A ketamine clinician in Utah is using a method of intramuscular injections which he says provides longer lasting benefits than more common protocols. The promising success rates claimed for patients receiving this therapy, who suffer from Treatment Resistant Depression (TRD), Post Traumatic Stress Disorder (PTSD), and suicidality, reflect continuing innovation in what a growing consensus of prominent mental health professionals say is the breakthrough potential of ketamine treatment for mental health conditions.
This therapy protocol was adapted by Dr. Robert Hiemstra, who worked as an emergency room doctor for more than three decades before founding the Ketamine SLC clinic in Salt Lake City. Patients at the clinic are administered increasingly higher dose intramuscular injections of ketamine, spread over two hours. This approach differs from the well-established “Yale Standard,” which was developed in 2000 by researchers at the Yale School of Medicine. That approach calls for intravenous injections at a lower dose of 0.5 milligrams of ketamine per kilogram of body weight, administered over the course of six treatments in two weeks. Ketamine SLC increases the dosage and compresses the course of therapy from two weeks to a single day, which Hiemstra says extends the benefits of the treatment, often by many months.
Hiemstra’s treatment typically includes two intramuscular injections of about 1 milligram per kilogram of body weight, or twice the dosage of the Yale Standard, though the dosage can vary based on his assessment of the patient’s reaction. The doses can then further escalate in ‘steps,’ if more treatments are needed. The primary benefit of this method, says Hiemstra, is that patients receive and metabolize twice as much ketamine as they would get from an intravenous dose, and build twice as many neural pathways in the brain. Hiemstra’s clinic is also offering a treatment regime at what they say is a lower price for patients.
Once a patient has established their specific course of treatment, which costs up to $300 per session, Ketamine SLC offers a six-treatment regime for $1,500, which does not include integration therapy or aftercare costs. The Ketamine SLC website claims that other ketamine therapy providers typically charge up to $1,000 per treatment and often continue patients on a six-treatment regime that can cost more than $1,500 per month. Hiemstra asserts that his clinic can provide treatments as infrequently as every three months for the same price. Ketamine SLC is also partnering with The Ketamine Fund to offer free treatment to veterans.
Hiemstra says he’s planning to patent his ketamine therapy method, though he’s been delayed by the challenges of providing care during the Covid-19 pandemic and is presently redirecting his focus toward maintaining his clinic with a significant reduction in clientele. According to Hiemstra, he is pursuing a patent to prevent other private practitioners from claiming ownership of his therapy thereby possibly preventing him and others from using the method he created, or charging them to use it. If granted the patent, he says he intends to license the therapy to other ketamine doctors and clinics at no cost, provided they commit to the treatment protocol he is codifying. Hiemstra says he intends to publish his protocol standards and treatment methods in a book later this year.
Ketamine SLC has treated over 8,000 patients with this innovative protocol, and has received no reports of major adverse effects, according to Hiemstra. “Forty percent of patients receive three months of relief [after the first treatment],” he says. “The rest fall into a different range, which is where I apply the step system which allows me to increase the dose sequentially and get them to that ‘Holy Grail’ of three months in between symptoms returning.” Ketamine SLC has compiled their patient treatment data, and Hiemstra says he welcomes the ability to publicize his results and methods for peer and public review. He intends to include these data, along with his assessment and critiques of other methods, in his upcoming book.
Examining Patient Outcomes
Hiemstra pursued his treatment protocols in part by using the Patient Healthcare Questionnaire, PHQ-9, a nine question system for measuring the severity of depression. According to the PHQ-9 instruction manual, the system, which was established at Columbia University in the late 1990s, recognizes that “a particularly important use of a measure is its responsiveness to changes of condition severity over time.” The PHQ-9 is used to assess the level of depression severity, establish initial treatment decisions, and as an outcome tool to determine treatment response. The scale ranges from zero to 27, with a zero score indicating no depression, and a range from moderate (five) to severe (20+).
Patricia Johnson, a clinical statistician contracted by Ketamine SLC to process and present the treatment data, sees evidence of the success of Hiemstra’s method after evaluating the outcomes of 200 patients who have received therapy at the clinic. “The sample data proves that with a step-up ketamine intramuscular approach, there is a consistent reduction in PHQ-9 scores,” showing that “as the milligram strength of ketamine goes up, the depression goes down,” says Johnson. She notes that multiple patients’ PHQ-9 numbers dropped ten points or more, and that a clear correlation to Hiemstra’s method will be shown in a full data release. “There appears to be an overwhelming success rate with this approach,” says Johnson.
While Hiemstra and his method represent a less common approach in the growing exploration of ketamine treatment methods, diverging from the Yale Standard and institutional models does not make him an outlier in the field.
Dr. Cole Marta is a psychiatrist and researcher who has studied ketamine since 2015 and co-authored a study that looked at different routes of therapeutic administration. He is the co-founder of the California Center for Psychedelic Therapy and a Clinical Investigator for the Phase 3 clinical trial conducted by the Multidisciplinary Association for Psychedelic Studies (MAPS) for MDMA-assisted psychotherapy. “Over the last 15 to 20 years, more studies have been done to build on the initial [Yale] study, because of all of these game changing qualities of ketamine for depression,” explains Marta. “It works rapidly, it works for people with treatment resistant depression, it seems to work even for bipolar depression in many cases.”
Marta notes that while the Yale Standard and IV treatment remain the most common forms of administration, ketamine therapy can be administered in a wide variety of ways, including intramuscular, oral, internasal, and intravenous delivery. “In the years since it was first shown to be effective for TRD, there have been a lot of different studies looking at how we can extend the benefits,” he says. “For example, is twice a week better than three times? Is one really big dose preferable?”
Marta further details how ketamine’s legal status lends itself to an exploratory clinical approach that is often more open to developing new methods in the field than other psychedelic therapies. Unlike other psychedelics, ketamine has been legal since 1970 and is widely used as an anesthetic. Doctors have the option to prescribe it for other conditions ‘off-label’ as Hiemstra does because of its relatively lenient DEA scheduling. Psilocybin, MDMA, and LSD, for example, are Schedule 1, a federal designation that indicates these substances have “no currently accepted medical use and a high potential for abuse,” which makes them almost impossible to legally prescribe or access. Ketamine is classified as Schedule 3, meaning “a moderate to low potential for physical and psychological dependence.”
“Because ketamine didn’t go through the formal FDA process [for use in therapy] that, for example, MDMA is going through, and psilocybin is trying to go through, and eventually these other [Schedule 1] psychedelics will probably go through, we have off-label use,” explains Marta. Prescribing drugs off-label is a common practice. For example, when the depression drug Prozac is prescribed for anxiety, its use is off-label.
“The only on-label use for ketamine is as an anesthetic,” says Marta. He notes, however, that there’s so much evidence for its usefulness for treatment resistant depression, “that at this point, it would be considered common practice to try this if you’ve tried other front line antidepressants and haven’t seen benefit from it.”
Hiemstra believes his compressed one-day therapy, and higher dose intramuscular injections in general, create an opportunity for the longer term extended benefits and relief that Marta describes.
“The major way that I’m pursuing success rates is with the measure of the interval,” Hiemstra says. “Ketamine offers a unique type of stability. And that requires a certain amount of dosage. If you don’t get the appropriate dosage up there, you aren’t going to get that ‘Holy Grail.’”
Growth in Demand for Ketamine Therapy
The expansion of ketamine clinics reflect the growing demand for innovative mental health treatments in the US, where mental health disorders are among the leading causes of disability. Rates of depression and suicide continue to escalate, particularly among young people and veterans. In 2019, the American Psychological Association reported “…a steady rise in mood disorder and suicide-related outcomes” among people born in the 1980’s and 1990’s.” The Veterans Administration reports that an average of 20 or more veterans die by suicide each day. The impact of Covid-19 is expected to increase the global need for effective mental health treatments.
Dr. Erica Zelfand is a family physician who consults for health care providers and patients on ketamine treatment options and methods. She is not surprised by the growth of interest in ketamine, and like Marta, encourages the discovery and development of new treatment methods. “The variety of administrative methods and protocols surrounding ketamine is a testament to the fact that using it in this context is fairly new, and there’s no agreed upon gold standard,” says Zelfand. “It’s a beautifully versatile molecule that works in a variety of contexts for a variety of different cases.”
The growth in ketamine clinics has also been driven by technological advances. At Ketamine SLC, Hiemstra and his staff employ CareTaker, a technology to wirelessly monitor the vital signs of patients with a noninvasive finger cuff that sends data to a monitor. This setup allows the clinic to treat multiple patients simultaneously and increase their revenue. The availability of diagnosis and treatment through telemedicine, as well as ketamine lozenges and nasal spray, make ketamine treatment accessible to people suffering from symptoms of depression who are reluctant to leave their home, or who have difficulty accessing a clinic due to geographic barriers. As Covid-19 social distancing measures sweep the country and in-person consultations become more challenging, these technological options become more critical to patients in need.
Ketamine SLC doesn’t offer traditional integration therapy as part of their package. Rather, they use a combination of set and setting applied to the experience, including using binaural beats to get patients into a quick theta state, and PHQ9 assessments before and after treatment to evaluate the patient. Hiemstra also applies his clinical expertise to determine the level of treatment and aftercare that is needed or appropriate for the individual. Patients in many areas of the US don’t have access to therapists who are experienced with psychedelic medicines, or if they do, the cost can be prohibitive. For those without access to trained therapists, Zelfand points to the online Psychedelic Support directory, which provides integration and other counseling from licensed practitioners remotely and by video. Zelfand herself is a member of the Psychedelic Support network.
“Ketamine synergizes incredibly with counseling,” Zelfand says. “If we are going to use this molecule to its fullest potential, we should optimally pair it with some kind of therapy, before and after.” With therapeutic doses, particularly the more intense intramuscular regimen offered by Ketamine SLC, patients aren’t able to engage in therapy during treatment due to the dissociative effect. Over the following days when they can, they should seek this care if possible, says Zelfand.
“Unpacking and making sense of what happened during the journey they had, and how those visions and that experience fits into their life or not moving forward, is very powerful, as it is with any psychedelic or mystical experience,” says Zelfand.
At Ketamine SLC, the staff are now adjusting to the Covid-19 pandemic and preparing for the impending mental health crisis that Hiemstra expects will follow. The need for treatment will likely be compounded by triggering media reports, personal experiences of death and illness, and extended social isolation.
A Clinic Staffed by Veterans
Ketamine SLC is largely staffed by veterans who received treatment from Hiemstra, many of whom say they found new meaning and purpose in helping their fellow vets and others to heal.
Auric Avila came to Ketamine SLC in 2019 seeking relief from PTSD and other symptoms stemming from his 8 and a half years as a Marine, including service in Iraq. After his second successful treatment he committed his life to introducing ketamine to suffering veterans and others in need.
“I was a patient going through the treatment and had a very profound message that I need to take charge of this experience and make it known to people,” Avila says. He is now the director of the clinic, and overseeing increasing success in outreach to his fellow veterans. “The biggest challenge in treating veterans is not that they don’t need help. It’s getting them to admit they need help and submit to the treatment,” says Avila. “As more veterans get treated, the word travels and more are open to admitting they need treatment and reaching out for it.”
Prior to the upheaval caused by Covid-19, Ketamine SLC had been treating about 30 new veterans weekly, a significant percentage of their overall patient load. The clinic has expanded their work with veterans thanks to a $60,000 financial commitment from The Ketamine Fund. The nonprofit is sponsoring 400 free treatments for veterans at the clinic, of which half have been administered to date.
The Ketamine Fund was co-founded by philanthropists and psychedelic activists Warren Gumpel and Mike “Zappy” Zapolin. According to the group’s website, the nonprofit is “dedicated to providing free treatments to veterans and those who need help now” via a network of over 25 clinics across the country. In addition to funding treatment for veterans, Zapolin and Gumpel have supported Hiemstra’s work by advising Ketamine SLC on set and setting, based on the feedback they say they’ve gathered from the diverse group of patients and practitioners they work with.
“The PTSD that people are getting from this pandemic is real,” says Zapolin. “Coming out of this, all the ketamine doctors and operators are prepping for a tsunami of people wanting and needing to try it, having got more in touch with themselves and their mental health while isolated.”
In addition to The Ketamine Fund, Zapolin, an entrepreneur who is considered a pioneer in the domain name industry, is the director of a documentary about his experience with ayahuasca, The Reality of Truth. His upcoming film, “Lamar Odom: Reborn,” follows the former NBA All-Star’s successful recovery from well-documented and high profile struggles with addiction through therapy with ketamine and ibogaine. Zapolin believes that with the proper funding, treatment methods, and access, ketamine can significantly reduce suicidality and depression in the US, both of which will be compounded by the Covid-19 crisis.
As an advocate for the health benefits of a variety of psychedelic medicines, Zapolin has concluded that ketamine is the safest FDA approved therapy currently available for many mental health conditions. “We need to lead people to ketamine as a light at the end of the tunnel,” says Zapolin, “and as advocates we can hold it up as the triage we need as a society.”
Correction: This article has been corrected to reflect that Dr. Hiemstra’s claims of developing a new protocol have been challenged by other therapists in the field. In a future article we will be looking at these challenges.
Main image: Founding clinician and nonprofit supporters of Ketamine SLC (l-r) Mike “Zappy” Zapolin, Robert Hiemstra, and Warren Gumpel