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Journal of Science Policy & Governance
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Policy Memo
Reducing Research Harms: Analysis and Recommendations for Researching Schedule I Substances Under the HALT Fentanyl Act
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Alaina M. Jaster (1), Joseph Hennessey (2,3), Tanner Anderson (4), Anna Tsyrulnikov (5), Amartya Pradhan (6,7), Gina Giorgio (8), Elijah Z. Ullman (9)
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Keywords: research harms; controlled substances; scheduling; FDA; DEA
Executive Summary
Research on Schedule I substances in the United States remains heavily restricted by the regulatory structure imposed by the Controlled Substances Act (CSA). This regulatory system creates significant Research Harm, which can be defined as the restriction or deterrence of legitimate scientific inquiry arising from governmental actions, such as regulatory controls or criminal prohibitions that limit researchers’ access to or use of substances for scientific investigation. The barriers identified in this policy brief, including lengthy Drug Enforcement Administration (DEA) registration timelines, inconsistent
guidance, and confusion around policies, limit access to substances with emerging therapeutic potential such as psilocybin, MDMA, cannabis, and DOI. The 2025 HALT Fentanyl Act introduces important procedural improvements, such as expedited registration, shared institutional access, and limited allowances for synthesis, but leaves key issues in regulatory processes unresolved. To ensure scientific progress and protect public health, we recommend
further reforms, including revising interpretations of medical utility,, conducting periodic evidence reviews, and establishing a specific scheduling framework that allows easy access to substances for research.
guidance, and confusion around policies, limit access to substances with emerging therapeutic potential such as psilocybin, MDMA, cannabis, and DOI. The 2025 HALT Fentanyl Act introduces important procedural improvements, such as expedited registration, shared institutional access, and limited allowances for synthesis, but leaves key issues in regulatory processes unresolved. To ensure scientific progress and protect public health, we recommend
further reforms, including revising interpretations of medical utility,, conducting periodic evidence reviews, and establishing a specific scheduling framework that allows easy access to substances for research.
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Background header image courtesy of flickr.
Alaina M. Jaster, Ph.D., is a scientist and communications professional with expertise in translational neuropharmacology research and a passion for science-informed and evidence- based discourse. She received her Ph.D. in Pharmacology & Toxicology from Virginia Commonwealth University where work focused on the molecular targets and mechanisms of psychedelics and addiction. She is the co-founder of Psychedelic Brain Science, a podcast and website aimed at bringing together the intersections of research, policy, and clinical application related to psychedelics. Jaster is also the Co-Chair of the Science Policy Committee of Students for Sensible Drug Policy (SSDP) where she works on a variety of policy issues.
Joseph Hennessey is an MD/PhD student at the Medical College of Wisconsin studying the effects of psychedelics on cognitive flexibility following chronic stress. Joe is also an Early Career Policy Ambassador with the Society for Neuroscience and is Co-Chair of the Science Policy Committee for SSDP. As a part of these roles, Joe has advocated for federal funding for biomedical research with legislators, attended policy workshops, and testified at the United Nations Commission on Narcotic Drugs.
Tanner L. Anderson, Ph.D. is a neuroscientist and Postdoctoral Fellow in the Department of Psychiatry at Yale University. He received his Ph.D. in Neuroscience at the University of Kentucky, where he was awarded an NRSA F31 Fellowship award from the National Institute on Drug Abuse. His doctoral work focused on the physiological effects of psychedelics on synaptic plasticity and neuronal signaling in models of cognitive flexibility and cocaine use disorder. Currently, he studies the underlying neurobiology of psychedelics in models of post-traumatic stress disorder. Anderson is a member of the Science Policy Committee of SSDP.
Anna Tsyrulnikov is a Biomedical Sciences PhD candidate investigating the neural circuitry underlying opioid use disorder. Her research focuses on delineating the pathways that drive drug- seeking and aversive behaviors using rodent models. She is particularly motivated by advancing evidence-based drug policy and promoting public understanding of addiction science. Anna is the founder and president of the first and only SSDP chapter in South Carolina. Through this organization, she works to bridge the gap between scientific researchers and the broader community, increasing awareness of drug pharmacology and the neurobiological mechanisms of substance use disorders.
Amartya Pradhan, M.Sc., is a doctoral candidate at Emory University. His research with Dr. Jeffrey Markowitz at Georgia Institute of Technology and Emory University involves developing next-generation animal behavioral tracking tools and investigating how psychedelics modulate naturalistic behaviors in mice. During his master's work with Dr. Vidita Vaidya at the Tata Institute of Fundamental Research, Amartya explored the impact of early life adversity on the emergence of neuropsychiatric disorders and examined mechanisms by which psychedelics alleviate anxiety-like behaviors in rodent models. Alongside his academic pursuits, Amartya is passionate about scientific outreach and actively engages with the local Atlanta community to make neuroscience more accessible for everyone.
Gina Giorgio, MA is a drug policy strategist and advocate focused on psychedelic policy reform, evidence-based drug education, and expanding access to care. She serves as the Director of Strategy and Development at SSDP, where she helps lead federal and state efforts to advance compassionate, research-informed drug policies and support career pathways for young advocates. She is the Founder of the North Carolina Psychedelic Policy Coalition and serves on the boards of The Pearl Institute and the National Psychedelics Association, as well as the
Veteran Mental Health Leadership Coalition. She earned her M.A. in Communication from Wake Forest University, where she conducted the first content analysis of psychedelic portrayals in major U.S. newspapers. She is an appointed member of the NCIOM Task Force on Veterans Health, which aims to improve care access, workforce development, and behavioral health support for North Carolina veterans.
Elijah Z. Ullman, Ph.D. is a post-doctoral research fellow studying the structure, function, and activity of the NMDA Receptor and drugs to modulate it. He received his Ph.D. in Molecular and Systems Pharmacology from Emory University, working on the mechanisms of action for a series of modulators with numerous first-in-class features with therapeutic potential for the NMDA Receptor. He is the former Chair and co-founder of the Science Policy Committee of Students for Sensible Drug Policy. He was a 2023 Washington Fellow of the American Society for Pharmacology and Experimental Therapeutics (ASPET). He will begin a one-year stint as an American Association for the Advancement of Sciences (AAAS) Legislative Branch Fellow in January 2026.
Joseph Hennessey is an MD/PhD student at the Medical College of Wisconsin studying the effects of psychedelics on cognitive flexibility following chronic stress. Joe is also an Early Career Policy Ambassador with the Society for Neuroscience and is Co-Chair of the Science Policy Committee for SSDP. As a part of these roles, Joe has advocated for federal funding for biomedical research with legislators, attended policy workshops, and testified at the United Nations Commission on Narcotic Drugs.
Tanner L. Anderson, Ph.D. is a neuroscientist and Postdoctoral Fellow in the Department of Psychiatry at Yale University. He received his Ph.D. in Neuroscience at the University of Kentucky, where he was awarded an NRSA F31 Fellowship award from the National Institute on Drug Abuse. His doctoral work focused on the physiological effects of psychedelics on synaptic plasticity and neuronal signaling in models of cognitive flexibility and cocaine use disorder. Currently, he studies the underlying neurobiology of psychedelics in models of post-traumatic stress disorder. Anderson is a member of the Science Policy Committee of SSDP.
Anna Tsyrulnikov is a Biomedical Sciences PhD candidate investigating the neural circuitry underlying opioid use disorder. Her research focuses on delineating the pathways that drive drug- seeking and aversive behaviors using rodent models. She is particularly motivated by advancing evidence-based drug policy and promoting public understanding of addiction science. Anna is the founder and president of the first and only SSDP chapter in South Carolina. Through this organization, she works to bridge the gap between scientific researchers and the broader community, increasing awareness of drug pharmacology and the neurobiological mechanisms of substance use disorders.
Amartya Pradhan, M.Sc., is a doctoral candidate at Emory University. His research with Dr. Jeffrey Markowitz at Georgia Institute of Technology and Emory University involves developing next-generation animal behavioral tracking tools and investigating how psychedelics modulate naturalistic behaviors in mice. During his master's work with Dr. Vidita Vaidya at the Tata Institute of Fundamental Research, Amartya explored the impact of early life adversity on the emergence of neuropsychiatric disorders and examined mechanisms by which psychedelics alleviate anxiety-like behaviors in rodent models. Alongside his academic pursuits, Amartya is passionate about scientific outreach and actively engages with the local Atlanta community to make neuroscience more accessible for everyone.
Gina Giorgio, MA is a drug policy strategist and advocate focused on psychedelic policy reform, evidence-based drug education, and expanding access to care. She serves as the Director of Strategy and Development at SSDP, where she helps lead federal and state efforts to advance compassionate, research-informed drug policies and support career pathways for young advocates. She is the Founder of the North Carolina Psychedelic Policy Coalition and serves on the boards of The Pearl Institute and the National Psychedelics Association, as well as the
Veteran Mental Health Leadership Coalition. She earned her M.A. in Communication from Wake Forest University, where she conducted the first content analysis of psychedelic portrayals in major U.S. newspapers. She is an appointed member of the NCIOM Task Force on Veterans Health, which aims to improve care access, workforce development, and behavioral health support for North Carolina veterans.
Elijah Z. Ullman, Ph.D. is a post-doctoral research fellow studying the structure, function, and activity of the NMDA Receptor and drugs to modulate it. He received his Ph.D. in Molecular and Systems Pharmacology from Emory University, working on the mechanisms of action for a series of modulators with numerous first-in-class features with therapeutic potential for the NMDA Receptor. He is the former Chair and co-founder of the Science Policy Committee of Students for Sensible Drug Policy. He was a 2023 Washington Fellow of the American Society for Pharmacology and Experimental Therapeutics (ASPET). He will begin a one-year stint as an American Association for the Advancement of Sciences (AAAS) Legislative Branch Fellow in January 2026.
References
- Advisory Council on the Misuse of Drugs. 2023. ACMD Consideration of Barriers to Research Part 2: Schedule 1 Controlled Drugs. https://www.gov.uk/government/publications/consideration-of-barriers-to-research-part-2/consideration-of-barriers-to-research-part-2-schedule-1-controlled-drugs-accessible-version.
- Andreae, M. H., E. Rhodes, T. Bourgoise, G. M. Carter, R. S. White, D. Indyk, H. Sacks, and R. Rhodes. 2016. “An Ethical Exploration of Barriers to Research on Controlled Drugs.” American Journal of Bioethics 16 (4): 36. https://doi.org/10.1080/15265161.2016.1145282.
- Barnett, B. S., M. F. Vest, M. S. Delatte, F. King IV, E. E. Mauney, A. J. Coulson, S. M. Nayak, P. S. Hendricks, G. R. Greer, and K. S. Murnane. 2025. “Practical Considerations in the Establishment of Psychedelic Research Programs.” Psychopharmacology 242 (1): 27–43. https://doi.org/10.1007/S00213-024-06722-6.
- Belouin, S. J., and J. E. Henningfield. 2018. “Psychedelics: Where We Are Now, Why We Got Here, What We Must Do.” Neuropharmacology 142: 7–19. https://doi.org/10.1016/j.neuropharm.2018.02.018.
- Booker, Cory. 2025. “Booker Statement on Vote Against HALT Fentanyl Act.” Press release, March 14, 2025. https://www.booker.senate.gov/news/press/booker-statement-on-vote-against-halt-fentanyl-act.
- Braun, R. L. 1991. “Controlled Substances Act of 1990.” Campbell Law Review 13: 365.
- Cameron, L. P., A. M. Jaster, R. Ramos, and E. Z. Ullman. 2025. “The Utility of DOI for the Study of Serotonin 2A and 2C Receptors.” Molecular Pharmacology 2025; 108. https://doi.org/10.1016/j.molpha.2025.100093.
- Chapman, A., M. Xu, M. Schroeder, et al. 2025. “Substructure-Specific Antibodies Against Fentanyl Derivatives.” ACS Nano 19 (3): 3714–3725. https://doi.org/10.1021/acsnano.4c14369.
- Cohen, Steve. 2026. Letter to Pam Bondi, Attorney General, U.S. Department of Justice, regarding rescheduling marijuana and HALT Fentanyl. March 27 2026. https://cohen.house.gov/sites/evo-subsites/cohen.house.gov/files/evo-media-document/letter-to-ag-bondi-and-dea-administrator-reschedule-and-halt_v2.pdf.
- Cummins, B & Swaminathan, S. 2026. “President Trump’s Fentanyl ‘Weapon of Mass Destruction’ Designation: A Misguided Escalation.” Students for Sensible Drug Policy, March 25, 2026. https://ssdp.org/blog/trumps-fentanyl-weapon-of-mass-destruction-designation-a-misguided-escalation/.
- “Denial of Petition to Initiate Proceedings to Reschedule Marijuana.” 2016. Federal Register 81: 53688.
- Flanagan, T. W., and C. D. Nichols. 2018. “Psychedelics as Anti-Inflammatory Agents.” International Review of Psychiatry 30 (4): 363–375. https://doi.org/10.1080/09540261.2018.1481827.
- Gabay, M. 2013. “The Federal Controlled Substances Act: Schedules and Pharmacy Registration.” Hospital Pharmacy 48 (6): 473–474. https://doi.org/10.1310/hpj4806-473.
- Gauvin, D. V., Z. J. Zimmermann, and T. J. Baird. 2018. “The Gold-Standard in Preclinical Abuse Liability Testing: It’s All Relative.” Journal of Pharmacological and Toxicological Methods 94 (Pt 2): 36–53. https://doi.org/10.1016/j.vascn.2018.08.001.
- Glennon, R. A., and M. Dukat. 2024. “1-(2,5-Dimethoxy-4-iodophenyl)-2-aminopropane (DOI): From an Obscure to Pivotal Member of the DOX Family of Serotonergic Psychedelic Agents—A Review.” ACS Pharmacology & Translational Science 7 (6): 1722–1745. https://doi.org/10.1021/acptsci.4c00157.
- Healey, N. 2025. “The Promise of Psychedelic Medicine in Psychiatry.” Nature Medicine. https://doi.org/10.1038/d41591-025-00062-4.
- Henningfield, J. E., J. Ashworth, D. J. Heal, and S. L. Smith. 2023. “Psychedelic Drug Abuse Potential Assessment for New Drug Applications and Controlled Substance Scheduling: A United States Perspective.” Journal of Psychopharmacology 37 (1): 33–44. https://doi.org/10.1177/02698811221140004.
- Henningfield, J. E., M. A. Coe, R. R. Griffiths, S. J. Belouin, A. Berger, A. R. Coker, S. D. Comer, et al. 2022. “Psychedelic Drug Abuse Potential Assessment Research for New Drug Applications and Controlled Substances Act Scheduling.” Neuropharmacology 218. https://doi.org/10.1016/j.neuropharm.2022.109220.
- Howard, A., J. C. Neill, A. K. Schlag, and C. Lennox. 2021. “Schedule 1 Barriers to Research in the UK: An In-Depth Qualitative Analysis.” Drug Science, Policy and Law 7. https://doi.org/10.1177/20503245211049313.
- Lampe, J. R. 2025. The Controlled Substances Act (CSA): A Legal Overview for the 119th Congress. https://crsreports.congress.gov.
- Lester Grinspoon, MD v. Drug Enforcement Administration. 1987. 828 F.2d 811 (1st Cir.).
- “Marijuana Scheduling Petition; Denial of Petition; Remand.” 1992. Federal Register 57: 10499.
- Marks, M. 2025. “Separation of Drug Scheduling Powers.” https://yalelawjournal.org/forum/separation-of-drug-scheduling-powers.
- McAllister, W. B. 2004. “The Global Political Economy of Scheduling: The International-Historical Context of the Controlled Substances Act.” Drug and Alcohol Dependence 76 (1): 3–8. https://doi.org/10.1016/j.drugalcdep.2004.02.012.
- Mikos, R. A. 2024. “Marijuana and the Tyrannies of Scheduling.” Fordham Law Review 93 (2): 473. https://ir.lawnet.fordham.edu/flr/vol93/iss2/4.
- Nichols, C. D. 2022. “Psychedelics as Potent Anti-Inflammatory Therapeutics.” Neuropharmacology 219. https://doi.org/10.1016/j.neuropharm.2022.109232.
- Nutt, D. 2015. “Illegal Drugs Laws: Clearing a 50-Year-Old Obstacle to Research.” PLOS Biology 13 (1): e1002047. https://doi.org/10.1371/journal.pbio.1002047.
- Nutt, D. J., L. A. King, and D. E. Nichols. 2013. “Effects of Schedule I Drug Laws on Neuroscience Research and Treatment Innovation.” Nature Reviews Neuroscience 14 (8): 577–585. https://doi.org/10.1038/nrn3530.
- Nutt, D. J., L. A. King, and L. D. Phillips. 2010. “Drug Harms in the UK: A Multicriteria Decision Analysis.” Lancet 376 (9752): 1558–1565. https://doi.org/10.1016/S0140-6736(10)61462-6.
- Palamar, J. J., and N. D. Fitzgerald. 2025. “The Epidemiology of Recreational Use and Availability of DOC and DOI in the United States.” Journal of Psychoactive Drugs. https://doi.org/10.1080/02791072.2025.2570937.
- Siegel, J. S., J. E. Daily, D. A. Perry, and G. E. Nicol. 2023. “Psychedelics Drug Legislative Reform and Legalization in the US.” JAMA Psychiatry 80 (1): 77. https://doi.org/10.1001/jamapsychiatry.2022.4101.
- Students for Sensible Drug Policy. 2025. “Trump’s Fentanyl ‘Weapon of Mass Destruction’ Designation: A Misguided Escalation.” December 2025. https://ssdp.org/blog/trumps-fentanyl-weapon-of-mass-destruction-designation-a-misguided-escalation/.
- U.S. Congress, House. 2026. Controlled Substances Act Clarification in Sciences Act of 2026 H.R.9186, 119th Cong., 2025-2026. https://www.congress.gov/bill/119th-congress/house-bill/9186.
- U.S. Department of Justice, Drug Enforcement Administration. 2022. Researcher’s Manual: An Informational Outline of the Controlled Substances Act.
- U.S. Department of Justice, Drug Enforcement Administration. 2025. In the Matter of Schedules of Controlled Substances: Placement of DOI and DOC in Schedule I. Docket No. 24-24.
- United States v. Hemani. 2025. Docket No. 24-1234. U.S. Supreme Court.
- van Dalen, H. P., and K. Henkens. 2012. “Intended and Unintended Consequences of a Publish-or-Perish Culture: A Worldwide Survey.” SSRN Electronic Journal. https://doi.org/10.2139/ssrn.1983205.
- Varshneya, N. B., S. H. Hassanien, M. C. Holt, et al. 2023. “Fentanyl Analog Structure-Activity Relationships Demonstrate Determinants of Diverging Potencies for Antinociception and Respiratory Depression.” Pharmacology Biochemistry and Behavior 226: 173572. https://doi.org/10.1016/j.pbb.2023.173572.
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ISSN 2372-2193
ISSN 2372-2193