Psychedelic Drug Therapy: Laying Out The Picture

There is a considerable buzz in the market concerning the brand-new psychedelics sector and emerging psychedelics companies.

The excitement is fueled by factoids such as these.

In a 2014 clinical study that used the hallucinogen known as psilocybin to treat nicotine addiction, researchers reported an abstinence rate of 80% after 6 months. This compares to a maximum abstinence rate of 35% for conventional treatments for nicotine addiction.

A 2017 study published in the American Journal of Drug and Alcohol Abuse on the use of the psychedelic drug ibogaine to treat opioid addiction reported that 50% of subjects had ceased opioid use for 30 days after a single dosage.

A 2016 study reported that 80% of terminally ill patients receiving psilocybin therapy experienced reduced depression and anxiety.

Another 2016 study on the use of psilocybin to treat depression reported that two-thirds (66%) of patients with “treatment-resistant depression” were in remission one week after a psilocybin therapy session.

A 2016 report by the Multidisciplinary Association for Psychedelic Studies (MAPS) focused on the use of MDMA to treat sufferers of PTSD. In a South Carolina study on female long-term sufferers of PTSD, 83% of patients receiving MDMA ceased to exhibit symptoms of PTSD (versus 25% who were given a placebo).

In turn, this excitement has translated into strong gains for a few of the public companies that have been early entrants to this space.
 
Are these new “miracle drugs”? Is this the next major trend in pharmaceuticals and healthcare?

The answer to the first question is “perhaps”, but with a major caveat. Consequently, it’s much too early to answer the second question.

Psychedelics are not cannabis.



Comparing the two is like comparing drinking lite beer with drinking hard liquor (straight).

Cannabis is a natural, non-toxic substance with relatively mild psychoactive properties. It has been demonized for many years as a “gateway drug” to harder drugs – harder drugs such as psychedelics.

We are more familiar with many of these psychedelics by their street-drug names: ecstasy (MDMA), acid (LSD), and magic mushrooms (psilocybin).

Are ecstasy, acid and magic mushrooms the next miracle drugs? Framed in that manner, it’s much more understandable why there is a need for caution – from both potential users of these substances and potential investors in these psychedelic drug companies.

These are hard drugs with significant psychoactive properties. Most of them are hallucinogens.

These substances are not self-administered in micro doses like cannabis. To date, ADHD is the only area of advanced medicinal research based around micro-dosing of psychedelics.

The results cited above are from heavy dosages of these psychedelics. They can only be administered by trained therapists who “guide” users on these 21st century psychedelic trips.

It’s Timothy Leary, 2020, but without the message to “tune in, turn on, drop out.”

Even the therapists themselves acknowledge that psychedelics therapy is “not for everyone”, as indicated in this March 2019 article from Vox.
 
The extraordinary therapeutic potential of psychedelic drugs, explained

…To understand the clinical side, I traveled to Johns Hopkins to sit down with Alan Davis, a clinical psychologist, and Mary Cosimano, a research coordinator and trained guide. Both help lead the psilocybin sessions at Hopkins.

Researchers at Hopkins have worked with a number of populations since they received approval from the FDA to study psilocybin in 2000 — healthy adults without any psychological issues, cancer patients suffering from anxiety and depression, smokers, and even seasoned meditators.

A key part of the process at Hopkins is what they call “life review.” Before they provide the drug, they want to know who you are, where you’re at in your life, and what kinds of emotional or psychological walls you’ve built up around yourself. The idea is to work with patients to determine what’s holding them back in their lives, and explore how they might overcome it.

Davis and Cosimano both say psilocybin has benefited every population they’ve worked with. “It’s not for everyone,” Cosimano told me, “but for the right person at the right time, it can be positively transformative.” (They don’t accept patients anywhere on the spectrum of psychosis — it’s just too dangerous.)

A November 2018 article from Quartz frames this therapeutic experience in more explicit terms.
 
Indeed, [Rick] Doblin and other psilocybin experts say it’s standard practice in all psychedelics research (which includes psilocybin, MDMA, and LSD), for therapists to have experience with the drug they’ve given to patients. Doblin explains that psilocybin therapy can be a terrifying experience. Patients experience the death of their ego, often fear that they’re dying, and confront disturbing features of themselves and reality. A therapist that has not experienced this themselves could well be frightened by the patient’s experience, says Doblin. Plus, it’s hugely valuable for patients to know that therapists have experienced similar and survived. [emphasis mine]

[Editor’s note: Rick Doblin is the head of the Multidisciplinary Association for Psychedelic Studies (MAPS), a U.S.-based psychedelic drug testing and advocacy organization]
Definitely not for everyone.

MindMed Inc. (CAN:MMED / US:MMEDF) claims to have overcome the problem of hallucinogenic side effects with its ibogaine derivative, 18-MC. MindMed is in a Phase 2 clinical trial to use 18-MC for the relief of opioid addiction, with promising results in its Phase 1 trial.

But even without the hallucinations, ibogaine is a powerful drug that frequently induces other serious and unpleasant side effects. A review of this drug at Drugs.com supplies additional details.
 
Adverse Reactions

Mild acute effects occur frequently and include nausea, vomiting, ataxia, tremors, headaches, and mental confusion. Manic episodes lasting 1 to 2 weeks have also been reported and manifested as sleeplessness, irritability, impulsivity, emotional lability, grandiose delusions, rapid tangential speech, aggressive behavior, and suicidal ideation.

Toxicology

Large doses of iboga [ibogaine] can induce agitation, hallucinations, vomiting, ataxia, muscle spasms, weakness, seizures, paralysis, arrhythmias, urinary retention, respiratory insufficiency, and cardiac arrest.

Definitely not for everyone, not even opioid addicts.

Then there is the cost. At $600 to $1,000 a session, psychedelic drug therapy will not be in the budget of most low-income patients.

While nicotine addicts range across the full economic spectrum, veterans with PTSD and those addicted to street narcotics tend to occupy the lowest economic rungs of society.

Without government subsidization and/or insurance coverage, many of the potential beneficiaries of psychedelic drug therapy may not be able to access this treatment.

Getting governments or insurance companies to pay for the therapeutic use of ecstasy, acid, and magic mushrooms (after 40 years of ‘War on Drugs’ programming) will not be an easy sell.

Societal acceptance is also a major question-mark. Cannabis use has been embraced by clear majorities in both the United States and Canada. But cannabis is mild and safe.

It will be much more difficult to win over the support of more conservative members of societies for medicinal therapies that require patients to go on “guided” hallucinogenic trips.

The commercial potential of psychedelics for a number of important medical health issues seems genuine. But these medical benefits occur in the context of therapies that are both intense and expensive.

There are strong societal biases against the consumption of these substances. And even without those biases, more conservative individuals (which includes politicians, regulators and insurance companies) will be very hesitant to legalize and/or finance such therapies.

In short, while psychedelics stocks have raced out of the starting blocks like many cannabis companies did 5 or 6 years ago, the journey to the finish line for psychedelics will (at best) be much longer than that of cannabis.

Caveat emptor.
 
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