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Clinical Trials

Below you can find an overview of current trials in Australia and New Zealand:

Psilocybin trials

Study Type Trial ID or DOI Condition Year Registered Ethics Status Status Year Complete Location Sponsor n Masking Intervention Control
Phase 2 ACTRN12621001097831 Treatment-Resistant Depression 2021 Approved Recruiting Ongoing VIC Swinburne University 15 Open 25mg psilocybin with psychotherapy​ None
Phase 2 ACTRN12621001358831 Generalised Anxiety Disorder 2021 Approved Not yet recruiting Ongoing VIC Monash University 62 Quadruple 25 or 30mg psilocybin with psychotherapy control with psychotherapy
Phase 2 ACTRN12619001225101 Depression and anxiety (in life-threatening illness)​ 2019 Approved Not yet recruiting 2023 VIC St Vincent’s Hospital Melbourne​ 35 Quadruple 25mg psilocybin with psychotherapy placebo with psychotherapy​
Phase 1 ACTRN12621000560897 Safety and Tolerability in Healthy Adults 2021 Approved Recruiting Ongoing VIC Austin Health​ 12 Open 5, 10 then 15mg psilocybin with physiotherapy None
Phase 1 ACTRN12621000578808 Functional Neurological Disorder 2021 Approved Not yet recruiting Ongoing VIC Austin Health​ 24 Open 5; 10; 15 mg None
Phase 1 ACTRN12621001375842 Mechanism​ 2021 Approved Not yet recruiting Ongoing VIC Monash University​ 60 Open 19mg psilocybin with meditation 19mg psilocybin without meditation
Phase 1 No ID yet​ Mechanism 2021 Approved Recruiting Ongoing VIC Monarch Mental Health 100 - n = 100 for psilocybin arm n = 100 for MDMA arm
Phase 3 / Phase 2 ACTRN12622000883718p Brain Activity in Healthy Adults 2022 Other Not yet recruiting Ongoing VIC TMS Clinics Australia 200 Open 25, 30, 35mg psilocybin; or 80 or 120mg MDMA None
Phase 1 ACTRN12621001375842 Brain Activity in Healthy Adults 2021 Approved Not yet recruiting Ongoing VIC Monash University 60 Open 19mg psilocybin Meditation verses No Meditation
Interventional ACTRN12623000827639 Prolonged grief 2023 Approved Recruiting Ongoing QLD QIMR Berghofer Medical Research Institute 15 Open 25mg of psilocybin None
Phase 1 ACTRN12622000463774 Methamphetamine Use Disorder 2022 Approved Recruiting Ongoing NSW St Vincent’s Hospital 15 Open Three sessions of 25mg psilocybin with Psychotherapy None
Phase 2/3 ACTRN12622001535763 Healthy 2023 Approved Recruiting Ongoing NSW, VIC Monarch Mental Health Group 100 Open MDMA (80 + 40 mg) or psilocybin (25; 30; 35 mg) None
Phase 2 ACTRN12623000667617 TR-MDD 2023 Approved Not yet recruiting Ongoing QLD, TAS, VIC Swinburne University of Technology 160 Quadruple 25 mg Inactive Placebo
Phase 2 ACTRN12623001004651 TRD 2023 Approved Not yet recruiting Ongoing ACT, NSW, VIC The Australian National University 150 Triple 25 mg Active Placebo
Phase 2 ACTRN12623001064695 MDD 2023 Approved Not yet recruiting Ongoing NSW Woke Pharmaceuticals 266 Triple 4 mg every 3-4 days for 6 weeks (microdose) Active Placebo
Phase 2 ACTRN12623000357651 TR Anorexia Nervosa 2023 Approved Not yet recruiting Ongoing NSW University of Sydney 30 Single 25 mg None
Phase 1 ACTRN12623000832673 TRD 2023 Approved Not yet recruiting Ongoing VIC St Vincent's Hospital, Darlinghurst 20 Open 15-45 mg None
Phase 0 ACTRN12623000618651 TR-MDD 2023 Approved Not yet recruiting Ongoing WA Reset Mind Science 60 Open 25 mg Active Placebo

MDMA trials

Study Type Trial ID or DOI Condition Year Registered Ethics Status Status Year Complete Location Sponsor n Masking Intervention Control
Phase 2 ACTRN12619001334190 Late-stage cancer patients, mood and anxiety 2019 Approved Recruiting Ongoing NZ University of Otago 32 Quadruple 120mg MDMA (supplemented 60mg) with psychotherapy​ None
Phase 1/2​ ACTRN12621001078842 PTSD 2021 Approved Recruiting Ongoing WA Edith Cowan University​ 4 Open 80 or 120mg MDMA (supplemented 40 or 60mg) with psychotherapy​ None
Phase 1 No ID yet​ Mechanism 2021 Approved Recruiting Ongoing VIC Monarch Mental Health 100 - n = 100 for MDMA arm n = 100 for psilocybin arm
Phase 0 ACTRN12613000685718 Tinnitus 2013 Approved Complete 2017 NZ The University of Auckland 40 Quadruple 30 or 70mg MDMA Placebo
Observational​ ACTRN12620001068954 Attitudes of psychotherapists towards MDMA-assisted psychotherapy 2020 Approved Recruiting Ongoing NSW University of Sydney 200 Triple MDMA-assisted psychotherapy questionnaire Fabricated drug-assisted psychotherapy questionnaire​
Phase 3 / Phase 2 ACTRN12622000883718p Brain Activity in Healthy Adults 2022 Other Not yet recruiting Ongoing VIC TMS Clinics Australia 200 Open 80 or 120mg MDMA; or 25, 30, 35mg psilocybin None
Phase 2 ACTRN12623000838617 PTSD 2023 Approved Recruiting Ongoing WA Emyria Ltd 5 Open 87 + 43.5 mg None
Phase 1 ACTRN12622001335785 Healthy 2023 Approved Recruiting Ongoing NZ EmpathBio Australia Pty Ltd 5 Triple 75; 125; 175; 225 mg EMP-01 (MDMA analogue) None
Phase 2 ACTRN12623000971639 PTSD, veterans 2023 Approved Not yet recruiting Ongoing VIC Monash University 24 Double 120 + 40 mg None
Phase 2 ACTRN12622001525774 TR-OCD 2023 Approved Not yet recruiting Ongoing NSW, VIC Australian National University 40 Double 100 mg Active Placebo

LSD trials

Study Type Trial ID or DOI Condition Year Registered Ethics Status Status Year Complete Location Sponsor n Masking Intervention Control
Phase 1 ACTRN12621000436875 Microdose, mechanism and creativity​ 2021 Approved Complete 2022 NZ The University of Auckland 80 Triple 5-15 mg Placebo
Phase 2 ACTRN12623000486628 MDD 2023 Approved Recruiting Ongoing NZ The University of Auckland 20 Open 5-15 mg None
Phase 2 ACTRN12623000478617 End-Of-Life Distress 2023 Approved Not yet recruiting Ongoing NZ The University of Auckland 40 Triple 5-15 mg (microdose) Inactive Placebo

Ibogaine trials

Study Type Trial ID or DOI Condition Year Registered Ethics Status Status Year Complete Location Sponsor n Masking Intervention Control
Phase 2 10.1080/00952990.2017.1310218 Addiction, opioid 2012 Approved Complete 2015 NZ University of Otago 14 Open 200mg ibogaine (supplementary dose 400-600mg) None
Phase 1 ACTRN12613000324718 Mechanism 2013 Approved Complete 2013 NZ University of Otago 24 Open 20mg ibogaine Placebo; or DXM control
Observational (Follow Up) 10.1080/00952990.2017.1310218​ Addiction, opioid​ 2015 Approved Complete 2016 NZ University of Otago 14 Open Addiction and depression severity at 12 month follow up post-ibogaine treatment​ None

DMT

Study Type Trial ID or DOI Condition Year Registered Ethics Status Status Year Complete Location Sponsor n Masking Intervention Control
Phase 1 ACTRN12622000851763 Healthy Adults 2022 Approved Recruiting Ongoing NZ Viridia Life Sciences Australia 48 Open VLS-01 Single-Ascending Dose Intravenous vs Buccal Administration
Phase 1 ACTRN12623000884606 Healthy 2023 Approved Not yet recruiting Ongoing VIC Swinburne University of Technology 30 Single 3 mg; 6 mg; 9 mg Inactive Placebo

Iprocin (4-OH-DiPT)

Study Type Trial ID or DOI Condition Year Registered Ethics Status Status Year Complete Location Sponsor n Masking Intervention Control
Phase 1 ACTRN12622000713796p Post Partum Depression and Treatment Resistant Depression 2022 Other Recruiting Ongoing Adelaide Field Trip 32 Blinded FT-104 Normal Saline (0.9% sodium chloride) for injection

Ayahuasca

Study Type Trial ID or DOI Condition Year Registered Ethics Status Status Year Complete Location Sponsor n Masking Intervention Control
Phase 1 ACTRN12622001315707 Healthy 2023 Approved Recruiting Ongoing VIC St Vincent's Hospital, Melbourne 8 Double DMT 1 mg/kg + Harmalas 4 mg/kg; or DMT 1.4 mg/kg + Harmalas 5.6 mg/kg None

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