The U.S. Department of Veterans Affairs announced the launch of a new clinical trial to evaluate the effectiveness and safety of psilocybin to treat major depression in Veterans, including those with concurrent PTSD. The new trial comes after a recent executive order on "Accelerating Medical Treatments for Serious Mental Illness," which aims to increase clinical trial participation and accelerate innovative research models and drug approvals for psychedelic drugs.

[...] The randomized, controlled trial will enroll Veterans diagnosed with treatment-resistant major depressive disorder, with or without concurrent PTSD, and will compare outcomes between two psilocybin dosage levels. The study will also assess participants' levels of depression before and after treatment, tolerability of side effects, and overall patient-reported depression. [...] In addition to this trial, VA is involved in 20 active clinical trials focused on psychedelic therapies for mental health conditions. All VA research -- including research into psychedelics -- is conducted under strict safety protocols and in full compliance with federal guidelines.

 

A new case report published in Frontiers in Neuroscience describes an extraordinary but highly preliminary observation: an 80-year-old woman with advanced Alzheimer's disease showed temporary multidomain improvement after receiving a high dose of psilocybin-containing mushrooms.

Following administration of 5g of mushrooms, she entered a prolonged deep sleep-like state. After waking, she reportedly regained the ability to speak in full sentences, recognised family members, dressed independently, and recovered urinary continence after five years.

A later 3g dose appeared to extend some of these improvements.

 

A small clinical trial involving 34 people found that psychedelic-assisted therapy prompted a swift reduction in depressive symptoms that endured long after the drug had worn off, with some still feeling the benefits six months later.

Although preliminary, the results add to a growing body of evidence that psychedelic drugs, when coupled with psychotherapy, could help to alleviate depression in the millions of people worldwide who do not respond to existing antidepressants or therapies.

The trial, reported in Nature Medicine, focused on people with moderate to severe treatment-resistant depression. One half received a single 21.5mg dose of DMT infused into a vein over 10 minutes. The other half received a placebo infused the same way. All of the participants had psychotherapy and follow-up assessments.

Patients given DMT improved significantly compared with the placebo group, as measured by scores on a standard depression questionnaire, with the antidepressant effects lasting from three to six months.

In the second stage of the trial, all participants received a dose of DMT with therapy, but the researchers found no additional benefit in those who had two doses in total, suggesting a single dose may suffice. The trial was designed, funded and sponsored by Cybin UK, a neuropsychiatric firm.

The study follows a positive trial with psilocybin, the active ingredient in magic mushrooms, which has raised hopes for the drug being approved for treatment of depression later this year.

At doses used in the trials, DMT induces a shorter but more intense trip than psilocybin, with the experience lasting about 25 minutes compared with a couple of hours for psilocybin. That could make DMT-assisted therapy easier for clinics to deliver, although patients may need more support to recover from particularly intense DMT trips.

If regulators were to approve psychedelics for treating depression in the UK, researchers expect them to become available only through private clinics, said Dr James Rucker, a consultant psychiatrist at King’s College London who worked on the psilocybin trial.

Last year the Feilding commission was set up to guide the safe, ethical and equitable rollout of psychedelic-assisted therapies amid concerns that commercial pressures at private clinics could undermine safety, leading to patient harm.

Rucker said: “Quite how these drugs will fit in this world of financial austerity, stigma and opprobrium towards anything that has the word psychoactive in it, I don’t know. It’s interesting to be a part of, but I can’t call it.”

 

The big bag of meth will get weighed out into individual doses and put into tiny cardboard boxes, labeled with its contents, purity, and the logo of Dulf – the Drug User Liberation Front.

The office’s location is not on any maps or findable by any search engines, but it is not exactly secret. Vancouver’s government, the cops, drug users and maybe even dealers all know where it is, and it turns out that has been pretty much fine, despite the fact that the people inside it are buying and selling felony-level quantities of drugs every week.

Such is life in Vancouver, where the drug problem has been so bad for so long that the authorities here have, reluctantly and with a lot of pressure, begun to allow for a kind of radical experimentation not really going on anywhere else.

She envisions a future in which heroin and every other drug are handled similarly to alcohol: regulated, free from impurities, legal and available to the public. She does not see any other way out of the crisis. Everything else people have tried has simply not worked.

Non-paywalled: https://archive.is/JpdEO