Could ibogaine help treat brain injuries? MAPS rebrands its for-profit company; New year, new bills in AZ and RI
Plus: VA announces psychedelic funding, and are mushroom spores legal?
Happy Friday and welcome back to The Microdose, an independent journalism newsletter brought to you by the U.C. Berkeley Center for the Science of Psychedelics.
Could ibogaine help treat brain injuries?
Ibogaine is a psychoactive substance found in plants like the iboga bush; it’s a Schedule I drug in the U.S., but in some countries, like Mexico, the Netherlands, and Costa Rica, it is not illegal, and has been used to treat addiction. According to a recent Nature Medicine study, it might also help treat mild to moderate brain injuries. In the study, 30 U.S. Special Operations Forces veterans with mild to moderate traumatic brain injuries attended an ibogaine retreat in Mexico. The study was conducted by researchers from Stanford in collaboration with researchers at Ambio Life Sciences, a Canadian-based psychedelic company which runs the Mexico retreat center. It was paid for by philanthropic donors including the Sergey Brin Family Foundation. The participants were organized by VETS, an organization that connects Special Operations veterans with psychedelic retreats and resources. (For more about VETS, read our interview with co-founder Amber Capone.)
The researchers reported that in the few days after participating in an ibogaine ceremony, participants’ self-reported levels of disability decreased significantly and those changes remained a month after the ceremony. Participants’ scores on tests of depression, PTSD, and anxiety — issues that often accompany traumatic brain injuries or TBIs, especially those sustained in combat — also decreased significantly.
This study is an exploratory study, not a randomized controlled trial, and the researchers write that “we cannot exclude the possibility that the therapeutic benefits were a result of expectancy.” (Subject-expectancy effects can occur when a research participant expects a particular result, thereby unconsciously affecting the outcome.) Nevertheless, they write, “given the alarming rates of suicide in veterans, as well as evidence that military-related TBI increases the risk of suicide in veterans (as TBI also does in the general population), the substantial reduction in [suicidal ideation] that we observed—which must be interpreted cautiously as an exploratory analysis—is noteworthy.” Moreover, the study suggests that some adverse effects of ibogaine — which can cause serious cardiac issues — may be managed in part by detailed screening of participants and administering ibogaine together with magnesium sulfate, which appears to mitigate the drug’s effects on the heart.
MAPS rebrands its for-profit company as Lykos Therapeutics
The Multidisciplinary Association for Psychedelic Science, or MAPS, has been at the center of the psychedelics movement for decades. The organization started as a non-profit and has long espoused a vision of bringing psychedelic medicine to the masses. In 2014, MAPS established a for-profit subsidiary known as the MAPS Public Benefit Corporation (or MAPS PBC, or MPBC), which was tasked with bringing MDMA to market while remaining fully owned by the non-profit MAPS. But last Friday, MAPS announced some major changes: the for-profit company is now called Lykos Therapeutics, and instead of being fully owned by the non-profit MAPS, other investors now hold shares in the company.
Lykos, the press release said, has now raised more than $100 million from investors including the Steven & Alexandra Cohen Foundation (the Cohens own the New York Mets), venture capital firm Vine Ventures, and Satori Neuro, a mental health investment firm that has also invested in psychedelics companies such as Beckley Waves. MAPS remains Lykos’s single largest shareholder and holds less than half of its stock, and it can appoint six of the company’s eight board positions.
In a letter to MAPS supporters, founder Rick Doblin, who remains on Lykos’s board, expressed the mix of emotions he felt in establishing Lykos. For the last few years, the non-profit had been trying to drum up donations, but ultimately it could not raise enough to cover the costs of bringing MDMA to market. “My dream was to develop MDMA-assisted therapy entirely with philanthropic funds,” he said, regarding his hope that MAPS PBC would have remained fully owned by the non-profit MAPS. “Despite my best-sustained effort for several years, I failed to inspire enough philanthropists to donate the ever-increasing millions of dollars required to both obtain FDA approval and to build the infrastructure needed for patient access, especially since there were many newly created investment opportunities in the psychedelic ecosystem.” Moving forward, Lykos awaits word from the U.S. Food and Drug Administration about its New Drug Application to use MDMA in treating PTSD, and Doblin says MAPS is interested in studying other psychedelics, including ibogaine.
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The State of Psychedelics: New year, new bills in AZ and RI
Last May, legislators in Arizona passed an appropriations bill that included $5 million for psilocybin research grants and created a psilocybin research advisory council. But that bill didn’t include language allowing the state’s Department of Health Services to distribute the money to research grantees over a multi-year period, meaning grantees would have to spend the money by July 1 or grants would revert to the state’s general fund. Given the slow pace of approvals and planning in clinical research, that timeline would be unrealistic.
Now, state legislator Kevin Payne has introduced House Bill 2105, which tries to amend the 2023 bill so that the psilocybin council can more effectively spend that $5 million in grants. Sue Sisley, a member of the advisory council, told The Arizona Republic that the odds of the bill’s success were “slim to none” but that the grant funding could still cover the administrative costs that researchers accrue in the early stages of their work.
Rhode Island representatives have introduced H 7047, which would amend current drug laws in the state for psilocybin. The amendments would allow people to cultivate and possess up to an ounce of psilocybin, and include allowances for the state’s Department of Health to approve psilocybin use if the U.S. Food and Drug Administration reschedules the drug and expands rules related to its access before July 2026.
Veterans Affairs announces psychedelic funding
Last Friday, the U.S. Department of Veterans Affairs announced a call for applications to study psychedelics, marking the first time since the 1960s that the department has supported psychedelics research. VA researchers have already conducted some research on psilocybin and MDMA by collaborating with non-profits and philanthropists, but the new call will allow those researchers to use government funds to complete their work. In particular, the department looks to fund research on psilocybin and MDMA in treating PTSD and major depression.
Are mushroom spores legal? A DEA official weighs in
Per federal law, psilocybin mushrooms are in Schedule I, making them illegal to possess. But according to a new letter from a U.S. Drug Enforcement Administration official obtained by an attorney, mushroom spores are legal, since they don’t contain psilocybin or psilocin until the germination stage of their growth. “The legal status of spores has been hotly contested over the years, and people have been convicted of crimes for selling and using spore kits,” writes attorney Rod Kight on his cannabis law website. But, he says, that doesn’t necessarily make spore kits legal. “Depending on how spore kits are marketed or used, they may fall within the definition of ‘drug paraphernalia.’”
BBC’s podcast Beyond Belief explores the intersection of spirituality, religion, and psychedelics.
Some psychedelic-assisted therapy practitioners are preparing for their sessions through practicing holotropic breathwork, which provides “a lawful taste of the therapeutic potential and pitfalls of altered states of consciousness,” according to The New York Times.
Psychedelic Alpha delves into how a California advisory panel’s recent canceled meetings have slowed approvals for research study applications that involve psychedelics.
After nine people were sent to the hospital after attending a Melbourne music festival, Australian harm reduction advocates are calling for state governments to establish and more widely implement drug testing, according to The Guardian.
Investments in psychedelic companies from Wall Street and big pharma lag behind the drugs’ popularity, The Wall Street Journal reports.
The Denver Post’s Tiney Ricciardi reports on AJNA BioSciences, a biotech firm developing psilocybin mushroom microdoses as an alternative to traditional antidepressants.
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