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Home»Mental Health»Psilocybin legislation helps psychedelic drugs make comeback – drug researcher explains challenges
Mental Health

Psilocybin legislation helps psychedelic drugs make comeback – drug researcher explains challenges

healthtostBy healthtostAugust 6, 2024No Comments6 Mins Read
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Psilocybin Legislation Helps Psychedelic Drugs Make Comeback – Drug Researcher
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A business manager finds relief from her depression with the help of psilocybin, the primary psychoactive ingredient in ‘magic mushrooms’. A veteran conquers post-traumatic stress disorder through treatment using MDMA, a synthetic compound known on the street as “ecstasy” or “moly.” A stay at home mom tries LSD, otherwise known as acid, for her anxiety.

Almost every day there are stories like this about the healing potential of psychedelic drugs.

These stories reflect the so-called “psychedelic revival“of the moment — a new interest in drugs most often associated with the counterculture of the 1960s, but now placed in therapeutic and not recreational purposes.

A handful of states, led by Oregon and Colorado, are leading the way in legalizing the use of various naturally occurring psychedelic compounds. in 2020, Oregonians passed Measure 109which legalized the supervised use of psilocybin and established a new system for its manufacture and consumption.

And in 2022 the Coloradans passed Proposition 122, the Natural Medicines for Health Act, which created a psilocybin program similar to Oregon’s. So far, Oregon and Colorado are the only states that have enacted such programs, but several other states are considering bills that would do so.

Like drug researcher, I have conducted interviews with psilocybin facilitators, service center owners, manufacturers, researchers, and policy makers in Oregon. My goal is to get their views on the pros and cons of their state’s model for legalizing psilocybin.

Oregon opened its first psilocybin treatment center in 2023.

Adult use, not for medical use

Oregon’s Measure 109 established a strict “adult use” program, meaning anyone age 21 and older can access psilocybin treatment without a medical diagnosis.

Under this program, consumers must purchase psilocybin through a state-licensed service center, where they must also consume it in the presence of a state-licensed intermediary. Facilitators are licensed through state-approved training institutions and do not need a specific medical background. Only natural psilocybin derived from mushrooms — unlike synthetic psilocybin that pharmaceutical companies like Compass Pathways are growing – be allowed. The first class of mediators graduated in the spring of 2023, and the first service center opened that summer.

The licensing process for facilitators not onerous — must have a high school diploma or equivalent and a relatively clean criminal record and must complete a 160-hour, state-approved training course that includes 40 hours of hands-on experience. This ease of licensure was by design: the architects of Measure 109 wanted to make room for people from diverse backgrounds to become facilitators. “Some people are amazing at what they do and school might not be the path for them,” one facilitator told me.

However, many service center owners and brokers feel that additional credentials or training would be helpful. One of my interviewees suggested that some courses in the required training could be taught by a psychiatrist or neurologist, as many clients who come for psilocybin services have existing mental health diagnoses and may already be taking a variety of psychotropic medications.

Studies have shown that psychedelic drugs can have positive clinical effects in patients with mental illness.

What does psilocybin cost?

As everyone I interviewed acknowledged, the primary problem with the Oregon model has to do with cost. It is estimated that the average route it costs about US$1,500. This includes $500-$2,000 for the moderator, $300-$600 for the room, and $150-$200 for the psilocybin itself. For more intensive facilitation at more expensive facilities, the cost can be over $5,000 per trip.

Part of the exorbitant cost lies in the initiation fees, which are substantial. The architects of Measure 109 wanted the state office of psilocybin services to be self-funding. As a result, annual license fees for intermediaries ($2,000 per year), service centers ($10,000 per year) and manufacturers ($10,000 per year) are relatively high. Special construction equipment and high taxes further increase costs.

All of this translates into higher prices for consumers, who they have not flocked to psilocybin service centers to the expected volume. The vast majority of psilocybin treatment clients come from out of statepossibly due to the fact that most Oregonians can easily obtain psilocybin at a lower cost outside of the legal market.

One service center owner told me, “We don’t have a really scalable or profitable model. It is very labor intensive on the part of the moderator. Investors usually want to make five times their money and don’t see how that can happen with the way the current industry is structured.”

Two moderators monitor the experiences of a subject taking psilocybin during a drug study at Johns Hopkins University.
Wikimedia, CC BY-SA

Other paths to legalization of psilocybin

The second state psilocybin program to go online will be in Colorado, where the Natural Medicine Health Law voted in 2022.

Currently, “natural medicine” for legal treatment only refers to psilocybin, but the act could be expanded in the future to include DMT, ibogaine and mescalineother naturally occurring psychedelic drugs.

Unlike Oregon’s program, which created a single permit facility, Colorado’s Bracket 122 establishes a tiered approach in facilitator licensure, with one track for those with clinical degrees and one for those without. Prop 122 also decriminalized the possession, use, cultivation, manufacture, and even sharing of natural medicines for “personal use.”

Other states have considered similar programs, but none have yet been passed. Two psychedelic accounts recently failed in California. In Arizona, Democratic Governor Katie Hobbs vetoed a bill in June 2024 that would allow psilocybin treatment and testing in the state. The bill was sponsored by Republican Senator TJ Shope.

For the most part, however, such bills have support on both sides of the aisle, a sign that state-level psilocybin legislation is likely to move forward in the coming years. This will happen alongside developments at the Food and Drug Administration, which has already approved multiple psychedelic drugs state of “revolutionary treatment”.a designation that speeds up the drug development and review process.

Developments at the FDA

The big pharmaceutical companies like Johnson & Johnson invest in the development of psychedelic drugs, but the fledgling industry is really driven by smaller market disruptors such as Compass and MindMedboth of which are seeking FDA approval for their own patented psychedelic formulations.

Many industry experts believe that the FDA will approve some psychedelic drugs, including synthetic psilocybin, in the following years. As the Oregon and Colorado programs operate only with natural substances, and as any FDA-approved psychedelics could likely only be prescribed by medical professionals, synthetic psilocybin will not be used in service centers under current law.

The development of the market for potentially FDA-approved psychedelics thus represents a parallel path to the psychedelic renaissance. Some of my interviewees predicted potential conflict between the state-level legalization path and that of FDA-approved drugs, but my research suggests that this conflict will not come to an end for many years.

challenges comeback drug drugs explains helps legislation Psilocybin psychedelic researcher
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