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

Trials May 21, 2024 DOI: 10.1186/s13063-024-08174-x (opens in new tab)

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Study at a glance

AI-extracted from the abstract
Characteristics Randomized controlled trial Double-blind Qualitative Peer reviewed
Sample size 32
Population Participants with advanced-stage cancer and associated depression and anxiety
Interventions MDMA-assisted therapy methylphenidate-assisted therapy
Dose 120 mg (+ 60 mg optional supplemental dose) MDMA; 20 mg oral (+ 10 mg optional supplemental dose) methylphenidate
Duration Follow-up until 12 months post-randomisation or death
Topics Anxiety Depression Psychedelic-assisted therapy MDMA
Keywords 3,4-Methylenedioxymethamphetamine MDMA Advanced-stage cancer MDMA-Assisted Therapy Palliative care Terminal illness End-of-life care Mental health treatment Cancer support Clinical research
Citations 7
Key findings The study will examine the effect of MDMA-assisted therapy on symptoms of anxiety and depression in advanced-stage cancer.

Abstract

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. 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. 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 registered on Australian New Zealand Clinical Trials Registry. ACTRN12619001334190p. Date registered: 30/09/2019. URL: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=378153&showOriginal=true&isReview=true.

Comparable studies

Other randomized controlled trials on MDMA for depression, most cited first.

Study Year Design Participants
3,4-Methylenedioxymethamphetamine-assisted psychotherapy for treatment of chronic posttraumatic stress disorder: A randomized phase 2 controlled trial. People with chronic posttraumatic stress disorder 2018 Randomized controlled trial n = 28
Depressive mood ratings are reduced by MDMA in female polydrug ecstasy users homozygous for the l-allele of the serotonin transporter Polydrug ecstasy users 2018 Pooled analysis of four placebo-controlled, within-subject studies n = 63
Self-compassion mediates treatment effects in MDMA-assisted therapy for posttraumatic stress disorder. Adults diagnosed with severe PTSD 2025 Secondary analysis of a randomized controlled trial n = 82
MDMA-assisted PTSD and Alcohol Therapy Trial (MPATHY): study protocol for a double-blind, randomised, controlled outpatient trial of MDMA-assisted integrated exposure-based therapy for comorbid post-traumatic stress disorder and alcohol use disorder Adults with comorbid post-traumatic stress disorder and alcohol use disorder 2026 Randomized controlled trial n = 100

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Related reading

Explore topics

Anxiety Depression Psychedelic-assisted therapy MDMA End-of-life distress Mystical experience Mysticism Psilocybin Serotonin

By condition and practice

MDMA and psychedelic-assisted therapy MDMA for anxiety MDMA for depression