Taking expectancy effects seriously; Australian psychedelic practitioners call for regulatory reform; New psilocybin grants in Arizona
Plus: Six counties and cities in Washington push decriminalization efforts; out-of-state clientele and rules amendments in Oregon; challenges to Massachusetts ballot initiative
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.
Taking expectancy effects seriously
In September, Nature Medicine published results from MAPP2, MAPS’s second phase 3 clinical trial investigating the efficacy of MDMA-assisted therapy in treating PTSD — an important step forward in MAPS’s goal of receiving approval from the U.S. Food and Drug Administration for MDMA. (The FDA typically considers applications for new drugs after numerous steps and studies, including three phases of clinical trials with human subjects.) This week, three researchers published commentary in ACS Chemical Neuroscience pointing out what they view as shortcomings in MAPP2’s methodology to measure expectancy effects. Such effects, the authors write, “typically occur when participants in a clinical trial identify which treatment arm they were assigned to and subsequently expect symptom alleviation if they are in the treatment group (i.e., placebo effects) or symptom worsening if they are in the control group (i.e., nocebo effects).” In other words, if people know they got the drug, they may report feeling better in part because they expect to feel better - a well-known and studied phenomenon. If they know they got the non-drug placebo, they could report feeling worse because they would be able to deduce that they didn’t get the active drug. Few psychedelics studies with human subjects measure expectations or assess the efficacy of blinding, which has prompted recent discussion among researchers.
While MAPP2 researchers reported that expectancy effects were mitigated in their study, the authors of this commentary say the MAPS researchers’ methodology did not include measurements that would probe participants’ expectations and those expectations’ effect on results. “The simple message is measure more and report more!” they write. “We need measurements of expectations and blinding not only at the end of the trial but throughout the different phases of the study.”
Australian psychedelic practitioners call for regulatory reform
Earlier this week, the Australian Multidisciplinary Association of Psychedelic Practitioners (AMAPP), a 160-member non-profit group, published a press release calling for a “comprehensive review” of the country’s recent policy changes that allow authorized psychiatrists to prescribe MDMA and psilocybin. “The current regulatory system is virtually unworkable, overly cautious and cumbersome and needs to evolve with the help and input from those practitioners who have appropriate knowledge and experience working in the psychedelic field,” said Anthony Bloch, AMAPP’s chairman. The organization calls on the relevant government agencies, academic researchers, and other professionals to discuss changes that would make current regulations less cumbersome, as well as set standards for “appropriate advertising, clinic locations and types, the need for uniform national standards, as well as the future collection of accurate treatment and research data.”
Want the latest psychedelics news? Subscribe! (It’s free!)
State of Psychedelics: New psilocybin grants in Arizona; Six counties and cities in Washington plan decriminalization efforts
In May, Arizona legislators passed SB 1720, an appropriations bill that provides $5 million for psilocybin research and establishes a psilocybin research advisory council. This week, that council met for the first time and announced that they would be opening submissions for grants at the end of December. According to a bulletin, the council will be considering grants that investigate the use of psilocybin to treat PTSD, long COVID, depression, anxiety, end-of-life distress, substance abuse, obsessive compulsive disorder, eating disorders, autoimmune and inflammatory disorders, degenerative disorders, and seizures. According to the bulletin, trials that use “veterans, first responders, frontline health care workers, and persons from underserved communities” will receive priority. But Axios reports that at the meeting, an official told the council they may need grantees to spend their funds before the state’s fiscal deadline, June 30 — which may be all but impossible given the often months-long logistical timeframe to begin clinical trials.
Advocates in Washington are preparing to launch campaigns for decriminalization measures in six local areas, reports Marijuana Moment. The Psychedelic Medicine Alliance of Washington told the drug policy site that they have begun drafting legislation for King County (home to Seattle), Olympia, San Juan County, Spokane, Bellingham, and Tacoma.
The Latest in Oregon: Out-of-state clientele and rules amendments
According to owners of Oregon psilocybin centers, a majority of clientele come from out of state to take psilocybin. Official demographic data about clients is not publicly available, but Oregon Public Broadcasting spoke with owners of several psilocybin businesses, one of whom estimated that 80 percent of his clientele are not Oregonians.
Meanwhile, some psilocybin services industry workers are pushing for amendments to the state’s rules on data collection. As the Oregon Health Authority collects public comment on their proposed rule changes, the Oregon Psilocybin Services Collaborative Community is calling on the agency to clarify clients’ rights to opt out of data collection and requesting that the state explicitly prohibit any entity that obtains client data from monetizing it.
Challenges to Massachusetts ballot initiative
In early November, we reported that the team seeking to introduce the Natural Psychedelic Substances Act in Massachusetts had collected more than 75,000 signatures, qualifying the initiative to advance to the state legislature for consideration in the state’s 2024 election. Two weeks later, Boston’s WBUR reported that thousands of gathered signatures might be invalidated, threatening the initiative’s chances of advancing — some ballot sheets were printed on paper bearing a labor union logo, which violates state signature-gathering regulations. However, the group was able to collect another 100,000 signatures in the following two weeks. “Although we hit a bump in the road, this gave us an opportunity to talk with even more Massachusetts residents, and there are a lot of people who want to see this on the ballot,” said Jared Moffat, deputy policy director at New Approach, the political action committee supporting the ballot initiative.
The initiative now faces challenges from local activists. In a press release, Bay Staters for Natural Medicine (BSNM) alleged that campaign canvassers misrepresented the ballot initiative when collecting signatures. New Approach denies the allegation. “The people who worked on gathering signatures are passionate about the issue. They are also thoroughly trained and educated about what the initiative does,” Moffat says. “They are not complete experts on the policy, though, and sometimes they may not know or forget specific details.”
In BSNM’s release, the group also announced their plans to try to amend the Natural Psychedelic Substances Act if it advances to the Massachusetts legislature for consideration. The text of their proposed amendment replaces the 27-page act — which would establish a commission to oversee regulated access to psilocybin, a tax structure for that program, and personal use allowances, among other things — with a single-page proposal that would make it state-legal for people over 18 to possess, ingest, obtain, grow, or give away (without financial gain) psychedelics, and establish basic rules outlining the licensing of trained psilocybin facilitators.
BSNM’s communications director Colomba Klenner told The Microdose that New Approach was “aware of our specific concerns,” and that the organizations have been in regular contact. However, New Approach’s Moffat said the organization has not heard from BSNM about these amendments. “This is the first time I have seen their proposed substitute,” Moffat said. Initially, BSNM publicly supported the ballot initiative; Moffat says he’s “eager to work collaboratively with them (and anyone) to identify potential improvements to the policy.”
Bloomberg profiles the environmentalists who believe psychedelics could help inspire more people to care about nature.
Psychedelic hype “leaves the public—especially vulnerable people who are desperate to find treatments that work—unaware of the potential risks and harms that can result from psychedelic use,” according to The Daily Beast.
Researchers who study psychosis are looking to psychedelics research for clues, writes a philosopher and medical ethicist in an essay for Aeon.
VICE highlights efforts to bring Israelis and Palestinians together through ayahuasca ceremonies.
“Policy reactions to illegal recreational drugs often fall within two categories: ignore the reality and hope the stories simply disappear; or overreact, executing ineffective and costly raids that do little to dissuade store owners (all while promising medical access that takes far too long to transpire). At present, the government appears to be missing the mark on both ends,” writes University of Toronto public health researcher Daniel Eisenkraft Klein in a piece in The Conversation about Canadian authorities’ recent raids of mushroom dispensaries.
Psychedelic company Beckley Waves just acquired online ketamine therapy company Nue Life; Lucid News spoke with Beckley’s co-founder Daniel Love about what the merger means for the psychedelics industry at large.
Advocates in Alaska are trying to raise awareness about the potential of psychedelic therapy, reports Alaska Public Media.
Looking to be a subject in a psychedelics study? The U.C. Berkeley Center for the Science of Psychedelics released a new map of global clinical trials.
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.
Got tips? Email us at email@example.com.