A new federal funding opportunity from the National Institutes of Health (NIH) will use $8.4 million to support clinical trials on the safety and efficacy of psychedelic-assisted therapy to treat chronic pain in older adults.
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An NIH notice of funding opportunity posted on Wednesday says the research can include “classic” psychedelics—including psilocybin, DMT, LSD and mescaline—as well as similar compounds such as MDMA. Cannabis and ketamine are not considered psychedelics for the purposes of the clinical trials.
“Approximately 40% of older Americans report living with chronic pain,” the funding notice says, with treatment of pain later in life—involving acetaminophen, NSAIDs, opioids and other drugs, along with behavioral therapy, physical activity, acupuncture and electrical stimulation— being “complex and often inadequate.”
“A potential novel approach to treatment of chronic pain in adults involves psychedelic-assisted therapy (PAT),” it continues. “Research with psychedelics was inspired by millennia of Indigenous experience incorporating sacred plant medicines in ceremonial healing practices.”
More recently, the notice says, “Evidence for the efficacy of PAT has been particularly notable in depression, anxiety (especially existential distress), post-traumatic stress disorder (PTSD), and substance use disorders, among other indications.”
The grant, which will be overseen by NIH component agencies the National Institute on Aging (NIA) and the National Center for Complementary and Integrative Health (NCCIH), will award up to $3.4 million per year in fiscal 2025–2026 and up to $5 million per year in fiscal 2027–2029. The broad range of eligible organizations includes colleges and universities, nonprofits, for-profit businesses, state or local governments, federal agencies and others, such as school districts or tribal organizations.
The new funding is aimed at supporting a “clinical trials network involving multiple institutions collecting safety and early efficacy data” among older people with chronic pain.
“The first phase will involve safety and efficacy study in older adults, and the second phase will involve expanded safety and efficacy studies in older adults with chronic pain conditions,”
the NIH posting says. “This funding structure is expected to lead to a higher level of collaboration, planning, and harmonization than would be possible through multiple individually funded grants.”
The federal agency notes that while “previous studies of PAT have included limited numbers of older adults who have tolerated treatment well without significant adverse effects, more focused safety and efficacy studies in older adults are needed.”
Applications for the new grant money can be submitted as of September 10. The application window will close a month later, on October 10. The earliest start date for the work is set for July 2025.
Recently, a separate study published by the American Medical Association found that single-dose psilocybin use was “not associated with risk of paranoia,” while other adverse effects such as headaches are generally “tolerable and resolved within 48 hours.”
That study, published in JAMA Psychiatry earlier this month, involved a meta-analysis of double-blind clinical trials where psilocybin was used to treat anxiety and depression from 1966 to last year.
AMA published a separate study last month that similarly contradicted commonly held beliefs about the potential risks of psychedelics use, finding the substances “may be associated with lower rates of psychotic symptoms among adolescents.”
Also, result of a clinical trial published by AMA in December “suggest efficacy and safety” of psilocybin-assisted psychotherapy for treatment of bipolar II disorder, a mental health condition often associated with debilitating and difficult-to-treat depressive episodes.
The association also published research last August that found people with major depression experienced “clinically significant sustained reduction” in their symptoms after just one dose of psilocybin.
Another recent study suggests that the use of full-spectrum psychedelic mushroom extract has a more powerful effect than chemically synthesized psilocybin alone, which could have implications for psychedelic-assisted therapy. The findings imply that the experience of entheogenic mushrooms may involve a so-called “entourage effect” similar to what’s observed with cannabis and its many components
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