Journal of Science Policy & Governance
  • Home
  • About
    • Leadership Team >
      • CEO
      • Operations Team
      • Editorial Board
      • Communications Team
      • Programs and Events Team
      • Evaluation and Analytics Team
      • Public Engagement​ and Development Team
      • Governing Board
      • Advisory Board
    • Partners
    • Sponsorships
  • Volumes
  • Submit to the Journal
  • Announcements
    • News
    • Blog
  • Resources
    • Writing
    • Science Policy Resources
    • Policy in action
    • Podcast

Policy Considerations for Psychedelics in Research and Medicine – What’s Next on the Schedule?

Journal of Science Policy & Governance
Volume 28, Issue 01 | July 6, 2026

Policy Analysis
Policy Considerations for Psychedelics in Research and Medicine – What’s Next on the Schedule?

Matthew A. Boehm (1), Oriana Mayorga (2)
  1. AAAS Fellowship Programs Inc., Washington, DC, USA
  2. Yale University, New Haven, CT, USA
​Corresponding author: [email protected]​
DowNLOAD PDF
Keywords: psychedelics; clinical research; drug policy; rescheduling; schedule I
https://doi.org/10.38126/JSPG280103​

Executive Summary

There is growing interest in psychedelic compounds such as psilocybin, 3,4-metheylenedioxymethamphetamine (MDMA), lysergic acid diethylamide (LSD), and dimethyltryptamine (DMT) given emerging research on potential uses as treatments for a variety of health conditions. The United States Food and Drug Administration (FDA) has granted multiple “Breakthrough Therapy” designations to various psychedelic drugs used as treatments for mental health conditions, including MDMA-assisted therapy for posttraumatic stress disorder, psilocybin and 5-MeO-DMT for treatment-resistant depression, and LSD for generalized anxiety disorder. However, most psychedelics remain classified as Schedule I under the US Controlled Substances Act (CSA) and are not yet FDA approved for medical use. The Schedule I classification is intended for substances with no accepted medical use and a high potential for abuse, and it carries the strictest federal regulations related to supply, access, distribution, and storage. Nonetheless, there is a growing body of evidence on the neurobiological mechanisms and therapeutic potential of Schedule I psychedelics and over 150 active clinical trials assessing the safety and efficacy of using psychedelics as treatments for various health conditions. There is also growing support from federal research agencies interested in potential medical applications of psychedelics, along with bipartisan activities in Congress and a wide variety of state- and local-level policy reforms. In addition, a recent Executive Order called for federal reforms to accelerate research and access to psychedelic drugs used in treatments for serious mental illness, including timely rescheduling by initiating reviews of relevant products upon successful completion of Phase 3 clinical trials. Rescheduling at the federal level could reduce costs and administrative barriers for legitimate uses of psychedelic drugs in research and medicine while maintaining necessary regulations to ensure safety and accountability of supply and access. This article outlines potential paths for rescheduling various Schedule I psychedelics given the emerging clinical applications. 
​

-Read the full article through download.-

DOWNLOAD PDF
<< Issue page
Next article >>

Background header image courtesy of istockphoto.

Matthew Boehm earned a PhD in neuroscience from Brown University in a partnership program with the National Institutes of Health and performed research at the National Institute on Drug Abuse (NIDA) in Baltimore, MD. After graduating, Matt volunteered in the NIDA Office of Science Policy & Communications and completed the Christine Mirzayan Science and Technology Policy Graduate Fellowship Program at the National Academies of Sciences, Engineering, and Medicine. He is currently an executive branch AAAS Science & Technology Policy Fellow in Washington, DC. All views expressed are personal opinions of the authors and do not represent official views of affiliations.

Oriana Mayorga earned an MDiv. in social ethics from Union Theological Seminary in 2022. After graduating, Oriana completed two residency programs in the Spiritual Care department at New York Presbyterian Hospital in Manhattan, New York. In her second year of residency, Oriana served as the chief 'lead' chaplain. She is currently an addiction chaplain fellow in an outpatient healthcare setting and a lecturer at Yale University. All views expressed are personal opinions of the authors and do not represent official views of affiliations.

References

  1. Adlin, B. 2025. “Marijuana’s Schedule I Status ‘Traps Researchers In A Paradox,’ Federally Funded Scientists Say.” Marijuana Moment, July 3, 2025. https://www.marijuanamoment.net/marijuanas-schedule-i-status-traps-researchers-in-a-paradox-federally-funded-scientists-say/.
  2. Arizona House of Representatives. 2025. “House Approves Funding for Ibogaine Research for Veterans with PTSD and TBI.” News release, March 4, 2025. https://www.azleg.gov/press/house/57LEG/1R/250304WILMETHHB2871.pdf.
  3. Armstrong, S. B., Xin, Y., Sepeda, N. D., Polanco, M., Averill, L. A., and Davis, A. K. 2024. “Prospective associations of psychedelic treatment for co-occurring alcohol misuse and posttraumatic stress symptoms among United States Special Operations Forces Veterans.” Military Psychology 36(2), 184–191.
    https://doi.org/10.1080/08995605.2022.2156200.
  4. Beckley Psytech. 2025. “Atai Life Sciences and Beckley Psytech Announce U.S. FDA Breakthrough Therapy Designation Granted to BPL-003, Underscoring its Potential in Treatment-Resistant Depression.” Beckley Psytech – Company Announcements, Oct 16, 2025. https://ir.ataibeckley.com/news-releases/news-release-details/atai-life-sciences-and-beckley-psytech-announce-us-fda/.
  5. Brown, T. K., and K. Alper. 2018. “Treatment of Opioid Use Disorder with Ibogaine: Detoxification and Drug Use Outcomes.” American Journal of Drug and Alcohol Abuse 44 (1): 24–36. 
    https://doi.org/10.1080/00952990.2017.1320802.
  6. California State Legislature. 2025. “Controlled Substances: Research. California Assembly Bill 1103.” LegiScan, October 10, 2025. https://legiscan.com/CA/text/AB1103/id/3227572.
  7. Cameron, L. P., Tombari, R. J., Lu, J., Pell, A. J., Hurley, Z. Q., Ehinger, Y., Vargas, M. V., McCarroll, M. N., Taylor, J. C., Myers-Turnbull, D., Liu, T., Yaghoobi, B., Laskowski, L. J., Anderson, E. I., Zhang, G., Viswanathan, J., Brown, B. M., Tjia, M., Dunlap, L. E., Rabow, Z. T., … Olson, D. E. 2021. “A non-hallucinogenic psychedelic analogue with therapeutic potential.” Nature, 589(7842), 474–479. https://doi.org/10.1038/s41586-020-3008-z.
  8. Canal, C. E. and Murnane, K. S. 2017. “The serotonin 5-HT2C receptor and the non-addictive nature of classic hallucinogens.” Journal of Psychopharmacology (Oxford, England), 31(1), 127–143. 
    https://doi.org/10.1177/0269881116677104.
  9. Cannabis Regulators Association (CANNRA). 2026. “Overview of DOJ Final Order on Marijuana Rescheduling.” CANNRA Reports and Factsheets, April 27, 2026.  https://static1.squarespace.com/static/5f7e577e23ad7c718c269776/t/69ef671deb38f3461212a4e9/1777297181494/Overview+of+April+23+DOJ+Final+Order+on+Rescheduling_Final.pdf.
  10. ClinicalTrials.gov. 2026. “A Phase 3 Trial of MM120 for Generalized Anxiety Disorder (Panorama).” NCT06809595. https://clinicaltrials.gov/study/NCT06809595.
  11. Cherian, K. N., J. N. Keynan, L. Anker, A. Faerman, R. E. Brown, A. Shamma, O. Keynan, J. P. Coetzee, J. M. Batail, A. Phillips, N. J. Bassano, G. L. Sahlem, J. Inzunza, T. Millar, J. Dickinson, C. E. Rolle, J. Keller, M. Adamson, I. H. Kratter, and N. R. Williams. 2024. “Magnesium-Ibogaine Therapy in Veterans with Traumatic Brain Injuries.” Nature Medicine 30 (2): 373–381. 
  12. COMPASS Pathways. 2018. “COMPASS Pathways receives FDA Breakthrough Therapy designation for psilocybin therapy for treatment-resistant depression.” Compass News Details, Oct 23, 2018. 
    https://ir.compasspathways.com/News--Events-/news/news-details/2018/COMPASS-Pathways-receives-FDA-Breakthrough-Therapy-designation-for-psilocybin-therapy-for-treatment-resistant-depression/default.aspx.
  13. Compass Pathways. 2025. “Compass Pathways Announces Third Quarter 2025 Financial Results and Business Highlights Including Acceleration of Commercial Launch Plans by 9-12 Months.” Compass News Details, Nov 4, 2025. https://ir.compasspathways.com/News--Events-/news/news-details/2025/Compass-Pathways-Announces-Third-Quarter-2025-Financial-Results-and-Business-Highlights-Including-Acceleration-of-Commercial-Launch-Plans-by-9-12-Months/default.aspx.
  14. Compass Pathways. 2025. Compass Pathways Successfully Achieves Primary Endpoint in First Phase 3 Trial Evaluating COMP360 Psilocybin for Treatment-Resistant Depression.Compass News Details, June 23, 2025.
    https://ir.compasspathways.com/News--Events-/news/news-details/2025/Compass-Pathways-Successfully-Achieves-Primary-Endpoint-in-First-Phase-3-Trial-Evaluating-COMP360-Psilocybin-for-Treatment-Resistant-Depression/default.aspx.
  15. Compass Pathways. 2026. “Compass Pathways Successfully Achieves Primary Endpoint in Second Phase 3 Trial Evaluating COMP360 Psilocybin for Treatment-Resistant Depression.” Compass News Details, Feb 17, 2026.
    https://ir.compasspathways.com/News--Events-/news/news-details/2026/Compass-Pathways-Successfully-Achieves-Primary-Endpoint-in-Second-Phase-3-Trial-Evaluating-COMP360-Psilocybin-for-Treatment-Resistant-Depression/default.aspx.
  16. Congress.gov. 2022. “S.5123: Breakthrough Therapies Act.” 117th Congress, Nov 2022.  https://www.congress.gov/bill/117th-congress/senate-bill/5123.
  17. Congress.gov. 2025. “S.3346: Freedom to Heal Act of 2025.” 119th Congress,  Dec 4, 2025.
    https://www.congress.gov/119/bills/s3346/BILLS-119s3346is.pdf.
  18. Congress.gov. 2025. “H.R.2623: Innovative Therapies Centers of Excellence Act of 2025.” 119th Congress, April 3, 2025. https://www.congress.gov/bill/119th-congress/house-bill/2623/text.
  19. Congress.gov. 2026. “S.4031: Innovative Therapies Centers of Excellence Act.” 119th Congress, March 9, 2026.
    https://www.congress.gov/bill/119th-congress/senate-bill/4031/text.
  20. Congress.gov. 2026. “S.4220 - Veterans Health Administration Novel Therapeutics Preparedness Act.” 119th Congress, March 26, 2026. https://www.congress.gov/bill/119th-congress/senate-bill/4220/text.
  21. Congressional Research Service. 2025. “The Controlled Substances Act (CSA): A Legal Overview for the 119th Congress.” CRS Products (Library of Congress), Jan 22, 2025.  https://www.congress.gov/crs_external_products/R/PDF/R45948/R45948.6.pdf.
  22. Convention on Biological Diversity. (2015). “About the Nagoya Protocol”. Convention on Biological Diversity. 
    https://www.cbd.int/abs/about
  23. Correa, L. 2023. “Reps. Correa, Bergman re-launch bipartisan caucus to explore psychedelic research for mental health.” Press Releases, Mar 3, 2023. https://correa.house.gov/news/press-releases/reps-correa-bergman-re-launch-bipartisan-caucus-to-explore-psychedelic-research-for-mental-health.
  24. Cuijpers, P., Miguel, C., Ciharova, M., Harrer, M., Basic, D., Cristea, I. A., de Ponti, N., Driessen, E., Hamblen, J., Larsen, S. E., Matbouriahi, M., Papola, D., Pauley, D., Plessen, C. Y., Pfund, R. A., Setkowski, K., Schnurr, P. P., van Ballegooijen, W., Wang, Y., Riper, H., van Straten A., Sijbrandij, M., Furukawa, T.A., and Karyotaki, E. 2024. “Absolute and relative outcomes of psychotherapies for eight mental disorders: a systematic review and meta-analysis.” World Psychiatry, 23(2), 267–275. https://doi.org/10.1002/wps.21203.
  25. Cybin Inc. 2024. “Cybin Receives FDA Breakthrough Therapy Designation for its Novel Psychedelic Molecule CYB003 and Announces Positive Four-Month Durability Data in Major Depressive Disorder.” News Releases, Mar 13, 2024. https://ir.cybin.com/investors/news/news-details/2024/Cybin-Receives-FDA-Breakthrough-Therapy-Designation-for-its-Novel-Psychedelic-Molecule-CYB003-and-Announces-Positive-Four-Month-Durability-Data-in-Major-Depressive-Disorder/default.aspx.
  26. Czopek, A., J. Jończyk, M. Fryc, D. Kluzik, and A. Zagórska. 2025. “Classic Psychedelics in Pain Modulation: Mechanisms, Clinical Evidence, and Future Perspectives.” ACS Chemical Neuroscience 16 (12): 2163–2177. https://doi.org/10.1021/acschemneuro.5c00152.
  27. Daly, N. 2025. “DOD commits $9.8 million to study psychedelics for active-duty troops.” MilitaryTimes, Mar 17, 2025. https://www.militarytimes.com/news/your-military/2025/03/17/dod-commits-98-million-to-study-psychedelics-for-active-duty-troops/.
  28. Davis, Alan K., Lynnette A. Averill, Nathan D. Sepeda, Joseph P. Barsuglia, and Timothy Amoroso. 2020. "Psychedelic treatment for trauma-related psychological and cognitive impairment among US special operations forces veterans." Chronic Stress 4: 2470547020939564. https://doi.org/10.1177/2470547020939564.
  29. Davis, A. K., Xin, Y., Sepeda, N., and Averill, L. A. 2023. “Open-label study of consecutive ibogaine and 5-MeO-DMT assisted-therapy for trauma-exposed male Special Operations Forces Veterans: prospective data from a clinical program in Mexico.” The American Journal of Drug and Alcohol Abuse 49(5), 587–596. 
    https://doi.org/10.1080/00952990.2023.2220874. 
  30. U.S. Drug Enforcement Administration (DEA). 2026. “Drug Scheduling.” DEA Drug Information. 
    https://www.dea.gov/drug-information/drug-scheduling.
  31. Feduccia, A. A., L. Jerome, B. Yazar-Klosinski, A. Emerson, M. C. Mithoefer, and R. Doblin. 2023. “Breakthrough for Trauma Treatment: Safety and Efficacy of MDMA-Assisted Psychotherapy Compared to Paroxetine and Sertraline.” Focus 21 (3): 306–314. https://doi.org/10.1176/appi.focus.23021013.
  32. Gilgamesh Pharmaceuticals. 2024. “Gilgamesh Pharmaceuticals Awarded $14 Million National Institute on Drug Abuse Grant to Advance Novel, Cardiac-Safe Ibogaine Analog for the Treatment of Opioid Use Disorder.” PR Newswire, Mar 14, 2024. https://www.prnewswire.com/news-releases/gilgamesh-pharmaceuticals-awarded-14-million-national-institute-on-drug-abuse-grant-to-advance-novel-cardiac-safe-ibogaine-analog-for-the-treatment-of-opioid-use-disorder-302089598.html.
  33. Heal, D. J., Gosden, J., and Smith, S. L. (2025). “Mind the gap! Addressing unresolved aspects of abuse potential evaluation and scheduling of classic and novel psychedelic drugs.” Journal of Psychopharmacology (Oxford, England), 2698811251382147. https://doi.org/10.1177/02698811251382147.
  34. Hendricks, P. 2026. “Trump’s executive order on psychedelics is the right move. But is my field ready for it?” Stat News, May 6, 2026. https://www.statnews.com/2026/05/06/psychedelics-executive-order-ibogaine-trump-research-funding-scheduling/.
  35. Henningfield, J. E., Ashworth, J., Heal, D. J., and Smith, S. L. 2023. “Psychedelic drug abuse potential assessment for new drug applications and controlled substance scheduling: A United States perspective.” Journal of Psychopharmacology (Oxford, England), 37(1), 33–44. https://doi.org/10.1177/02698811221140004.
  36. Johnson & Johnson. 2016. “Esketamine Receives Breakthrough Therapy Designation from U.S. Food and Drug Administration for Major Depressive Disorder with Imminent Risk for Suicide.” Press Releases, Aug 16, 2016. 
    https://www.jnj.com/media-center/press-releases/esketamine-recieves-breakthrough-therapy-designation-from-us-food-and-drug-administration-for-major-depressive-disorder-with-imminent-risk-of-suicide.
  37. Johnson, M. W., Griffiths, R. R., Hendricks, P. S., and Henningfield, J. E. 2018. “The abuse potential of medical psilocybin according to the 8 factors of the Controlled Substances Act.” Neuropharmacology, 142, 143–166. 
    https://doi.org/10.1016/j.neuropharm.2018.05.012.
  38. Kappel, J., et al. 2025. “The Ultimate Guide to Colorado’s Natural Medicine Health Act (SB23-290 Psychedelics Law).” Vicente LLP Insights. https://vicentellp.com/insights/ultimate-guide-to-sb23290-colorado-natural-medicine-psychedelics-regulation-and-legalization-bill/.
  39. Kheirbek, Raya Elfadel, Rebecca Hudson, and Stacy Gwatura. "The High Cost of Low Evidence: Why Cannabis Research Lags Behind its Use." The American Journal of Medicine, 138 (12): 1607-1608. 
    https://www.amjmed.com/article/S0002-9343(25)00396-1/fulltext.
  40. Köck, P., Froelich, K., Walter, M., Lang, U., & Dürsteler, K. M. 2022. “A systematic literature review of clinical trials and therapeutic applications of ibogaine.” Journal of Substance Abuse Treatment 138, 108717.  https://doi.org/10.1016/j.jsat.2021.108717.
  41. Kolar D. 2018. “Addictive potential of novel treatments for refractory depression and anxiety.” Neuropsychiatric Disease and Treatment, 14, 1513–1519. https://doi.org/10.2147/NDT.S167538.
  42. Kozlowska, U., C. Nichols, K. Wiatr, and M. Figiel. 2022. “From Psychiatry to Neurology: Psychedelics as Prospective Therapeutics for Neurodegenerative Disorders.” Journal of Neurochemistry 162 (1): 89–108. 
    https://doi.org/10.1111/jnc.15509.
  43. Lewis, B. R., and K. Byrne. 2023. “A Review of MDMA-Assisted Therapy for Posttraumatic Stress Disorder.” Focus 21 (3): 247–256. https://doi.org/10.1176/appi.focus.20220088.
  44. Lewis, S.P., Clark-Soles, J., Mayorga, O., Sawyer, S.K., Slavet, E., Vidt, B.J., Shanti, S., Wiggins, R., Willis, K., Frey, J., Grace, R.M., and Cherniak, A.D. 2026. “Chaplains in Psychedelic Assisted Therapy: Rationale and Competencies.” J Relig Health. https://doi.org/10.1007/s10943-026-02591-9.
  45. Lopes Guerra, L. T., da Silva Dias, I. C., Hallak, J. E. C., and dos Santos, R. G. 2025. “Clinical pharmacology of ayahuasca: potential applications and future considerations.” Expert Review of Clinical Pharmacology, 18(10), 771–784. https://doi.org/10.1080/17512433.2025.2577726.
  46. Lotsof, H. 1985. “Rapid method for interrupting the narcotic addiction syndrome.” United States Patent, US4499096A. https://patents.google.com/patent/US4499096A/en.
  47. Mash D. C. 2023. “IUPHAR - invited review - Ibogaine - A legacy within the current renaissance of psychedelic therapy.” Pharmacological Research 190, 106620. https://doi.org/10.1016/j.phrs.2022.106620.
  48. Milligan, T., Smolenski, D., Lara-Ruiz, J., & Kelber, M. S. (2025). Loss of PTSD Diagnosis in Response to Evidence-Based Treatments: A Systematic Review and Meta-Analysis. JAMA Psychiatry, 82(7), 718–727. https://doi.org/10.1001/jamapsychiatry.2025.0695.
  49. MindMed. 2024. “MindMed Receives FDA Breakthrough Therapy Designation and Announces Positive 12-Week Durability Data From Phase 2B Study of MM120 for Generalized Anxiety Disorder.” MindMed Press Releases, March 7, 2024.  https://ir.mindmed.co/news-events/press-releases/detail/137/mindmed-receives-fda-breakthrough-therapy-designation-and-announces-positive-12-week-durability-data-from-phase-2b-study-of-mm120-for-generalized-anxiety-disorder.
  50. Mitchell, J. M., et al. 2021. “MDMA-Assisted Therapy for Severe PTSD: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study.” Nature Medicine 27 (6): 1025–1033. https://doi.org/10.1038/s41591-021-01336-3.
  51. Mitchell, J. M., M. Ot’alora G, B. van der Kolk, S. Shannon, M. Bogenschutz, Y. Gelfand, C. Paleos, C. R. Nicholas, S. Quevedo, B. Balliett, S. Hamilton, M. Mithoefer, S. Kleiman, K. Parker-Guilbert, K. Tzarfaty, C. Harrison, A. de Boer, R. Doblin, B. Yazar-Klosinski, and MAPP2 Study Collaborator Group. 2023. “MDMA-Assisted Therapy for Moderate to Severe PTSD: A Randomized, Placebo-Controlled Phase 3 Trial.” Nature Medicine 29 (10): 2473–2480. https://doi.org/10.1038/s41591-023-02565-4.
  52. Mitchell, J. M., M. Bogenschutz, A. Lilienstein, C. Harrison, S. Kleiman, K. Parker-Guilbert, M. Ot’alora G, W. Garas, C. Paleos, I. Gorman, C. Nicholas, M. Mithoefer, S. Carlin, B. Poulter, A. Mithoefer, S. Quevedo, G. Wells, S. S. Klaire, B. van der Kolk, K. Tzarfaty, and R. Doblin. 2023. “MDMA-Assisted Therapy for Severe PTSD: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study.” Focus 21 (3): 315–328.  https://doi.org/10.1176/appi.focus.23021011.
  53. Mithoefer, M. C., Wagner, M. T., Mithoefer, A. T., Jerome, L., and Doblin, R. 2011. “The safety and efficacy of±3, 4-methylenedioxymethamphetamine-assisted psychotherapy in subjects with chronic, treatment-resistant posttraumatic stress disorder: the first randomized controlled pilot study.” Journal of Psychopharmacology 25(4), 439-452. https://doi.org/10.1177/0269881110378371.
  54. Mithoefer, M. C., Wagner, M. T., Mithoefer, A. T., Jerome, L., Martin, S. F., Yazar-Klosinski, B., Michel, Y., Brewerton, T.D., and Doblin, R. 2013. “Durability of improvement in post-traumatic stress disorder symptoms and absence of harmful effects or drug dependency after 3, 4-methylenedioxymethamphetamine-assisted psychotherapy: a prospective long-term follow-up study.” Journal of Psychopharmacology 27(1), 28-39. https://doi.org/10.1177/0269881112456611.
  55. Mithoefer, M.C., Mithoefer, A.T., Feduccia, A.A., Jerome, L., Wagner, M., Wymer, J., Holland, J., Hamilton, S., Yazar-Klosinski, B., Emerson, A., and Doblin, R. 2018. “3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy for post-traumatic stress disorder in military veterans, firefighters, and police officers: a randomised, double-blind, dose-response, phase 2 clinical trial.” The Lancet Psychiatry, 5 (6), 486 – 497. 
    https://doi.org/10.1177/0269881112456611.
  56. Multidisciplinary Association for Psychedelic Studies (MAPS). 2017. “FDA Grants Breakthrough Therapy Designation for MDMA-Assisted Therapy for PTSD, Agrees on Special Protocol Assessment for Phase 3 Trials.” MAPS Press Releases, August 26, 2017. https://maps.org/news/media/press-release-fda-grants-breakthrough-therapy-designation-for-mdma-assisted-psychotherapy-for-ptsd-agrees-on-special-protocol-assessment-for-phase-3-trials/.
  57. National Conference of State Legislatures (NCSL). 2024. “Cannabis Overview.” NCSL Report, June 20, 2024. 
    https://www.ncsl.org/civil-and-criminal-justice/cannabis-overview.
  58. NIH RePORTER. 2026. “Advanced Search: “psilocybin MDMA psilocin Dimethlytryptamine 5-MeO-DMT psychedelic LSD ibogaine, (or)”, Chart summary - funding by Fiscal Year.” accessed Nov 11, 2025. 
    https://reporter.nih.gov/search/ljea6k3I5E-sUT6hKr_tqA/projects/charts.
  59. Norman, S.B. and Maguen, S. 2025. “Moral Injury.” VA National Center for PTSD, March 25, 2025. 
    https://www.ptsd.va.gov/professional/treat/cooccurring/moral_injury.asp.
  60. 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.
  61. Oehen, P., Traber, R., Widmer, V., and Schnyder, U. 2013. “A randomized, controlled pilot study of MDMA (±3, 4-Methylenedioxymethamphetamine)-assisted psychotherapy for treatment of resistant, chronic Post-Traumatic Stress Disorder (PTSD).” Journal of Psychopharmacology 27(1), 40-52. https://doi.org/10.1177/0269881112464827.
  62. Office of the Texas Governor, Greg Abbott. 2025. “Governor Abbott Signs Ibogaine Treatment Research Law at Texas Capitol.” Press Release, June 11, 2025. https://gov.texas.gov/news/post/governor-abbott-signs-ibogaine-treatment-research-law-at-texas-capitol.
  63. Oregon Health Authority. 2025. “Oregon Psilocybin Services.” Public Health Division, January 2025.  
    https://www.oregon.gov/oha/PH/PREVENTIONWELLNESS/Documents/Manufacturer-License-Fact-Sheet.pdf.
  64. Ot'alora G, M., Grigsby, J., Poulter, B., Van Derveer, J. W., 3rd, Giron, S. G., Jerome, L., Feduccia, A. A., Hamilton, S., Yazar-Klosinski, B., Emerson, A., Mithoefer, M. C., and Doblin, R. 2018. “3,4-Methylenedioxymethamphetamine-assisted psychotherapy for treatment of chronic posttraumatic stress disorder: A randomized phase 2 controlled trial.” Journal of Psychopharmacology (Oxford, England) 32(12), 1295–1307.  https://doi.org/10.1177/0269881118806297.
  65. Psychedelic Alpha. 2023. “Bifurcated Scheduling.” Pα+ Library, December 6, 2023. 
    https://psychedelicalpha.com/news/p%CE%B1-library-bifurcated-scheduling.
  66. Psychedelic Alpha. 2025. “Psychedelic Policy Push Continues: Over 60 Bills Introduced Across 22 States.” Pα+ News, February 27, 2025. https://psychedelicalpha.com/news/psychedelic-policy-push-continues-over-60-bills-introduced-across-22-states.
  67. Psychedelic Alpha. 2026. “Psychedelic Legalization and Decriminalization Tracker. Mapping Psychedelic Drug Policy Reform in the United States.” Pα+ Tracker.  https://psychedelicalpha.com/data/psychedelic-laws.
    Psychedelic Alpha. 2025. “One Year After FDA’s MDMA Rejection: Insiders and Observers Reflect.” Pα+ Analysis, Aug 15, 2025. https://psychedelicalpha.com/news/one-year-after-fdas-mdma-rejection-insiders-and-observers-reflect/.
  68. Psychedelic Alpha. 2026. “Trump’s Psychedelics Executive Order: Reactions From Across the Field and Beyond.” Pα+ Analysis, April 22, 2026. https://psychedelicalpha.com/news/trumps-psychedelics-executive-order-reactions-from-across-the-field-and-beyond/.
  69. Psychedelic Alpha. 2026. “April 2026 Psychedelic Bill Roundup.” Pα+ Analysis, May 12, 2026. 
    https://psychedelicalpha.com/news/april-2026-psychedelic-bill-round-up/.
  70. Psychedelic Alpha. 2026. “Psychedelic Drug Development Tracker: Mapping Drug Development in Psychedelics.” Pα+ Tracker, Q1 2026. https://psychedelicalpha.com/resources/psychedelic-drug-development-tracker/.
  71. U.S. Congress. (Oct 27, 1970). “Comprehensive Drug Abuse Prevention and Control Act of 1970, Public Law 91-513.” Govinfo.gov, Oct 27, 1970. https://www.govinfo.gov/content/pkg/STATUTE-84/pdf/STATUTE-84-Pg1236.pdf.
  72. Reunion Neuroscience, Inc. 2026. “U.S. FDA Grants Reunion Neuroscience’s Luvesilocin (RE104) Breakthrough Therapy Designation.” Press Releases, Feb 23, 2026. https://reunionneuro.com/2026/02/23/u-s-fda-grants-reunion-neurosciences-luvesilocin-re104-breakthrough-therapy-designation-status/.
  73. Romero, L. 2025. “Medical Psilocybin Act Becomes Law in New Mexico, but What’s Next? A Psychedelic Law Expert Previews What to Expect.” Source NM, April 10, 2025. https://sourcenm.com/2025/04/10/medical-psilocybin-act-becomes-law-in-new-mexico-but-whats-next/.
  74. Ruffell, S. G. D., M. Crosland-Wood, R. Palmer, N. Netzband, W. Tsang, B. Weiss, S. Gandy, T. Cowley-Court, A. Halman, D. McHerron, A. Jong, T. Kennedy, E. White, D. Perkins, D. B. Terhune, and J. Sarris. 2023. “Ayahuasca: A Review of Historical, Pharmacological, and Therapeutic Aspects.” PCN Reports: Psychiatry and Clinical Neurosciences 2 (4): e146. https://doi.org/10.1002/pcn5.146.
  75. Shnayder, S., Ameli, R., Sinaii, N., Berger, A., & Agrawal, M. 2023. “Psilocybin-assisted therapy improves psycho-social-spiritual well-being in cancer patients.” Journal of Affective Disorders, 323, 592–597. https://doi.org/10.1016/j.jad.2022.11.046.
  76. Sheehy, T. March 27, 2026. “Sheehy Introduces Bipartisan Veterans Health Administration Novel Therapeutics Preparedness Act.” Press Releases, March 27, 2026. https://www.sheehy.senate.gov/news/press-releases/sheehy-introduces-bipartisan-veterans-health-administration-novel-therapeutics-preparedness-act/.
  77. Smith, K. W., D. J. Sicignano, A. V. Hernandez, and C. M. White. 2021. “MDMA-Assisted Psychotherapy for Treatment of Posttraumatic Stress Disorder: A Systematic Review With Meta-Analysis.” Journal of Clinical Pharmacology 62: 463–471. https://doi.org/10.1002/jcph.1995.
  78. Soylemez, K. K., E. M. de Boo, A. Susuzlu, and J. Lusher. 2025. “Neuroplasticity and Neuro-Generation: The Promise of Psychedelics in Dementia Care.” Psychoactives 4 (3): 31. 
    https://doi.org/10.3390/psychoactives4030031.
  79. Stanicic, F., V. Zah, D. Grbic, D. Vukicevic, and D. de Angelo. 2025. “MDMA-Assisted Therapy and Current Treatment Options for Chronic, Treatment-Resistant, Moderate or Higher Severity Post-Traumatic Stress Disorder: Systematic Literature Review.” PLOS ONE 20 (7): e0327778. https://doi.org/10.1371/journal.pone.0327778.
  80. Stone, W. 2024. “FDA Gives Thumbs Down to MDMA for Now, Demanding Further Research.” NPR, August 9, 2024. https://www.npr.org/sections/shots-health-news/2024/08/09/nx-s1-5068634/mdma-therapy-fda-decision-ptsd-psychedelic-treatment.
  81. Swieczkowski, D., A. Kwaśny, and W. J. Cubała. 2025. “Safety and Tolerability of NN-Dimethyltryptamine (DMT) in Healthy Volunteers and Major Depressive Disorder (MDD) Patients: A Systematic Review of Early-Phase Clinical Trials.” Progress in Neuro-Psychopharmacology & Biological Psychiatry 140: 111419.  https://doi.org/10.1016/j.pnpbp.2025.111419.
  82. Transcend Therapeutics. 2025. “Transcend Therapeutics Receives Breakthrough Therapy Designation for TSND- 201 (methylone) for the Treatment of PTSD.” Press Release, July 10, 2025. https://transcendtherapeutics.com/transcend-therapeutics-receives-breakthrough-therapy-designation-for-tsnd-201-methylone-for-the-treatment-of-ptsd/.
  83. United Nations. 1961. “Single Convention on Narcotic Drugs.” United Nations Office on Drugs and Crime. 
    https://www.unodc.org/pdf/convention_1961_en.pdf.
  84. United Nations. 1971. “Convention on Psychotropic Substances.” United Nations Office on Drugs and Crime. 
    https://www.unodc.org/pdf/convention_1971_en.pdf.
  85. United Nations. 1988. “United Nations Convention Against Illicit Traffic in Narcotic Drugs and Psychotropic Substances.” United Nations Office on Drugs and Crime. https://www.unodc.org/pdf/convention_1988_en.pdf.
  86. United Nations. 2023. “United Nations system common position supporting the implementation of the international drug control policy through effective inter-agency collaboration.” United Nations Office on Drugs and Crime..
  87. U.S. Department of Justice (DOJ). 2026. “Justice Department Places FDA-Approved Marijuana Products and Products Containing Marijuana Subject to a Qualifying State-issued License in Schedule III, Strengthening Medical Research While Maintaining Strict Federal Controls.” Press Release, April 23, 2026. https://www.justice.gov/opa/pr/justice-department-places-fda-approved-marijuana-products-and-products-containing-marijuana.
  88. U.S. Department of Veterans Affairs (VA). 2024. “VA funds first study on psychedelic-assisted therapy for Veterans.” VA News: Press Room, Dec 3, 2024. https://news.va.gov/press-room/va-funds-first-study-on-psychedelic-assisted-therapy-for-veterans/.
  89. U.S. Department of Veterans Affairs (VA). 2024. “Overview of VA research on Posttraumatic Stress Disorder (PTSD)”. Office of Research & Development: Topics, June 6, 2024. https://www.research.va.gov/topics/ptsd.cfm.
  90. U.S. Food & Drug Administration (FDA). 2018. “Learn About Drug and Device Approvals: Breakthrough Therapy”. FDA, Jan 4, 2018. https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/breakthrough-therapy.
  91. U.S. Food & Drug Administration (FDA). 2026. “FDA Accelerates Action on Treatments for Serious Mental Illness Following Executive Order”. FDA News Release, April 24, 2026. 
    https://www.fda.gov/news-events/press-announcements/fda-accelerates-action-treatments-serious-mental-illness-following-executive-order.
  92. Usona Institute. 2019. “FDA grants Breakthrough Therapy Designation to Usona Institute's psilocybin program for major depressive disorder.” Usona Institute Updates, Nov 22, 2019. https://www.usonainstitute.org/updates/fda-grants-breakthrough-therapy-designation-to-usona-institutes-psilocybin-program-for-major-depressive-disorder.
  93. Wang, Z., & Woolverton, W. L. 2007. “Estimating the relative reinforcing strength of (+/-)-3,4-methylenedioxymethamphetamine (MDMA) and its isomers in rhesus monkeys: comparison to (+)-methamphetamine.” Psychopharmacology 189(4), 483–488. https://doi.org/10.1007/s00213-006-0599-5.
  94. The White House. 2025. “Increasing Medical Marijuana and Cannabidiol Research.” Executive Orders, Dec 18, 2025. https://www.whitehouse.gov/presidential-actions/2025/12/increasing-medical-marijuana-and-cannabidiol-research/.
  95. The White House. 2026. “Accelerating Treatments for Serious Medical Illness.” Executive Orders, April 18, 2026. 
    https://www.whitehouse.gov/presidential-actions/2026/04/accelerating-medical-treatments-for-serious-mental-illness/.
  96. The White House. 2026. “Fact Sheet: President Donald J. Trump is Accelerating Medical Treatments for Serious Mental Illness”. Fact Sheets, April 18, 2026. https://www.whitehouse.gov/fact-sheets/2026/04/fact-sheet-president-donald-j-trump-is-accelerating-medical-treatments-for-serious-mental-illness/.
  97. Werner, M. J., and S. M. Klock. 2024. “FDA Rejects Application for Psychedelic Drug.” Holland & Knight Healthcare Blog, August 12, 2024. https://www.hklaw.com/en/insights/publications/2024/08/fda-rejects-application-for-psychedelic-drug.
  98. Williams, T., Phillips, N. J., Stein, D. J., & Ipser, J. C. 2026. “Pharmacotherapy for post traumatic stress disorder (PTSD).” The Cochrane Database of Systematic Reviews, 5(5), CD002795. https://doi.org/10.1002/14651858.CD002795.pub4.
  99. Wittenkeller, L., G. Gudelsky, T. J. Winhusen, and D. Amato. 2025. “Psychedelics as Pharmacotherapeutics for Substance Use Disorders: A Scoping Review on Clinical Trials and Perspectives on Underlying Neurobiology.” British Journal of Pharmacology. Advance online publication. https://doi.org/10.1111/bph.70181.
  100. Yao, Y., D. Guo, T. S. Lu, F. L. Liu, S. H. Huang, M. Q. Diao, S. X. Li, X. J. Zhang, T. R. Kosten, J. Shi, Y. P. Bao, L. Lu, and Y. Han. 2024. “Efficacy and Safety of Psychedelics for the Treatment of Mental Disorders: A Systematic Review and Meta-Analysis.” Psychiatry Research 335: 115886. https://doi.org/10.1016/j.psychres.2024.11588. 
  101. Young, F.L. 1986. “In the Matter of MDMA Scheduling, Docket No 84-48, Opinion and Recommended Ruling, Findings of Fact, Conclusions of Law and Decision of Administrative Law Judge on Issues Two through Seven.” United States Department of Justice, Drug Enforcement Administration, May 22, 1986. https://maps.org/research-archive/dea-mdma/pdf/0112.PDF.
  102. Zhdanava, M., D. Pilon, I. Ghelerter, W. Chow, K. Joshi, P. Lefebvre, and J. J. Sheehan. 2021. “The Prevalence and National Burden of Treatment-Resistant Depression and Major Depressive Disorder in the United States.” Journal of Clinical Psychiatry 82 (2): 20m13699. https://doi.org/10.4088/JCP.20m1369 https://doi.org/10.1016/j.jclepro.2021.127516.

DISCLAIMER: The findings and conclusions published herein are solely attributed to the author and not necessarily endorsed or adopted by the Journal of Science Policy and Governance. Articles are distributed in compliance with copyright and trademark agreements.

ISSN 2372-2193
Picture
© 2022 - 2026 Journal of Science Policy & Governance, Inc. All rights reserved. The opinions, findings and conclusions from JSPG publications, additional article commentaries and related events do not necessarily reflect the views of the journal.
  • Home
  • About
    • Leadership Team >
      • CEO
      • Operations Team
      • Editorial Board
      • Communications Team
      • Programs and Events Team
      • Evaluation and Analytics Team
      • Public Engagement​ and Development Team
      • Governing Board
      • Advisory Board
    • Partners
    • Sponsorships
  • Volumes
  • Submit to the Journal
  • Announcements
    • News
    • Blog
  • Resources
    • Writing
    • Science Policy Resources
    • Policy in action
    • Podcast