Ketamine

KEY TAKEAWAYS

  1. Unlike other psychedelics, ketamine has been available as a medicine (general anaesthetic) for decades. For this reason, it is on the World Health Organisation’s List of Essential Medicines. It is also used as an ‘off-label’ treatment for depression, anxiety and suicidal ideation in ketamine-infusion therapy clinics.
  2. There has been a proliferation of ketamine infusion therapy clinics throughout the US and to a lesser extent in Europe. These clinics may well become a prototype in the market, occupying a prime position to take advantage of future expansion into psilocybin and MDMA assisted-therapy, when these substances receive FDA and EMA approval. The sector is relatively unregulated and ketamine infusion therapy is often not combined with talk therapy.
  3. Esketamine, a subtype of ketamine, in the form of a nasal spray (Spravato) has been patented by Johnson & Johnson and has been approved for the treatment of TRD with accompanying suicidal ideation. The costs of Spravato are significantly higher than that of ketamine which has led the UK’s National Institute for Health and Care Excellence (NICE) and Health Canada to not approve it as a medicine.
  4. Ketamine is the only psychedelic substance, among those profiled in this report, to be the focus of clinical trials in Asia. In China, specifically, clinical trials are focused on ketamine as an intervention, to study the impact of ketamine on health conditions such as postnatal depression, autism in children and arthritis.

Ketamine was first synthesised in 1956 and is used most commonly in veterinary practice as an animal tranquilliser. It is also a human anaesthetic and a powerful psychoactive substance and is available in liquid-soluble form as ketamine hydrochloride. Ketamine was granted US FDA approval for medical use as a general anaesthetic and sedative back in 1970 and has been classified as ‘safe to use’ as an anaesthetic because it does not reduce blood pressure or compromise a patient’s respiratory system. Ketamine may be injected into the muscle (IM), passed through an intravenous (IV) drip, taken orally, or absorbed via an oromucosal (nasal) spray.

Clinical trials and research

Ketamine is the most widely studied psychedelic to date. Excluding studies that look at the anaesthetic effects of ketamine, there are 140 clinical trials of which 22 are phase III trials and 32 are phase IV trials. Phase IV trials observe the real-world application of approved medicines in large patient populations to monitor the effectiveness, after it has been approved. Ketamine has been shown to be effective, starting almost immediately and then for up to seven days or more, for a wide range of mental health disorders. The following is a list of conditions for which ketamine has potential therapeutic benefits based on clinical trials and academic studies conducted to date:

  • Depression, major depressive disorder (MDD), treatment-resistant depression (TRD), and bipolar disorder;
  • Suicidal ideation;
  • Anxiety;
  • Social anxiety for those with autism;
  • Substance misuse, including alcohol, cocaine, and opioid dependence;
  • Eating disorders such as anorexia nervosa;
  • Chronic pain;
  • Inflammation;
  • Cluster headaches/migraines; and
  • Symptoms of OCD.

In these 140 clinical trials, nearly 11,000 patients have been enrolled as of July 2021. Among the active trials are those investigating ketamine for the treatment of depression in veterans, ketamine for the treatment of depression in teenagers and late-life depression, and a head-to-head comparison of ketamine versus electroconvulsive therapy for depression. Some studies are taking place in China, Israel, the United Kingdom, Canada and Mexico; most studies however are being done in the US.

Legality of Ketamine worldwide

Ketamine is something of an outlier among the other psychedelics presented in this report in that it is not classified as a Schedule I drug. It is a Schedule III drug under the Controlled Substances Act in the US and is categorised as a Class B drug in the UK. The exception to this is in Singapore, where ketamine is classified as a Schedule I narcotic. 

Ketamine has been legal for medical use by medical professionals and veterinarians for decades in most parts of the world. In 1985, ketamine was placed on the WHO List of Essential Medicines and is currently one of the most widely used sedatives in the world. 

A WHO expert committee has repeatedly recommended against placing ketamine on international controlled substance lists, as controlling the drug could make accessing it for medical purposes more difficult. In 2015, following the most recent review of its efficacy, the organisation stated ‘the medical benefits of ketamine far outweigh the potential harm from recreational use.’ The WHO has also stated that, in its view, ketamine does not pose a sufficient health risk to warrant scheduling under the 1961 and 1971 conventions.

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