Marion A Coe

PinneyAssociates, Inc, 4800 Montgomery Lane, Suite 400, Bethesda, MD, USA.

2 papers in the library · 39 citations · publishing 2022-2026

Papers

Psychedelic drug abuse potential assessment research for new drug applications and Controlled Substances Act scheduling

Neuropharmacology August 17, 2022 Jack E Henningfield, Marion A Coe, Roland R Griffiths et al. 34 citations

New medicines containing classic hallucinogenic and entactogenic psychedelics like psilocybin, LSD, and MDMA are being developed for psychiatric and neurological disorders. These substances are currently Schedule I under the US Controlled Substances Act (CSA) and similarly controlled globally. The CSA framework governs research, drug approval, and rescheduling; upon FDA approval, a drug containing a Schedule I substance must be rescheduled. Abuse potential research informs the eight CSA factors used for rescheduling, as well as product labeling and required risk evaluation and mitigation strategies (REMS). Standard human abuse potential studies are problematic for strong hallucinogens like psilocybin, so alternative strategies are discussed. Abuse-related research may also illuminate mechanisms of action, therapeutic effects, and effects on brain, behavior, mood, spirituality, and consciousness.

DOI: 10.1016/j.neuropharm.2022.109220 Clinical study design Consciousness Controlled substance regulation Drug scheduling +9

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

Journal of psychopharmacology (Oxford, England) January 1, 2026 Jack E Henningfield, Sandra D Comer, Matthew L Banks et al. 5 citations

A panel of abuse potential experts convened to discuss challenges in assessing the abuse potential of novel drugs, especially psychedelics and cannabinoids. The U.S. Controlled Substances Act scheduling process, intended to balance public safety with medicinal access, can be overly restrictive when abuse potential is overestimated, as postmarketing evaluations have suggested for some substances. Existing methods recommended by the FDA are generally reliable for many drug categories but require modifications—such as behavioral economic assessments and broader outcome measures in human abuse potential studies—to accurately characterize newer agents. The commentary emphasizes the need for updated approaches to ensure valid scheduling decisions that protect public health without hindering access to beneficial medicines.

DOI: 10.1177/02698811251378511 Full text Abuse potential Novel drugs Psychedelic