Events & Ideas

In response to the Congressional Request for Information (RFI) issued by the bipartisan Psychedelic-Assisted Therapy to Heal (PATH) Caucus, a wide range of responders provided input including medical professionals, researchers, veterans’ advocates, medicinal developers, Indigenous leaders, community organizations, payors, state regulatory bodies, and patients. Their wide-ranging comments provide insights into how psychedelic-assisted therapy (PAT) could… Read More

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 volunteers… 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 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

Bradford RD, Farnsworth SJ, Laurora I, Sober S, Guillard H, Glasier A, Shiffman S. Contraception 112 (2022) 48–53. https://doi.org/10.1016/j.contraception.2022.04.006 Objectives: To measure adherence over six months of progestin-only pill (POP) use. Study Design: Prospective observational cohort study measuring adherence to daily dosing and timing of dose in patients prescribed a POP, with up to six… Read More