A new SAMHSA paper explains how little is known about psychedelic medicine, then instructs state mental health agencies to start building the systems to deliver it.
The report is blunt about the gaps. “The data to date does not establish efficacy at large, including for those individuals with complex conditions typically served by public behavioral health systems,” it reads. “The data does not yet establish optimal dosing, frequency of administration, or long-term trajectories.”
It goes further. The evidence does not establish whether benefits last beyond 6 to 12 months, or whether they hold “if people return to substance use, unemployment, unstable housing, or other risk factors that precipitated or exacerbated the initial condition being treated.” Trial samples run 30 to 250 participants, drawn from populations unlike the general public. No classic psychedelic has FDA approval for any indication.
That is a description of a field that has not answered its basic questions.
The same document’s policy recommendations tell states to plan now for Medicaid coverage obligations and to develop “credentialing standards, safety protocols, informed consent processes, and complaint mechanisms proactively, before psychedelic therapies are formally made available.”
SAMHSA’s rationale is that the decisions are coming regardless, and that residents are already using these substances outside clinical settings. But the paper’s own framing is that psychedelic therapy is “moving from research settings toward clinical practice faster than most observers anticipated even 5 years ago,” and that approval “may arrive soon.”
The report also supplies the reason for hurry that has nothing to do with evidence. Executive Order 14401, signed April 18, directs the FDA to hand priority review vouchers to breakthrough-designated psychedelics, cutting review from 10 to 12 months to as little as 1 to 2. It orders the Attorney General to move on rescheduling once Phase 3 wraps. It tells FDA and DEA to open a Right to Try pathway for ibogaine, a Schedule I compound in no FDA trial that carries documented cardiac deaths.
Meanwhile, the underlying science keeps getting smaller. SAMHSA cites a 24-trial meta-analysis finding no significant difference between psychedelic therapy and open-label antidepressants once unblinding was equalized. The co-first author works at UCSF’s Translational Psychedelic Research Program and expected the opposite. “What I wanted to show is that even if you compare psychedelics to open-label antidepressants, psychedelics are still much better,” Balázs Szigeti said. “Unfortunately, what we got is the opposite result, that they are the same.”
The American Medical Association created billing codes for psychedelic monitoring in January 2024. SAMHSA notes the codes “signal expectation of regulatory approval.” Nothing is approved. Nothing is reimbursable.
The infrastructure is arriving first. The evidence is supposed to catch up.