Breaking Historic Barriers to Ensure Psychedelic Therapy’s Future

Angela Terhune-Hargrove, MHA, Senior Director of Business Development, Elligo Health Research

Over 55 million adults in the United States are living with any mental illness (AMI). About 14 million suffer from serious mental illness (SMI).¹ However, the efficacy of existing treatments often falls far short of expectations, leaving patients and their loved ones teetering on the brink of hopelessness.²

Psychedelic therapy stands as a potentially transformative tool that can address the limitations of current medications and therapies. Research has shown psychedelics can alleviate a spectrum of mental health challenges, including anxiety, depression, post-traumatic stress disorder (PTSD), and substance use disorder.² For example, the nonprofit Multidisciplinary Association for Psychedelic Studies (MAPS) has had great success in its two Phase III MDMA therapy clinical trials for adults with PTSD. The studies found that patients who received the MDMA treatment showed “significant improvement over therapy with placebo when measured at two months after the last experimental session.”³ Another compelling case is ibogaine’s success in addressing opioid addiction. In a survey of opioid users who had undergone ibogaine treatment, a remarkable 80% of respondents reported that the treatment “eliminated or drastically reduced withdrawal symptoms,” and 30% attested to the complete elimination of opioid use post-treatment.⁴

But if psychedelics are so effective, why isn’t there more research into psychedelic treatments? Why aren’t they already approved and widely used? The answer partially lies in the past.

Are preconceived notions around psychedelics hindering innovation?

Drugs like psychedelics have a terrible reputation that can easily be related to federal laws and policies. In 1970, President Richard M. Nixon signed the Controlled Substances Act (CSA)—a landmark law that regulated specific drugs and substances and classified drugs into “schedules” based on their medical applications and abuse potential.5 Nixon then announced a “War on Drugs” in June of 1971, emphatically declaring drug abuse as “public enemy number one.”⁵ The 1980s witnessed the reinforcement and expansion of Nixon’s War on Drugs with First Lady Nancy Reagan’s “Just Say No” campaign.⁶ Surveys from the 1980s show that her campaign contributed to a notable increase in public concern regarding drugs. In 1985, less than 6% of Americans viewed drug abuse as the nation’s “number one problem.” By 1989, this percentage had skyrocketed to 64%.⁶

Nixon and the Reagans’ work fighting drug use in America did a great disservice to the future of psychedelic therapies by turning potentially lifesaving treatments into taboo substances.Because many still consider psychedelics to be unseemly and dangerous, industry pioneers face an uphill battle to get funding, enroll patients in trials, earn FDA approval, and one day, market their products. It will be difficult, but not impossible; especially if the industry stands together in support of these groundbreaking treatments.

4 critical industry actions to secure the future of psychedelic therapy

To overcome preconceived notions, optimize psychedelic therapy, and maximize the psychedelic patient experience, the industry should focus its efforts on four main tasks: education and training, setting safety standards, cultivating specialty research sites, and ensuring access for traditionally underserved communities.

Education and training

Educating both the public and the healthcare industry about the potential benefits and safety of psychedelics is paramount. By doing so, we can cultivate more openness and acceptance of these pioneering therapies. Societal resistance has been overcome before. Consider medical advancements like open heart surgery, Lasik, and even antibiotics—not too long ago they seemed daunting or inconceivable but now, with education and training, they’re commonplace.

Safety standards

To protect patients and future developments, we must set and solidify safety standards for psychedelic research and treatments. The FDA’s 2023 guidance on psychedelic research serves as a promising starting point, addressing critical aspects of safety in psychedelic trials such as the importance of on-site psychotherapists in every psychedelic treatment setting.⁷ Psychotherapists help patients comprehend their psychedelic experiences and offer the vital support required for integration after treatment. By incorporating psychotherapy sessions and post-treatment follow-ups into the study protocol, we can help safeguard a positive patient experience. Enshrining safety standards doesn’t just protect patients. Regulations also lend greater credibility to psychedelic therapy, thereby making it easier for developers to get essential funding and attention.

Specialty sites

Psychedelic therapy demands an optimal healing environment, making proper site selection integral to study success. Due to the oftentimes frightening or overwhelming nature of psychedelic treatment, sites should have an inviting, serene setting to help put patients at ease. Sites should also pay attention to specifics, as even the most minor detail can greatly impact patient experience and study success. Take specific entrances and covering mirrors as examples. These small steps can go a long way toward diminishing potential sources of anxiety or distraction in support of the patient’s experience and the trial’s overall success.

Access

We must make accessibility a priority, ensuring psychedelic treatments are readily available to everyone who needs or desires them, no matter their background or demographic.

A large part of this work is undoing the historic discrimination associated with Schedule I drugs and the Anti-Drug Abuse Act.5 Culturally informed research design is one possible strategy with the MAPS MDMA study again standing out as a prime example. The study team developed a site focused on a diverse treatment team, special informed consent documents, and engagement with communities of color.⁸

Another way to ensure minority access to psychedelic treatment and research is to use alternative recruitment methods. Racial, ethnic, and other minority groups often seek alternative providers for mental healthcare because they may not have the means for traditional psychological care or because of their cultural or religious beliefs.⁹ Alternative recruitment methods such as seeking referrals from general practitioners, psychological providers, and outpatient providers who accept forms of affordable care reduce these common barriers.

Embracing change to unlock hope

The potential of psychedelic therapy to revolutionize mental healthcare is undeniable. However, it is imperative to recognize and address the hurdles that have historically hindered its progress, from federal laws and societal stigma to racial disparities.

To move forward, we must focus on education, safety standards, and creating optimal environments for healing. Moreover, we must strive to dismantle the vestiges of discrimination and ensure equitable access. By doing so, we can unlock the transformative power of psychedelics, offering hope and healing to countless individuals who have long awaited more effective treatments for their mental health challenges.

Angela Terhune-Hargrove, MHA, senior director of business development, Elligo Health Research

References

1. Mental Illness. National Institute of Mental Health. Accessed 2023 Oct. 6.
2. REPS. CORREA, BERGMAN RE-LAUNCH BIPARTISAN CAUCUS TO EXPLORE PSYCHEDELIC RESEARCH FOR MENTAL HEALTH. Representative Lou Correa for California’s 46th District. Published 2023 March 2.
3. MAPS PBC Announces Positive Topline Results from Long-Term Observational Follow-Up Study on MDMA-Assisted Therapy for Treatment of PTSD. MAPS Public Benefit Corporation. Published 2023 April 5.
4. Davis, A., et al. Subjective effectiveness of ibogaine treatment for problematic opioid consumption: Short- and long-term outcomes and current psychological functioning. J Psychedelic Stud. Published 2017 Nov. 1.
5. War on Drugs. History.com. Accessed 2023 Oct. 6.
6. Just Say No. History.com. Accessed 2023 Oct. 6.
7. FDA Issues First Draft Guidance on Clinical Trials with Psychedelic Drugs. U.S. Food & Drug Administration. Published 2023 June 23.
8. Williams, M., et al. Diversity, equity, and access in psychedelic medicine. Journal of Psychedelic Studies. Published 2020 March 1.
9. Michaels, T.I., et al. Inclusion of people of color in psychedelic-assisted psychotherapy: a review of the literature. BMC Psychiatry. Published 2018 July 31.