North AmericaUSCountry Report

Psychedelic Research in

United States

The United States has the deepest psychedelic research ecosystem in the world, but it does not have a single psychedelic legal status. Federal law, FDA drug approval, DEA scheduling, clinical-trial authorisation, state-regulated service systems, local deprioritisation, religious-use claims and off-label ketamine practice all operate on different tracks.

Key Insights

A concise read of the policy, research, and stakeholder signals shaping psychedelic medicine in United States.

  • 1

    The US is not "legal" or "illegal" in one simple sense; it is a layered system where federal scheduling, FDA approval, state service models and local policing priorities diverge sharply.

  • 2

    Ketamine and esketamine are still the only scalable, verified medical-access routes with national reach; everything else is either research, state experimentation, local deprioritisation or no verified pathway.

  • 3

    Oregon is a real live market, but it is explicitly non-medical and self-pay.

  • 4

    Colorado is important, but publication should not imply mature service availability statewide until operating-site status is rechecked.

  • 5

    New Mexico's medical psilocybin law is significant because it is closer to a supervised medical programme than Oregon's adult service model, but it is still in implementation.

  • 6

    Texas has become the most aggressive state funder of ibogaine drug-development work, but that is research policy, not patient access.

  • 7

    The 2024 midomafetamine setback means FDA clinical evidence standards remain high, especially on blinding, safety, psychotherapy standardisation and overall trial credibility.

  • 8

    The research centre of gravity still sits in a handful of institutions and regions: Johns Hopkins, NYU Langone, UCSF/Stanford, VA systems, Utah and Texas public-university networks.

Research Snapshot

Blossom currently tracks 515 psychedelic clinical trials connected to the United States, including 163 active studies.

Active trials
163

Currently active in Blossom

Total trials
515

Country-linked records

Stakeholders
902

Linked organisations

Events
107

Linked event records

Top Compounds

  • Ketamine(214)
  • Psilocybin(173)
  • MDMA(60)
  • Esketamine(25)
  • LSD(11)

Top Study Topics

  • Major Depressive Disorder (MDD)(88)
  • Treatment-Resistant Depression (TRD)(76)
  • Healthy Volunteers(61)
  • PTSD(60)
  • Depressive Disorders(45)

Medical Access Snapshot

Esketamine nasal spray is the clearest nationally reimbursable psychiatric access pathway, with SPRAVATO administered under a REMS in certified healthcare settings. Off-label racemic ketamine is widely available in private clinics, but insurance coverage is inconsistent and compounded products carry additional regulatory and safety caveats. Psilocybin, MDMA, LSD, DMT, 5-MeO-DMT, ibogaine and mescaline still lack FDA approval, so access is mainly through clinical trials, state-specific programmes, or self-pay service models where lawful.

State and Territory Pages

Subnational reports track local policy, access implementation, research sites, stakeholders, and events where Blossom has state-level coverage.

Alabama

state - AL

deep

24 trials, 14 stakeholders

Alaska

state - AK

deep

0 trials, 1 stakeholders

American Samoa

territory - AS

enhanced

0 trials, 0 stakeholders

Arizona

state - AZ

deep

16 trials, 41 stakeholders

Show all 57 state and territory pages

Arkansas

state - AR

deep

12 trials, 0 stakeholders

California

state - CA

deep

112 trials, 77 stakeholders

Colorado

state - CO

deep

23 trials, 53 stakeholders

Connecticut

state - CT

deep

66 trials, 6 stakeholders

Delaware

state - DE

deep

1 trials, 2 stakeholders

District of Columbia

district - DC

deep

2 trials, 0 stakeholders

Florida

state - FL

deep

35 trials, 61 stakeholders

Georgia

state - GA

deep

44 trials, 9 stakeholders

Guam

territory - GU

deep

0 trials, 0 stakeholders

Hawaii

state - HI

deep

1 trials, 3 stakeholders

Idaho

state - ID

deep

0 trials, 5 stakeholders

Illinois

state - IL

deep

43 trials, 27 stakeholders

Indiana

state - IN

deep

3 trials, 5 stakeholders

Iowa

state - IA

deep

9 trials, 5 stakeholders

Kansas

state - KS

deep

7 trials, 9 stakeholders

Kentucky

state - KY

deep

2 trials, 2 stakeholders

Louisiana

state - LA

deep

13 trials, 0 stakeholders

Maine

state - ME

deep

0 trials, 0 stakeholders

Maryland

state - MD

deep

87 trials, 6 stakeholders

Massachusetts

state - MA

deep

54 trials, 9 stakeholders

Michigan

state - MI

deep

10 trials, 5 stakeholders

Minnesota

state - MN

deep

20 trials, 10 stakeholders

Mississippi

state - MS

deep

2 trials, 0 stakeholders

Missouri

state - MO

deep

20 trials, 2 stakeholders

Montana

state - MT

deep

2 trials, 2 stakeholders

Nebraska

state - NE

deep

7 trials, 1 stakeholders

Nevada

state - NV

deep

3 trials, 10 stakeholders

New Hampshire

state - NH

deep

0 trials, 1 stakeholders

New Jersey

state - NJ

deep

18 trials, 10 stakeholders

New Mexico

state - NM

deep

11 trials, 12 stakeholders

New York

state - NY

deep

93 trials, 37 stakeholders

North Carolina

state - NC

deep

18 trials, 5 stakeholders

North Dakota

state - ND

deep

0 trials, 2 stakeholders

Northern Mariana Islands

territory - MP

deep

0 trials, 0 stakeholders

Ohio

state - OH

deep

35 trials, 12 stakeholders

Oklahoma

state - OK

deep

10 trials, 2 stakeholders

Oregon

state - OR

deep

8 trials, 9 stakeholders

Pennsylvania

state - PA

deep

29 trials, 3 stakeholders

Puerto Rico

territory - PR

deep

0 trials, 0 stakeholders

Rhode Island

state - RI

deep

5 trials, 0 stakeholders

South Carolina

state - SC

deep

19 trials, 1 stakeholders

South Dakota

state - SD

deep

0 trials, 0 stakeholders

Tennessee

state - TN

deep

9 trials, 8 stakeholders

Texas

state - TX

deep

69 trials, 54 stakeholders

U.S. Minor Outlying Islands

minor-outlying-island - UM

deep

0 trials, 0 stakeholders

U.S. Virgin Islands

territory - VI

deep

0 trials, 0 stakeholders

Utah

state - UT

deep

24 trials, 17 stakeholders

Vermont

state - VT

deep

4 trials, 1 stakeholders

Virginia

state - VA

deep

7 trials, 6 stakeholders

Washington

state - WA

deep

26 trials, 19 stakeholders

West Virginia

state - WV

deep

2 trials, 2 stakeholders

Wisconsin

state - WI

deep

22 trials, 2 stakeholders

Wyoming

state - WY

deep

0 trials, 2 stakeholders

Regulatory Status

At federal level, the governing structure is still the Controlled Substances Act plus FDA's drug-approval framework. Psilocybin, psilocin, MDMA, LSD, DMT, 5-MeO-DMT, ibogaine and mescaline are Schedule I; ketamine and its isomers are Schedule III. FDA's current nationally lawful psychedelic-adjacent medicines are ketamine as an anaesthetic and esketamine nasal spray under a REMS. FDA's 2023 psychedelic clinical-investigation guidance remains a key methodological document, and FDA's April 2026 announcement signalled continued regulatory interest without changing the hard fact that no classic psychedelic medicine has yet won FDA approval. At state level, the position is fragmented and should never be collapsed into a single national legal status. Oregon has live state-regulated psilocybin services; Colorado has a live licensing architecture for natural medicine with implementation still maturing; New Mexico is building a medical psilocybin programme; Texas, Utah and Arizona are using research-led models; DC has only a lowest-priority enforcement policy; and states such as California, Maryland and New York matter mainly because they host major research institutions and state oversight mechanisms rather than broad legal access. None of these state arrangements displaces federal Schedule I controls.

History of Research in United States

Modern US psychedelic policy still rests on the Controlled Substances Act framework and DEA scheduling. Under that federal baseline, psilocybin, psilocin, LSD, MDMA, DMT, 5-MeO-DMT, ibogaine and mescaline remain Schedule I, which means no recognised medical use under federal law and correspondingly tighter research controls. Ketamine followed a different path: DEA placed it in Schedule III in 1999, preserving ordinary medical use while keeping it under controlled-substances rules.###

That split matters historically. Ketamine entered routine medicine decades ago as an anaesthetic and later became the foundation for a much broader psychiatric practice ecosystem through off-label prescribing, while esketamine moved through the formal FDA process and gained psychiatric approval in 2019, later adding further label expansion. The clinic economy that followed racemic ketamine is therefore not evidence of psychedelic legalisation; it is an outgrowth of ordinary off-label practice around a Schedule III drug that already had FDA approval for a different indication.####

The research restart in classic psychedelics has been driven largely by academic centres and federally authorised IND work rather than by state legalisation. Johns Hopkins launched its dedicated centre in 2019, NYU Langone established its own centre in 2021, and NIDA and NIMH now publish formal research-facing material on psychedelics and related compounds. FDA's 2023 guidance made that shift more explicit by giving sponsors a formal framework for clinical-development design.####

MAPS/Lykos's MDMA development effort became the most visible attempt to convert that research revival into a first-in-class federal authorisation for a classic psychedelic-related therapy. FDA's June 2024 advisory-committee review and August 2024 complete response letter showed that the agency was not prepared to accept the package as submitted. In practical terms, that setback reset expectations not just for MDMA but for the evidentiary bar across psychedelic drug development.#

State reform then accelerated on a separate track. Oregon voters created the first psilocybin services framework, Colorado followed with a natural medicine system, DC adopted a lowest-priority policing model for entheogenic plants and fungi, and later states turned to hybrid models ranging from New Mexico's supervised medical programme to Texas's ibogaine development law and Utah's research-first legislation. The national picture is therefore a convergence of three histories: federal prohibition, academic/clinical revival, and state experimentation.#####

Regional and State Spotlights

Oregon and Portland#

Oregon is the clearest proof that a state can run a licensed psychedelics service market without claiming to create medical treatment. OHA's model is adult, supervised and non-prescription based. Portland matters because it concentrates service centres, facilitators, training activity and media attention around the first functioning US system of this type.##

Colorado and Denver#

Colorado matters because it is building the next major state system and because its regulators have had to design a more complex natural medicine architecture than Oregon's. Denver remains the symbolic and practical centre of that process because the state's licensing, training, compliance and stakeholder conversations are concentrated there. As of February 2026, public state data showed approved healing-centre applications, but the number of actually operating centres still needs direct manual verification.##

California, the Bay Area and Los Angeles#

California remains the country's largest research and ecosystem state rather than a service-access state. The Research Advisory Panel of California continues to review Schedule I/II studies; UCSF and Stanford are active in psilocybin pain and neuroimaging work; and UCLA appeared in RAPC meeting materials as part of the ongoing research pipeline. Los Angeles and the Bay Area also matter because they combine academic medicine, biotech formation and philanthropy.##

Maryland and Washington DC#

This corridor matters for two different reasons. Baltimore is home to Johns Hopkins, which remains one of the field's most influential academic centres. Washington DC matters not because it created a clinical market, but because it is where federal policy, litigation, agency signalling and lowest-priority local reform intersect in the same geography.##

New York#

New York's importance rests on institutional density rather than permissive state law. NYU Langone's Center for Psychedelic Medicine is one of the flagship East Coast centres and remains active across cancer-related distress, addiction, depression and neurobiological mechanism work. New York also remains a media, philanthropy and professional-network hub for the field.#

Texas and the Austin-Houston-Galveston corridor#

Texas now matters nationally because it is the most ambitious public-sector ibogaine state. The state's policy is not liberal access; it is industrial-scale drug-development ambition tied to veterans, addiction and brain-injury narratives. Austin matters politically, while Houston and Galveston matter because UTHealth Houston and UTMB have been identified in reporting around the research effort.##

New Mexico, Arizona and Utah###

Taken together, these states form a notable south-western policy laboratory. New Mexico is building a supervised medical psilocybin programme; Arizona chose bounded grant-funded psilocybin research; Utah has kept the narrowest and most conservative evidence-first approach, first through healthcare-system pilot authority and then through a veteran PTSD study. None of the three should be described as broad psychedelic legalisation.###

Research Focus

Pathway: federally authorised clinical trial. Psilocybin remains the broadest non-ketamine development lane in the US. Research centres at Johns Hopkins and NYU Langone continue to focus on depression, cancer-related psychiatric and existential distress, addiction and related mental-health indications, while UCSF-led work includes chronic low-back pain, anorexia nervosa and mechanistic studies of psychedelic experience. This makes psilocybin the clearest bridge between academic psychiatry, philanthropy-supported centres and sponsor-led drug development.####

Compass Pathways' COMP360 is now the highest-signal US psilocybin development programme for near-term regulatory change. The sponsor has reported positive primary-endpoint results from both pivotal Phase 3 treatment-resistant depression trials, FDA Breakthrough Therapy designation, and an FDA-granted rolling NDA submission/review request plus Commissioner's National Priority Voucher selection. It remains investigational rather than patient access, but it materially affects the US outlook for psilocybin approval, reimbursement design, delivery infrastructure and state implementation planning if FDA approval follows.##

LSD and psilocybin-derived sponsor programmes are also advancing through later-stage US trials. UCSF's clinical-trial portal lists the MM120 phase 3 generalised anxiety disorder programme as accepting new patients, and San Francisco sites also appear in the CYB003 phase III long-term extension work in major depressive disorder. These are important signals that late-stage commercial development is still moving despite the MDMA/PTSD setback.#

Ketamine and esketamine remain the most clinically mature US research and delivery category. FDA still frames ketamine as an anaesthetic rather than a psychiatric medicine, but VA now has both an intranasal esketamine protocol and a ketamine-infusion protocol for treatment-resistant depression, alongside a community-care coverage determination for IV ketamine. UCSF is also studying ketamine-assisted recovery in methamphetamine use disorder. In the US, this is the area where formal evidence generation and real-world clinical delivery are most tightly entwined.#####

Ibogaine and its derivatives remain earlier-stage but have become strategically important. FDA said in April 2026 that it had allowed an early-phase US study of noribogaine hydrochloride for alcohol use disorder to proceed after an IND submission. At state level, Texas has created a publicly funded FDA-directed ibogaine drug-development effort, while Utah authorises a veteran PTSD study that can include MDMA, psilocybin and 5-MeO-DMT. That makes the US ibogaine story a mix of federal early-phase drug development and unusually assertive state-level public funding.###

Public funders and public institutions now matter more than they did a decade ago. NIDA says it supports and conducts research on psychedelic and dissociative drugs, NIMH has published formal considerations for research involving psychedelics and related compounds, and the VA has moved from cautious observation to operational protocols for esketamine and ketamine in depression care. That does not amount to federal endorsement of classic psychedelic treatment, but it does mark a substantial institutional normalisation of the research agenda.####

Key Milestones

1970
The modern federal baseline is set by the Controlled Substances Act framework later codified in 21 CFR Part 1308, under which classic psychedelics are placed in Schedule I.
13 Jul 1999
DEA places ketamine in Schedule III, preserving ordinary medical use while imposing controlled-substance rules.
5 Mar 2019
FDA approves SPRAVATO for treatment-resistant depression, creating the first modern psychiatric medicine in this field with a dedicated REMS pathway.
4 Sep 2019
Johns Hopkins launches its Center for Psychedelic and Consciousness Research, marking a major institutional milestone in the US research restart.
31 Jul 2020
FDA expands esketamine's labelled use to depressive symptoms in adults with major depressive disorder with acute suicidal ideation or behaviour.
2021
NYU Langone formally establishes its Center for Psychedelic Medicine.
16 Mar 2021
DC Initiative 81 takes effect, making adult non-commercial entheogenic plant and fungi offences among the city's lowest law-enforcement priorities.
2022
Colorado voters approve Proposition 122, beginning the state's natural medicine implementation process.
Summer 2023
Oregon service centres begin serving clients under the state psilocybin services framework.
23 Jun 2023
FDA issues its first psychedelic clinical-investigation guidance in draft form.
21 Mar 2024
Utah SB 266 becomes law, authorising narrow healthcare-system behavioural-health programmes using psilocybin or MDMA in federal phase 3 testing.
Jun 2024
FDA reviews Lykos's midomafetamine application for PTSD and publishes a detailed briefing document laying out substantial concerns.
8 Aug 2024
FDA issues a complete response letter to Lykos for midomafetamine.
5 Nov 2024
Massachusetts voters reject Question 4 on natural psychedelic substances.
Jan 2025
Esketamine gains a monotherapy indication for treatment-resistant depression in adults, reflected in VA's 2025 national protocols.
Apr 2025
New Mexico enacts the Medical Psilocybin Act.
11 Jun 2025
Texas Governor Greg Abbott signs SB 2308 on ibogaine treatment research.
23 Jun 2025
Compass Pathways reports positive primary-endpoint results from COMP005, the first Phase 3 trial of COMP360 psilocybin for treatment-resistant depression.
17 Feb 2026
Compass Pathways reports positive primary-endpoint results from COMP006, the second pivotal Phase 3 trial of COMP360 for treatment-resistant depression.
19 Mar 2026
Utah enacts HB 390 authorising a state-funded clinical study of psychedelic-assisted therapy for veterans with treatment-resistant PTSD.
31 Mar 2026
Texas leaders announce that the state will move forward with its ibogaine research effort using $50 million even after the original partner model failed.
24 Apr 2026
FDA announces new psychedelic-development actions, including priority vouchers and an early-phase US noribogaine study, while signalling further guidance activity.
24 Apr 2026
FDA grants Compass Pathways a rolling NDA submission/review request and selects COMP360 for the Commissioner's National Priority Voucher pilot.

Future Outlook

Over the next 12 to 24 months, the likeliest changes are not nationwide psychedelic legalisation but incremental movement across separate channels. Evidence development should continue in psilocybin, LSD/MM120, ketamine/esketamine and ibogaine-related programmes, with academic centres and sponsor-led multicentre work continuing to define the field. FDA's April 2026 announcement suggests a more active federal posture on study design and development support, but not a lowered approval bar. The midomafetamine/PTSD experience indicates that classic psychedelic approval will still depend on unusually robust trial design, clean safety narratives and high confidence in psychotherapy standardisation and data integrity.####

COMP360 should be treated as the main near-term FDA watch item for psilocybin. The practical question is not whether psilocybin is broadly legal, but whether a sponsor-led synthetic psilocybin medicine can move through rolling NDA review and then into scheduling, REMS-like controls, coverage decisions and provider training. Approval remains uncertain until FDA completes review.###

At state level, Oregon is likely to deepen operationally rather than change category; Colorado is likely to move from implementation architecture to more visible real-world service delivery; and New Mexico is likely to stay focused on rulemaking, training and infrastructure rather than broad immediate enrolment. Texas and Utah are likely to be watched as test cases for publicly backed research-first models, with Texas focused on ibogaine drug development and Utah on tightly supervised veteran PTSD research.#####

Reimbursement is the least likely area to liberalise quickly outside esketamine and existing ketamine channels. Medicare, VA and some commercial plans already provide viable esketamine payment routes, but state psilocybin and natural medicine systems are likely to remain predominantly self-pay while substances stay federally illegal and outside standard drug-benefit structures. Off-label ketamine will remain available, but regulator and payer scrutiny of compounded at-home and telemedicine-heavy models is likely to continue.#####

The biggest uncertainty is timing. Colorado's real operating footprint, New Mexico's first-patient timeline, Texas's consortium mechanics, and any resubmission strategy after the Lykos complete response letter are all moving targets. For publication, those should be treated as implementation questions rather than settled facts.####

Sources and Verification

Last updated 18 May 2026. Source links are drawn from citation annotations in the country report.

  1. 1Arizona SB 1726
  2. 2CMS esketamine billing article A59249
  3. 3Colorado Natural Medicine Programme
  4. 4Compass Pathways COMP006 Phase 3 announcement
  5. 5Compass Pathways rolling NDA review announcement
  6. 6DC Law 23-268
  7. 7eCFR 21 CFR 1308.11
  8. 8eCFR 21 CFR 1308.13
  9. 9FDA ketamine therapeutic interest page
  10. 10FDA Lykos midomafetamine briefing document
  11. 11FDA psychedelic clinical investigation guidance
  12. 12FDA serious mental illness treatment announcement
  13. 13FDA SPRAVATO label
  14. 14Johns Hopkins psychedelics research
  15. 15New Mexico Medical Psilocybin Program
  16. 16NIDA psychedelics and dissociative drugs page
  17. 17NYU Langone Center for Psychedelic Medicine
  18. 18Oregon Psilocybin Services
  19. 19Oregon Psilocybin Services Data Dashboard
  20. 20Research Advisory Panel of California
  21. 21Texas SB 2308
  22. 22Utah HB 390
  23. 23VA intranasal esketamine national protocol

Country Details

Region
North America
Last updated
18 May 2026

Country Report

Mixed: esketamine/ketamine access, trials, and state-specific programmes

Medical Access and Reimbursement

Esketamine nasal spray is the clearest nationally reimbursable psychiatric access pathway, with SPRAVATO administered under a REMS in certified healthcare settings. Off-label racemic ketamine is widely available in private clinics, but insurance coverage is inconsistent and compounded products carry...

Open access guide →

External Policy Trackers

Find more information on state law and bill discovery from our friends at Psychedelic Alpha.