The Food and Drug Administration (FDA) is seeking public input on how to design research on the potential therapeutic benefits of the psychedelic ibogaine.
The agency’s request for information (RFI), released on Monday, seeks comments and data in four main areas:
General study design, including appropriate patient populations; Dose selection and escalation, including the proposed use of small, sequential dose-ascending groups and a starting dose justified by available data and not exceeding 10 mg/kg; Safety considerations, including monitoring for cardiac and neurologic adverse events and other safeguards for clinical trials; and Ethical and oversight considerations, including informed consent and appropriate independent safety oversight.
The RFI comes months after President Donald Trump signed a psychedelics executive order aimed at streamlining research on and access to substances such as ibogaine and psilocybin.
“Patients facing serious conditions that have not responded to existing treatments deserve rigorous scientific investigation of promising new approaches,” Michael Davis, director of FDA’s Center for Drug Evaluation and Research, said. “With ibogaine, there are important scientific questions as well as serious safety concerns. We are seeking high-quality data and input that can help inform clinical research while putting patient safety first.”
FDA is seeking public
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