Blog
Psychedelic drugs - a credible therapy?
Posted on the 5th March 2024
With the rising prevalence of mental health disorders and the limited availability of treatments, could hallucinogenic substances as therapeutic interventions?
While already a pressing issue, many pre-existing conditions were exacerbated by the isolation and loneliness brought about by lockdowns during the COVID-19 pandemic (Mental Health and Disabilities Directorate, 2021; MIND, 2021).
The UK Office for National Statistics (ONS, 2022) reports a dramatic increase in depression, affecting nearly 1 in 6 adults, up from 10 before the pandemic. As the cost-of-living crisis adds stress, the need for effective mental health treatments becomes increasingly urgent.
In response to the rising prevalence of mental health disorders and the limited availability of treatments, research institutes are exploring the potential of hallucinogenic substances as therapeutic interventions.
Post-traumatic stress disorder (PTSD) is a common consequence of extremely stressful circumstances, including the recent experiences of COVID-19 survivors (Chamberlain et al., 2021) and frontline healthcare staff (De Castella, 2021).
While trauma-focused cognitive behavioral therapies (CBT) supplemented with medications are recommended by the UK National Institute for Clinical Excellence (NICE, 2018), some patients find these approaches challenging.
The Multidisciplinary Association for Psychedelic Studies (MAPS) conducted a trial using MDMA (3,4 methylenedioxy methamphetamine), commonly known as ecstasy, alongside talking therapy for PTSD.
Remarkably, 88 per cent of patients experienced a "meaningful reduction in symptoms," with 67 per cent no longer qualifying for a PTSD diagnosis, compared to 60 per cent and 32 per cent, respectively, for those undergoing talking therapy alone (Mitchell et al., 2021).
Research at John Hopkins University suggests that MDMA induces a neural response known as the "Critical Period," potentially allowing the brain to form new connections not typically possible in adults (Wasta & Butch, 2019).
Furthermore, MDMA calms the amygdala, the brain's stress response center, flooding it with serotonin and dopamine, thereby diminishing the response to fear (Wolfson et al., 2020).
In another trial at Imperial College London’s Centre for Psychedelic Research, psilocybin, the psychoactive ingredient in hallucinogenic mushrooms, was compared with the antidepressant escitalopram.
Both groups experienced reductions in depressive symptoms, but psilocybin showed superior results in social functioning, mental well-being, and overall happiness (O'Hare, 2021).
Promising results from an early-stage clinical trial, published in the New England Journal of Medicine, explored the use of psilocybin for treatment-resistant major depression (TRD). Higher doses significantly reduced depression scores over 12 weeks, although longer and larger trials are deemed necessary (Goodwin et al., 2022).
In a groundbreaking move, the Therapeutics Goods Administration (TGA) of Australia approved MDMA and psilocybin for prescription by psychiatrists, specifically for PTSD and TRD, respectively (The Department of Health and Aged Care - Therapeutics Goods Administration, February 2023).
Several jurisdictions, including Oregon and Colorado in the US, Israel, and Canada, have made strides in allowing the use of psychedelic substances in clinical trials or for medical treatment.
In response to the growing interest, lawmakers in the US have proposed a bill to regulate the conduct of clinical trials on psychedelic-assisted therapy, emphasizing the need for a regulatory framework endorsed by authorities (US House of Representatives, 2023).
The US Food and Drug Administration (FDA) has taken steps in this direction, issuing a draft guidance on clinical trials with psychedelic drugs (FDA, 2023).
The FDA has already designated psilocybin and MDMA as "breakthrough therapies" for various medical conditions, including psychiatric and substance use disorders (US Food and Drug Administration, 2023) and has recently granted a priority review to Lykos Therapeutics midomafetamine capsules ("MDMA") used in combination with psychological intervention, which includes psychotherapy (talk therapy) and other supportive services provided by a qualified healthcare provider for individuals with post-traumatic stress disorder ("PTSD").
The target action date for approval of this psychedelic-assisted therapy is August 2024 (Lykos Therapeutics, 2024).
While these developments mark a significant shift in the therapeutic landscape, it is crucial to acknowledge the need for further research into the safety and efficacy of these treatments. While the current data from clinical trials have demonstrated that these treatments are potentially beneficial for patients with TRD and PTSD, prescribing must be managed by appropriately qualified professionals (The Department of Health and Aged Care - Therapeutics Goods Administration, June 2023).
Potential challenges, such as vivid hallucinations and substance abuse, must be carefully addressed (Guy M. Goodwin, 2022).
References:
Chamberlain, S. et al., 2021. Post-traumatic stress disorder symptoms in COVID-19 survivors: Online population survey. BJPsych Open, 7(2), p. 4.
De Castella, T., 2021. 'Staggering rise' in mental health issues among NHS staff since Covid-19. (Online)
Available at: https://www.nursingtimes.net/news/workforce/staggering-rise-in-mental-health-issues-among-nhs-staff-since-covid-19-30-04-2021/
(Accessed 5 December 2023).
Goodwin, G. M. et al., 2022. Single-Dose Psilocybin for a Treatment-Resistant Episode of Major Depression. The New England Journal of Medicine, 387(18), pp. 1637 - 1648.
Lykos Therapeutics, 2024. ‘Lykos Therapeutics Announces FDA Acceptance and Priority Review of New Drug Application for MDMA-Assisted Therapy for PTSD’
(Accessed 27 February 2024).
Mental Health and Disabilities Directorate, 2021. COVID-19 Mental Health and Wellbeing Recovery Action Plan, London: HM Government.
MIND, 2021. Coronavirus: the consequences for mental health., London: MIND.
Mitchell, J. et al., 2021. MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study. Nature Medicine, 27(6), pp. 1025-1033.
NICE, 2018. National Institute for Health and Care Excellence guideline [NG116]- Recommendations - Post-traumatic stress disorder. (Online)
Available at: https://www.nice.org.uk/guidance/ng116
(Accessed 05 December 2023).
Office for National Statistics (ONS), 2022. Cost of living and depression in adults, Great Britain: 29 September to 23 October 2022. (Online)
(Accessed 05 December 2023).
O'Hare, R., 2021. Magic mushroom compound performs as well as antidepressant in small study. (Online)
Available at: https://www.imperial.ac.uk/news/219413/magic-mushroom-compound-performs-well-antidepressant/
(Accessed 05 December 2023).
The Department of Health and Aged Care - Therapeutics Goods Administration, February 2023. Change to classification of psilocybin and MDMA to enable prescribing by authorised psychiatrists. (Online)
(Accessed 05 December 2023).
The Department of Health and Aged Care - Therapeutics Goods Administration, June 2023. Re-scheduling of psilocybin and MDMA in the Poisons Standard: questions and answers (Online)
Available at:https://www.tga.gov.au/resourc...
(Accessed 05 December 2023)
US Food and Drug Administration, 2023. FDA Issues First Draft Guidance on Clinical Trials with Psychedelic Drugs. (Online)
Available at: https://www.fda.gov/news-events/press-announcements/fda-issues-first-draft-guidance-clinical-trials-psychedelic-drugs
(Accessed 05 December 2023).
Wasta, V. & Butch, R., 2019. Johns Hopkins study explains why MDMA may help treat PTSD. (Online)
Available at: https://hub.jhu.edu/2019/04/04/mdma-opens-critical-period-for-social-behavior/
(Accessed 05 December 2023).
Wolfson, P. . E. et al., 2020. MDMA-assisted psychotherapy for treatment of anxiety and other psychological distress related to life-threatening illnesses: a randomized pilot study. Scientific Reports, 10, p. 20442.