Psychedelics Investing 101: Past and Current Psychedelic Drug Clinical Studies

Psychedelics Investing 101: Past and Current Psychedelic Drug Clinical Studies

Previously, we have laid out some basic tips for investing in psychedelics stocks. We have explained the (long and arduous) clinical trials process – which is essential for drug licensing and commercialization.

As we continue our investor series to assist psychedelics investors in their due diligence, we turn to the actual clinical studies on these substances that have either already been completed or are currently underway.

Below is a breakdown of the psychedelic drugs currently under research, known and potential medical uses, past/current clinical studies, and details on the nature and number of such studies.

Ayahuasca

Ayahuasca is a plant-based psychedelic drug. It is brewed as a tea and is made from the leaves of the Psychotria viridis plant and the stalks of the Banisteriopsis caapi vine. It has been used for spiritual/religious purposes in both North and South America. The tea has significant hallucinogenic properties.

Potential medicinal uses:

Proponents of this plant-based psychedelic tout its potential for the treatment of PTSD, depression, anxiety, addiction and cancer. It may also be generally beneficial for brain health. DMT, an active ingredient in ayahuasca has neuroprotective/neurorestorative properties.

Ongoing or completed clinical studies:
 

  • Treatment-resistant depression (Phase II clinical trial, 2016) – A single dose of ayahuasca followed by assessment of changes in severity of depression involving a test population of 35 participants (sponsor: Universidade Federal do Rio Grande do Norte)
  • Treatment-resistant depression (2018) – A single dose of ayahuasca to patients with treatment-resistant depression along with a control group of healthy volunteers, changes in cortisol levels assessed
  • Substance dependence (2014) – Interviews with 13 therapists using ayahuasca for addiction therapy, two expert researchers, and 14 individuals who received ayahuasca therapy for substance abuse

Ibogaine

Ibogaine is another plant-based psychedelic drug, derived from the root of the iboga plant, an African herb. It has long been used for religious and ceremonial purposes in African cultures. It has also been used medicinally for a wide assortment of medical/health issues.

Potential medicinal uses:

Most research involving ibogaine centers around substance abuse. However, it has also been used anecdotally as a treatment for fever, flu, HIV/AIDS, high blood pressure and nerve disorders. Lower doses have been used as a general stimulant/tonic or to increase sex drive.

Ongoing or completed clinical studies:
 

  • Alcoholism (Phase II clinical trial, not yet recruiting) – Testing the efficacy of increasing doses of ibogaine as a treatment for alcoholism for a test group of 12 patients, follow-up weekly/monthly evaluations for one year (sponsor: University of São Paulo)
  • Methadone detoxification (Phase II clinical trial, not yet recruiting) – A group of 20 patients split into two test populations, with one receiving a lower dose of ibogaine (100 mg) and the other receiving ascending dosages (up to 600 mg) with monitoring of withdrawal symptoms (sponsor: International Center for Ethnobotanical Education, Research, and Service)
  • Opioid addiction (2017) – 30 patients received a single dose of ibogaine to treat either oxycodone or heroin addiction, half of the participants reported zero opioid use 30 days after treatment

Ketamine

Ketamine is a synthetic psychedelic drug first developed in 1963. It was originally used as an anesthetic or sedative, but medical applications have been extended into other areas. There are two forms of ketamine: R-ketamine (a non-hallucinogenic derivative) and S-ketamine (Esketamine), which can induce hallucinations at higher doses but has already been brought to market by Johnson&Johnson (brand name: Ketanest).

Potential medicinal uses:

Because of its anesthetic properties, use of ketamine has been extended to the treatment of severe pain as an alternative to opioids. Esketamine (Ketanest) is already being used for treatment-resistant depression.

Ongoing or completed clinical studies:

Because ketamine has always been legal for approved uses, much more research has already been done on ketamine. This amounts to hundreds of clinical studies and ~200 clinical trials, all the way up to Phase IV clinical trials (long-term studies on efficacy/side effects). All research on ketamine has centered around its existing usage to treat pain or more recent use of ketamine as a treatment for depression. More recent research on (non-hallucinogenic) R-ketamine has focused on depression.
 

  • Depression (R-ketamine, Phase I clinical trial, active) – Testing the safety/tolerance of an R-ketamine nasal spray on healthy subjects (sponsor: Jiangsu HengRui Medicine Co., Ltd)

Lysergic Acid Diethylamide (LSD)

LSD is one of the first synthetic psychedelic drugs to have been created, in 1938, by Swiss chemist Albert Hoffman. But Hoffman didn’t discover its psychoactive/hallucinogenic properties until 1943 – by accident. Made (in)famous by 1960’s cultural renegade, Timothy Leary, LSD has been strictly prohibited as a Schedule 1 narcotic for several decades.

Potential medicinal uses:

Pre-Prohibition (1950 – 1965), there was medical experimentation using LSD as a treatment for assorted mental illnesses and disorders including schizophrenia, OCD, depression, autism, and even some use for “sexual perversions”. More recently, formal research has centered around its potential to treat depression, anxiety and cluster headaches. It’s also seen as a potential substance abuse therapy. Recreationally, the (illicit) micro-dosing of LSD has become a growing trend – especially in Silicon Valley – where it is believed to do everything from boosting productivity/creativity to general mood enhancement and well-being.
 

Ongoing or completed clinical studies:

There has been an explosion in new research into medicinal applications for LSD, with over 100 clinical studies either completed, underway, or currently recruiting patients. Among the most advanced research are four Phase II clinical trials, all at the recruiting stage.
 

  • Alzheimer’s Disease (Phase I clinical trial, complete) – A safety/tolerance trial administering micro-doses of LSD to Alzheimer’s patients, in preparation for testing the efficacy of LSD to treat Alzheimer’s (sponsor: Eleusis Ltd.)
  • Adult ADHD (Phase II clinical trial, recruiting) – Evaluating the efficacy of micro-doses of LSD as a treatment for adult (sponsor: University Hospital, Basel, Switzerland) (collaborator: MindMed Inc CAN:MMED / US:MMEDF)
  • Cluster headaches (Phase II clinical trial, recruiting) – A trial of 30 patients who suffer chronic or episodic cluster headaches, receiving three 100-µg doses of LSD to determine if it will either abort attacks or reduce frequency/intensity (sponsor: University Hospital, Basel, Switzerland) (collaborator: MindMed Inc CAN:MMED / US:MMEDF)
  • Major depression (Phase II clinical trial, recruiting) – Two moderate-to-high doses of LSD (100-µg or 200-µg doses) will be administered to 60 patients, including a placebo group who will receive low doses of LSD to test efficacy as a depression treatment (sponsor: University Hospital, Basel, Switzerland)
  • Anxiety disorders (Phase II clinical trial, recruiting) – A study to determine the effectiveness of single doses of LSD to alleviate anxiety disorder, with 40 patients (including control group) receiving either two high doses of LSD (200 µg) or two placebo sessions (sponsor: University Hospital, Basel, Switzerland)

Methylenedioxymethamphetamine (MDMA)

More commonly known by its street-drug name “ecstasy” (and a host of other nicknames), MDMA was actually created back in 1912 as an input in the creation of other pharmaceuticals. Its psychoactive properties weren’t discovered until much later. By the 1980s, it had become a popular street drug and the drug-of-choice for nightclubs and millennial “raves”, despite being strictly prohibited as a Schedule 1 narcotic.

Potential medicinal uses:

Because of the purported relaxation and feeling of well-being that accompanies the use of MDMA, scientific research is exploring the potential of this psychedelic drug to treat PTSD, anxiety and depression (as part of psychotherapy), as well as pain/anxiety relief among terminally-ill cancer patients and even addiction therapy.

Ongoing or completed clinical studies:

Over 80 clinical studies on medicinal applications of MDMA are either underway or completed. A total of 15 Phase II clinical trials involving MDMA have now been completed. Most of this research is on PTSD. The most advanced studies are two Phase III trials of MDMA for the treatment of PTSD. In 2017, the UK commenced the first clinical study of MDMA as a treatment for alcohol addiction.
 

  • PTSD (Phase III clinical trial, active) – A broader trial involving ~100 participants over a 12-week treatment period of psychotherapy, with participants receiving 80 mg to 180 mg of MDMA in three treatment sessions, preceded by three preparatory therapy sessions (sponsor: MAPS)
  • PTSD (Phase III clinical trial, not yet recruiting) – similar to previous study (sponsor: MAPS)

N-Dimethyltryptamine (DMT)

More commonly known as dimethyltryptamine, DMT is a powerful psychedelic hallucinogen. It is prohibited as a Schedule 1 narcotic by both the U.S. and United Nations although it is only Schedule 3 In Canada and “Class A” in the UK. DMT is unique in that it has multiple plant and animal sources (including humans). First synthesized in 1931, its psychoactive effects weren’t “discovered” until 1956 although religious/ritual use in South America dates back nearly a millennium (in the form of ayahuasca).

Potential medicinal uses:

DMT induces a shorter “trip” than other psychedelics, yet despite this benefit surprisingly little clinical research has taken place on this drug. Like other psychedelics, it is believed to have potential medicinal benefit in applications such as depression, anxiety and substance abuse.

Ongoing or completed clinical studies:
 

  • Safety and tolerance (Phase I clinical trial, not yet recruiting) – 30 healthy participants will receive doses ranging from 0 mg (placebo) to 115 mg in a basic assessment of safety and tolerance, investigating the subjective and autonomous effects (sponsor: University Hospital, Basel, Switzerland) (collaborator: MindMed Inc CAN:MMED / US:MMEDF)

Psilocybin

Psilocybin is a natural psychedelic compound that is found in more than 100 species of mushrooms. It’s what puts the “magic” in “magic mushrooms”. It is a hallucinogenic psychedelic that is classified as a Schedule 1 narcotic in the U.S. and UN, Schedule 3 in Canada, and Class A in the UK. Albert Hoffman also played a prominent role in bringing psilocybin to the attention of Western culture. Hoffman began synthesizing psilocybin in the late 1950s.

Potential medicinal uses:

Like LSD, the medical and scientific community now sees psilocybin as having medicinal properties that could apply to a wide array of health conditions, primarily mental health disorders. Proponents of psilocybin see potential in the treatment of depression, anxiety, addiction, OCD, PTSD, migraines/cluster headaches, anorexia, bipolar disorder and even general inflammation.

Like LSD, psilocybin is now being embraced (at the micro-dose level) as purportedly providing a wide assortment of health & wellness benefits. Like LSD, psilocybin micro-dosing has a strong following in Silicon Valley.
 

Ongoing or completed clinical studies:

Nearly 50 clinical studies involving psilocybin are completed or underway, this includes over two dozen Phase I and Phase II clinical trials. Phase 1 clinical trials have focused on depression, OCD, anorexia, and migraines/cluster headaches. In addition to these treatment areas, Phase 2 trials have also addressed substance abuse treatment.

Notable Phase II trials include:
 

  • Major depressive disorder (Phase II clinical trial, recruiting) – A total of 80 participants including the placebo control group will receive a 25 mg oral dose of psilocybin under the supervision of two Facilitators assessing the efficacy of psilocybin to alleviate symptoms (sponsor: Usona Institute)
  • Alcohol addiction (Phase II clinical trial, recruiting) – A six-week study involving 60 participants receiving weekly therapy sessions to assess the immediate efficacy of psilocybin in treating alcohol use disorder along with two follow-up surveys (sponsor: University of Zurich)
  • Cocaine-related disorders (Phase II clinical trial, recruiting) – An open-ended study to examine the potential of psilocybin to impact everything from cocaine use to criminal behavior with a test population of 40 participants (sponsor: University of Alabama)
  • Treatment-resistant depression (Phase II clinical trial, recruiting) – This will be a dose-ranging study on a population of 216 participants to study the effects of psilocybin on treatment-resistant depression, fast-tracked by the FDA as a “breakthrough therapy” (sponsor: Compass Pathways)
  • Chronic cluster headaches (Phase II clinical trial, recruiting) – A sample of 20 patients with chronic cluster headaches (CCH) will receive low doses of psilocybin prophylactically spread across three visits, spaced at one-week intervals, with participants assessed for one year following treatment (sponsor: Gitte Moos Knudsen)
  • Bipolar disorder (Phase II clinical trial, not yet recruiting) – The study will administer 25 mg doses of psilocybin to 12 participants suffering from Type 2 Bipolar Disorder for an assessment of efficacy (sponsor: Sheppard Pratt Health System) (collaborator: Compass Pathways)

A Psychedelics Revolution is currently underway in our societies, in part due to changing social attitudes.
 

But this Revolution is also being driven by medical need and economic imperatives. Mental health issues could cost the global economy as much as $16 trillion by 2030. Current medical options to treat many of these conditions are grossly inadequate.

These dynamics have sparked an explosion in psychedelics-based research. To prosper in this emerging sector, investors will need to keep on top of these clinical studies and drug trials.
 

Published at Thu, 09 Jul 2020 06:00:00 +0000