Welcome to The Trip Report, a newsletter on the future of psychedelic medicine, legalization and the businesses, professions, policy, and issues that will come with it.

If you’re as obsessed with thinking about the emerging psychedelic space then you’ve come to the right place. If you’re new, welcome.

And please hit the ‘heart’ button above or the share button below if you have enjoyed receiving The Trip Report.

Share

Who is Responsible for Training Psychedelic Therapists?

I spend a lot of time thinking about careers, businesses, professions, sub-industries, and opportunities that are going to be required in order to grow psychedelic medicine.

A huge sub-industry in healthcare is education.

(No shit, dude.)

Continuing Ed

I mean continuing education, special training, credentialing, certifications.

The kind of training that might be required of, say, a social worker, therapist or psychiatrist in order to administer psychedelic-assisted therapy.

Virtually all healthcare professionals and increasingly more and more jobs and positions require some kind of certification, credentialing or training that is done by a third-party company.

A quick glance at the International Association for Continuing Education and Training indicates that architects, engineers, electricians, bankers, doctors, bus drivers, dental hygienists, IT professionals, lawyers, and daycare professionals all require some form of on-going education or certification.

The companies that offer these courses, credentials, and certifications can make a lot of money and the quality of such programs can range from the dregs of online-lecture-watching-followed-by-multiple-choice-test to an in-person technical training required to implant medical device delivered by a world-class surgeon

Share The Trip Report

One of the key Last Mile/First Mile issues for Psychedelic Medicine is training providers.

Holding space for someone undergoing ego-disillusionment and possibly reliving past trauma is a major responsibility and shoddy therapist training will translate into less effective results and possible adverse events.

Training needs to be thorough, but thorough training is expensive.

This week I had the chance to speak with a primary investigator for MAPS’ MDMA phase 3 trial. In reflecting on the conversation something struck me. Unlike most other forms of treatment, Psychedelic Assisted Therapy combines a compound in conjunction with a therapeutic relationship and the people who seek to provide Psychedelic Assisted Therapy will require training.

(Nothing novel there, dude.)

Risk Evaluation and Mitigation Strategy

But unlike most drugs, the FDA is sure to require an additional measure called Risk Evaluation and Mitigation Strategy (REMS) for MDMA, psilocybin and future psychedelic medicines.

“A Risk Evaluation and Mitigation Strategy (REMS) is a drug safety program that the U.S. Food and Drug Administration (FDA) can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks. REMS are designed to reinforce medication use behaviors and actions that support the safe use of that medication. While all medications have labeling that informs health care stakeholders about medication risks, only a few medications require a REMS.”

Only 57 out of 20,000 FDA approved drugs require a Risk Evaluation and Mitigation Strategy (REMS).

The requirements for a REMS program is unique to each drug. They can be as simple as additional information communicated to the patient in the form of a brochure or information that the drug manufacturer makes available to the prescriber or dispenser.

Other REMS programs, and presumably what MAPS, USONA and COMPASS will have to develop will be more elaborate, require dedicated training and credentialing and are called Elements to Assure Safe Use (ETASU). These are requirements that a clinic or setting must satisfy and advanced training and credentialing that providers must attain before administering.

The companies that bring a drug to market are responsible for REMS programs. But they can hire contractors to create and deliver REMS programs. This is where I see the starting point of a training, certification and credentialing sub-industry for psychedelic medicine.

Not So Straightforward with Psychedelics

Here’s the thing with psychedelics; the studies and the intervention require a therapist to be involved with the treatment in a unique way.

The therapist is part of the treatment.

Most REMS are not part of the therapy itself, they are merely training to mitigate risk, offer additional education, or requirements that the patient’s name must be included in a register or database.

This relationship has been part of the protocols for MDMA and psilocybin. Therapists who seek to do this work will be required to undergo training in order to administer treatment.

Here’s what I am wondering:

What, if any, is the difference between therapist training and required REMS training? What conflicts arise for the manufacturer if they are responsible for training that is part of the intervention? If a therapist or clinician has received training, say through MAPS, will they need to undergo training from USONA and Compass in order to administer psilocybin? Or will someone who has gone through USONA’s REMS be required to complete COMPASS’? If a REMS program replaces current therapist training programs who bears the cost? The manufacturer or the provider? The research that has been generating promising results includes psychotherapy. How much flexibility will there be to scale back the required psychotherapy hours if this is part of a REMS program? Can group therapy be offered or will it require another entire drug development cycle?

Share

Group therapy and reducing the required therapy hours is where a lot of people see cost savings and making psychedelic medicine more accessible to uninsured, underinsured, and those who can’t afford what could be a $20,000 treatment.

If training to become an approved/certified psychedelic-assisted therapist is done through an FDA sanctioned REMS program do we lose the flexibility to be creative with how this medicine is delivered and therefore who can access it?

I suppose we’ll find out.