Investigation of 5-MeO-DMT’s potential for therapeutic use

INSTITUTION: Usona Institute

PROJECT LEADERS: Theraysa Gapasin (Director, Clinical Operations), Robert Kargbo PhD (CMC Program Lead)

PROJECT DURATION: 2021-2023

LAB WEBSITE: Usona Institute

Usona Institute conducts and supports pre-clinical and clinical research to further the understanding of the therapeutic effects of psilocybin and other consciousness-expanding medicines. Our current focus is on alleviating depression in people for whom current medical treatments fall short in offering relief and a better quality of life.

5-MeO-DMT is a novel molecule recognized to have high therapeutic potential; however, to date, scientific research on this compound has been scarce. 

 As an FDA drug “sponsor”, Usona is responsible for the initiation, management, and financing of the clinical trials towards FDA new drug approval, as well as to produce cGMP drug product that is tested for safety and purity under highly controlled and monitored conditions.

Funding from Tiny Blue Dot is being used to cover the costs of a Phase 1, first-in-human, clinical trial to assess the safety, pharmacokinetics, and tolerability of single and multiple ascending doses of 5-MeO-DMT administered by intramuscular injection in healthy subjects. This study will enable future efficacy studies in a variety of mental health disorders. In parallel, the Usona team will be initiating start-up activities for a multisite Phase 2 efficacy study targeted to begin in 2023. Usona also aims to support other qualified studies that will enable broader understanding of the safety and efficacy profile of the molecule.

Broader Impact:

Early published reports point to significant therapeutic potential across multiple indications—including, depression, PTSD, substance use disorders, and traumatic brain injury. This project will be instrumental in opening the field for more rigorous scientific research as well as a path to regulatory approval. . Our aim is to enable and support research toward the goal of an FDA registration for 5-MeO-DMT as an approved medicine to improve mental health outcomes and provide an effective, affordable, and accessible option for those in need. 

Publications:

• Synthesis and Characterization of 5-MeO-DMT Succinate for Clinical Use
  Alexander M. Sherwood, Romain Claveau, Rafael Lancelotta, Kristi W. Kaylo, and Kelsey Lenoch. ACS Omega 2020 5 (49), 32067-32075. DOI: 10.1021/acsomega.0c05099.

• Clinical Consideration of 5-MeO-DMT.
  Sherwood, A.; Kaylo, K.; Kargbo, R.; Davis, A. K.; Lancelotta, R.; Uthaug, M.; Barrow, R. International Forum on Consciousness – Psychedelic Therapy and Society. 2019. 

• A single inhalation of vapor from dried toad secretion containing 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) in a naturalistic setting is related to sustained enhancement of satisfaction with life, mindfulness-related capacities, and a decrement of psychopathological symptoms.
  Uthaug MV, Lancelotta R, van Oorsouw K, Kuypers KPC, Mason N, Rak J, Šuláková A, Jurok R, Maryška M, Kuchař M, Páleníček T, Riba J, Ramaekers JG. Psychopharmacology (Berl). 2019 Sep;236(9):2653-2666. doi: 10.1007/s00213-019-05236-w. Epub 2019 Apr 13. PMID: 30982127; PMCID: PMC6695371.

• A comparison of reactivation experiences following vaporization and intramuscular injection (IM) of synthetic 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) in a naturalistic setting.
  Uthaug, M. V., Lancelotta, R., Ortiz Bernal, A. M., Davis, A. K., & Ramaekers, J. G. (2020). Journal of Psychedelic Studies, 4(2), 104-113. Retrieved Apr 8, 2022

• A narrative synthesis of research with 5-MeO-DMT.
  Ermakova AO, Dunbar F, Rucker J, Johnson MW. Journal of Psychopharmacology. 2022;36(3):273-294. doi:10.1177/02698811211050543.

• Intensity of Mystical Experiences Occasioned by 5-MeO-DMT and Comparison With a Prior Psilocybin Study
  Davis, A. K.; Barsuglia, J. P.; Lancelotta, R.; Grant, R. M.; Renn, E. J Psychopharmaco. 2018, 1-14.

• Psychedelic Treatment for Trauma-Related Psychological and Cognitive Impairment Among US Special Operations Forces Veterans
  Davis, A. K., Averill, L. A., Sepeda, N. D., Barsuglia, J. P., & Amoroso, T. (2020). Chronic Stress, 4, 2470547020939564

• Psychedelic N,N-Dimethyltryptamine and 5-Methoxy-N,N-Dimethyltryptamine Modulate Innate and Adaptive Inflammatory Responses through the Sigma-1 Receptor of Human Monocyte-Derived Dendritic Cells
  Szabo, A., Kovacs, A., Frecska, E., & Rajnavolgyi, E. (2014). PLoS ONE, 9(8).