Effect of MDMA-Assisted Therapy on Mood and Anxiety Symptoms in Patients with Advanced-Stage Cancer Study (INZL1)

This study is a double-blind, randomized controlled trial of methylphenidate-assisted versus MDMA-assisted therapy for mood and anxiety symptoms in advanced-stage cancer patients.

Professor Paul Glue of the University of Otago in Dunedin, New Zealand, is the Principal Investigator of a double-blind, randomized controlled trial on the effect of MDMA-assisted therapy for mood and anxiety symptoms in advanced-stage cancer patients. The study will enroll up to 32 participants with stage 3 or 4 cancer and a prognosis of at least three months life expectancy. This Phase 2 trial, with a second site at the University of Auckland, will use methylphenidate as a psychoactive placebo in the control group. This is the first multi-site investigator-initiated trial to which MAPS Public Benefit Corporation (MAPS PBC) has donated the study drug.

People living with advanced-stage cancer can experience existential distress, one of the most challenging problems for palliative care professionals. The symptoms of existential distress can include depression, anxiety, and posttraumatic stress disorder (PTSD). Researchers hypothesize that the qualitative effects of MDMA-assisted therapy, which are described as prosocial feelings, trust, communication, and empathy, may have the potential to generate positive mental health outcomes in people with advanced-stage cancer.Enrolled participants in this study will be randomized into two blinded, parallel treatment arms. Each group will receive one dose of either MDMA or the psychoactive control  methylphenidate. Participants will receive two 90-minute therapeutic preparatory sessions the week of dosing, followed by one 90-minute session the day after dosing to integrate the experiences of the medication session. This study will follow the MAPS Manual for MDMA-Assisted Therapy in the Treatment of PTSD for therapy sessions where participants will be under the supervision of two therapists for the duration of the in-person sessions. Each participant will receive follow-ups from the researchers one, two, six, and twelve months or until death. The primary endpoint is the change from participants’ baseline ratings in depression and anxiety four weeks after the end of the trial, using the Montgomery-Asberg Depression Rating Scale (MADRS). This is the first investigator-initiated trial of MDMA-assisted therapy in New Zealand; a prior trial with a different research team looked at outcomes related to tinnitus after MDMA administration. Veteran psychedelic researcher Paul Glue, and Co-Investigator Dr. Will Evans , a palliative care specialist, will lead the teams  of researchers from the University of Otago and the University of Auckland in this study. More information about this study can be found here.

  • Name of site:  University of Otago and University of Auckland
  • Primary contact: Professor Paul Glue; paul.glue@otago.ac.nz
  • Location:  Auckland and Dunedin, Aotearoa, New Zealand
  • Records link: Australian New Zealand Clinical Trials Registry