Abuse potential assessment of novel central nervous system active and psychedelic substances for controlled substances act scheduling recommendations

The core abuse potential methods that serve U.S. CSA scheduling and global new drug scheduling are generally reliable for many categories of drugs but need to be modified and perhaps supplemented with additional outcome measures to more fully and accurately characterize potential abuse-related risks. This may include behavioral economic assessments in preclinical and clinical studies and a broader range of outcome measures in HAP studies and adverse event assessment in all clinical studies in drug development programs.