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Colorado race heats up, Compass Phase 2b results, and Indigenous Ayahuasca Conference declaration
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This Week in Psychedelics

Colorado race heats up, Compass Phase 2b results, and Indigenous Ayahuasca Conference declaration

Plus: New Oregon Psilocybin Services rules and psychedelic-induced belief changes

jane c. hu
Nov 4, 2022
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Colorado race heats up, Compass Phase 2b results, and Indigenous Ayahuasca Conference declaration
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Happy Friday, and welcome back to The Microdose. 

The State of Psychedelics: More controversy in Colorado

Next Tuesday, Coloradoans will vote on Proposition 122, also known as the Natural Medicine Health Act, which would establish psilocybin services in the state and leave the door open to other services using other naturally occurring psychedelics in the future. The ballot initiative also reduces penalties for possession, use, and sharing of psilocybin and psilocin, DMT, ibogaine, and mescaline (but not peyote). The initiative has been contentious since its inception (for more on that, we recommend listening to the podcast Ballot Trip). 

Colorado Public Radio reports on the growing opposition to the ballot initiative. Last week, a group of thirty Colorado elected officials, including the state’s attorney general, released a statement urging voters to reject it, and a new group called Protect Colorado’s Kids has targeted voters in four counties in the Denver metro area with online ads and texts. Colorado Public Radio also reports that therapists who already provide ketamine therapy are torn about the new initiative.

Meanwhile, in WIRED, attorney Mason Marks explains how the ballot initiative could lead to the surveillance of people who use psychedelics. “The initiative requires the Department of Regulatory Agencies (DORA) to gather sensitive information about clients’ psychedelic experiences at healing centers, which would be a gold mine of psychological data unavailable elsewhere, and a tantalizing prize for advertisers and pharmaceutical companies,” Marks writes. 

The Latest in Oregon: More data privacy concerns

The data privacy concerns Marks raised in his WIRED piece also apply to Oregon’s Measure 109. The Oregon Psilocybin Advisory Board recommended adding privacy protections, like a Client Bill of Rights and a document to obtain informed consent from those seeking psilocybin services. But, Marks writes, the Oregon Health Authority (OHA) “overruled the board and deleted data protections in the Client Bill of Rights without explanation.” When Marks asked OHA whether people could decline to share their data, the agency’s communications officer declined to answer and referred to a new set of rules to be published by the agency on November 1. Those rules have now been released, and the public can provide comments on them through November 21. In a tweet, Marks points out that in those rules, OHA will deny service to those who decline to share their data.

Twitter avatar for @MasonMarksMD
Mason Marks, MD, JD @MasonMarksMD
In latest rules for #Oregon's #psilocybin program, the Health Authority (@OHAOregon) has further eroded client #privacy. It will deny service to people who choose not to share #data with third parties to be used for any purpose. Nov 1 rules: oregon.gov/oha/PH/PREVENT…
Image
11:34 PM ∙ Nov 1, 2022

 Many voters in Oregon will also be deciding on county and city-wide initiatives to ban psilocybin services as a way to opt out of Measure 109. 

There has never been a more exciting – or bewildering – time in the world of psychedelics. Don’t miss a beat.

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Compass Phase 2b results 

Last month, we reported that Compass Pathways would be starting the first Phase 3 clinical trial with psilocybin. This week, long-awaited results from Compass’s Phase 2B clinical trial with psilocybin were published in the New England Journal of Medicine. In the study, 233 participants were given a single dose of Compass’s formulation of psilocybin; roughly a third received 25mg, another third received 10mg, and a third received 1mg, a dose the researchers considered to be low enough to serve as a control. Compared with those in the lowest dose control group, participants who received 25 mg had lower depression scores three weeks later. It’s still too early to know how these results might influence whether the U.S. Food and Drug Administration could approve psilocybin as a treatment for depression. The results didn’t seem to have an immediate effect on Compass stock either; shares held steady at roughly $10, as they have for the last month.

The study was released at 5pm Eastern Time on Wednesday, and on Twitter, researchers and clinicians immediately began dissecting the results. Many, like emergency psychiatrist Tyler Black, pointed to the high rate of participants who experienced adverse effects in the study, including suicidal ideation:

Twitter avatar for @tylerblack32
Tyler Black, MD @tylerblack32
A real trial of psilocybin (not exactly placebo, but randomized!). My comments: * 77% adverse event rate is quite high * new-onset Suicidality occurred in all treatment groups * psychological support + expectation might carry a lot of this effect (not a representative sample)
Twitter avatar for @SameiHuda
Doctor Who(da) the Unretracted @SameiHuda
Single-Dose Psilocybin for a Treatment-Resistant Episode of Major Depression Comments ? ⁦@dawso007⁩ ⁦@sanilrege⁩ ⁦@sameerjauhar⁩ ⁦@Keith_Laws⁩ https://t.co/xqarEUsJEp
9:41 PM ∙ Nov 2, 2022
105Likes13Retweets

In one thread, Johns Hopkins psychiatrist Natalie Gukasyan discussed the challenges of defining what qualifies as an adverse effect:

Twitter avatar for @N_Gukasyan
Natalie Gukasyan, MD @N_Gukasyan
It's helpful to compare the rates of AE's between groups - while the high dose group had a 61% rate of AE's on session day, the rate of AE's in the placebo group (1 mg) was 38%. 3/
10:02 PM ∙ Nov 2, 2022
13Likes1Retweet

In another, psychologist Eiko Fried pointed out that the study did not assess whether participants were truly “blind” to the condition they were in:

Twitter avatar for @EikoFried
Eiko Fried @EikoFried
WHY 👏 WOULD 👏 YOU 👏 NOT 👏 ASSESS 👏 BLINDING 👏 IN 👏 A 👏 RANDOMIZED 👏 "DOUBLE-BLIND" 👏 TRIAL 👏 WHEN 👏 LACK 👏 OF 👏 BLINDING 👏 IS 👏 ONE 👏 OF 👏 THE 👏 LARGEST 👏 THREATs 👏 TO 👏 VALID 👏 INFERENCES
Twitter avatar for @eturnermd1
Erick Turner @eturnermd1
Pub today in NEJM: Single-dose psilocybin for TRD. Buried in Discussion: "We didn't assess participants’ ability 2 guess their dose assignment, & ensuring blinding is an inherent limitation of studies of drugs that produce psychedelic subjective effects." https://t.co/VjJ0JWV9pz
5:17 PM ∙ Nov 3, 2022
148Likes25Retweets

And psychiatrist Ishrat Husain raised questions for future studies:

Twitter avatar for @IshratHusain_
Ishrat Husain @IshratHusain_
...E.g., number of doses needed for sustained response? Role of expectancy? Role of psychological support? Role of the subjective psychedelic experience? Longer-term safety and efficacy? Comparison with current interventions for TRD e.g. ECT, IV ketamine...the list goes on...
9:44 PM ∙ Nov 2, 2022

Indigenous Ayahuasca Conference declaration

The fourth Indigenous Ayahuasca Conference was held last month in Marechal Thaumaturgo, Brazil, and the group published a declaration based on the conversations and takeaways from that gathering. The conference included representatives of 35 peoples indigenous to North and South America, and their declaration asserts their continued dedication to working together to preserve the cultural heritage of ayahuasca and to work against cultural appropriation and criminalization of those traditions. Several statements addressed the group’s opposition to non-Indigenous people’s approaches to psychedelics:

We demand the immediate release of people arrested for transporting and using ayahuasca in countries like Mexico and Spain, in cases where our leaders are being denounced as criminals and traffickers of illicit substances. We stand for the autonomy of indigenous peoples to handle their traditional medicines.

We do not accept patents on ayahuasca and other indigenous medicines, and we disallow any appropriation for the purpose of developing commercial products that disregard our rights related to the associated traditional knowledge. We pledge to fight to break these illegitimate patents.

Psychedelic-induced belief changes

A new study by Johns Hopkins researchers explores how psychedelic use might affect people’s beliefs about “non-physicalist beliefs,” which the researchers define as “claims that parts of reality and/or consciousness are not reducible to matter.”

The researchers surveyed over 2,000 people who reported having a belief-changing psychedelic experience. Those participants shared what type of psychedelic they took and how much they agreed with statements like “telepathy is possible” and “the universe is conscious” before and after their psychedelic experience. Participants’ acceptance of superstitious beliefs, like “the number ‘13’ is unlucky”, did not change, but in general, after a psychedelic experience, participants were more likely to say they agreed with statements about the existence of the paranormal or the possibility that plants or inanimate objects have consciousness.

  • A public trial for a wrongful death lawsuit filed against MAPS and the Zendo Project began this week, Lucid News reports.

  • Austin’s NPR station KUT covers a new research program at The Center for Psychedelic Research and Therapy at University of Texas in Austin studying how psychedelics can be used to treat not only veterans, but the spouses of those who died serving in the military.

  • Canada’s CTV news covers the first take-home psilocybin clinical trial in North America.

  • Half of psychedelic start-ups are running out of cash, according to Psychedelic Alpha.

  • Chacruna Institute and Horizons propose guidelines for ethical sponsorship and transparency in psychedelic conferences.

  • In Seattle, The Stranger’s Jas Keimig tries shroom coffee. 

You’re all caught up! Have a great weekend. We’ll be back in your inbox on Monday with a new issue of 5 Questions. 

If you know anyone who might like the latest on psychedelics in their inbox, feel free to forward this to them, or click below.

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Colorado race heats up, Compass Phase 2b results, and Indigenous Ayahuasca Conference declaration
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1 Comment
Charles Davy
Nov 4, 2022

PRI just posted results of UK study on psilocybin clinical study.

https://theworld.org/media/2022-11-03/magic-mushrooms-increasingly-show-promise-treating-depression

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