Tag: magic mushrooms

Psilocybin’s ‘Efficacy And Safety’ For Bipolar II Depression Demonstrated By American Medical Association Study

Results of a new clinical trial published by the American Medical Association “suggest efficacy and safety” of psilocybin-assisted psychotherapy for treatment of bipolar II disorder, a mental health condition often associated with debilitating and difficult-to-treat depressive episodes.

“The 15 participants in this trial had well-documented treatment-resistant BDII depression of marked severity and a lengthy duration of the current depressive episode,” authors wrote. After seven psychotherapy sessions, one involving a single dose of psilocybin, the paper says, study subjects “displayed strong and persistent antidepressant effects, with no signal of worsening mood instability or increased suicidality.”

In the nonrandomized controlled study, which was conducted at Sheppard Pratt Hospital in Baltimore, “12 patients met both response and remission criteria” at the end of a 12-week study period, the trial found, meaning that measures of the diagnosis had dropped by more than half and fell below a minimum threshold.

“The findings in this open-label nonrandomized controlled trial suggest efficacy and safety of psilocybin with psychotherapy in BDII depression.”

Patients’ self-reported quality of life scores “demonstrated similar improvements,” the study, which was funded by the biotechnology company COMPASS Pathways that develops psychedelic treatments, found. In terms of safety, metrics of suicidal ideation and mania “did not change significantly at posttreatment compared to baseline.”

The nine-author study, published on Wednesday in the journal JAMA Psychiatry, involved administering a single, 25-milligram dose of psilocybin. Patients with bipolar II disorder (BDII) met with therapists seven times—during three pre-treatment sessions, once during an “8-hour dosing day” and at three post-treatment integration sessions.

“In this study, most participants remitted rapidly (ie, within 1 week of dosing), and in most participants, remission persisted for the 12-week study duration,” the report says. “The 3 participants who restarted medication due to lack of benefit or relapse following improvement generally had poorer response throughout the trial.”

“In a sample of patients with treatment-resistant cyclical mood disorder, achieving persistent remission over a 3-month period is notable, especially given the single dosing of psilocybin,” it continues. “Further follow-up is warranted.”

Keep reading

Health Benefits Provider Will Cover Psilocybin-Assisted Therapy In States Where It’s Legal

A Massachusetts company that bills itself as “the first and only licensed provider of psychedelic health plans” announced on Tuesday that it will cover psilocybin-assisted therapy in states where it’s legal.

“Given the evidence of effectiveness seen in clinical trials in the U.S. and elsewhere, we have decided to give our employers the option of including psilocybin-assisted therapy in their benefit plans,” said Sherry Rais, CEO and co-founder of Enthea, a third-party health insurance benefits administrator. “Oregon and Colorado have already legalized the use of psilocybin, and we expect others to do so next year.”

Enthea announced earlier this year that it would cover ketamine treatment nationwide. The nonprofit previously worked with soap company Dr. Bronner’s last year to offer psychedelic-assisted therapy to workers through their employee health plans.

Enthea said this week that it plans to expand its standards of care to include adult use of psilocybin “in combination with psychotherapeutic support.” The company expects to publish the change to its provider network sometime in the first quarter of next year.

The goal, Enthea said, is to be able to cover psilocybin-assisted treatment by mid-2024.

“We have had our eye on the potential benefits of psilocybin therapy since we founded our company,” Dan Rome, Enthea’s co-founder and chief medical officer, said in a press release. “We are very encouraged by published results as well as what we hear from practicing therapists, and are confident that this brings an important new option for combating mental illness.”

Enthea has said its services will expand further to include therapies with other substances, such as MDMA, “as they are approved.”

The Food and Drug Administration (FDA) designated MDMA as a “breakthrough therapy” in 2017, and the substance is now on track for FDA consideration next year following successful Phase 3 clinical trials published in September in the journal Nature that found that MDMA-facilitated talk therapy reduced symptoms in patients with moderate to severe PTSD.

Keep reading

Bipartisan Wisconsin Lawmakers File Bill To Create Psilocybin Research Pilot Program For Military Veterans With PTSD

As marijuana reform continues to stagnate in the Wisconsin legislature, bipartisan and bicameral lawmakers have come together to introduce a new bill that would create a psilocybin research pilot program in the state.

Sens. Jesse James (R) and Dianne Hesselbein (D), as well as Reps. Nate Gustafson (R) and Clinton Anderson (D), are sponsoring the legislation, which would focus on exploring the therapeutic potential of the psychedelic in the treatment of post-traumatic stress disorder (PTSD) among veterans.

The pilot program would be facilitated through the University of Wisconsin at Madison, which already operates a multidisciplinary psychedelics research division that launched in 2021.

Veterans who are 21 and older with diagnosed treatment-resistant PTSD would be eligible to participate in the program. Psilocybin would need to be provided through existing pathways under the federal Food and Drug Administration (FDA), which has designated the psychedelic as a “breakthrough therapy.”

Keep reading

House Committee Will Consider Protecting State Medical Psilocybin Laws From Federal Interference Under New Amendment

A pair of Democratic congressmen have filed an amendment to a large-scale spending bill that would prohibit the use of federal funds to interfere with state and local laws allowing the use and sale of psilocybin for medical purposes.

Reps. Robert Garcia (D-CA) and Earl Blumenauer (D-OR) are seeking to attach the psychedelics measure to appropriations legislation covering Commerce, Justice, Science, and Related Agencies (CJS). It will be up to the House Rules Committee to determine whether the amendment will be made in order for a floor vote.

The members separately introduced standalone legislation in September to prevent federal interference in any jurisdiction that legalizes the psychedelic.

The new CJS amendment, meanwhile, states that no appropriated funds under the spending bill “may be used to prevent any State, the District of Columbia, any territory, commonwealth or possession of the United States, or any unit of local government from implementing its own laws authorizing the use, distribution, sale, possession, research, or cultivation of medical psilocybin.”

That language is similar to an existing CJS rider that has been annually renewed each year since 2014 prohibiting the use of federal funds to interfere in state medical marijuana programs. Efforts to expand that protection to cover adult-use cannabis laws have passed the House on several occasions but have never been enacted into law.

“I just think that there’s an opportunity to have a more progressive worldview on legalization and on [preventing] harm to people that are, in many ways, receiving huge medicinal benefits or recreational benefits” from cannabis and psychedelics, Garcia told Marijuana Moment in a phone interview on Tuesday before the psilocybin amendment was publicly posted.

If the psychedelics appropriations measure is cleared for the floor and ultimately enacted, it would specifically focus on medical psilocybin laws, so its practical impact may be limited in the short-term given that no states have explicitly authorized it as a therapeutic in the way they have for marijuana, with qualifying conditions and doctor recommendations, for example.

Keep reading

Advocates File California Ballot Initiative To Legalize Psychedelics For Medical, Therapeutic And Spiritual Use In 2024

Advocates in California filed a ballot initiative with state officials on Friday that would create a right “to obtain and use psychedelics for medical, therapeutic and spiritual purposes” with the recommendation of a doctor. It would also allow adults to possess and use the substances in their home as well as cultivate entheogenic plants and fungi on private property.

Known as the Psychedelic Wellness and Healing Initiative of 2024, the measure is the third psychedelics-related prospective citizen-led measure attempting to qualify for next year’s ballot. Another would legalize psilocybin for adult and therapeutic use, while a third would commit $5 billion to create a state agency focused on advancing research and development of psychedelic therapies.

Dave Hodges, an initiative organizer and the founder of the Church of Ambrosia, in Oakland, acknowledged in an interview earlier this month that the campaign behind the newest proposal is filing its paperwork later than initially hoped. Advocates won’t be able to start gathering signatures until the state attorney general’s office issues the proposal an official ballot title and summary, which can take more than a month.

Hodges said the goal of the proposal is to ensure broad access to psychedelics while ensuring a base level of safety.

“We aren’t just saying, ‘Everybody gets psychedelics!’” Hodges said. “We’re saying you gotta go talk to a doctor first, and if the doctor recommends that you try them, then you can come get them.”

Gov. Gavin Newsom’s (D) recent veto of an adult-use psilocybin bill passed by the legislature this session was a disappointment, he added, “but at the same time, I completely agree with it.” The governor said in his veto statement that he couldn’t support allowing access to psilocybin without first establishing therapeutic standards.

“My church now has over 100,000 members,” Hodges said. “If each of them could have gone and talked to a doctor before having access to psychedelics, I would have considered that a great thing.”

Keep reading

Eureka, CA Decriminalizes Psychedelic Plant Medicines

Eureka, CA, has passed a resolution decriminalizing entheogens and psychedelic plant medicines, making it the sixth California city to do so and the second such city in Humboldt County.

The Eureka City Council unanimously approved an initiative last week to decriminalize plant medicines such as psilocybin mushrooms within city limits. The announcement came less than two weeks after CA Gov. Gavin Newsom vetoed an initiative which would have decriminalized psychedelics statewide. The City of Arcata, just a few miles to the north, voted to decriminalize in 2021 thanks to efforts by a group who also provided the language used in the Eureka resolution, Decriminalize Nature Humboldt.

According to an article in the Lost Coast Outpost, the resolution was passed without much trouble from the council, though a particular phrase was removed from the language of the bill. The council voted to remove language which seemed to endorse entheogenic plants’ ability to “catalyze profound experiences of personal and spiritual growth.” Not for nothing, but one of recently deceased Johns Hopkins professor Roland Griffiths’ first studies on psilocybin in 2006 was on psilocybin’s ability to induce mystical and spiritual experiences in the user. Much of Griffiths’ later work at Johns Hopkins has been referenced in similar legislative discussions surrounding the legality of psychedelics.

Other than the removal of the aforementioned phrase, the resolution was passed without much protest from the rest of the council members.There were some concerns voiced by local law enforcement representatives, mirroring Gov. Newsom’s concerns about potentially unforeseen consequences to the resolution. City Manager Miles Slattery, however, pointed out that he had consulted with the Arcata Police Department who reported no serious issues to him after just over two years of psychedelic decriminalization. He also pointed out that the City of Eureka only saw five cases of arrests related to entheogens in the previous year and almost every case was related to something more serious such as domestic violence. 

Keep reading

California Governor Signs Bills To Let Doctors Prescribe Psilocybin And MDMA If They’re Federally Rescheduled And To Change Marijuana Testing Rules

California Gov. Gavin Newsom (D) has signed a bill that would allow doctors to immediately start prescribing certain currently illicit drugs like psilocybin and MDMA if they’re federally rescheduled, and he also approved separate legislation to amend THC variance testing requirements for marijuana.

The governor signed off on the measures—which are just two of more than a dozen cannabis and drug policy reform proposals on his desk—on Saturday.

AB 1021, sponsored by Assemblymembers Buffy Wicks (D), Isaac Bryan (D) and Corey Jackson (D), says that, if the federal government reschedules any Schedule I drug under the Controlled Substances Act (CSA), California health professionals will automatically be able to legally prescribe and dispense it.

This could be especially relevant to the psychedelics psilocybin and MDMA, which have been designated as breakthrough therapies by the federal Food and Drug Administration (FDA) and are expected to be approved for medical use as early as next year.

Following a recent Phase 3 clinical trial, a peer-reviewed study published in the journal Nature last month found that treatment with MDMA reduced symptoms in patients with moderate to severe PTSD. The findings mean federal regulators could consider approving the drug for wider use as soon as next year.

Keep reading

Detroit Police Raid Psilocybin Church After Newspaper Feature

A church that purportedly uses entheogenic plants like psilocybin mushrooms as a holy sacrament was raided by officers with the Detroit Police Department Friday just two days after having a newspaper article about them published in the Detroit Metro Times.

According to a follow up article by the Detroit Metro Times, officers confiscated about $700,000 Friday in psilocybin mushroom products as well as ayahuasca and iboga from Soul Tribes International Ministries at 15000 Southfield Freeway in Detroit. Officers with the Detroit Police Department confirmed the raid took place to the Metro Times but would not comment on what was taken or any other details about what happened there.

Owner of Soul Tribes, ‘Shaman Shu’ (formerly named Robert Shumake) said 15 officers from DPD showed up armed and masked, seized the mushroom products and ordered a closure of the church. Shu told the outlet he believes the actions taken by police were in violation of Proposal E, a 2021 city initiative that decriminalized the use of psychedelic plants and fungi like psilocybin.

“They stole ancient sacrament. It was prayed over and meditated over. It’s a healing sacrament… They blocked my property down without due process. You can’t do that,” Shu said to the Metro Times. “They think we’re not a church. But that’s why the federal government was created, to separate church and state so that cities do not opine on what churches are [and] what ministries are. We’re a ministry and a religious organization.”

The original article said Soul Tribes was operating a “sacrament center” within the church where they sold dried psilocybin fruits, capsules and gummies to church members based on language in Proposal E that included using psilocybin therapeutically under the supervision of religious leaders, though they remain illegal under Michigan state law.

Regardless, Proposal E did not allow for the sale of entheogenic plants and fungi, which is likely where Soul Tribes ran into trouble with the police. The Metro Times asked for comment from the Mayor of Detroit’s office regarding the raid and whether or not DPD’s actions were sanctioned by the City, to which they received the following comment from Doug Baker, the city’s assistant corporation counsel:

“The Detroit Police Department worked in close coordination with the city’s law department and building safety, engineering and environmental department in preparing this enforcement action,” Baker said. “It is the law department’s position that this local ordinance, despite its intent, does not override state law, which considers psilocybin to be a controlled substance. Most importantly, the city ordinance itself does not allow for the sale or distribution of psilocybin.”

DPD Sgt. for media relations, Jordan Hall, told the outlet, “My understanding was that [the raid] was due to a lack of licensing and the amount of substances that were distributed.”

Keep reading

America’s First ‘Shroom Clinic’ Opens In Oregon

America’s first licensed health clinic to sell ‘magic mushrooms’ opened in June in Oregon and has been swamped with surging demand. The waitlist for the clinic exceeds 3,000 people, some of whom are searching for ways to treat depression and PTSD. 

No prescription or referral is needed for Epic Healing Eugene, but customers must be over 21 to receive psilocybin services. 

AP News said some customers complained the ‘mind-bending’ experience is too costly: 

“A client can wind up paying over $2,000, which helps cover service center expenses, a facilitator and lab-tested psilocybin. Annual licenses for service centers and growers cost $10,000, with a half-price discount for veterans.” 

Even though The Oregon Psychiatric Physicians Association opposed legalizing psilocybin in 2020, voters thought otherwise and also decriminalized the possession of hard drugs. 

Epic Healing Eugene’s owner Cathy Jonas told AP that providing legal access to mushrooms is a ‘dream come true’: 

“The plant medicines have communicated to me that I’m supposed to be doing this thing.”

Keep reading

Depressed by the War on Drugs? Magic Mushrooms May Help.

Hallucinogenic drugs like psilocybin-containing magic mushrooms are closely linked in the public imagination with hippies and pleasure-seeking. While there’s nothing inherently wrong with pleasure-seeking (we’ll see about hippies), growing evidence suggests that, properly used, these drugs may be just as effective for healing minds as they are at blowing them. A recently published study reports that, among other uses, psilocybin is a very effective treatment for depression.

“In a randomized, placebo-controlled, 6-week trial in 104 adults, a 25-mg dose of psilocybin administered with psychological support was associated with a rapid and sustained antidepressant effect, measured as change in depressive symptom scores, compared with active placebo,” according to the authors, led by Dr. Charles L. Raison of Wisconsin’s Usona Institute, of “Single-Dose Psilocybin Treatment for Major Depressive Disorder: A Randomized Clinical Trial,” published in August in the Journal of the American Medical Association. “No serious treatment-emergent adverse events occurred.”

The trial, conducted at different locations between December 2019 and June 2022, included participants between ages 21 and 65 who had been diagnosed with major depressive disorder of at least 60 days’ duration. Half of the participants were given a 25-mg dose of psilocybin and the other half were given niacin as a placebo, administered in identical capsules. The patients were assessed at eight days (the original end point of the study) and then at 43 days (the extended time frame).

Over the course of the study, “a single 25-mg dose of psilocybin administered with psychosocial support was associated with clinically and statistically significant reductions in depressive symptoms and improvement in measures of functional disability compared with a 100-mg dose of niacin placebo administered under an identical protocol.” The researchers also found a higher rate of sustained remission from depression symptoms among those who received psilocybin, “but the difference was not statistically significant.”

Adverse events potentially related to psilocybin consumption included one reported migraine, a headache, and one participant experiencing panic attack and paranoia. Nothing similar was found among the placebo group. As side effects go, that’s pretty mild and comparable to those linked to commonly used antidepressant drugs. Hence the finding that the study resulted in “no serious treatment-emergent adverse events.”

Keep reading