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. 2024 May 21;25(1):336.
doi: 10.1186/s13063-024-08174-x.

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

Chiranth Bhagavan  1 , Paul Glue  2 , Will Evans  3 , Lisa Reynolds  4 , Thivya Turner  5 , Chris King  5 , Bruce R Russell  6 , Eva Morunga  7 , Jessica Lee Mills  8 , Geoff Layton  9 , David B Menkes  10
Affiliations

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

Chiranth Bhagavan et al. Trials. .

Abstract

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.

Keywords: 3,4-Methylenedioxymethamphetamine (MDMA); Advanced-stage cancer; Anxiety; Depression; MDMA-assisted therapy; Palliative care; Terminal illness.

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Conflict of interest statement

Professor Paul Glue has a research contract with Douglas Pharmaceuticals to develop novel ketamine formulations for depression.

Associate Professor David B. Menkes, Dr Lisa Reynolds and Dr Will Evans have each been employed as an independent contractor for a psychedelic drug trial by New Zealand Clinical Research.

All other authors declare that they have no competing interests.

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