Psychedelic Assisted Therapy
Update: MMHG now offering MDMA assisted therapy for PTSD and psilocybin assisted therapy for treatment resistant depression
I am pleased to advise that Dr Ted Cassidy, co-founder of MMHG is officially a TGA and HREC approved prescriber of both MDMA and psilocybin. He is one of the first in Australia, and the world, able to legally prescribe psychedelics as a treatment for mental health concerns, within the context of a psychotherapy program. It’s an exciting time to be a mental health professional in Australia, and particularly to work at MMHG as we make history. Australia is really at the forefront of the world, many countries are watching closely how these treatments roll out within the mainstream healthcare space. Please see the training module in ISOPRO for an overview of the training.
A course of MDMA or psilocybin assisted therapy follows the below program cycle.
The psychedelic assisted therapy program is for a minimum of 12 weeks. Upon completing screening, there are three preparatory counselling sessions (each week 1-3) followed by the first dosing session (week 3) then another three integration counseling sessions (week 4-6), then second dosing session (week 6) followed by three integration sessions (week 7-9), then third dosing session occurs in week 9. A further three integration sessions occur over weeks 10-12. Note that the length of time between each dosing session can be extended by the Authorised Prescriber in collaboration with the client and the therapy team, where this would be beneficial to the client's process.
There are several cost components to our psychedelic assisted therapy programs: screening, therapeutic program, and the psychiatrist fees.
The main cost is the therapist time, because PAT is an intensive therapy program of 40+ hours psychotherapy with two therapists.
The cost of each component is as follows:
1. The screening and assessment service is $1000 (Medicare rebate available)
2. The therapeutic program is $25,000, with a reduced fee of $19,000 for private patients experiencing financial hardship (no medicare rebates).
3. The prescriber psychiatrist fees are $5000 (No Medicare rebates)
Total treatment cost for a private patient after the reduced fee is $24,000 (therapeutic program and psychiatrist). Screening assessment a separate fee of $1000 before enrolling in the treatment.
Patients may explore using funding sources such as NDIS, DVA, other Third Party funders.
The treatment program looks like this:
Preparation counselling sessions x 3: Preparation counselling is talk-therapy, focused on building a therapeutic, collaborative alliance and establishing an intention for the first dosing session. This includes exploring a person's hopes and fears, discussing what to expect during the dosing and preferences for support and grounding for the dosing session.
Dosing sessions x 3: The psychedelic medicine is administered under the supervision of medically trained professionals and therapists on three occasions during the psychotherapy program. Two clinicians are with the client during dosing, aside from when one of them takes a break, the client is always supported by a clinician and never left alone. All dosing sessions are on site at MMHG Surrey Hills Clinic in Victoria. The room is similar to a tranquil lounge room, with soft furnishings and soft lighting. The dosing session lasts approximately 6-8 hours for psilocybin, and 8-10 hours for MDMA. The client's blood pressure and heart rate are monitored by medically trained staff during the dosing, and there is rescue medication available if needed on site (note rescue medications have not been needed in clinical trials to date). The client takes the psychedelic dose, then is invited to 'go within' and listen to a curated music soundtrack designed for the session. Eyeshades are available and the client can lie down or sit upright whatever is comfortable. Light snacks are provided. The therapist team provide unintrusive support, and only intervene when required. When the client is cleared by the clinical team they are ready to leave in the company of a designated support person, who accompanies them after dosing until the next day.
Integration counselling sessions x 9: Integration counselling sessions are talk-therapy sessions, focused on making meaning of the dosing session, exploring what arose and what insights or realizations can be embedded into a person's life to support their mental health, sense of connectedness and recovery into the future. Integration helps to process difficult psychedelic experiences toward adaptive resolution and expands the benefits of the psychedelic session into ongoing changes and momentum after the program. There are three integration sessions after each psychedelic dosing session.
Authorised Prescriber reviews occur throughout the treatment and again at discharge from the program, where a case conference occurs with the person's treating team. As part of discharge planning, ongoing aftercare is arranged which may include referral to other MMHG services.
Many patients are interested in psychedelic assisted therapy: How do I know whether they are a suitable candidate?
Many patients are interested in psychedelic assisted therapy (PAT), especially those who have difficult-to-treat mental health concerns. As health professionals we are keen to help patients access safe and effective next-step mental health treatments. Despite the promise and hope of these emerging treatments, psychedelic assisted therapy is not safe or appropriate for everyone. We developed a screening service as a stand alone assessment, and where the patient does not meet eligibility for psychedelic therapy, they may be referred for other suitable alternative treatment options.
Screening and assessment for psychedelic assisted therapy
MMHG Screening and assessment service: This process includes an assessment with a psychologist and the Authorised Prescriber, as well as online questionnaires and medical screening. When a person meets initial criteria as per the below decision tree, they can be referred to this service as the next step.
· Diagnostic assessment: The Australian Therapeutic Goods Administration (TGA) has permitted two psychedelics, MDMA and psilocybin, to be prescribed for specific diagnoses by authorised prescriber psychiatrists. MDMA may be prescribed as part of a psychotherapy program for people with a diagnosis of PTSD, under specific medically supervised conditions. Psilocybin may be prescribed as part of a psychotherapy program for people with ‘treatment resistant’ depression, meaning the person has not found sufficient benefit from 2 or more treatments for depression. For example, a patient may have tried 2 antidepressants, cognitive behavioural therapy or TMS, and still is experiencing symptoms. A psychiatric assessment is important to ensure a patient meets criteria for one of these diagnoses to be eligible, and ensure their symptoms are not better explained by another cause.
o What about co-morbidities? Are there any exclusion criteria?
Experienced health professionals know that having more than one mental health condition is the norm, rather than the exception in clinical practice. In clinical trials, certain mental health conditions are considered exclusion criteria, as there has not been enough research to suggest psychedelic medicines are safe and effective for certain patients at this time. For example, people with a history of bipolar disorder, mania, schizophrenia or psychosis, current substance use difficulties, acute suicidality, dissociative identity disorder or borderline personality disorder are typically excluded from clinical trials for the aforementioned reasons. There is evidence supporting the effectiveness of psilocybin assisted therapy for alcohol use disorder (Bogenschutz & Ross et al., 2022) and safety of MDMA assisted therapy for alcohol use disorder (Sessa, Sekal, O’Brien & Nutt 2019). However, an assessment is important to understand the pattern and severity of a patient’s substance use and the best treatment plan for them.
· Physical: For patients with certain medical conditions, the use of psychedelic medicines is considered unsafe or there is not enough data yet to indicate safety. This is because both MDMA and psilocybin increase heart rate and blood pressure temporarily. It is important to note these medicines have a good safety profile with no serious adverse events have reported in psilocybin trials to date (Hodge, Sukpraprut-Braaten, Narlesky, Strayhan 2023), and only one self-limiting serious adverse event in MDMA trials so far recorded (Sessa, Higbed & Nutt 2019).
Contraindicated medical conditions include:
o Medically unstable diabetes
o Moderate to severe liver or renal conditions
o Moderate to severe cardiovascular conditions.
o Epilepsy
o Patients with abnormal QT interval prolongation at screening or with a history of this (QTc at screening above 440ms for men and above 470ms for women)
o If the person is a smoker, they need to reduce their use of nicotine to be able to attend dosing sessions of up to 8 hours without a cigarette
o History of ventricular arrhythmia at any time, other than occasional premature ventricular contractions (PVCs) in the absence of ischemic heart disease.
o Have Wolff-Parkinson-White syndrome or any other accessory pathway that has not been successfully eliminated by ablation.
o Have a history of stroke or Transient Ischemic Attack (TIA).
Patients who are pregnant or breastfeeding are not eligible (as safety is not established for a fetus or breastmilk) and for the same reason participants must agree to practice contraception during psychedelic assisted therapy participation. In addition, most clinical trials include people within the age of 18-75, with patients over 75 often being excluded (Johnston, Mangini, Grob & Anderson 2023). This is because psilocybin and MDMA can increase blood pressure and heart rate, which could be a concern if used in older adults with cardiovascular disease. Very few older adults or patients with serious comorbidities have been included in clinical trials (Johnston et al., 2023).
· Psychological: To be considered eligible under the new authorised prescriber scheme, patients must meet diagnostic criteria for either PTSD or ‘treatment-resistant’ depression. Clinical trials usually do not include people with a history of psychosis (including having a first-degree relative diagnosed with a psychotic disorder), mania, bipolar disorder, dissociative identity or personality disorder as psychedelics have not demonstrated safety for these groups. It is important that a patient has capacity to give informed consent to treatment, and is committed to the time-intensive nature of the program. A psychological assessment can assist identifying a person’s treatment history, readiness and motivation for seeking psychedelic assisted therapy, and their set of expectations for the treatment. Preparation is very important for psychedelic assisted therapy treatment outcomes. Ideally a patient will have tried psychological interventions, and had psychotherapy before, prior to considering psychedelic assisted therapy.
· Psychosocial: Psychedelic assisted therapy requires a significant time commitment from patients and therapists, in order to complete 1-3 in-clinic dosing sessions of up to 8 hours apart over several weeks. They also need to attend regular non drug psychotherapy and psychiatry sessions. The cost of the treatment is another consideration. In time, we hope these treatments can become more affordable and accessible. Patients need to identify a support person who can accompany them home from the dosing clinic, to ensure they are supported and monitored after the psychedelic session. Ideally the patient is able to take some time out from their ordinary duties and obligations, to process their psychedelic experience. People who are experiencing extreme psychosocial disadvantage, such as homelessness and living with family or domestic violence, may do well to engage in support services first to establish core needs such as safety and stability, before committing to an intensive program like psychedelic assisted therapy. Finally, a patient may benefit from ongoing integration after completing psychedelic therapy, so a person with the resources and commitment to continuing their recovery post-treatment may be better suited to this intervention.
· Willingness to taper off prescribed or herbal medications, including some psychiatric medications (such as SSRIs), for psychedelic medicine to be a safe and effective option.
There is much to learn about the provision psychedelic assisted therapy for diverse mental health conditions and patient populations. An assessment is very important, to understand a person’s context and symptoms, and their suitability and eligibility for these emerging treatments. With careful screening and a supported clinical environment, psilocybin and MDMA have been reported to be safe in clinical populations (Bender & Hellerstein, 2022; Jerome, Feduccia & Wangerome 2020).
References
Bender D, Hellerstein DJ: Assessing the risk−benefit profile of classical psychedelics: a clinical review of second-wave psychedelic research. Psychopharmacology 2022 Jan 13: 1–26 19.
Bogenschutz, Ross, S., Bhatt, S., Baron, T., Forcehimes, A. A., Laska, E., Mennenga, S. E., O’Donnell, K., Owens, L. T., Podrebarac, S., Rotrosen, J., Tonigan, J. S., & Worth, L. (2022). Percentage of Heavy Drinking Days Following Psilocybin-Assisted Psychotherapy vs Placebo in the Treatment of Adult Patients With Alcohol Use Disorder: A Randomized Clinical Trial. JAMA Psychiatry (Chicago, Ill.), 79(10), 953–962. https://doi.org/10.1001/jamapsychiatry.2022.2096
Hodge AT, Sukpraprut-Braaten S, Narlesky M, Strayhan RC. The Use of Psilocybin in the Treatment of Psychiatric Disorders with Attention to Relative Safety Profile: A Systematic Review. J Psychoactive Drugs. 2023 Jan-Mar;55(1):40-50. doi: 10.1080/02791072.2022.2044096. Epub 2022 Feb 28. PMID: 35225726.
Jerome JL, Feduccia AA, Wangerome JB: Long-term follow-up outcomes of MDMA-assisted psychotherapy for treatment of PTSD: a longitudinal pooled analysis of six phase 2 trials. Psychopharmacology 2020; 237:2485–2497, 16
Johnston, Mangini, M., Grob, C., & Anderson, B. (2023). The Safety and Efficacy of Psychedelic-Assisted Therapies for Older Adults: Knowns and Unknowns. The American Journal of Geriatric Psychiatry, 31(1), 44–53. https://doi.org/10.1016/j.jagp.2022.08.007
Sessa, Sakal, C., O’Brien, S., & Nutt, D. (2019). First study of safety and tolerability of 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy in patients with alcohol use disorder: preliminary data on the first four participants. BMJ Case Reports, 12(7), e230109–. https://doi.org/10.1136/bcr-2019-230109
Sessa B, Higbed L and Nutt D (2019) A Review of 3,4-methylenedioxymethamphetamine (MDMA)-Assisted Psychotherapy. Front. Psychiatry 10:138. doi: 10.3389/fpsyt.2019.00138