Ten practical suggestions for setting up a psychedelic study

Area of Science:

• Neuroscience
• Psychopharmacology
• Clinical Research

Background:

• Psychedelics show therapeutic potential for neuropsychiatric conditions.
• Schedule 1 status creates significant research barriers.
• Knowledge gaps exist regarding psychedelic treatment mechanisms.

Purpose of the Study:

• Provide practical guidance for setting up human psychedelic studies.
• Address challenges in study design, legislation, and drug sourcing.
• Facilitate investigator-initiated research in the UK and beyond.

Main Methods:

• Drawing on experience from setting up non-clinical studies in the UK.
• Offering practical advice applicable to investigator-initiated studies.
• Focusing on navigating regulatory and economic barriers.

Main Results:

• Guidance presented for study design, legislation, and drug sourcing.
• Challenges in human psychedelic research are addressed.
• Experience from UK-based non-clinical studies is leveraged.

Conclusions:

• Overcoming regulatory and economic barriers is crucial for psychedelic research.
• Practical guidance can assist researchers in establishing human studies.
• Further mechanistic studies are needed to understand psychedelic treatment effects.