Ketamine therapy for mental health a ‘wild West’ for doctors and patients

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By late 2022, Sarah Gutila’s treatment-resistant depression had become so severe, she was actively considering suicide. Raised in foster care, the 34-year-old’s childhood was marked by physical violence, sexual abuse and drug use, which left him with life-threatening psychological scars.

Out of desperation, her husband scraped together $600 for the first of six rounds of intravenous ketamine therapy at the Ketamine Clinic in Los Angeles, which administers the generic anesthetic for off-label uses such as treating depression. When Gutilla hopped into an Uber for the 75-mile drive to Los Angeles, it was the first time she’d left her home in Llano, California, in two years. The results, he said, were immediate.

“The amount of relief I felt after the first treatment felt ‘normal’ to me,” she said. “I’ve never felt so right and at peace.”

For-profit ketamine clinics have expanded over the past few years, offering infusions for a wide array of mental health problems, including obsessive-compulsive disorder, depression and anxiety. Although the off-label use of ketamine hydrochloride, a Schedule III drug approved as an anesthetic by the FDA in 1970, was considered radical just a decade ago, 500 to 750 ketamine clinics have now sprung up across the country.

Market researcher Grand View Research estimates industry revenues at $3.1 billion in 2022, and projects them to more than double to $6.9 billion by 2030. Most insurance does not cover ketamine for mental health, so patients must pay out of pocket

Although it is legal for doctors to prescribe ketamine, the FDA has not approved it for mental health treatment, which means that individual practitioners must develop their own treatment protocols. Results vary widely among providers, with some favoring gradual, low-dose treatment, while others favor larger amounts that can induce hallucinations, as the drug is psychedelic in the right dose.

“Ketamine is the Wild West,” said Dustin Robinson, managing principal of Eater Investments, a venture capital firm specializing in hallucinogenic drug treatments.

Ketamine practitioners stress that the rise of the drug as a mental health treatment is driven by a desperate need. According to the National Institute of Mental Health, depression is the leading cause of disability for people ages 15-44 in the United States, and about 25% of adults experience a diagnosable mental disorder in any given year.

Meanwhile, many insurance plans cover mental health services at a lower rate than physical health, despite equality of laws. Many patients with this disorder receive little or no care initially and are desperate by the time they visit a ketamine clinic, says Steven Siegel, chair of psychiatry and behavioral sciences at the University of Southern California’s Keck School of Medicine.

But the revelation that “Friends” star Matthew Perry died in part from a large dose of ketamine, billionaire Elon Musk’s open use of the drug, has drawn fresh scrutiny of ketamine and its regulatory environment, or lack thereof.

Commercial ketamine clinics often offer same-day appointments, where patients can pay out-of-pocket for drugs that provide immediate results. Ketamine is administered intravenously, and patients are often given blankets, headphones, and eye masks to increase the feeling of isolation. A typical dose of ketamine to treat depression, which is 10 times less than the dose used for anesthesia, costs the clinic about $1, but clinics charge $600-$1,000 per treatment.

Ketamine is still overshadowed by its reputation as a party drug known as “Special K”; Siegel’s first grant from the National Institutes of Health was to study ketamine as a drug of abuse. It has the potential to send users down a “K hole”, otherwise known as a bad trip, and can induce psychosis. Studies of animals and recreational users have shown that chronic use of the drug impairs both short- and long-term cognition.

Perry’s death in October raised alarm when initial toxicology screenings attributed his death to an overdose of ketamine. A December report revealed that Perry had received infusion therapy a week before her death but that the fatal injury was a high dose of the substance taken with an opioid and a sedative on the day of her death — suggesting that medical ketamine was not responsible.

Different protocols

Sam Mandel co-founded Ketamine Clinic Los Angeles in 2014 with his father, Steven Mandel, an anesthesiologist with a background in clinical psychology, and Sam said the clinic established its own protocol. This includes monitoring the patient’s vital signs during treatment and keeping psychiatrists and other mental health practitioners on standby to ensure safety. Initial treatment starts with low doses and increases as needed.

While many clinics follow Mandel’s graduated method, the dosing protocol at My Self Wellness, a ketamine clinic in Bonita Springs, Florida, is designed to trigger a psychedelic episode.

Christina Thomas, president of My Self Wellness, says she based her clinic’s procedures against a list of “don’ts” based on bad experiences people have reported at other clinics.

The field is not entirely unregulated: State medical and nursing boards oversee doctors and nurses, while the FDA and Drug Enforcement Administration regulate ketamine. But most anesthesiologists don’t have a mental health background, while psychiatrists don’t know much about anesthesia, Sam Mandel points out. A collaborative, multidisciplinary approach is needed to improve standards across the field, he said, especially because ketamine can affect vital signs such as blood pressure and breathing.

The protocols governing Spravato, an FDA-approved drug based on a close chemical cousin of ketamine called esketamine, are illustrative. Because it has the potential for serious side effects, it falls under the FDA’s Risk Assessment and Mitigation Strategy program, which has additional requirements, Robinson said. Spravato REMS requires monitoring for two hours after each dose and prohibits patients from driving on the day of treatment.

In contrast, generic ketamine has no REMS requirements. And because it’s generic and cheap, drugmakers have little financial incentive to conduct the expensive clinical trials required for FDA approval.

This leaves it up to the patient to evaluate ketamine providers. Clinics dedicated to intravenous infusion rather than offering treatment as an add-on may be more familiar with the nuances of drug administration. Ideally, practitioners should have expertise in mental health and anesthesia, or multiple specialties under one roof, and clinics should be equipped with hospital-grade monitoring equipment, Mandel said.

Siegel, who has researched ketamine since 2003, said the drug is particularly effective as an emergency intervention, alleviating suicidal thoughts long enough to give traditional treatments, such as talk therapy and SSRI antidepressants, time to take effect. “The solutions we’ve had up until now have failed us,” Mandel said.

The drug is now popular enough as a mental health treatment that the name of Mandel’s clinic is in daily sight for thousands of Angelenos as it appears on 26 Adopt-a-Highway signs along the 405 and 10 freeways.

And the psychedelic renaissance in mental health is accelerating. A drug containing MDMA, known as Ecstasy or Molly, is expected to receive FDA approval in 2024. A drug with psilocybin, the active ingredient in “magic mushrooms,” could launch as early as 2027, the same year a stroke drug with active ingredient DMT, a hallucinogen, is expected to debut.

Many ketamine clinics have opened in anticipation of the expanding psychedelic market, Robinson said. Because these new drugs will likely be covered by insurance, Robinson advises clinics offering FDA-approved treatments such as Spravator to ensure they have the proper insurance infrastructure and staff.

For now, Sarah Gutila will pay out-of-pocket for ketamine treatment. A year after her first round of infusions, she and her husband are saving her second. Meanwhile, she spends her days at her ranch in Llano where she rescues dogs and horses and relies on telehealth therapy and psychiatric medication.

Although infusions are not “a magic solution”, they are a tool to help get him on the right track

“There was no light at the end of the tunnel,” he said. “Ketamine literally saved my life.”

Kaiser Health NewsReprinted from this article khn.orgA national newsroom that produces in-depth journalism about health issues and is one of KFF’s core operating programs – the independent source for health policy research, polling and journalism.

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