ICAN1: A Phase 2 Open-Label Treatment Development Study of MDMA-Assisted Psychotherapy in Conjunction with Cognitive Processing Therapy (CPT) for Chronic Posttraumatic Stress Disorder (PTSD)

Anne Wagner, Ph.D. of Remedy Institute is the sponsor and Principal Investigator of this open-label treatment development study of MDMA-assisted cognitive processing therapy (CPT) for posttraumatic stress disorder (PTSD). This pilot Phase 2 open-label study is designed to evaluate the safety and effectiveness of MDMA, combined with CPT, in treating 10 participants with a confirmed PTSD diagnosis.

CPT is a specific type of cognitive behavioral therapy that has been shown to reduce symptoms of PTSD. CPT’s main utilization is for helping participants challenge and modify the unhelpful thoughts related to their traumatic experience(s). Researchers hypothesize the traits of this therapy should partner well with the reported subjective clinical effects of MDMA. When combined together, researchers hope MDMA and CPT (as the assisted therapy) could be a more beneficial treatment for PTSD than the treatments which are currently available. 

Participants enrolled in this study will undergo a two-month course of therapy that includes CPT sessions integrated with elements of the MAPS Treatment Manual for MDMA-assisted psychotherapy. Participants will receive two doses of MDMA, used as an adjunct to the therapeutic process initiated by CPT.  The primary endpoint being measured is the change in participant Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) score from baseline to the final follow-up session approximately six months following the final CPT session. This is the first investigator-initiated trial with MDMA in Canada, and the first MDMA study to run in Ontario. Principal Investigator Anne Wagner, PhD., previously conducted a similar, MAPS-sponsored study in 2020 which examined MDMA-facilitated cognitive-behavioral conjoint therapy for PTSD. The current study, for which MAPS Public Benefit Corporation (MAPS PBC) is providing MDMA, is being sponsored by Remedy Institute in Toronto, Ontario, Canada, in collaboration with Toronto Metropolitan University. More information can be found here.

Name of site:  Remedy Institute
Primary contact: Anne Wagner, Ph.D., dr.wagner@remedycentre.ca
Location:  Toronto, Ontario, Canada
Records link: ClinicalTrials.gov