A double-blind, randomised trial of methylphenidate-assisted versus MDMA-assisted therapy for mood and anxiety symptoms in advanced-stage cancer patients

This double-blind, randomised trial (n=32) will compare the effects of methylphenidate- versus MDMA-assisted therapy (120mg) for mood and anxiety symptoms in advanced-stage cancer patients.

Participants will receive a single session of either MDMA (120mg oral dose with an optional 60mg supplemental dose) or methylphenidate (20mg oral dose with an optional 10mg supplemental dose). The therapy sessions will last for 8 hours in a comfortable non-clinical environment and will be guided by specific therapy manuals. Both groups will undergo pre and post-therapy sessions, including therapeutic support sessions before and after dosing.

The primary outcome measure is the change from the baseline score of the Montgomery Asberg Depression Scale, assessed 28 days post-dosing. Secondary outcomes include changes in anxiety symptoms, palliative outcomes, mystical experiences, and adverse events.

The trial is being conducted at the University of Otago, New Zealand, and is funded by various sources, including individual donors and the Multidisciplinary Association for Psychedelic Studies (MAPS).

The principal investigator is Prof Paul Glue, who can be contacted for further information. Data sharing will be available upon request, subject to approval by the principal investigator, and includes individual participant data, study protocol, statistical analysis plan, informed consent form, clinical study report, ethical approval, and analytic code.

Please find the study protocol here.

Topic Palliative Care Depression Anxiety
Compound Placebo MDMA
Country New Zealand
Visit trial
Status Recruiting
Results Published No
Start date 31 July 2023
End date 30 December 2024
Phase Phase II
Design Blinded
Type Interventional
Generation First
Participants 32
Sex All
Age 16- 99
Therapy Yes

Trial Details

EMMAC is a randomised controlled trial studying the effects of MDMA-assisted therapy on mood and anxiety symptoms in advanced-stage cancer patients. Standard dose MDMA (120mg + optional 60mg) will be compared to a psychoactive placebo (Methylphenidate 20mg + optional 10mg) with both being given as a single dose. On the basis of MDMA pharmacology and recent research showing promising results with the use of psilocybin to reduce anxiety and depression in patients with advanced-stage cancer (Grob et al., 2011, Griffiths et al., 2016, Ross et al., 2016) we hypothesise that MDMA may have the potential to achieve similar positive mental health outcomes with reduced psychological risk given the differences in psychopharmacological effects.

NCT Number ACTRN12619001334190

Sponsors & Collaborators

University of Otago
The University of Otago (specifically the Dunedin School of Medicine) is associated with psychedelic research but doesn't yet have a full profile.

Data attribution

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