Advancing the Methods to Evaluate Abuse and Dependence-Potential in Clinical Studies for CNS-Active Drugs and Novel Psychedelics
Chairs: Beatrice Setnik, PhD; Jadwiga Martynowicz, PhD
Upcoming Activity: Working Group Meeting, 21st Annual Scientific Meeting, 19-21 February 2025, Washington DC
INAUGURAL MEETING: 20th Annual Scientific Meeting, 21-23 February 2024, Washington DC – View summary, View slides
The pre-marketing evaluation of abuse and dependence potential of CNS-active drugs is an integral part of safety assessment and drug scheduling in the US, as per the Controlled Substances Act. Development of new classes of drugs with unique pharmacological attributes (i.e., psychedelics) for targeted medical use and occasional cases of discordant findings between pre-marketing abuse potential studies and real-world data, as seen with dual orexin receptor antagonists, give rise to the need to further examine methodological approaches. While most classic psychedelics will likely rely on the literature to support scheduling decisions at the time of NDA submission, new chemical entities and derivatives may require a full abuse and potential dependence evaluation. The unique pharmacology of psychedelic drugs presents the need for study design adaptation and consideration of appropriate study endpoints for human abuse potential evaluation. This workshop will focus on the key points raised during the recent meeting of the Cross-Company Abuse Liability Council and the FDA Controlled Substance Staff that warrant further discussion amongst the scientific community. The workshop will be structured to share brief presentations followed by group discussions on each topic. The goals of this working group are to continue contributing and outlining best practices in the evolving area of clinical abuse and dependence evaluation that can be shared with stakeholders and regulatory agencies.