Psilocybin rescheduling petition now with Department of Health and Human Services; Did ancient peoples in Greece and India partake in psychedelics?; Germany approves “compassionate use” psilocybin
Plus: Is Colorado’s next “natural medicine” ibogaine? And how important is the therapy part of psychedelic-therapy?
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.
Psilocybin rescheduling petition now in HHS’s hands
A petition to reschedule psilocybin from Schedule I — the U.S.’s most restricted drug category — to Schedule II is now in the hands of the U.S. Department of Health and Human Services, according to Washington-based attorney Kathryn Tucker.
Over the last several years, Tucker and Sunil Aggarwal, a palliative care physician at the Seattle-based integrative clinic AIMS Institute, have been seeking the right for Aggarwal to provide psilocybin to his patients as part of their health care. The first of those lawsuits — AIMS v. U.S. Drug Enforcement Administration — was filed in 2021 to seek guidance from the DEA for accessing the drug via federal Right to Try (RTT) laws, which allow terminally ill patients to try investigational drugs that haven’t yet been approved by the U.S. Food and Drug Administration. In February, the Ninth Circuit Court of Appeals effectively denied that request.
In 2022, Tucker and Aggarwal also filed a petition requesting the court review the DEA’s classification of psilocybin as a Schedule I drug, arguing instead it should be moved to the less restrictive Schedule II category. Initially, the DEA denied that petition, but in October 2023, the Ninth Circuit Court of Appeals ruled that the DEA’s rejection was inappropriate. The DEA “failed to ‘clearly indicate that it has considered the potential problem identified in the petition,’” according to the decision, which also stated that the DEA did not adequately explain why it rejected Aggarwal’s request. “We thus remand for the DEA to either clarify its pathway for denying Aggarwal’s petition or reevaluate Aggarwal’s petition,” the court concluded.
Tucker received confirmation this week from a DEA official that their petition was transmitted to the HHS on August 11, and that the agency confirmed receipt. Tucker provided a copy of this emailed confirmation to The Microdose. (We also reached out to HHS on Monday to confirm or provide comment about this development, but did not receive a response before the deadline.)
Did the ancient people of Greece and India partake in psychedelics?
For years, psychedelics enthusiasts have subscribed to the theory that human use of psychedelics goes back to the ancients. The claim is that things like the ritual drink “soma,” which was mentioned in the Bhagavad Gita, or the secret rites of the Greek cult in Eleusis involved psychedelic substances. But in a paper recently published in Psychedelic Medicine, Queen’s University religious scholars Sharday Mosurinjohn and Richard Ascough argue the evidence for these ancient uses are scant, and moreover, that continuing to assert these poorly-evidenced claims can be harmful. Those claims are “attempts to show that a relatively new practice is the old, true religion, in this case, the ‘religion with no name’ that underlies every religious tradition,” they write. “In doing so, they miss seriously relating to the many well-documented historical and living Indigenous histories of psychedelics, or seeing contemporary psychedelic practice in continuity with other, and maybe even older, nonpharmacological methods of changing consciousness.”
Germany approves “compassionate use” psilocybin
Germany’s Federal Institute for Drugs and Medical Devices has approved a compassionate use program for psilocybin, allowing licensed psychiatrists to treat patients with treatment-resistant depression. According to a press release from Berlin’s OVID Clinic, the clinic is one of two institutions in the country approved to provide treatment — the other is the Central Institute for Mental Health in Mannheim. Psilocybin will be provided by Canadian company Filament Health, which has also been providing psilocybin for Canada’s compassionate use program. But unlike Canada, German psychiatrists will be able to treat patients without first getting federal approval, according to Psychedelic Alpha — and in the future, the program will likely expand to allow more than the two existing sites.
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Is Colorado’s next “natural medicine” ibogaine?
Last week, Colorado’s Natural Medicine Advisory Board held a meeting in which they discussed the potential of adding ibogaine to the state’s natural medicine program. (State-licensed psilocybin facilitators started seeing clients several months ago.) Ibogaine is a psychoactive substance that is found in plants, including the iboga bush. According to a short statement on the Colorado Department of Regulatory Agencies’ site, the board recommended that “the state write a letter of intent to start and follow Nagoya Protocol, the state should request a waiver to the Controlled Substance[s] Act from the Federal Government to import Iboga or Ibogaine extract/powder from existing Gabon infrastructure that is Nagoya protocol compliant." The Nagoya Protocol on Access and Benefit-sharing is an international agreement developed through the United Nations, which is meant to protect Indigenous knowledge and resources. Much of the iboga used around the world is harvested in Gabon.
It will be particularly interesting to see how successful the state is in requesting a waiver to the Controlled Substances Act from the federal government to import ibogaine, a Schedule I drug. At some federal agencies — in particular, Veterans Affairs and HHS — officials have gone on record with their excitement about ibogaine. In May, U.S. Commissioner of Food and Drugs Marty Makary said that potential mental health treatments for post-combat veterans, such as ibogaine, are a “top priority” for the agency, and Veterans Affairs Secretary Doug Collins has said he’s open to exploring the use of ibogaine in treating veterans. But it is the DEA who would need to approve the Controlled Substances Act ibogaine import waiver and thus far, the agency has not indicated any interest in loosening restrictions on federally controlled substances.
How important is the therapy part of psychedelic-therapy?
The number of hours spent in psilocybin therapy is not correlated with improvement of depression symptoms, according to a meta-analysis recently published in General Hospital Psychiatry. The authors, psychologists from Stockholm, analyzed a total of 35 papers that used psilocybin-assisted therapy to treat depression, and found that effect size — the degree to which treatment was associated with lower depression scores — was not associated with the amount of therapy participants received. “Our results indicate that neither the number of therapy sessions nor the number of psilocybin doses explains the variability in effect sizes across the included studies. If anything, the results support the notion that extensive therapy may not be essential for positive effects in PAT,” the authors write.
Jasveen Sangha, a ketamine dealer charged with illegally selling the drug to late actor Matthew Perry, has agreed to plea guilty to five federal drug charges, according to the U.S. Attorney’s Office. Sangha has previously been called the “Ketamine Queen,” and while she has pled guilty to charges that she sold Perry ketamine, it’s worth noting that Perry’s death appears to be related to drowning in a hot tub after taking the drug, not an overdose of the drug itself.
The state of Alaska has officially certified the Alaska Natural Medicine Act, a ballot initiative modeled on Colorado’s Natural Medicine Program. It proposes the decriminalization of natural medicines in the state, along with the launch of a state-regulated access program. The initiative’s organizers have a year to collect roughly 34,000 signatures (10% of those who voted in the preceding general election) to qualify for the 2026 ballot.
Psychedelic Alpha’s Josh Hardman talked with psychedelic insiders about the one-year anniversary of the FDA’s decision not to approve MDMA as a drug to treat PTSD. Hardman reports that people’s thoughts on what drove the FDA’s decision ultimately fell into two categories: “issues or decisions internal to Lykos (such as those related to trial design and conduct, but also corporate decisions around communications) and those external to it (such as the ICER review process, Psymposia’s intervention, and the institutional dynamics of FDA).” Meanwhile, Doblin tells Hardman that he believes MDMA will be approved in the next 12 months if the FDA and Lykos can agree that the Phase 3 studies it submitted last year contained “no collusion or inappropriate behavior or data mismanagement.”
On Thursday, The New York Times reporters answered reader questions about psychedelics, which included “Is there a way to avoid a bad trip?”
The New York Times also profiled former Texas Governor Rick Perry and his devotion to advocating for ibogaine as a mental health treatment. “My goal is to sit down with the president and his senior staff and say, ‘Here’s what we’ve got,’” he told the newspaper. He also recounts his own experience of taking ibogaine in Mexico to treat his persistent anxiety.
Former staffers on Massachusetts’ Yes on 4 campaign — the failed 2024 ballot initiative which would have decriminalized personal use of psychedelics and created a psychedelic-assisted therapy program in the state — alleged earlier this summer that the campaign’s funds were inappropriately used. Further allegations, reported on by Noah Daly and Jack Gorsline in Lucid News, claim that nonprofit advocacy groups Heroic Hearts Project and Open Circle Alliance did not properly disclose funding sources for the campaign.
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