Funding for Arizona's first magic mushrooms study in danger

For decades, some advocates have believed psychedelic mushrooms — and specifically their active ingredient, psilocybin — could provide useful treatments for a variety of conditions. Until recently, though, it’s been incredibly difficult to secure government permission to test such claims.

This year, the Scottsdale Research Institute plans to lead the first government-funded human trial to study the effect of whole psilocybin mushrooms on the treatment of life-threatening illnesses. But, because nothing with such endeavors has ever been easy, the study is now in danger of losing its funding.

The triple-blind study — meaning no one involved will know which participants receive which doses until after each phase of the study is complete — will be carried out in two parts and will include 24 participants, each of whom will receive either an active dose of psilocybin mushrooms or a placebo. Most notably, it was to be funded by a grant of $5 million from the Arizona Department of Health Services that was awarded on Feb. 21.

Another portion of the grant went to the University of Arizona College of Medicine to study the effect of psilocybin mushrooms as a treatment for severe OCD.

However, the grant stipulates that SRI will receive no reimbursement after June 30, when the current state budget for fiscal year 2024 ends. Funding for the project is unlikely to come from the fiscal year 2025 budget that lawmakers are currently negotiating as the state scrambles to cut spending in the wake of a $1.3 billion budget deficit.

Funding issues

Speaking to Phoenix New Times, John Lenstrohm, the board chairman at SRI, expressed concern that funding for the study would not be included in the budget for the next fiscal year. But he suggested a possible financing alternative in the opioid settlement funding distributed to Arizona.

In 2021, Arizona was allocated $1.14 billion in settlement funds resulting from lawsuits against pharmaceutical companies that played a role in the opioid epidemic. The money can be awarded to recipients who present an application to use it for “opioid education, rehabilitative resources, evidence-based harm reduction strategies, prison and jail opioid programs,” according to the One Arizona Agreement, the pact state and local governments reached to disburse settlement funds.

Sue Sisley, the founder and executive director of SRI, expressed her intent to apply for that funding, though some of the settlement money has gone to test other treatment drugs, such as Suboxone and methadone, and not for psilocybin. Last year, SRI applied for similar opioid settlement funds from the Maricopa County Public Health Department — for a Suboxone treatment study, not the psilocybin one —– but was denied.

“What better use of opioid funds than to do research on psilocybin mushroom data to keep people off opioids,” Lenstrohm said.

Lenstrohm and Sisley both mentioned another avenue to revive their funding in the state legislature’s House Bill 2105, which would preserve their current grant funding through July 1, 2026. They expressed some hope in the bill and its prime sponsor, Republican Rep. Kevin Payne, but no action has been taken on the proposed law since January of this year.

How the study will work

If SRI’s study does get off the ground, it will be a first of its kind. Though other states, such as Oregon in 2020 and Colorado in 2022, have decriminalized the use of psilocybin mushrooms in controlled settings, the Arizona trial will be the first to study the effects of whole psilocybin mushrooms rather than synthetic molecules. Oregon, which began opening its licensed psilocybin mushroom therapy centers in 2023, uses a synthetic molecule and not a psilocybin mushroom itself.

Sisley said that by using the whole mushroom, SRI hopes to obtain a fuller picture of psilocybin’s treatment potential. Using just synthetic molecules, she said, “takes some intelligence from the mushroom but leaves the wisdom behind.”

Sisley hopes to begin the study before the end of the year, though the study itself must pass through government hoops before it can be fully approved. The Food and Drug Administration, Institutional Review Board and Drug Enforcement Administration all will need to sign off.

A crucial element is proper dosing, Sisley said. The study will start when SRI receives the approved psilocybin mushrooms from the DEA. The composition of each mushroom must be approved by a qualified laboratory to ensure even dosing.

“That’s really the problem with real-world mushrooms — they’re alive,” Sisley said. “The potency changes.”

Part one of the study will take place over two days. Twenty-four participants will be selected, many through referrals from mental health professionals and also via responses to advertisements SRI will disseminate. All will have life-threatening illnesses, which Sisely said includes hospice patients, veterans with PTSD and those at risk of suicide or fatal overdoses due to drug addiction.

Half of the study’s participants will be given 2.5 grams of active psilocybin mushrooms that have been dried, ground and baked into a piece of chocolate. The other 12 will be given a placebo dose also in chocolate form. Each group will ingest the chocolate during a symbolic ceremony “in which intentions are set,” according to a protocol for the trial released by SRI. A facilitator will assess each participant’s vital signs and behavior.

The next day, the participants will meet individually with a facilitator to determine whether they should continue to the study’s second phase, which begins a month later. During this meeting, the participant will be given the opportunity to discuss their thoughts, feelings and experiences from the day prior. They will review mindfulness techniques and discuss how the experience can be integrated into the participant’s life.

In the second phase, those who received the 2.5-gram dose the first time around either will receive 2.5 grams again or 5 grams of mushrooms. Those who were given placebos will receive 2.5 grams of mushrooms. Then, the same ceremony and assessment will take place, after which the facilitators will review their observations.

Participants will return for follow-up sessions one and three months after the second phase of the study. During these follow-ups, they will complete questionnaires to evaluate their mental health, current substance use, long-term anxiety and any change in therapy or medication.

From the results, researchers will evaluate overall changes in physical characteristics such as vital signs and lab tests. Any change in anxiety, existential distress, depression, pain rating scale, suicide severity rating and quality of life will be evaluated within the experimental participants against the results of the placebo group.

Including the prescreening and patient-selection process, the trial will last about six and a half months.