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Dominic Chiapperino

Controlled Substance Staff, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, 20910, USA.

2 papers in the library · 15 citations · publishing 0-2022

Papers

Considerations in assessing the abuse potential of psychedelics during drug development

Neuropharmacology November 28, 2022 Steven Galati, Dominic Chiapperino, Silvia N. Calderon et al. 14 citations

The abuse potential of classic psychedelics—serotonergic 5-HT2A agonists such as psilocybin—has not been systematically assessed using modern methods since they were placed in Schedule I of the Controlled Substances Act in 1970. This paper reviews the scientific evaluation of their abuse potential and outlines the data required to support a rescheduling recommendation if a classic psychedelic drug product receives FDA approval. The authors argue that renewed clinical research necessitates revisiting these drugs' regulatory classification, given that Schedule I status assumes high abuse potential and no accepted medical use, a designation that may no longer align with current evidence.

A Pilot, Dose-Finding, Pharmacodynamic and Pharmacokinetic Study of Orally Administered Botanical Kratom.

Journal of clinical psychopharmacology Chad J Reissig, Ling Chen, Srikanth C Nallani et al. 1 citation

A single dose of kratom, a plant from Southeast Asia, produced some opioid-like effects in recreational polydrug users with opioid experience. In a double-blind, placebo-controlled study with 40 participants, kratom at doses of 3 grams or more caused pupil constriction, and the 12 gram dose increased ratings of drug liking, good effects, and high. No deaths or serious adverse events occurred; the most common side effects were somnolence, vomiting, and nausea. The findings suggest kratom can produce effects associated with drugs of abuse, but results may not apply to other kratom products.