The Story: A trip down memory lane

History, relevance, and current position

The word psychedelic can be defined as a mental state characterized by a profound sense of intensified sensory perception, sometimes accompanied by severe perceptual distortion and hallucinations and by extreme feelings of either euphoria or despair (Psychedelic, 2020). Psychedelic substances have been referred to as entheogens. An entheogen is a psychoactive substance that induces a spiritual experience, aimed at personal development or sacred use (Korn, 2018). Humans have used entheogens for thousands of years, for example, Native Americans and peyote, Urarina shaman and ayahuasca, and indigenous Siberians and Amanita muscaria. In the 1960s and ’70s in the United States, psychedelic substances became part of the counterculture and were used irresponsibly and indiscriminately, ultimately leading to their criminalization and the shut down of research.

Current legislation around these substances is outlined in the Controlled Substances Act and the Comprehensive Drug Abuse Prevention and Control Act of 1970. The Controlled Substances Act places all substances regulated under federal law into one of five schedules. The placement is dependent on medical use, the potential for abuse, and safety or dependence liability. Schedule I criteria are as follows: the drug has a high potential for abuse, the drug or other substance has no currently accepted medical use in treatment in the United States, and there is lack of accepted safety for use of the drug or other substance under medical supervision (Drug Enforcement Agency & U.S. Department of Justice [DEA & DOJ], 2017). Current schedule I hallucinogens include MDMA, LSD, DMT, Psilocybin, Peyote, and Mescaline. Marijuana is not a hallucinogen but is currently listed as a Schedule I.

In 1999 Ketamine became a Schedule III. The schedule change was proposed by the American Animal Hospital Association (AAHA), the American Veterinary Medical Association (AVMA), the American Association of Equine Practitioners (AAEP), and a practicing veterinarian (“Schedules of Controlled,”1999). The process to add, delete, or change the schedule of a drug can be done by any of the following: Drug Enforcement Administration (DEA), Department of Health and Human Services (HHS), the manufacturer of a drug, a medical society or association, a pharmacy association, a public interest group concerned with drug abuse, a state or local government agency, or an individual citizen (DEA & DOJ, 2017). Schedule I further specifies that all use is prohibited except within research and very limited medical purposes in scientific establishments that are directly under control of the government or specifically approved by them (Butt, King, & Nichols, 2013). The DEA is the agency that gives this approval. The decision to list LSD, psilocybin, MDMA, and other hallucinogens as Schedule I was not based on consideration of physical harm but rather the assumption that there were no medical benefits (Nutt, King, & Nichols, 2013). This is how drugs like opiates, with high abuse potential, managed to be schedule II instead of I. The criminalization and legal consequences of drug possession can be extreme and damage individuals and families (Nutt, King, & Nichols, 2013). Penalization of illegal drug possession continues to severely limit the neuroscientific research and the discovery of new treatments (Nutt, King, & Nichols, 2013).

The widespread perception that because a substance is classified as a Schedule I mean that it poses a significant risk to humans is still widespread among lawmakers and the general public. This perception is generally incorrect and current regulations are based on this misperception further inhibiting research (Nutt et al, 2013). In the United Kingdom, it is easier to study heroin than it is to study MDMA or psilocybin. If a researcher is able to gain the necessary approvals and licensing required for research, they would then be faced with the difficulty of obtaining the substance. Because these drugs are not manufactured by standard companies the cost of custom synthesis is often too high (Iserson, 2019). Furthermore, companies that can synthesize these drugs are often reluctant to do so because it requires extensive documentation, a controlled substance manufacturer’s license, controlled storage (Iserson, 2019). Gaining grants for the research of schedule I drugs is also difficult seemingly because of the perception of these substances. MAPS used MDMA to treat PTSD and demonstrated that 80% of patients showed benefits up to one year later opposed to 20% that received a placebo (Nutt et al, 2013). LSD demonstrated efficacy in the treatment of alcohol use disorder (Nutt et al, 2013). The ability to research these drugs and their mechanisms of action could lead to the development of new therapeutic treatment.

In 2018, the DEA opened a dedicated web portal to improve efficiency, security, and application speed for researchers who want to study Schedule I substances (“DEA Speeds Up,” 2018). The DEA administrator stated “Research is the bedrock of science… and we will continue to support and promote legitimate research with Schedule I controlled substances” (“DEA Speeds Up,” 2018). However, the significant legal, financial, and scientific barriers limitations to research still remain. There is a limited process for the review of scheduling at national and international levels. Nutt et al (2013) state that once a drug is classified under Schedule I, it becomes extremely difficult to research it, thus limiting any potential for medical discovery/use. There is no standard for moving drugs out of Schedule I after medical benefits have been found. This continues to limit the potential for research and treatment.

Additional scientific evidence for the use of the controlled substances could help decrease the stigma associated with their use and promote the controlled, therapeutic use (Andreae et al., 2016). Considering the ubiquitous and socially acceptable use/abuse of incredibly detrimental substances such as alcohol and tobacco, it raises concerns regarding the agendas beneath these policies. Current treatments for mental health and substance use disorders have mixed effectiveness. We should always be striving to develop new and improved treatment options to improve the outcomes for those who are suffering.

References

Andreae, M. H., Rhodes, E., Bourgoise, T., Carter, G. M., White, R. S., Indyk, D., … Rhodes, R. (2016). An Ethical Exploration of Barriers to Research on Controlled Drugs. The American journal of bioethics : AJOB, 16(4), 36–47. doi:10.1080/15265161.2016.1145282

DEA speeds up application process for research on schedule I drugs. (2018). Retrieved from https://www.dea.gov/press-releases/2018/01/18/dea-speeds-application-process-research-schedule-i-drugs

Drug Enforcement Agency & U.S. Department of Justice. (2017). Drugs of abuse, a DEA resource guide. Retrieved from https://www.dea.gov/sites/default/files/drug_of_abuse.pdf

Iserson, K. V. (2019). “Go Ask Alice”: The Case for Researching Schedule I Drugs. Cambridge Quarterly of Healthcare Ethics, 28(1), 168–177. https://doi-org.ezproxy1.lib.asu.edu/10.1017/S0963180118000518

Korn, L. (2018). Entheogens & Psychedelic Medicine [Lecture notes]. Retrieved from PESI, Inc.: https://catalog.pesi.com/viewer/classroom/3144435

Nutt, D. J., King, L. A., & Nichols, D. E. (2013). Effects of Schedule I drug laws on neuroscience research and treatment innovation. Nature Reviews Neuroscience, 14(8), 577–585. https://doi-org.ezproxy1.lib.asu.edu/10.1038/nrn3530

Psychedelic. (2020) In Dictionary.com Unabridged. Retrieved from https://www.dictionary.com/browse/psychedelic

Schedules of Controlled Substances: Placement of Ketamine into Schedule III, 21 CFR Part 1308 Federal Register. (1999). Retrieved from https://www.deadiversion.usdoj.gov/fed_regs/rules/1999/fr0713.htm