The top federal agency for health is seeking proposals to fund a series research initiatives that explore the use of psychedelics to treat drug abuse.
The National Institute on Drug Abuse published this week three Notices of Funding Opportunities (NOFOs), which are for research projects aimed at better understanding how drugs such as psilocybin or ayahuasca can help people with substance abuse disorders.
Advancing Psychedelics Research for Treating Addiction (R61/R33 Clinical Trial Required) https://t.co/kr3xqmsJGM
May 16, 2023 HTML0 — NIH funding (@NIHFunding).
All three notices have the same general objective. However, one of them would be focused on the mechanisms involved in psychedelics while the other would require clinical trials involving human subjects.
In a notice about upcoming clinical trials, NIDA stated that “Empirical tests and refinement of these overarching frameworks is necessary to move this field forward.”
The agency “is particularly interested in better understanding the types of changes to the neurobiology and networks that result in improved cognitive and emotion regulation, and sustained behavioral changes associated with the administration psychedelics.”
NIDA stressed that “modern neuroimaging tools and behavioral analytical tools” would be required for this type research to demonstrate the “changes elicited [by psychedelics].
This information would allow the field to better identify neuroplastic changes that indicate symptom improvement and design future psychedelic treatments.
Advancing Psychedelics Research for Treating Addiction (R61/R33 Basic Experimental Study with Humans Required) https://t.co/e1xdeIBlYy
HTML0 — NIH funding (@NIHFunding May 16, 2020
NIDA warned that clinical trials “may be fraught with considerable failure risk” due to the complexity of conducting such studies.
They “may lead to breakthroughs in certain areas, or the development of new techniques, agents or methodologies, or models that could have an impact on SUD Research involving psychedelics.”
NIDA provided with examples to questions that they hoped such research would answer:
- What cognitive constructs are modulated by psychoactives that may be relevant for SUD treatment?
- What changes in neurobiology, if any are facilitated by these compounds, that would account for their broad clinical potential?
- How does the network connectivity and the task-evoked activation correlate with or predict the observed effects?
- What is the role of psychedelics in changing the dynamics of brain networks? What is the relation between these changes and behavior relevant to SUD
- What are the time trajectories and dose-response relations of the neurobiological effects, cognitive and behavioral effects, of psychedelics?
- What are the effects on the 5HT2 receptor and other signaling pathways, e.g. dopaminergic?
- Can the neuroplastic effects observed in animal research be replicated in humans? These changes are responsible for the improvements in symptoms that have been observed over a long period of time.
NIDA stated that “the overarching goal of the non-clinical research opportunity is to elucidate, validate, and understand the molecular and cellular mechanisms, circuitry, and structural pathways that are underpinning the pharmacology and psychedelic compound pharmacology for treating substance abuse disorders (SUDs), and co-morbid psychiatric, neurological, and other co-morbidities.”
Advancing Psychedelics Research for Treating Addiction (R01 Clinical Trial Not Allowed) https://t.co/s55l2w7Huz
— NIH funding (@NIHFunding May 16, 2020
The funding will “support the design of chemical probes that provide mechanistic insight on biological targets modulated and pathways/targets common to SUD and psychedelics.”
The agency is interested in learning how psychedelics function on a mechanical level. There are many studies that show that substances such as psilocybin have a great deal of potential to treat addiction. Clinical trials are also ongoing that further support this. However, there are still “knowledge gaps” regarding the more fundamental question.
NIDA stated that although “classic” psychedelics are known to activate the serotonin system, different entheogens target different biological targets.
As an example, “psilocin [the active metabolite from psilocybin], LSD and DMT exhibit considerable heterogeneity of signaling that is dominated by multiple biogenic-amine receptors which are themselves linked to multiple signaling paths.”
NIDA stated that “Ayahuasca is a multi-component drug with a promiscuous pharmacology, including additional interactions with the glutamatergic, endocannabinoid, and sigma-1 receptor systems, as well as several accessory proteins involved in neurotransmission monoaminergic,”
There is not enough data on the biological mechanisms that psychedelics use to affect brain function. It is important to understand which of their many targets is responsible for therapeutic efficacy, and which is responsible for any adverse effects. Chemical biology tools and probes that have well-defined selectivity metrics will help in the systematic investigation and elucidation mechanisms of action for psychedelic compounds. The information will be necessary to rationally develop psychedelics for therapeutic purposes.”
NIDA plans to award four grants totaling $1.5 million collectively during the Fiscal Year 2024.
Applicants include non-profits, businesses for-profit, local and state governments, and federal agencies.
At a Senate Committee hearing earlier this week, NIDA Director Nora Volkow informed members that new evidence is emerging that psychedelics have “significant potential” to treat certain mental health disorders.
Last year, Sens. Brian Schatz, D-HI and Cory Booker, D-NJ, urged top federal officials to give an update on studies into the therapeutic potentials of psychedelics. They argued that federal prohibition had stymied research.
NIDA’s response to the question was that the federal prohibition made it harder to study the benefits of psychedelics and required researchers to jump through extra regulatory hoops. Volkow said previously that she hesitates personally to study Schedule I drug due to these complications.
In 2021, the director told Marijuana Moment that researchers should prioritize psychedelics research because more people will use the substances as they are exposed to studies showing their therapeutic potential.
Congress is now taking psychedelics seriously, as research and reform initiatives have been renewed. In March, bipartisan and multi-party congressional members filed an updated version to streamline federal rescheduling for “breakthrough therapies” such as psilocybin or MDMA to promote drug research.
Booker, Sen. Rand Paul, (R. KY) and Rep. Nancy Mace, (R. SC) led another bill last year, which was designed to clarify federal “Right to Try”, (RTT), laws that give seriously ill people access to Schedule I medications, such as marijuana and psychedelics, like psilocybin, and MDMA. The bill was not passed by the end the session.
The bipartisan psychedelics legislation introduced this session coincided roughly with a relaunch of a Congressional caucus dedicated to promoting research into therapeutic potential of entheogenic drugs.
Michigan Officials Move to End Pre-Employment Marijuana Tests For Government Workers
Photo elements are courtesy of carlosemmaskype, and Apollo.
The post Federal Agency Announces Funding of $1.5 Million for Research on Psychedelics to Treat Drug Addiction first appeared on Marijuana Moment.
