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How Psychedelics Became The Next Wave

Feeling kind of blue? Experiencing intimacy issues or just plain anxious?  Help may be right around the corner in the form of legalized hallucinogens.

Ranging from plant drugs, like mushroom-derived psilocybin and cactus-derived peyote, to synthetics like Lysergic acid diethylamide (“LSD”) and Methyl​enedioxy​methamphetamine (“MDMA”), hallucinogens are increasingly used to treat recognized disorders, including depression, anxiety, and post-traumatic stress disorder (“PTSD”), and for wellness applications like enhancing emotional empathy, increasing feelings of closeness and promoting thoughtfulness and contemplativeness.‌

Although presently listed next to heroin on Schedule I of the Comprehensive Drug Abuse Prevention and Control Act of 1970, 21 U.S.C. §§ 801, Et. Seq(1970) (“Controlled Substance Act” or “Act”), hallucinogens path to commercial sales begins with removing criminality and the cities of Denver, Oakland, Santa Cruz, Portland, Chicago and Berkeley lead the nation’s psychedelics decriminalization efforts.

What Are Hallucinogens and How Are They Used

Divided into three drug sub-classes, “hallucinogens” are: (1) “dissociative” causing a sense of detachment and amnesia-like memory issues; (2) “psychedelics” producing trancelike states, hallucinations and altered consciousness; or (3) “deliriants” causing confusion and reduced impulse control.  “Psychedelics”, in turn, are comprised of naturally occurring plant drugs, like mushroom-derived psilocybin and cactus-derived peyote, or synthetics like LSD and MDMA (commonly known as Ecstasy or Molly).

Dissociative hallucinogens, like Ketamine, induce a trance-like state while providing pain relief and sedation and are used in intensive care to treat pain and depression.  Psychedelics, like LSD, induce altered thoughts, feelings, and hyper awareness of one’s surroundings and treat depression, anxiety, and drug dependence.

Some hallucinogens have traditional or shamanic uses like peyote, which, before becoming a federally protected usage for tribal peoples, was historically used to induce religious hallucinations.

Despite psychiatry’s increased interest in hallucinogens use, particularly LSD, during the 20th century, unpredictable side effects prevented hallucinogens’ wide-spread research or prescribing.

Hallucinogens Classifications

Consolidating laws regulating narcotics, stimulants, depressants, hallucinogens, and anabolic steroids’ manufacture and distribution, andthe chemicals used in these controlled substances’ illicit production, the Controlled Substance Act is the federal government’s foundation for fighting drug abuse.  If believing it constitutes a potential public danger, the Food and Drug Administration (“FDA”) places a drug on the Act’s “controlled substance list” which the Drug Enforcement Administration (“DEA”) then slots into an illicit drug category, called schedules (ranging from most restrictive, Schedule I, to the least, Schedule V), specifying conditions under which it can be legally used based on perceived legitimate medical value and potential public danger.

Schedule I is reserved for drugs having a high potential for abuse, no accepted medical value, and considered unsafe for use even under medical supervision.  21 U.S.C. §812(b)(1).  Based on these criteria, the DEA places most hallucinogens on Schedule I, but has approved approximately one thousand licenses for physicians, researchers and drug companies to handle for controlled medical and scientific research.

Although recognizing them as nonaddictive, the DEA offers only two explanations for hallucinogens’ Schedule 1 listing.  First, at the time of the Act’s passage and Schedules’ creation, based on the lack of research regarding potential danger, the FDA had already banned hallucinogens usage causing the DEA to automatically add them to Schedule I where they remain.  Second, as articulated by General Barry McCaffrey, the drug policy adviser under President Bill Clinton, hallucinogens are “gateway” drugs whose usage may lead to harder drugs experimentation, which, if kept off the streets, reduces the likelihood that users will move on to more dangerous addictive Schedule I drugs.

Psychedelics’ Medical and Wellness Application

Over the past year, the FDA both approved depression treatment drug Esketamine (making it the first “FDA approved” psychedelic) and conferred “breakthrough therapy” status on MDMA and psilocybin enabling fast-tracked research to study as a PTSD and major depression treatment, respectively.

Beyond showing promise as treatment for specific illnesses, FDA approval signifies potentially prescribing psychedelics to enhance the quality of life for those not suffering from any particular disorder.  Thus, if gaining PTSD treatment approval, psychiatrists could prescribe MDMA to improve intimate relationships’ quality based on research that MDMA enhances emotional empathy, increases feelings of closeness, and promotes thoughtfulness and contemplativeness.‌

Similarly, having shown “depression and anxiety treatment potential”, physicians could prescribe psilocybin to promote healthy individuals’ well-being. After Johns Hopkins researchers gave psilocybin to healthy participants with zero hallucinogen-use-history, nearly eighty percent (80%) reported “current sense of personal well-being or life satisfaction” increase ranging from “very much” to moderate for a duration exceeding 12 months.‌

Stated another way, although qualifying for “medical” use requires prescribing to treat a recognized disorder, medicine also encompasses interventions to promote healthy individuals’ well-being.  Regardless of whether patients meet a specific disorder’s diagnostic criteria, physicians presently prescribe stimulants to improve academic focus or minor tranquilizer to ease modern life’s ordinary stresses.

This “health and wellness” application requires a more sophisticated approach to minimizing psychotropic drugs’ risks akin to the FDA’s Risk Evaluation and Mitigation Strategies (“REMS”) used to promote the safe use of drugs that the FDA deem as posing special risks.  Rather than focusing on whether a drug is prescribed for a “legitimate medical purpose,” REMS can require physicians to register with the FDA and receive special training to prescribe the drug.   Risk management plans can stipulate that only those “certified” physicians dispense the drug in specific healthcare settings with a healthcare professional monitoring each patient using the drug.

Similar strategies could be used to mitigate any unique risks posed by psychedelics, without limiting their use by patients suffering from particular disorders.

Six Cities’ Psychedelic-Decriminalization-Efforts

Tracking cannabis’ legalization path to commercial sales, which began by removing its criminality, the cities of Denver, Oakland, Portland, Santa Cruz, Chicago, and Berkeley lead the nation in psychedelics’ decriminalization efforts through either city council action or ballot measures.

On May 7, 2019, Denver voters passed municipal code ordinance “Initiative 301, the Denver Psilocybin Mushroom Decriminalization Ballot Initiative” (“I-301”) making personal-use amounts of psilocybin mushrooms’ possession, use and cultivation Denver’s lowest law enforcement priority, prevents using city funds or resources to enforce laws imposing criminal penalties for psilocybin mushrooms’ personal use and possession, and directs the Mayor to appoint a “Psilocybin Mushroom Policy Review Panel” to assess and report on I-301 effects at the City Council’s first 2021 meeting.

On June 4, 2019, Oakland, California’s City Council decriminalized Schedule I listed “entheogenic plants” “adult use” including: “psilocybin, naturally occurring in entheogenic mushrooms”; “cacti that contain phenethylamine compounds such as mescaline”; “plants or combinations of plants such as ayahuasca that contain forms of DMT”; and “plants containing ibogaine”.  Oakland’s City Council deemed the plants to have medical applications for “substance abuse, addiction, recidivism, trauma, post-traumatic stress symptoms, chronic depression, severe anxiety, end-of-life anxiety, grief, diabetes, cluster headaches and other conditions.”

On February 3, 2020, Santa Cruz’ City Council unanimously approved a resolution making investigating and arresting people 21 and older for using, possessing or cultivating psychoactive plants and fungi among law enforcement’s lowest priorities.  While not legalizing natural psychedelics, the resolution does prohibit Santa Cruz from deploying resources to investigate or arrest for personal, but not commercial, usage, possession or cultivation.

In October 2019, a Portland, Oregon ballot initiative was submitted stipulating that no laws can be enacted prohibiting or regulating entheogenic plants and fungi’s possession, cultivation or distribution and prohibits use of city funds to assist in the enforcement of laws against personal possession and cultivation.  To qualify for the ballot, Decriminalize Nature Portland, the group behind the campaign, needs to collect 37,638 valid voter signatures.

Pursuant to an October 2019 introduced resolution to have the Department of Public Health explore natural psychedelics’ potential benefits in treating illnesses ranging from PTSD to drug addiction, Chicago’s City Council is considering whether to decriminalize “entheogenic” plants that contain psychoactive substances.  The resolution recommends that law enforcement reduce the pursuit of criminal cases involving organic psychedelics to “amongst the lowest priority.”

After it’s Council’s Public Safety Committee unanimously voted in favor of sending the resolution to a separate, health-focused panel, on November 21, 2019, the City of Berkley’s citizen-led commission held a hearing on a measure to decriminalize psychedelics, which, in turn, is scheduled for a 2020 vote.

Reprinted with permission from the March 19, 2020 edition of © 2020 ALM Media Properties, LLC. All rights reserved. Further duplication without permission is prohibited, contact 877-257-3382 or [email protected].

Steven SchainSteven Schain

Steven Schain

2019 National Law Journal “Finance, Banking, & Capital Markets Trailblazer” award winner, Steve Schain is Senior Counsel at Smart-Counsel, LLC, a 100% female owned boutique Cannabis law firm.  Steve  represents entities, governments and individuals in litigation, regulation and compliance, financial services, license applications and entity formation. Reach Steve at [email protected]

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