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

Autor: Bhagavan C; Department of Psychological Medicine, Faculty of Medical and Health Sciences, University of Auckland, 22-30 Park Avenue, Grafton, Auckland, 1023, New Zealand. cbha783@aucklanduni.ac.nz., Glue P; Department of Psychological Medicine, Division of Health Sciences, University of Otago, 464 Cumberland Street, Central Dunedin, Dunedin, 9016, New Zealand., Evans W; Mana Health, 7 Ruskin St, Parnell, Auckland, 1052, New Zealand., Reynolds L; Department of Psychological Medicine, Faculty of Medical and Health Sciences, University of Auckland, 22-30 Park Avenue, Grafton, Auckland, 1023, New Zealand., Turner T; Te Whatu Ora Southern, Dunedin Public Hospital, 201 Great King Street, Dunedin, 9016, New Zealand., King C; Te Whatu Ora Southern, Dunedin Public Hospital, 201 Great King Street, Dunedin, 9016, New Zealand., Russell BR; School of Pharmacy, University of Otago, 18 Frederick Street, Dunedin North, Dunedin, 9016, New Zealand., Morunga E; Te Whatu Ora Te Toka Tumai, Auckland City Hospital, 2 Park Road, Grafton, Auckland, 1023, New Zealand., Mills JL; University of Auckland, 6 Symonds Street, Auckland, 1010, New Zealand., Layton G; Ashburn Clinic, 496 Taieri Road, Halfway Bush, Dunedin, 9010, New Zealand., Menkes DB; Department of Psychological Medicine, Faculty of Medical and Health Sciences, University of Auckland, Waikato Clinical Campus, Peter Rothwell Academic Centre, Pembroke Street, Hamilton, 3240, New Zealand.
Jazyk: angličtina
Zdroj: Trials [Trials] 2024 May 21; Vol. 25 (1), pp. 336. Date of Electronic Publication: 2024 May 21.
DOI: 10.1186/s13063-024-08174-x
Abstrakt: 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.
(© 2024. The Author(s).)
Databáze: MEDLINE
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