Psychedelic drug abuse potential assessment for new drug applications and controlled substance scheduling: A United States perspective
Journal of Psychopharmacology January 1, 2023 Jack E Henningfield, Judy Ashworth, David J Heal et al. 13 citations
Psychedelics present unique challenges for abuse potential assessment due to their distinct pharmacological profiles: entactogens act as weak reinforcers and hallucinogens as non-reinforcers, requiring more flexible approaches than standard regulatory guidelines. Standard nonclinical techniques like receptor binding and physical dependence tests adapt easily, while human abuse trials need modification because supratherapeutic doses may be unsafe and safety monitoring procedures can bias outcomes. Existing knowledge varies widely, from extensive data on psilocybin to none for novel compounds. Many assessments can be applied to animals and humans without compromising scientific integrity, but human abuse studies merit reconsideration to ensure safety and validity. Other methods can evaluate pharmacological equivalence to known drugs of abuse to guide scheduling.