Understanding variability in psychedelic treatment responses

The US National Institute on Drug Abuse (NIDA) has earmarked $2 million in funding for psychedelic treatment research into Substance Use Disorder (SUD).

NIDA will commit the funds to three to five awards with a budget of $2 million per year. The NIDA Notice of Funding Opportunity has been made available under the UG3/UH3 Phased Innovation Awards Cooperative Agreement.

The funding will go toward research that explores the development of classic psychedelics such as psilocybin and LSD, empathogens like MDMA, dissociatives such as ketamine, and other hallucinogens for the treatment of SUD.

The NOFO is calling for applications that focus on preclinical and clinical research to evaluate the safety and efficacy of psychedelics in treating various substance use disorders, excluding alcohol and studies that do not include a behavioral treatment component.

Research that will be considered includes those which explore lead compound optimisation, drug-delivery technology, preclinical drug interaction studies and clinical development phases.

Some of objectives of the research may include addressing neuropathological mechanisms, medical/psychiatric complications associated with different SUDs, pharmacokinetics, toxicological properties, and more.

NIDA has confirmed that the UG3/UH3 grant mechanism will be employed, requiring applicants to provide clear milestones for the UG3 phase at two years. Successful completion of these milestones will determine funding decisions for the UH3 phase.

Milestones for research that will be considered could include identifying lead candidates, filing Investigational New Drug applications, completing clinical studies, and obtaining FDA agreements on study endpoints.

Submissions will be open for one month, starting on 28 January, 2024, with a letter of intent due on the same day, and closing on 28 February, 2024. Early submissions are encouraged to allow time for corrections.

The anticipated start date for successful applicants is December 2024, with an expiration date of February 29, 2024.

Find out more: grants.nih.gov/grants/guide/rfa-files/RFA-DA-25-058.html

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