Australian Psychedelic Clinical Trials

Here is a list of current Australian clinical trials of psychedelic medicines.

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	Not yet 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	72	Quadruple	25 or 30mg psilocybin with psychotherapy	control with psychotherapy
Phase 2	ACTRN12619001225101	Depression and anxiety (in life-threatening illness)	2019	Approved	Recruiting	Ongoing	VIC	St Vincent’s Hospital Melbourne	40	Quadruple	25mg psilocybin with psychotherapy	placebo with psychotherapy
Phase 1	ACTRN12621000560897	Functional Neurological Disorder	2021	Approved	Not yet recruiting	Ongoing	VIC	Austin Health	22	Open	5, 10 then 15mg psilocybin with physiotherapy	None
Phase 1	ACTRN12621000578808	Functional Neurological Disorder	2021	Approved	Not yet recruiting	Ongoing	VIC	Austin Health	15	Open	0.08-0.1mg/kg psilocybin with physiotherapy	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
Phase 1	ACTRN12622000463774	Methamphetamine Use Disorder	2022	Approved	Not yet recruiting	Ongoing	NSW	St Vincent’s Hospital	15	Open	Three sessions of 25mg psilocybin with Psychotherapy	None

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	Not yet recruiting	Ongoing	NZ	University of Otago	32	Quadruple	120mg MDMA (supplemented 60mg) with psychotherapy	None
Phase 1/2	ACTRN12621001078842	PTSD	2021	Approved	Not yet 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	Ongoin	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

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	Not yet recruiting	Ongoing	NZ	The University of Auckland	80	Triple	10ug LSD	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	Opwn	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	Not yet recruiting	Ongoing	NZ	Viridia Life Sciences Australia	48	Open	VLS-01 Single-Ascending Dose	Intravenous vs Buccal Administration

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