The scientific research on ibogaine provides insights into its potential effectiveness and safety concerns in treating drug dependence. Here are key findings from various studies:

1. Efficacy in Treating Drug Dependence: A retrospective study in Brazil found that ibogaine treatment, combined with psychotherapy, led to abstinence in 61% of participants, with no serious adverse reactions or fatalities reported. Those treated multiple times showed a statistically significant increase in abstinence duration compared to single treatments (Schenberg et al., 2014).
2. Animal Model Efficacy: A systematic review and meta-analysis of animal studies concluded that ibogaine reduced drug self-administration, especially within the first 24 hours after administration. However, it also caused motor impairment and cerebral cell loss (Belgers et al., 2016).
3. Transitioning to Sobriety: Clinical observations and treatment outcomes suggest that ibogaine may effectively transition opioid and cocaine-dependent individuals to sobriety. This conclusion is based on public testimonials and preclinical studies, although rigorous validation in humans is needed (Mash et al., 2018).
4. Potential Safety Concerns: The relationship between ibogaine and heart health is delicate, with alarming reports of life-threatening complications and sudden deaths associated with its use. These adverse reactions are thought to be linked to ibogaine’s tendency to induce cardiac arrhythmias (Koenig & Hilber, 2015).
5. Cardiac Risks and Safety in Detoxification: A descriptive open-label observational study on the safety of ibogaine in opioid-dependent individuals showed clinically relevant but reversible QTc prolongation, bradycardia, and severe ataxia. This highlights the importance of close monitoring during treatment (Knuijver et al., 2021).
6. Systematic Review of Ibogaine/Noribogaine: A systematic review assessing the role of ibogaine and noribogaine in treating substance use disorders (SUD) highlighted some efficacy but also raised concerns about cardiotoxicity and mortality, underscoring the need for further research to evaluate their therapeutic efficacy and safety (Mosca et al., 2022)

The New Zealand Experience
In New Zealand, Ibogaine has been a subject of significant interest, especially after legislative changes in 2010 that allowed its prescription as a non-approved medicine for therapeutic use. The New Zealand model of Ibogaine treatment involves comprehensive assessment, the development of a treatment plan, and post-treatment support, emphasizing the importance of aftercare and continued counselling.

Ibogaine in Australia
Ibogaine has been subject to quite a few critical new stories in Australia due to its potential for cardiotoxicity however, looking at the science, relative to methadone (a popular treatment for opioid addiction) it has a much better mortality rate profile. As such Ibogaine is classified as a Schedule 4 substance on the Therapeutic Goods Administration poisons list in Australia. This classification makes it a prescription-only medicine. However, it’s important to note that Ibogaine is not a controlled substance under Australian state and federal laws.

MDMA-assisted therapy has shown significant promise in the treatment of various psychiatric disorders, including post-traumatic stress disorder (PTSD), depression, and anxiety. This article provides an overview of the best practices in MDMA-assisted therapy, synthesized from recent scientific research.

Introduction

MDMA, commonly known as ecstasy, when used in a controlled therapeutic setting, has been shown to enhance the effectiveness of psychotherapy for certain mental health conditions.

Best Practices in MDMA-Assisted Therapy

1. Therapeutic Setting: MDMA is administered in a controlled clinical setting, often accompanied by psychotherapy sessions. This combination is critical for achieving the desired therapeutic outcomes (Yazar‐Klosinski & Mithoefer, 2017).
2. Dosage and Administration: Clinical trials have experimented with different dosages to find the optimal amount for therapeutic use. Typically, MDMA is administered in a single dose during therapy sessions (Oehen, Traber, Widmer, & Schnyder, 2013).
3. Safety and Tolerability: Research indicates that MDMA can be safely administered in a clinical setting, with no significant drug-related serious adverse events (Feduccia & Mithoefer, 2018).
4. Efficacy: Studies have shown that MDMA-assisted psychotherapy can lead to clinically significant improvements in PTSD symptoms and potentially other disorders (Smith, Sicignano, Hernández, & White, 2021).
5. Extended Benefits: MDMA catalyzes shifts toward openness and introspection that can result in lasting benefits without the need for ongoing administration (Danforth, Struble, Yazar-Klosinski, & Grob, 2016).
6. Patient Diversity: Recent trials indicate the efficacy of MDMA therapy across a diverse range of patients, including those with severe PTSD and other comorbidities (Mitchell et al., 2021).
7. Mechanism of Action: MDMA enhances the release of neurotransmitters and hormones that modulate emotional memory circuits, aiding in the reprocessing of traumatic memories and facilitating fear extinction (Feduccia & Mithoefer, 2018).

Conclusion

MDMA-assisted therapy represents a breakthrough in the treatment of certain psychiatric disorders, offering a unique combination of pharmacological and psychotherapeutic interventions. The controlled use of MDMA in therapeutic settings has shown significant efficacy and safety, making it a promising option for patients who are resistant to traditional treatments.

The information presented in this article is based on current scientific research and is subject to change as new studies emerge. Always consult with a healthcare professional for medical advice and treatment.

There has been a recent increase in interest in MDMA therapy as Lykos Therapeutics intends to launch MDMA as a licensed medicine towards the end of 2024. This marks a significant milestone in the evolving landscape of psychedelic-assisted therapy, particularly for conditions like post-traumatic stress disorder (PTSD) and alcohol use disorder (AUD).

MDMA-assisted psychotherapy represents a novel approach to mental health treatment. Its efficacy primarily revolves around its ability to enhance the therapeutic process by fostering a sense of openness, empathy, and reduced fear response during psychotherapy sessions. This environment is conducive for patients to process and integrate challenging emotions and memories, particularly those related to traumatic experiences.

The safety and tolerability of MDMA therapy have been major points of consideration. Recent studies indicate that when administered in a controlled clinical setting, MDMA treatment is well-tolerated by participants. Adverse events have been rare and non-life-threatening, emphasizing the controlled use of MDMA in clinical environments as a key factor for safety. Research shows that MDMA therapy for PTSD is entering the final phase of drug development, with an aim for FDA and EMA licensing in the near future. This progress indicates the potential for MDMA to become a medicine, assuming clinical efficacy criteria are achieved (Sessa, Higbed, & Nutt, 2019).

Further, MDMA-assisted therapy has shown promising results in treating social anxiety in autistic adults and anxiety associated with life-threatening illnesses. Unlike conventional drug treatments, MDMA-assisted therapy is not intended for ongoing administration. It is used on one to several occasions within a psychotherapy protocol, potentially reducing the frequency of adverse events and improving the risk/benefit ratio. This aspect may present a significant advantage over medications that require daily dosing (Danforth, Struble, Yazar-Klosinski, & Grob, 2016).

As such, there are lots of ongoing clinical research on the subject, the most important of which include:

1. MDMA-Assisted Therapy for PTSD: A study analyzed brain activity and connectivity via functional MRI during both rest and autobiographical memory response before and two months after MDMA-assisted therapy in veterans and first responders with chronic PTSD. The study found reduced activation contrast after MDMA-assisted therapy in the cuneus and a correlation between recovery from PTSD and changes in functional connections during autobiographical memory recall (Singleton et al., 2023).
2. DNA Methylation and MDMA-Assisted Therapy: A pilot study suggested that DNA methylation of the glucocorticoid receptor gene is associated with treatment response in severe PTSD following MDMA-assisted therapy. The study examined epigenetic changes in key hypothalamic-pituitary-adrenal (HPA) axis genes before and after MDMA and placebo with therapy, finding significant methylation changes that may predict treatment response (Lewis et al., 2023).
3. Effects of MDMA-Assisted Therapy on Self-Experience in PTSD: Another study reported on the effects of MDMA-assisted therapy on patients with severe PTSD. It found that MDMA-assisted therapy, compared with psychotherapy alone, significantly altered domains of alexithymia, self-compassion, and altered self-capacities, suggesting substantial improvement in mental processes associated with poor treatment response (van der Kolk et al., 2023).

Other MDMA studies include:

Alongside this, there is a wide range of small investigator-led MDMA trials including:

• ICAN1: A Phase 2 Open-Label Treatment Development Study of MDMA-Assisted Psychotherapy in Conjunction with Cognitive Processing Therapy (CPT) for Chronic Posttraumatic Stress Disorder (PTSD)
• Influence of MDMA on Risk and Reward Circuits of the Brain
• MDMA-Assisted Psychotherapy for the Treatment of Social Anxiety Disorder
• Low-dose MDMA Versus Standard-dose MDMA in Therapy for Mood and Anxiety Symptoms in Advanced-stage Cancer Patients
• Feasibility Trial of MDMA-Assisted Psychotherapy for Depression
• Adjustment Disorder (AD) in Dyads (patient pairs) of Patients with Breast Cancer and a Concerned Significant Other

The development of MDMA-assisted psychotherapy heralds a new era in mental health treatment, promising a potentially transformative approach for patients with conditions resistant to current treatments. As Lykos Therapeutics prepares to introduce MDMA as a licensed medicine, the medical community and patients alike await with anticipation the outcomes and broader implications of this novel therapeutic approach.

In 6 months (around June 2024) the FDA (US medicine regulator) will likely approve MDMA (ecstasy) as a licensed medicine in the US. This will present a pivotal moment for mental health care around the world as the efficacy rates of MDMA relative to traditional treatments for PTSD, depression and addictions are impressive.

As you can see from above, the most recent data indicates high rates of remission from PTSD (red) with MDMA in comparison to placebo (blue). Further comparing these rates (see picture below) to traditional antidepressant effectiveness rates i.e. from 19 to 70% within SSRIs (Prozac et al.), from 31 to 70% within the SNRI (Duloxetine et al.) treatment arms, and from 23 to 54% within TCAs (Amitriptyline et al.).

This may not seem very impressive, however, there is one major distinction, MDMA is curative. The importance of this cannot be stressed enough. Aside from the cost of having to take traditional antidepressants every day which comes with a wide range of side effects, such as with, TCAs treatment: dry mouth (58%), sweating (28%) and constipation (26%)² there’s the additional burden of anhedonia (not being able to feel anything good, or bad!).

MDMA is different. The medicine treats the root cause of the disease instead of just tranquilising the symptoms such as poor mood or lack of motivation. MDMA does this through a process known as fear memory extinction, which modulates fear memory consolidation. At its simplest, this means MDMA can dissolve bad feelings associated with a memory which in extreme cases is termed trauma. This makes it more comparable to traditionally stronger, last-line treatments like ECT which has its major side effects of memory loss.

When will MDMA be available in Australia?

Well in theory, due to the changes put forth by the TGA on 1 July 2023, it should already be available. However, due to the huge amount of red tape and high demand, the vast majority of 1 in 7 depressed patients in Australia cannot get access. This is why the licensing by MAPS is so important, it puts the medicine in a licensed category meaning, that doctors will have better coverage by indemnity insurance if something were to go wrong, therefore, they will have a higher propensity to prescribe. i.e. the risk to them is a lot lower and therefore, given the demand this should cause an upsurge in supply.

So where to go from here? Stay updated with the latest developments. Whilst it’s likely the FDA will license the medicine in the US in June, it will take a bit of time to come to Australia (usually another 6 months). At this point, it is more than likely it will be considered a Controlled Drug and hopefully be prescribable by regular doctors (however this may be limited to psychiatrists only). By whichever route, it should be available this time next year, for a high price due to the overwhelming demand, this is why we have created the Psychedelic Buyers Club to ensure a lower cost via a bulk buy.

References

¹ MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study. Published in the Nature Medicine Journal: 10 May 2021: Jennifer M. Mitchell. Accessed on 2 January 2024 via: https://www.nature.com/articles/s41591-021-01336-3

² Tricyclic Antidepressants. Moraczewski J, Awosika AO, Aedma KK. [Updated 2023 Aug 17]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK557791/

³ Remission, dropouts, and adverse drug reaction rates in major depressive disorder: a meta-analysis of head-to-head trials. Review published: 2006. Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet]. M Machado, M Iskedjian, I Ruiz, and TR Einarson. https://www.ncbi.nlm.nih.gov/books/NBK73259/

Note: As of October 2023, psilocybin remains a Class A drug in the UK. The following article provides informational content and does not endorse or encourage illegal activities. Always adhere to local laws and regulations.

Introduction

The world of mental health treatments is rapidly evolving, and among the emerging therapies are psilocybin as a medicine. Traditionally psilocybin is consumed as the dry weight of magic mushrooms, however, in recent years, as there has been an explosion in clinical trials of psychedelics; psilocybin has been isolated / manufactured and formulated as pills.

1. Psilocybin: A Brief Overview

Psilocybin is a naturally occurring compound found in certain mushrooms. Historically used in ritualistic and spiritual contexts, modern science is now exploring its potential therapeutic benefits, especially for conditions like depression and anxiety.

2. Legal Status in the UK

In the UK, psilocybin is currently classified as a Class A drug. This classification makes its production, possession, and supply illegal. However, for research purposes, certain exceptions may apply, given the proper licensing and permissions.

3. The Rise of Psilocybin Pills

While traditional consumption methods involved eating raw mushrooms, advancements have led to the extraction and encapsulation of psilocybin into pill form. These pills offer a controlled dosage, making them more suitable for therapeutic and research settings.

4. Ongoing Research and Trials

The UK has been home to several groundbreaking studies on psilocybin. Prestigious institutions are delving into its efficacy as a treatment for various mental health disorders. Preliminary results have shown promise, though extensive research is still needed.

5. The Future of Psilocybin Pills in the UK

Given the growing body of evidence supporting the therapeutic potential of psilocybin, there is hope that regulations might evolve. However, any changes would require rigorous scientific backing, coupled with societal and political will.

Conclusion

Psilocybin pills in the UK represent a fascinating intersection of tradition, science, and regulation. As research progresses and our understanding deepens, the landscape may shift, offering new avenues for mental health treatments. Until then, it’s crucial to stay informed, adhere to current laws, and watch this space for developments.

Introduction

Ketamine, once primarily known as an anaesthetic agent, is gaining traction in Australia as a potential breakthrough treatment for mental health conditions. With the rise of ketamine clinics across the country, Australians now have more options to explore novel therapies. But what should you know about these clinics? Let’s delve into the world of ketamine treatments Down Under.

1. The Therapeutic Potential of Ketamine

Recent studies have indicated that low doses of ketamine can have rapid antidepressant effects, especially for individuals resistant to traditional treatments. These findings have led to a surge in interest and the establishment of specialized clinics offering ketamine-infused therapies for conditions like depression, PTSD, and anxiety.

2. The Legal Landscape in Australia

Ketamine is a Schedule 8 controlled drug in Australia, which means its use is restricted and closely monitored. However, certain approved clinics and practitioners can administer it under strict guidelines for therapeutic purposes.

3. What to Expect at a Ketamine Clinic

Typically, patients undergo a thorough assessment to determine their suitability for ketamine therapy. Once deemed appropriate, they receive the treatment in a controlled environment, often starting with a series of infusions. It’s essential to understand that while many individuals report significant improvements, results can vary.

4. The Rise of Clinics Across Australia

Major cities like Sydney, Melbourne, and Brisbane have seen a steady increase in ketamine clinics, reflecting the growing demand and recognition of its potential benefits. These clinics often have multidisciplinary teams, including psychiatrists, anaesthetists, and nurses, ensuring comprehensive care.

5. Staying Informed and Safe

While the promise of ketamine treatment is exciting, it’s crucial to approach it with an informed perspective. Ensure the clinic is licensed, the practitioners are experienced, and they follow the stringent guidelines set by Australian health authorities.

Conclusion

Ketamine clinics in Australia represent a new frontier in mental health treatments, offering hope to many who haven’t found relief through conventional means. As with any medical treatment, it’s essential to do thorough research, consult with professionals, and stay updated on the latest regulations and findings. If you would like us to help you find the right type of treatment get in contact with one of our healthcare professionals using this form.

As of the last update of this article in October 2022, psilocybin remains a Class A drug in the UK, making it illegal to produce, supply, or possess. The following article is meant for informational purposes only and does not endorse or encourage illegal activities. Always consult with local laws and regulations.

Introduction

Psilocybin, the active compound found in certain mushrooms, has been the subject of much medical and scientific interest in recent years. While it remains a controlled substance in many countries, the potential therapeutic applications of psilocybin are being explored extensively. If you’re interested in understanding the process of obtaining a psilocybin prescription in the UK, here’s what you need to know.

1. Understanding Psilocybin’s Legal Status

Before diving into the intricacies of obtaining a prescription, it’s essential to be clear about psilocybin’s legal status. In the UK, psilocybin mushrooms are classified as a Class A drug. This means it’s illegal to possess, produce, or supply them. Any attempt to procure psilocybin without appropriate authorisation can lead to severe legal consequences.

2. The Potential Therapeutic Uses

Research studies have shown that psilocybin may have potential therapeutic effects, particularly for conditions like depression, anxiety, and PTSD. Clinical trials are underway in various parts of the world to better understand its safety and efficacy.

3. Special Licences for Research

While general possession and supply are prohibited, specific licences can be granted for research purposes. Institutions or researchers looking to study psilocybin’s therapeutic effects can apply for such a licence from the UK Home Office.

4. Consulting with a Healthcare Professional

If you believe that psilocybin might be beneficial for your health, it’s crucial to consult with a healthcare professional. They can provide guidance on potential treatment options, risks, and the legal aspects surrounding psilocybin in the UK.

5. Staying Updated with Changing Regulations

Laws and regulations around controlled substances can evolve. It’s vital to stay informed about any changes in the legal status of psilocybin or its potential therapeutic applications in the UK.

Conclusion

While the therapeutic potential of psilocybin is promising, it remains a controlled substance in the UK. Those interested in its benefits should approach the topic with caution, always prioritising legal considerations and consulting with healthcare professionals. By staying informed and adhering to regulations, individuals can navigate this complex landscape safely and responsibly.

Esketamine mechanism of action

The exact mechanism by which esketamine works to relieve depression symptoms is not fully understood, but it is thought to involve changes in brain chemistry and the activity of certain neurotransmitters.

One possible mechanism is that Esketamine works by inhibiting the reuptake of the neurotransmitter glutamate in the brain. Glutamate is involved in the regulation of mood and behavior, and inhibiting its reuptake leads to an increase in its concentration in the brain. This increase in glutamate is thought to be responsible for the rapid antidepressant effects of esketamine.

In addition to its effects on glutamate, esketamine is also believed to have an effect on other neurotransmitter systems in the brain, including dopamine and norepinephrine. It is not fully understood how these additional mechanisms contribute to the antidepressant effects of the drug.

The Role of Esketamine in a Comprehensive Depression Treatment Plan

Esketamine is typically reserved for patients who have not responded to other treatments for depression and is used on an as-needed basis in conjunction with regular therapy sessions. It is not intended to be used as a standalone treatment for depression, but rather as a part of a comprehensive treatment plan that may include other therapies such as cognitive-behavioral therapy, psychotherapy, and/or medication management.

The role of esketamine in a comprehensive depression treatment plan is to provide rapid symptom relief for patients who have not responded to other treatments. It is usually used in combination with other therapies in order to help patients achieve and maintain symptom improvement over the long-term. It is important for patients to work closely with their healthcare team to develop a treatment plan that is tailored to their specific needs and goals.

There are some exceptions to this rule, such as in the case of telemedicine, where a healthcare provider may prescribe controlled substances via a video call if certain conditions are met. However, the use of psychedelics for medical purposes is still highly regulated and not widely accepted.

One recent example of poor online prescribing practice is a story of a patient who was prescribed 75 doses of Ketamine in 5 minutes online which was then delivered to his house for under $300. Whilst providing access to low-cost medicine for patients is an ethical virtue of practice one should keep in mind that there is an online prescribing best practice which should be followed. This includes online prescribing risk analysis and subsequent mitigation which should be performed after each medicine is added to an online prescribing formulary.

However, if proper safeguards are in place there are a wide range of opportunities in the medical space, including:

• Psilocybin availability in the UK

If you would like more information concerning these opportunities you can contact one of our expert consultants here.