Medicinal Psychedelics Research Network (MPRN)
Background
There is currently a renewed focus on the potential medical use of various psychotropic plants and related substances. Best known of these is the cannabis plant, which is now being investigated for efficacy in the treatment of a wide range of conditions and has had legal access pathways created in all Australian jurisdictions.
At the same time there has been a resurgence of interest in the therapeutic use of various psychedelic compounds such as psilocybin, MDMA, LSD and ayahuasca, primarily for the treatment of mental health and substance use disorders. Research programs with these drugs have been established at eminent institutions internationally such as Johns Hopkins, Imperial College, Kings College, Yale and NYU with researchers involved reporting remarkable early results. Both psilocybin and MDMA are now entering Phase 3 trials and have recently been granted ‘breakthrough therapy’ status by the FDA on the basis of initial evidence they may provide a substantial improvement over existing treatments.
However, the possible therapeutic use of such substances differs in important respects from existing approaches, and presents new challenges for medicines regulation and health policy, patient safety, and the design of appropriate treatment protocols that can optimise contextual and psychological factors shown to affect clinical outcomes. There are also further interesting issues related to the current socio-cultural and policy understandings of psychedelic plants and substances.
MPRN aims
The MPRN aims to facilitate engagement between Australian and international colleagues to consider research, policy and regulatory questions, as well as potential new opportunities for patient treatment.
The MPRN will provide an opportunity for:
- Facilitating research collaborations between academic researchers, NGOs and industry
- Exploring regulatory approaches and issues relating to medicinal psychedelics
- Hosting research seminars, round-tables or workshops
- Leveraging established connections with leaders in this field in North America and Europe
- Sharing of new research and resources relevant to this area
- Considering issues of safety and ethics relating to patient access, models of treatment, and clinician training
- Researchers, government and NGO representatives to meet and share information in this rapidly evolving area
June 2019
Medicinal cannabis and psychoactive plants (and related substances) for mental health and addiction
This one-day research forum took place on Friday 28 June at the University of Melbourne and was hosted by the School of Social and Political Science and Department of Psychiatry, in partnership with the Penington Institute (please see the event flyer (380kb pdf)). The event brought together invited researchers, policy makers and regulators working across mental health, addiction and medicines regulation to hear from eminent local and international researchers on the potential use of cannabinoids and medicinal psychedelics in the treatment of psychiatric and substance use disorders.
Event recordings
Keynotes
- Associate Professor Matthew Johnson, Johns Hopkins Medical School, Therapeutic potential of psilocybin for psychiatric and substance use disorders
- Dr Rick Doblin, Executive Director and founder MAPS, and Board member MAPS Public Benefit Corporation, Making MDMA into a prescription medicine for the treatment of PTSD
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Session 1
Introduction and context, Dr Daniel Perkins – School of Social and Political Science
MDMA assisted psychotherapy for severe PTSD: Therapeutic approach in a phase 3 trial, Dr Ingmar Gorman – Behavioral Sciences Training in Drug Abuse Research (BST) Program, New York University
Medicinal cannabis and Kava: potential applications in psychiatric disorders, Professor Jerome Sarris–NICM, Western Sydney University; and Department of Psychiatry, University of Melbourne.
Psilocybin for the treatment of anxiety among terminally ill patients: the first Australian clinical trial at St Vincent’s Hospital, Melbourne, Dr Martin Williams –Monash University; and PRISM
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Session 2
Regulatory requirements: clinical trials, access to un-approved medicines and the TGA registration process (slides only), Adjunct Prof John Skerritt – Deputy Secretary, Health Products Regulation, Department of Health
Medicinal Cannabis for psychiatric conditions and addictions: The current state of play in Australia, Dr Melissa Benson –Lambert Institute of Cannabinoid Therapeutics, University of Sydney
Ayahuasca as a potential therapeutic agent for the treatment of mental health and substance use disorders? Dr Daniel Perkins–School of Social and Political Science, University of Melbourne
Swiss research exploring the therapeutic potential of psilocybin, LSD, MDMA and DMT and the Swiss compassionate use framework, Dr Milan Scheidigger – Department of Psychiatry, University of Zurich
Research centres and regulators
International research centres
- John Hopkins, Psychedelic Research Unit
- Imperial College London, Centre for Psychedelic Research
- Multidisciplinary Association for Psychedelic Studies, MDMA-Assisted Psychotherapy
- King’s College London, Centre for Affective Studies, psilocybin trials
Australian regulatory agencies
- Office of Drug Control
- Therapeutic Goods Administration, Accessing unapproved products
- Medicines and Poisons Regulation, DHHS, Victoria
Recent publications
A range of additional research will be added shortly.
- Carhart-Harris, R. L., Bolstridge, M., Day, C. M. J., Rucker, J. and Watts, D. E. et al. (2018). "Psilocybin with psychological support for treatment-resistant depression: six-month follow-up," in Psychopharmacology 235(2), pp. 399-408
- Danforth, A. L., Grob, C. S., Struble, C., Feduccia, A. A. and Walker, N. et al. (2018). "Reduction in social anxiety after MDMA-assisted psychotherapy with autistic adults: a randomized, double-blind, placebo-controlled pilot study," in Psychopharmacology (Berl) 235(11), pp. 3137-3148
- Doss, M. K., Weafer, J., Gallo, D. A. and Wit, H. de (2017). "MDMA Impairs Both the Encoding and Retrieval of Emotional Recollections," in Neuropsychopharmacology 43, pp. 791
- Hamill, J., Hallak, J., Dursun, S.M. and Baker, G. (2019). "Ayahuasca: Psychological and Physiologic Effects, Pharmacology and Potential Uses in Addiction and Mental Illness," in Curr Neuropharmacol 17(2), pp. 108-128
- Johnson, M. W., Garcia-Romeu, A. and Griffiths, R. R. (2017). "Long-term follow-up of psilocybin-facilitated smoking cessation," in American Journal of Drug & Alcohol Abuse 43(1), pp. 55-60
- Johnson, M. W., Griffiths, R. R., Hendricks, P. S. and Henningfield, J. E. (2018). "The abuse potential of medical psilocybin according to the 8 factors of the Controlled Substances Act," in Neuropharmacology 142, pp. 143-166
- Johnson, M.W., Hendricks, P.S., Barrett, F.S. and Griffiths, R.R. (2019). "Classic psychedelics: An integrative review of epidemiology, therapeutics, mystical experience, and brain network function," in Pharmacology & Therapeutics 197, pp. 83-102
- Mithoefer, M. C., Feduccia, A. A., Jerome, L., Mithoefer, M., Wagner, Z. and Walsh, S. et al. (2019). "MDMA-assisted psychotherapy for treatment of PTSD: study design and rationale for phase 3 trials based on pooled analysis of six phase 2 randomized controlled trials," in Psychopharmacology
- Mithoefer, M. C., Mithoefer, A. T., Feduccia, A. A. and Jerome, L. et al. (2018). "3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy for post-traumatic stress disorder in military veterans, firefighters, and police officers: a randomised, double-blind, dose-response, phase 2 clinical trial," in The Lancet Psychiatry 5(6), pp. 486-497
- Muttoni, S., Ardissino, M. and John, C. (2019). "Classical psychedelics for the treatment of depression and anxiety: A systematic review," in Journal of Affective Disorders 258, pp. 11-24
- Nutt, D. (2019). "Psychedelic drugs - a new era in psychiatry?" in Dialogues in Clinical Neuroscience 21(2), pp. 139-147
- Palhano-Fontes, F., D. Barreto, H. Onias, K. C. Andrade, M. M. Novaes, J. A. et al. (2018). "Rapid antidepressant effects of the psychedelic ayahuasca in treatment-resistant depression: a randomized placebo-controlled trial." Psychological Medicine: 1-9.
- Roseman, L., Demetriou, L., Wall, M.B., Nutt, D.J. and Carhart-Harris, R.L. (2018). "Increased amygdala responses to emotional faces after psilocybin for treatment-resistant depression," in Neuropharmacology 142, pp. 263-269
- Ross, S., Bossis, A., Guss, J., Agin-Liebes, G., Malone, T. and Cohen, S. E. et al. (2016). "Rapid and sustained symptom reduction following psilocybin treatment for anxiety and depression in patients with life-threatening cancer: a randomized controlled trial," in Journal Of Psychopharmacology (Oxford, England) 30(12), pp. 1165-1180
- Sessa, B., L. Higbed and D. Nutt (2019). "A Review of 3,4-methylenedioxymethamphetamine (MDMA)-Assisted Psychotherapy." Frontiers in psychiatry 10: 138-138.
- Smigielski, L., Scheidegger, M., Kometer, M. and Vollenweider, F.X. (2019). "Psilocybin-assisted mindfulness training modulates self-consciousness and brain default mode network connectivity with lasting effects," in NeuroImage 196, pp. 207-215
- Tang, S. W. and Tang, W. H. (2019). "Opportunities in Novel Psychotropic Drug Design from Natural Compounds," in Int J Neuropsychopharmacol
Current or recent research in Australia and New Zealand
Current or recent medicinal psychedelics research led by researchers/institutions in Australia or New Zealand.
- Title: Global Cross-sectional study of the health and wellbeing harms and benefits associated with consumption of ayahuasca. Cross-sectional observational study of >7000 ayahuasca drinkers in over 50 countries (current).
Investigators: Dr D Perkins, Dr V D Schubert, A/Prof J Sarris, Dr J Carlos Bouso, Dr M Horák, Dr M Scheidegger, Ms H Simonova, Professor L Tófoli, Dr. E Opaleye.
Lead Institution (contact): University of Melbourne (Dr Daniel Perkins d.perkins@unimelb.edu.au) - Title: Mental health, addiction and wellbeing effects associated with the use of ayahuasca tea in religious contexts. Longitudinal observational study at two sites (current).
Investigators: Dr D J Perkins, A/Prof R D Chenhall, A/Prof J Sarris.
Lead Institution (contact): University of Melbourne (Dr Daniel Perkins d.perkins@unimelb.edu.au) - Title: Multi-site study investigating the mental health, addiction and wellbeing effects of ayahuasca consumption in facilitated contexts. Multi-site longitudinal observational study, with comparison group (current).
Investigators: Dr D J Perkins, A/Prof R D Chenhall, A/Prof J Sarris.
Lead Institution (contact): University of Melbourne (Dr Daniel Perkins d.perkins@unimelb.edu.au) - Title: Psilocybin-assisted psychotherapy for the treatment of depression and anxiety associated with life-threatening illness. Interventional RCT (current)
Investigators: M.Ross, J.Dwyer, M.Williams
Lead Institution (contact): St Vincent’sHospital (Dr Margaret Ross margaret.ross@svha.org.au) - Title: Kava for the Treatment of Generalised Anxiety Disorder: A Double-Blind Randomised Placebo-Controlled Trial (KGAD). Interventional RTC (completed).
Investigators: Sarris J., Savage KM, Stough CK, Byrne GJ, Scholey A, Bousman C, Murphy J, Macdonald P, Suo C, Hughes M, Thomas S, Teschke R, Xing C.
Lead Institution (contact): University of Melbourne (A/Prof Jerome Sarris jsarris@unimelb.edu.au) - Title: A systematic study of microdosing psychedelics. Cross-sectional observational study (completed).
Investigators: Vince Polito , Richard J. Stevenson
Lead Institution (contact): Macquarie University (Dr Vince Polito vince.polito@mq.edu.au) - Title: Ibogaine treatment outcomes for opioid dependence from a twelve-month follow-up observational study. Longitudinal observational (completed).
Investigators: G. Noller, C. Frampton, B. Yazar-Klosinski.
Lead Institution (contact): University of Otago (Dr Geoff Noller Geoff.noller@otago.ac.nz) - Title: Ascending Single‐Dose, Double‐Blind, Placebo‐Controlled Safety Study of Noribogaine in Opioid‐Dependent Patients. Interventional RCT (completed)
Investigators: P. Glue, G. Cape, D. Tunnicliff, M. Lockhart, F. Lam, N. Hung, C. Hung, S. Harland, J. Devane, R. Crockett, J. Howes, B. Darpo, M. Zhou, H. Weis, L. Friedhoff.
Lead Institution (contact): University of Otago (Prof Paul Glue paul.glue@otago.ac.nz
The Medicinal Psychedelics Research Network is based at the University of Melbourne involving researchers from the School of Social and Political Science, Department of Psychiatry, and School of Population and Global Health, and is open to academic researchers, government health policy and medicines regulation agency staff, representatives from NGOs working across drug policy, mental health, addiction, and industry representatives.
Contacts
Dr Daniel Perkins
Email: d.perkins@unimelb.edu.au
Dr Violeta Schubert
Email: violetas@unimelb.edu.au
Associate Professor Jerome Sarris
Email: jsarris@unimelb.edu.au
Associate Professor John Fitzgerald
Email: jlfitz@unimelb.edu.au