Policy considerations that support equitable access to responsible, accountable, safe, and ethical uses of psychedelic medicines

Affiliations

¹ United States Public Health Service, Germantown, MD, USA; Substance Abuse and Mental Health Services Administration (SAMHSA), Rockville, MD, USA; Pain and Palliative Care, NIH Clinical Research Center, Bethesda, MD, USA. Electronic address: sjbelouin@gmail.com.
² Menninger Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, Houston, TX, USA; US Department of Veterans Affairs, Michael E. DeBakey Veterans Administration Medical Center, Houston, TX, USA; Department of Psychiatry, Yale School of Medicine, New Haven, CT, USA; US Department of Veterans Affairs, National Center for PTSD - Clinical Neurosciences Division, Orange, CT, USA; Reason for Hope, New York, NY, USA.
³ Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, USA; Research, Health Policy and Abuse Liability, Pinney Associates, Bethesda, MD, USA.
⁴ Reason for Hope, New York, NY, USA; United States Army, Hallandale Beach, FL, USA; Uniformed Services University of the Health Sciences (UHSUS), Bethesda, MD, USA.
⁵ Office of Prevention Innovation, Center for Substance Abuse Prevention, SAMHSA, Rockville, MD, USA.
⁶ David Geffen School of Medicine at University of California (UCLA), Los Angeles, CA, USA; Division of Child and Adolescent Psychiatry, Harbor-UCLA Medical Center, Torrance, CA, USA.
⁷ Pain and Palliative Care, NIH Clinical Research Center, Bethesda, MD, USA.
⁸ Gender, Equity and Human Rights, World Health Organization (WHO), Geneva, Switzerland.
⁹ The Lundquist Institute, Harbor-UCLA Medical Center, Torrance, CA, USA.
¹⁰ University of California San Francisco (UCSF) Department of Psychiatry & Behavioral Sciences, San Francisco, CA, USA; University of California Berkeley Center for the Science of Psychedelics, Berkeley, CA, USA.

PMID: 35973601
PMCID: PMC9536012
DOI: 10.1016/j.neuropharm.2022.109214

Review

Policy considerations that support equitable access to responsible, accountable, safe, and ethical uses of psychedelic medicines

Sean J Belouin et al. Neuropharmacology. 2022.

. 2022 Nov 15:219:109214.

doi: 10.1016/j.neuropharm.2022.109214. Epub 2022 Aug 13.

Authors

Affiliations

¹ United States Public Health Service, Germantown, MD, USA; Substance Abuse and Mental Health Services Administration (SAMHSA), Rockville, MD, USA; Pain and Palliative Care, NIH Clinical Research Center, Bethesda, MD, USA. Electronic address: sjbelouin@gmail.com.
² Menninger Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, Houston, TX, USA; US Department of Veterans Affairs, Michael E. DeBakey Veterans Administration Medical Center, Houston, TX, USA; Department of Psychiatry, Yale School of Medicine, New Haven, CT, USA; US Department of Veterans Affairs, National Center for PTSD - Clinical Neurosciences Division, Orange, CT, USA; Reason for Hope, New York, NY, USA.
³ Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, USA; Research, Health Policy and Abuse Liability, Pinney Associates, Bethesda, MD, USA.
⁴ Reason for Hope, New York, NY, USA; United States Army, Hallandale Beach, FL, USA; Uniformed Services University of the Health Sciences (UHSUS), Bethesda, MD, USA.
⁵ Office of Prevention Innovation, Center for Substance Abuse Prevention, SAMHSA, Rockville, MD, USA.
⁶ David Geffen School of Medicine at University of California (UCLA), Los Angeles, CA, USA; Division of Child and Adolescent Psychiatry, Harbor-UCLA Medical Center, Torrance, CA, USA.
⁷ Pain and Palliative Care, NIH Clinical Research Center, Bethesda, MD, USA.
⁸ Gender, Equity and Human Rights, World Health Organization (WHO), Geneva, Switzerland.
⁹ The Lundquist Institute, Harbor-UCLA Medical Center, Torrance, CA, USA.
¹⁰ University of California San Francisco (UCSF) Department of Psychiatry & Behavioral Sciences, San Francisco, CA, USA; University of California Berkeley Center for the Science of Psychedelics, Berkeley, CA, USA.

PMID: 35973601
PMCID: PMC9536012
DOI: 10.1016/j.neuropharm.2022.109214

Abstract

There is mounting evidence suggesting psychedelic and entactogen medicines (namely psilocybin and 3,4-methylenedioxymethamphetamine [MDMA]), in conjunction with proper psychosocial support, hold the potential to provide safe, rapid acting, and robust clinical improvements with durable effects. In the US, both psilocybin and MDMA have been granted Breakthrough Therapy designations by the US Food and Drug Administration and may potentially receive full FDA approval with similar regulatory considerations occurring in multiple countries. At the same time, regulatory changes are poised to increase access to legal or decriminalized psychedelic use in various non-medical settings. This review provides a brief discussion on the historical use of psychedelic medicines, the status of the empirical evidence, and numerous significant policy considerations that must be thoughtfully addressed regarding standards-of-practice, consumer protection, engagement of communities, safeguarding access for all, and developing data standards, which supports the responsible, accountable, safe, and ethical uses of these medicines in clinical, faith-based, and other contexts. We provide suggestions for how public health and harm reduction can be supported through a public-private partnership that engages a community of stakeholders from various disciplines in the co-creation and dissemination of best practices and public policies.

Keywords: Hallucinogen; Harm reduction; MDMA; Policy; Psilocybin; Psychedelic.

Published by Elsevier Ltd.

PubMed Disclaimer

Conflict of interest statement

Declaration of competing interest Through Pinney Associates, JEH has consulted and/or are presently on the evaluation and regulation of pharmaceutical products including opioid and nonopioid analgesics, psilocybin, and other CNS acting products. SNX has been a consultant to Tonix Pharmaceuticals. LAA has served as a consultant, speaker, and/or on advisory boards for Guidepoint, Transcend Therapeutics, Beond, Source Research Foundation, Ampelis, and Reason for Hope. CSG serves on the Scientific Advisory Panel, Lobe Sciences. ALD serves on the advisory board of Wavepaths, a company that develops adaptive music technology for psychedelic therapy. In the past three years, BTA has conducted research supported by the NIH, the San Francisco VA, and the Steven & Alexandra Cohen Foundation; he has received consulting fees from Journey Colab. BTA is a member of an ayahuasca religion.

References

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Policy considerations that support equitable access to responsible, accountable, safe, and ethical uses of psychedelic medicines

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Policy considerations that support equitable access to responsible, accountable, safe, and ethical uses of psychedelic medicines

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Conflict of interest statement

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