The Medicines (Deep Dives) – PSYCH: The Psychedelics as Medicine Report 2nd Edition

Psilocybin

• Legality: The UN Convention on Psychotropic Substances (the ‘Vienna’ Convention), 1971, identifies psilocybin as a Schedule 1 substance, a category of illicit drugs deemed to offer no medical benefit and with a high potential for abuse³³.
• Mechanism: Psilocybin is a 5-Ht2a agonist, which means it can promote serotonin activity in the human brain and possibly also disrupt dysfunctional brain connectivity, thus offering a potent new alternative for the treatment of a wide variety of neurological and mental health conditions³⁴.
• Key Insight: Academic studies conducted in the US and the UK using psilocybin with accompanying psychological support demonstrated rapid and long-lasting positive effects on patients suffering from depression and anxiety³⁵. In one study the positive effects were still evident up to four and a half years later³⁶.

LSD (Lysergic Acid Diethylamide)

• History: LSD-25 is a psychoactive substance first synthesised in 1938 by Dr Albert Hofmann, the same person to first synthesise psilocybin (Indocybin)³⁷. As early as the 1960s, LSD was proposed as a treatment for neuroses, including schizophrenia, as well as for alcohol and narcotic addiction and to ease the suffering of terminally ill cancer patients³⁸.
• Research Highlight: Researchers at the Eleusis Benefit Corporation in New York are seeking to leverage the anti-inflammatory effect of low doses of LSD to stave off Alzheimer’s disease³⁹. The company so far has been successful in stage I clinical trials, which demonstrated the safety of doses up to 20 micrograms in geriatric populations⁴⁰.

Ketamine

• Status: Unlike other psychedelics, ketamine has been available as a medicine (general anaesthetic) for decades⁴¹. It is also used as an ‘off-label’ treatment for depression, anxiety and suicidal ideation in ketamine-infusion therapy clinics⁴².
• The Clinic Model: There has been a proliferation of ketamine infusion therapy clinics throughout the US and to a lesser extent in Europe⁴³. 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 approval⁴⁴.

MDMA

• Classification: MDMA is not regarded as a classic psychedelic. It is an outlier among the other substances profiled in this report as its use is not generally associated with hallucinations, and it has a high potential for abuse, unlike the other psychedelics profiled⁴⁵.
• Therapeutic Potential: MDMA-assisted psychotherapy for the treatment of PTSD received Breakthrough Therapy Designation from the US FDA in 2017. Phase III clinical trials are underway in the US and Europe and licensing approval is expected as early as 2022⁴⁶.

Ibogaine

• Legal Status: Ibogaine is not listed as a scheduled substance on the UN International Narcotics Control Board’s (INCB) Green List Psychoactive Substances under International Control⁴⁷.
• Medical Application: Ibogaine has the potential to decrease a patient’s misuse of stimulants, opiates and alcohol, and reduces symptoms of withdrawal (from opiates) after the administration of a single dose⁴⁸. Ibogaine therapy can cost between US$5,000 and US$8,000 per course of treatment when paid for privately⁴⁹.