EXECUTIVE SUMMARY

In the United States, half of all people will be diagnosed with a mental health disorder in their lifetime, and depression is the leading cause of years of life lost due to disability worldwide. Given the burden of mental health disorders, it is vital to explore all treatment options to improve population health. Although they are classified by the Drug Enforcement Administration as Schedule I substances—a designation reserved for drugs with no current accepted medical purpose and high abuse potential—psychedelics show significant promise in treating mental health disorders. This paper describes the current evidence for using psychedelics as a treatment for mental health disorders, explores the existing policy landscape and offers suggestions for future psychedelic policy.

A number of clinical trials have assessed the use of different psychedelics to treat a wide range of mental health disorders, including depression, post-traumatic stress disorder (PTSD) and substance use disorders. Most of these trials combine psychedelic doses with guided therapy, which is often referred to as psychedelics-assisted therapy. There are relatively few clinical trials that have reported outcomes on psychedelics-assisted therapy; however, the initial results are extremely promising. Clinical research combined with observational studies demonstrate the relatively low abuse potential and low toxicity of psychedelics, which makes them even more appealing as a therapeutic option.

Although more research into psychedelic-assisted therapy is needed to refine methodology, some jurisdictions are already legalizing or decriminalizing certain psychedelics. The most prominent example of this is in Oregon, which legalized the use of psychedelics for therapeutic use in 2020. Several cities have also legalized possession and use of psychedelics, with other states considering similar policies.

This paper sets out to familiarize policymakers with the existing body of research on psychedelics use for the treatment of mental health disorders. Additionally, the paper will highlight several factors for policymakers to consider when developing policies associated with psychedelic medicine. These factors include the need for more research into psychedelic medicine, the need to educate and increase the mental health workforce, and the need to ensure equity and access.

INTRODUCTION

Mental health disorders account for 7.4 percent of the global disease burden, translating to about 970 million cases and a global economic cost of $1 trillion per year. Individuals with mental health disorders often face significant stigma and marginally effective treatment options. Many current pharmaceutical treatments take upwards of seven weeks to become effective—if they do—and many people experience intolerable side effects that negatively impact treatment adherence. New treatments are needed to address the individual and societal toll of mental health disorders.

Despite the high need for new treatments, psychiatric pharmaceutical development has slowed significantly. Many of the recently introduced psychiatric pharmaceuticals constitute small changes to the chemical structure of existing drugs or revised methods of drug delivery. These changes rarely produce significant improvements in efficacy. Some researchers, however, are looking beyond the existing classes of psychiatric drugs. Psychedelics represent one new area of consideration for treating mental health disorders.

Western exploration of psychedelics began in the 1950s. Despite the positive finding of early psychedelics researchers, sensationalized media coverage and recreational use in the 1960s resulted in psychedelic drugs being classified as Schedule I by the Drug Enforcement Administration (DEA) and the United Nations Convention on Psychotropic Substances, a classification reserved for substances with no currently accepted medical use and high abuse potential. Schedule I substances are illegal to use or possess, making it difficult for researchers to obtain and study these substances and stifling research into the medical use of these substances.

It was not until the 1990s that clinical trials on the use of psychedelics for treating mental health disorders resumed. Initially, positive outcomes led the Food and Drug Administration (FDA) to classify both 3,4-Methyl​enedioxy​methamphetamine (MDMA or ecstasy) and psilocybin as “breakthrough therapies” in 2017 and 2019, respectively, allowing for an expedited drug development and approval process. As a result of publishing more clinical trials , interest in psychedelic medicine continues to grow. Although there is great optimism about psychedelic medicine, especially for the treatment of mental health disorders, psychedelic-assisted therapy researchers are still establishing best practices for delivering treatment. Furthermore, sound regulatory models and jurisdictional oversight are necessary to ensure patient safety once psychedelic medicine is ready for broad application.

This paper will describe the current state of psychedelics research for the treatment of mental health disorders, explain the policy landscape surrounding psychedelics and provide policy considerations for preparing for broad application of psychedelic-assisted therapy.

Press Release: A Long, Strange Trip: Psychedelic Use in the Treatment of Mental Health Disorders

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