The TDR Three Key Takeaways regarding NIH Initiative on Psychedelic Therapy:
- Federal backing of psychedelic research marks a shift in policy.
- NIH to conduct extensive trials on psychedelics’ efficacy and safety.
- NIH initiative could transform treatment paradigms for chronic pain.
This week, the National Institutes of Health (NIH) announced an initiative to fund research into the use of psychedelics for treating chronic pain in older adults. Despite the Drug Enforcement Administration’s (DEA) resistance to allowing terminally ill patients the right to try experimental treatments, this NIH program, supported by federal funds, aims to explore the potential benefits of psychedelic-assisted therapy (PAT) for this group.
The NIH’s Notice of Funding Opportunity (NOFO) introduces a two-phase UG3/UH3 Exploratory/Developmental Phased Award Cooperative Agreement. The primary goal is to establish a clinical trials network that will assess the safety and preliminary efficacy of PAT in older individuals with specific chronic pain conditions. This initiative presents a significant governmental effort into psychedelic research, differing from other government positions.
The first phase of the program will span up to two years, focusing on initial studies to evaluate the safety, pharmacokinetics, and pharmacodynamics of various psychedelic agents, excluding cannabis and ketamine. These studies will begin to test the components of PAT on healthy older adults. The subsequent phase, lasting up to three years, will expand these studies to include older adults with chronic pain, particularly those with co-occurring conditions typical of this age group.
This detailed exploration aims to provide robust safety and efficacy data, investigate different dosing strategies and therapeutic environments, and measure clinical outcomes relevant to chronic pain and overall health. Additionally, the trials are designed to ensure diverse representation among participants in terms of age, race, ethnicity, and gender. A key component of this initiative is the establishment of a coordinating center to oversee consortium activities, with the transition from UG3 to UH3 contingent upon meeting specific milestones including safety outcomes and participant enrollment.
Interestingly, the NIH has scheduled a pre-application webinar to address any questions prospective applicants might have, emphasizing the agency’s commitment to inclusivity and meticulous management of clinical research through the Clinical Research Operations & Management System (CROMS).
Despite the promising nature of this research, it occurs against a backdrop of bureaucratic inconsistency. On one hand, the NIH is advancing innovative research on psychedelics, while on the other, the DEA maintains restrictive policies that limit access to these potentially transformative therapies for those at the end of their lives. This dichotomy not only highlights the complex interaction between different government functions but also underscores the ongoing debate regarding the role of psychedelic in medicine and therapy.It is important to monitor how research influences regulatory policies and public attitudes towards psychedelics’ therapeutic uses. The NIH’s initiative represents a significant step towards integrating psychedelics into mainstream medicine, aiming to enhance life quality for older adults with chronic pain.Want to keep up to date with all of TDR’s research and news, subscribe to our daily Baked In newsletter.