7 new psychedelic bills passed in one month

New Trial Data: Chronic Suicidal Ideation and Cocaine Use Disorder

• An open-label JCP pilot (n=20) of a single 25 mg psilocybin dose plus psychological support in TRD patients with chronic suicidal ideation found 75% response (≥50% MSSI reduction) and 45% full remission at week 3 (Cohen d=1.73); 70% retained zero or minimal SI at week 12. No serious adverse events; hopelessness predicted non-response. First prospective study to enroll patients specifically for chronic suicidal ideation.

• A JAMA Network Open RCT (n=40; UAB/Johns Hopkins/Karolinska) — the first controlled trial for cocaine use disorder — found single-dose psilocybin (25 mg/70 kg) plus CBT significantly increased cocaine-abstinent days, complete abstinence, and time-to-first-lapse vs. diphenhydramine placebo at 6 months. Over 80% of participants were Black and 65% earned under $20,000 annually, addressing a major demographic gap in psychedelic research; only 3 participants had prior psychedelic experience, supporting blinding validity. No approved pharmacotherapy for CUD exists.

---

Pipeline: COMPASS NDA Sections Filed; Adjunctive Psilocin; First Psychedelic CDMO IPO

• COMPASS Pathways' Q1 2026 earnings (May 13) confirm rolling NDA sections already submitted to FDA; 26-week COMP006 follow-up data expected early Q3, full submission on track for Q4. Cash stands at $466M (funded into 2028); COMPASS cites 7,300+ existing clinical sites capable of multi-hour treatment sessions as evidence of launch readiness by end-2026.

• Helus Pharma's Phase 1/2a data for HPL-003 (deuterated psilocin) showed statistically significant MDD improvement vs. placebo when dosed alongside ongoing antidepressants — no washout required. The adjunctive profile differentiates HPL-003 from standard psilocybin protocols that require antidepressant discontinuation; Helus positions it as a second- or third-line add-on pending Phase 3 confirmation.

• Optimi Health (Nasdaq: CMND) completed a 2.5M-share IPO, becoming the first psychedelic CDMO to go public in the current environment. The company supplies GMP-certified natural psilocybin ($20/capsule) and MDMA ($33.33/capsule) to Australian commercial prescribers and global trials at 2M capsules/year capacity; ibogaine manufacturing is also being pursued. The CEO cited the Trump EO as a catalyst for investor interest.

---

State Legislation: Oklahoma, Louisiana, Colorado Advance; West Virginia Vetoes

• Oklahoma's legislature passed HB 3834 (Breakthrough Therapy Act) on April 29, sending to Gov. Kevin Stitt a bill authorizing state-funded ibogaine clinical trials for SUDs, PTSD, and TBI. The bill requires developer cost-matching and FDA approval plans; medical professionals receive immunity from adverse licensing actions. Oklahoma joins Texas, Tennessee, Mississippi, and Arizona in advancing ibogaine research legislation.

• Louisiana's SB 43 passed both chambers unanimously (37–0 Senate, 97–0 House) and heads to Gov. Jeff Landry (previously reported as House-advancing in the April 30 issue — both chambers now confirmed). The bill establishes a Psychedelic-Assisted Therapy Initiative for opioid use disorder and treatment-resistant mental health conditions, covering ibogaine and psilocybin; opioid settlement funds are a potential funding source. Effective August 1 if signed.

• Colorado's legislature passed an ibogaine research study bill in its final hours (May 14), adding a state ibogaine pilot for PTSD and opioid use disorder to the existing natural medicine framework. A separate Colorado bill (SB 26-31) explicitly protects the Prop 122 community facilitator model from displacement if DEA rescheduling activates a prescription-only pathway — ensuring both access routes coexist. Both bills head to Gov. Polis.

• Minnesota's House approved a medical psilocybin research program capped at 1,000 participants in its first three years, advancing past the committee stage where passage had been considered unlikely (April 16 issue). The Senate has not scheduled a vote; proponents argue ARPA-H's EVIDENT funds could make the program cost-neutral to the state.

• West Virginia's governor vetoed two ibogaine research bills citing fiscal concerns — the sole setbacks in a month when seven psychedelic bills became law across U.S. states. Psychedelic Alpha's April roundup counted 36+ bills across 20 states with substantive activity.

• Ohio's Ibogaine Treatment Study Committee heard testimony May 13 on joining a multistate ibogaine research consortium backed by $50M in ARPA-H funds; Mississippi has already committed $5M. Ibogaine's non-patentability was cited as the core reason no pharmaceutical company will lead development; Ohio's $2B in opioid settlement funds was raised as a potential match source.

---

Rescheduling Complexity and Shifting Public Opinion

• The National Law Review analyzes that the DEA's marijuana rescheduling used a legal shortcut tied to the 1970 Single Convention on Narcotic Drugs — a pathway unavailable for psychedelics, which are governed by the 1971 Convention on Psychotropic Substances. Psychedelic rescheduling requires the full APA notice-and-comment process under Sections 811(a)/(b), relying on HHS scientific findings; slower, but likely more legally durable.

• A UC Berkeley Center for the Science of Psychedelics survey of 1,500 U.S. voters found 63% strongly support lowering barriers to study psychedelics, up from 49% in 2023 (+14 points). Support for therapeutic legalization rose from 36% to 46%; prescription access support from 29% to 41%; decriminalization held flat at ~28%. The survey was conducted April 2025, predating the Trump EO; researchers flagged that voters may interpret "therapeutic" vs. "decriminalization" differently.