Summary: The Colorado Sun reports on the recent decriminalization of psilocybin mushrooms in Denver, CO, while highlighting that current psychedelic research has shown promising results to treat variety of mental health disorders, including psilocybin and MDMA which both received breakthrough therapy designation from the FDA. “There is a major unmet medical need where I think researchers, and even the federal government funding agencies, see that we should be studying everything and anything to help people suffering from these disorders,” explains David Kroll, a professor at the University of Colorado’s Skaggs School of Pharmacy.
Originally appearing here.
Denver is treading trippy new ground with this psilocybin vote.
With voters requiring police to slacken enforcement of laws around psilocybin mushrooms, Colorado and the Mile High City are poised to anchor an emerging psychedelic renaissance, where once maligned psychoactive drugs are being championed as therapeutic remedies for illnesses like anxiety, depression, obsessive-compulsive disorder and post-traumatic stress disorder.
LSD and psilocybin were once heralded as genuine medical tools. In the late 1950s and 1960s, psychoactive drugs were researched for a host of benefits, but any biochemical promise of the drugs was swept up in a cultural revolution that ultimately led to their prohibition.
After a half-century ban, the dark age of psychedelic research is ending as the federal government begins to allow the use of drugs like ketamine and research into drugs like MDMA and psilocybin that could spur a psychopharmacological revolution in the treatment of mental illnesses.
And Colorado, blazing a progressive trail on both cannabis and psilocybin, joins California as anchors for the modern psychedelic revolution that explores long-maligned recreational drugs as medicine.
Dr. Roman Langston has been offering ketamine infusions to patients at his Vitalitas clinics in Littleton and Westminster for three years, forging a treatment for depression using a chemical the anesthesiologist had previously known as a rapidly acting general anesthetic first approved by the FDA in 1970.
Today, Langston sees ketamine “as an absolute game-changer for many people.”
His patients have long histories battling depression with pills, electroconvulsive therapy, sweeping lifestyle changes and years of talk therapy.
“They have done it all to treat their mental illness and nothing else works for them. They are suffering a great deal and, for them, ketamine is the only thing that has ever worked and it’s able to change their life,” Langston said.
Like Gail Barry. She suffered abuse growing up in West Texas. After serving in the Navy, she worked as a psychiatric nurse at intensive treatment centers across the country, working with patients crippled by mental illness.
She herself fell into a deep depression that spanned decades. She took psychiatric medications for many years. She smoked marijuana to treat her depression. Several times she found herself a patient in the same types of critical-care treatment centers where she once worked.
“They would send in people to make sure I was eating. I was really overweight. I wouldn’t move at all. I cried all the time. I had terrible intrusive memories. I was sent to the emergency room several times because I couldn’t stop crying,” says the 66-year-old who lives in Loveland.
On May 21 last year she went to the Vitalitas clinic in Westminster and started ketamine infusions, even though some of her doctors and her mental health counselors recommended against it.
“In two hours after the first treatment, I was a new person. Immediately the memories went away. The crying stopped. I stopped feeling suicidal. I’ve stopped taking any medication. I’ve lost 93 pounds. I get out and see people,” she said. “Ketamine has given me a whole new perspective. I am normal. Do you know what that’s like after being so depressed for so many years?”
Barry said the Veterans Administration recently approved payment for her ketamine infusions, which her insurance company will not do.
“My VA psychiatrist, when she sees me now, she gets tearful because I’ve changed so much,” Barry said. “We are so far behind in medications for psychiatric illnesses. Just in the dark ages. Everyone needs to know about ketamine. It’s a flat-out miracle what it’s done for me.”
It wasn’t that long ago that ketamine, known as the euphoric “Special K,” was popular among the dancing kids in the clubs.
Drug abuse websites still refer to ketamine as a date-rape drug or as a tranquilizer used by veterinarians.
But last month the FDA, after a clinical study involving 1,700 adults with treatment-resistant depression, approved a new form of ketamine — esketamine — in a nasal spray made by Johnson & Johnson’s Janssen Pharmaceutical Cos. for patients who have not responded to other antidepressant medications.
Researchers only recently began hypothesizing why ketamine works so effectively and so quickly. Essentially the drug focuses on a particular set of proteins in the brain that tempers inhibition and excites some brain circuits that make a patient more sensitive to the world around them, lifting them from their funk.
Scientists have noted that recreational users typically walk away from a ketamine dosing in an exhausted, even hungover state while depressed patients emerge from a ketamine session with their depression symptoms simply gone.
Langston said the approval of the esketamine nasal treatment, marketed under the name Spravato, will spur the ongoing discussion on the therapeutic value of psychoactive substances.
“This will be the one thing that makes the biggest difference in terms of the acceptance of IV ketamine and other drugs that fall under the psychedelic realm of medications,” said Langston, who offers treatments that involve four to six ketamine infusions over several weeks.
When Langston started, it was rare to see a patient referred to his clinic by their psychiatrist. Most found their way toward ketamine on their own.
Today, it’s common for doctors to refer patients struggling with depression to Langston. He describes responses to intravenous treatments of ketamine like this: a third have “a dramatic, game-changer response; a third have a modest response with symptoms of their depression reduced incrementally and a third do not respond to treatment.”
That’s as good or better a success rate than just about any psychiatric medication out there now, Langston said. (Last year, the largest-ever analysis of antidepressants looked at 21 of the most common medications — corralling research gleaned from 522 clinical trials involving more than 100,000 patients — and found that most of the pills were about 50 percent more likely than placebos to have some impact on a patient’s depression symptoms.
And the results of that study, published in The Lancet medical journal, were scrutinized for not noting the side-effects of some antidepressant medications and not including more details on the reduction of symptoms.)
“The rate of mental illness is astonishing right now and it’s on the rise. Our conventional approaches for treating mental illnesses are coming up short for a lot of people. These chemicals have been around a long time and they are worth studying, especially if they can help at least a subset of all these people who are not responding to a lot of stuff,” said Langston, who is quick to note that psychedelics “will not be the entirety of the answer, but can play a role in addressing the nation’s mental health crisis.”
Langston said he expects psilocybin mushrooms soon could emerge from the underground with clinics offering treatment under the care of a doctor and psilocybin expert.
“People are realizing that we need to start looking at other solutions,” Langston said, noting that traditional pharmaceutical treatments for depression — namely, selective serotonin reuptake inhibitors, or SSRIs — “have sort of run their course.”
“They have helped a lot of people and they have a good safety profile, but what other things can be done? What other classes of drugs can be explored? I think the next 10 to 20 years can be very fruitful from a psychopharmacological standpoint.”
David Kroll, a professor at the University of Colorado’s Skaggs School of Pharmacy, has spent 35 years studying drugs from nature — like psilocybin mushrooms and other naturally occurring chemicals — that he says have given rise to 25% of all prescription drugs and 65% of all the country’s over-the-counter medications.
Kroll said the growing population of patients who are not responding to traditional treatments for depression, anxiety, PTSD and substance abuse has opened the door to further investigation of any chemicals that may deliver relief.
“There is a major unmet medical need where I think researchers, and even the federal government funding agencies, see that we should be studying everything and anything to help people suffering from these disorders,” Kroll said. “I’m of the mind that if a good black bean salsa can cure depression, we should be investigating it.”
Kroll sees the Denver vote as a sign that the public is softening its stance on the now-48-year-old war on drugs.
“Talk to any pharmacologist and they will tell you that we have failed in the war on drugs and we have inadvertently shot ourselves in the foot by not investigating these so-called recreational chemicals for therapeutic benefit,” Kroll said. “I think the groundswell from the majority of the public speaks to the fact that yeah sure some people may want to use these things recreationally, but I think the public has the appetite for these drugs that have some cultural baggage to be investigated rigorously and formally in clinical trials.”
In 2017, the FDA gave “breakthrough therapy” designation to MDMA — or 3,4-methylenedioxymethamphetamine, also known as ecstasy — allowing California’s Multidisciplinary Association for Psychedelic Studies to study MDMA-assisted psychotherapy treatment for PTSD.
The association began recruiting volunteers with PTSD into 12-week, 15-session programs last fall at 14 locations around the world. Clinics in Boulder and Fort Collins were among the five U.S. locations chosen for the study.
Studies measuring psilocybin’s effect on depression — at London’s Imperial College and Johns Hopkins’ Psychedelic Research Unit — show that the mushrooms can reduce symptoms, with the relief from a single treatment lasting more than a month.
The FDA last year gave the U.K.’s Compass Pathways a “breakthrough therapy” designation that allowed the company to conduct clinical trials studying the effect of psilocybin on 216 patients. Voters in Oregon could get a chance next year to vote on legislation that would develop a psilocybin therapy program with state-licensed therapists and mushroom production centers under the Oregon Health Authority.
(A psilocybin decriminalization measure failed to make the ballot in California in 2018.)
Dr. Randy Buzan, a psychiatrist with patients in Denver and Southern California, has a patient with severe bi-polar disorder, panic disorder and suicidal thoughts. He’s been living with his disorders all his life.
He’s tried every possible therapy and when he approached Buzan with a plan to try psilocybin, “he was in great fear that I would fire him as a patient,” said Buzan, who has worked with the man for more than 20 years.
The man began microdosing — taking small doses of mushrooms — on a regular basis. It wasn’t enough to get high, said Buzan, who did not provide psilocybin to his patient.
“It changed his life. I’m so impressed with how well it worked. He’s just a different guy,” said Buzan, noting that he has not identified any side effects of his patient’s microdosing. “His son came in and said ‘I just have to thank you. I got my daddy back.’ And he really is back.”
Buzan has talked with researchers involved in psilocybin clinical trials around the country. Buzan said the early data from those double-blind trials — meaning neither the researchers nor the patients know if the medicine they were testing was a placebo or the real thing — indicates psilocybin is effective for 60% of patients with PTSD and 80% of patients with treatment-resistant depression.
Like Langston, Buzan expects psilocybin will soon be available as yet another medical possibility for doctors treating depression and other illnesses.
“There is a huge need for us to find new therapies. Depression is the leading cause of disability worldwide,” Buzan said. “I know it’s controversial and it’s not proven and it’s not FDA approved and it’s illegal, but for guys like me who see miserable, functionally impaired, depressed patients who have tried everything and are suffering, for us to have another tool in our kit to treat them and help them have happy, healthy lives … how can we not consider this?”
Eric Osbourne was a gourmet mushroom grower when he began offering therapeutic sessions with psilocybin mushrooms at his remote farm in Indiana and at a beach resort in Jamaica five years ago.
After he was arrested in Indiana in 2015 for possession of psilocybin mushrooms, he moved his MycoMeditations to Jamaica full-time, where he offers week-long retreats with three psilocybin sessions that are not about microdosing. He’s about 70 percent booked for trips through the rest of this year and has given out 1,750 mushroom doses in the past four years, not counting the 200 he’s taken.
Osbourne said it’s hard to generalize a psilocybin experience, but he’s seen his clients find “deep self-reflection” after a session. Like Langston, many of his clients find their way to psychedelics after exhausting many other remedies.
“I’ve had a number of clients I sincerely thought were close to suicide and they found their way back,” Osbourne said. “We see so many people who are able to come off their SSRIs after working with psilocybin and working with our therapists.”
A month ago he hosted a U.S. police officer, who heralded the treatment and now Osbourne is planning to organize a retreat specifically for law enforcement. He watched the Denver vote closely from Jamaica. The same day the vote results were announced, he heard from his lawyer in Indiana that his felony charges from 2015 had been dismissed and erased from his record.
“Psilocybin is definitely starting to gain the public respect that is deserves,” he said.