, with about 80% of participants continuing to show clinically significant decreases in depressed mood and anxiety. November 2016
This double-blind placebo-controlled study (n=29) for those suffering from anxiety and depression, related to cancer, improved significantly (60-80% of participants) after a single dose of psilocybin (21mg/70kg) in combination with psychotherapy. November 2016
This is a follow-up study (n=16) at an average of 3.8 years after a single dose of psilocybin, combined with psychotherapy, for patients suffering from cancer-related existential distress. Approximately 60-80% of participants experienced reduced anxiety or depressive symptoms. This adds to the body of research that indicates that the positive of a guided psychedelic experience can be long-lasting. January 2020
MDMA Research
PTSD:
This multi-site, randomized, double-blind, Phase IIIb trial (n=104) evaluated the efficacy and safety of MDMA-assisted therapy (MDMA-AT) for individuals with moderate to severe PTSD. The study found significant reductions in PTSD severity (CAPS-5 score) and functional impairment (SDS score) for the MDMA-AT group compared to placebo with therapy. Seven participants experienced severe treatment-emergent adverse events, but no deaths or serious adverse events were reported. The treatment was found to be generally well tolerated in a diverse population. September 2023
This systematic review and meta-analysis (2020) found 5 trials (n=106) that found large reductions in PTSD symptoms after MDMA-assisted psychotherapy. The studies showed large improvements, but were only moderate in quality. January 2020
This Phase II clinical trial (n=26) finds that MDMA-assisted psychotherapy (75-125 mg) led to significant and sustained decreases in PTSD (CAPS-IV) scores as compared to an active placebo (30 mg). At the 12-month follow-up, the average CAPS-IV score had dropped from 87 to 39 (67% no longer qualified for PTSD diagnosis). June 2018
Explore More Research with Blossom
While our page highlights studies linked to SAP-approved conditions, Blossom offers a comprehensive database on psychedelics for other areas such as disordered eating, chronic pain, and smoking cessation. For more in-depth studies on psilocybin, MDMA, and other promising compounds, visit Blossom’s extensive research database.
About Blossom
Blossom has been a driving force in psychedelic research since 2019, uniting diverse perspectives in the field. Their mission is to accelerate the acceptance of psychedelics as effective tools in therapy and personal growth. Grounded in scientific rigor and critical thinking, Blossom continues to be a trusted voice for the future of psychedelics as approved medicines.