Journal Article

Effect of MDMA-assisted therapy on mood and anxiety symptoms in advanced-stage cancer (EMMAC): study protocol for a double-blind, randomised controlled trial

Evans, Will, Morunga, Eva, Menkes, David B., Bhagavan, Chiranth, King, Chris, Russell, Bruce R., Layton, Geoff, Glue, Paul, Mills, Jessica Lee, Reynolds, Lisa, Turner, Thivya

2024

Overview

Background Symptoms of anxiety and depression are common in patients with terminal illness and multiple challenges exist with timely and effective care in this population. Several centres have reported that one dose of the serotonergic psychedelic psilocybin, combined with therapeutic support, improves these symptoms for up to 6 months in this patient group. Drawing upon related therapeutic mechanisms, 3,4-methylenedioxymethamphetamine (MDMA)-assisted therapy may have the potential to achieve similar, positive mental health outcomes in this group. Preliminary evidence also supports the tolerability of MDMA-assisted therapy for anxiety and depression in advanced-stage cancer. Methods Up to 32 participants with advanced-stage cancer and associated depression and anxiety will be randomised in a 1:1 ratio into one of two blinded parallel treatment arms. The intervention group will receive 120 mg (+ 60 mg optional supplemental dose) MDMA-assisted therapy. The psychoactive control group will receive 20 mg oral (+ 10 mg optional supplemental dose) methylphenidate-assisted therapy. For each medication-assisted therapy session, participants will undergo two 90-min therapeutic support sessions in the week preceding, and one 90-min support session the day after the experimental session. A battery of measures (mood, anxiety, quality of life, mystical experience, spiritual wellbeing, attitudes towards death, personality traits, holistic health and wellbeing, connectedness, demoralisation, expectations, qualitative data and safety measures) will be assessed at baseline and through to the end of the protocol. Participants will be followed up until either 12 months post-randomisation or death, whichever occurs first. Discussion This study will examine the effect of MDMA-assisted therapy on symptoms of anxiety and depression in advanced-stage cancer. Potential therapeutic implications include establishing the safety and effectiveness of a novel treatment that may relieve mental suffering in patients with life-threatening illness. Trial registration Trial registered on Australian New Zealand Clinical Trials Registry. Registration number: ACTRN12619001334190p. Date registered: 30/09/2019. URL: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=378153&showOriginal=true&isReview=true

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
• Subject: 3,4-Methylenedioxymethamphetamine (MDMA) / Advanced-stage cancer / Affect - drug effects / Anxiety / Anxiety - psychology / Batteries / Biomedicine / Cancer / Care and treatment / Clinical trials / Consciousness / Corporate sponsorship / Depression / Depression - drug therapy / Depression - psychology / Depression - therapy / Double-Blind Method / Drug dosages / Ecstasy / Ecstasy (Drug) / Hallucinogens - administration & dosage / Hallucinogens - adverse effects / Hallucinogens - therapeutic use / Health aspects / Health Sciences / Hospitals / Humans / Male / MDMA-assisted therapy / Medicine / Medicine & Public Health / Mental depression / Mental health / Methylphenidate - administration & dosage / Methylphenidate - adverse effects / Methylphenidate - therapeutic use / Mysticism / N-Methyl-3,4-methylenedioxyamphetamine - administration & dosage / N-Methyl-3,4-methylenedioxyamphetamine - adverse effects / Neoplasm Staging / Neoplasms - complications / Neoplasms - psychology / Neurobiology / Oncology, Experimental / Palliative care / Palliative treatment / Pharmacokinetics / Pilot projects / Post traumatic stress disorder / Psychedelic drugs / Quality of Life / Randomized Controlled Trials as Topic / Resveratrol / Social anxiety / Statistics for Life Sciences / Study Protocol / Terminal illness / Time Factors / Treatment Outcome