Events & Ideas

Background Kratom use is rising, increasing the need for safety and tolerability studies of high-quality and well-characterized kratom products in humans. Kratom’s risk–benefit ratio, recommended dose, treatment-emergent adverse events (TEAEs), abuse potential, and withdrawal require evaluation. Thus, the safety and tolerability of 4 escalating single and 15 daily dried kratom leaf powder doses in human… Read More

Kratom leaves, consumed by millions worldwide as tea or ground leaf powder, contain multiple alkaloids, with mitragynine being the most abundant and responsible for most effects. Mitragynine is a partial µ-opioid receptor agonist and competitive antagonist at κ- and δ-opioid receptors; however, unlike morphine, it does not activate the β-arrestin-2 respiratory depression pathway. Due to… Read More

Kratom is increasingly used in the United States for energy and self-management of pain and mood. While its active alkaloid, mitragynine, has partial μ-opioid receptor agonist activity, clinical data on its abuse potential remain limited. This study evaluated abuse-related outcomes following single and multiple doses of dried kratom leaf powder in healthy kratom-naive adults in… Read More

The Agriculture Improvement Act of 2018 (Farm Bill) removed hemp from the definition of marijuana in the Controlled Substances Act (CSA). This led to proliferation of CBD products available to consumers, many containing other cannabinoids that may produce psychoactive or “high” effects. Epidiolex (CBD) was approved in 2018 and initially placed in Schedule V of… Read More

Per the United States Food and Drug Administration (FDA’s) 2017 abuse potential guidance document, all drugs with central nervous system (CNS) activity under development should be evaluated for abuse potential. A full abuse potential assessment (APA) includes identifying potential abuse-related adverse events (ARAEs) in all clinical safety and efficacy studies. S1-221 is a combination cannabidiol… Read More

The present document provides an 8-FA of 7-OH according to the 1970 Controlled Substances Act. This  has been developed following the model laid out in FDA’s guidance, Assessment of the Abuse Potential of Drugs, while also taking into consideration the experience and evolution in approach to such assessments since the CSA was signed into law… Read More

Indigenous Peoples have cultivated and protected natural psychoactive medicines through ceremony, kinship, and spiritual responsibility across generations, yet their long-standing contributions have often been marginalized through extractive research, commercialization, and policy exclusion. It is Indigenous communities that have stewarded and gained expertise working with psychoactive medicines for centuries, yet they remain underrepresented within the scientific… Read More

Abuse potential assessment of drugs with central nervous system activity is a critical component of the development of new medications for regulatory filings for approval worldwide. These new drug applications typically include recommendations for scheduling status as a controlled substance, if scheduling is warranted. This commentary focuses on the approach and current issues related to… Read More