Ketamine Clinicians Publish Ethical Guidelines to Raise Treatment Standards
As psychedelics therapy continues to gain in popularity, clinics are beginning to change rules in order to build trust.
A new paper published in the Journal of Psychedelic Psychiatry lays out guidelines that propose a standard of care for the growing number of clinicians providing ketamine for mental health indications. The authors of the paper note that despite the rapid expansion of these services, many providers of therapeutic ketamine do not have training in psychological or psychiatric treatment.
“The majority of ketamine providers draw from limited, if any, formal psychiatric or psychological training or experience, and provide in-office ketamine without psychiatric treatment planning or psychotherapy,” write authors Dr. Wesley Ryan and Raquel Bennett PsyD.
Ryan and Bennett cite the Directory of the American Society of Ketamine Physicians, Psychotherapists, and Practitioners (ASKP), as support for this observation. They note in their commentary that while some medical practitioners remain skeptical of including ketamine therapies in their broader clinical practice, promising clinical findings are being put into practice “by a variety of professionals, some with a high degree of rigor and others without.”
A message received by a ketamine clinician from a patient who had received ketamine treatment at an anesthesiologist’s office illustrates this concern. “I then sat in the chair with the ketamine going into my vein, alone in the cold room, behind a closed door, for the entire hour of the treatment,” wrote the patient who agreed to share their experience. “No one checked on me as I sat there for an hour with a powerful drug going into my body. Given that the nurse didn’t know how to take my weight correctly, and given that she didn’t know enough to check both my arms to find the best vein, I could not be confident that the treatment had been set up correctly. I felt abandoned and afraid.”
The Ethical Guidelines for Ketamine Clinicians have been compiled by the KRIYA Institute which provides clinical services to patients receiving therapeutic ketamine, and training to health care professionals who offer this treatment. The guidelines advise that clinicians providing therapeutic ketamine not practice outside the scope of their training.
“I think teaching about and discussing ethical guidelines is a crucial piece of the work with ketamine and the emerging field of psychedelic-assisted therapy,” says Veronika Gold, co-founder and therapist at Polaris Insight Center, who believes that the guidelines are an important step forward. “There are providers who are coming from the medical field and do not have a knowledge of mental health field or psychiatry and psychotherapy, there are psychiatric providers who are not well familiar with psychotherapy, and there are many providers on all fronts that are not familiar with psychedelic/shamanic/transpersonal paradigm. The new paradigm that is emerging in the psychedelic renaissance promotes cross-fertilization among various disciplines in contrast to competition and segmentation.”
The guidelines describe three domains of responsibility for patients, psychotherapists, and medical prescribers. They advise that patients receiving ketamine treatment have a responsibility to clearly and honestly communicate with clinicians and make an effort to actively participate in the agreed on integration plan to the best of their abilities.
For mental health professionals providing therapeutic ketamine, the guidelines recommend that they conduct a clinical intake interview and assessment, do integrative treatment planning and provide psychological preparation before the administration of the ketamine. Mental health professionals are also advised to provide psychological support and integration while the patient is receiving the ketamine. In addition, the guidelines recommend that these providers should manage any psychological or psychiatric emergencies that arise during the treatment itself.
In regards to medical professionals who prescribe ketamine, the guidelines advise that their responsibilities include, “assessing the patient’s physical condition before ketamine treatment; attending to the physical and medical safety of the patient during ketamine treatment; and assessing and treating any adverse reactions during the course of ketamine treatment.”
Clinicians who provide therapeutic ketamine say that common physical side effects include an increase in heart rate and blood pressure (hypertension), nausea, headache, changes in vision, and or muscle spasms. Occasionally, serious adverse reactions can occur, including loss of airway, which can be life-threatening. Ketamine sessions can also be disorienting or frightening, especially if the patient has not had adequate psychological preparation.
“Ketamine is a very powerful tool with some special safety considerations,” says Bennett. “People need to be concerned about psychological safety, as well as physical safety, when working with this unique medicine.”
Bennett, who founded KRIYA Institute, says the guidelines were drafted over a period of years and reflect expertise from a range of medical practitioners who contributed to their creation. She notes that this process included a 10 week period when draft guidelines were posted online for comment from the public as well as clinicians.
The guidelines advocate for the involvement of clinicians who are not just prescribers of ketamine, but also those well trained in psychotherapy and the process of maintaining a therapeutic plan that supports the growth of the patient. According to Bennett, the guidelines can be used by those seeking treatment to evaluate providers of therapeutic ketamine and their clinical team. In addition, Bennett says patients can use the guidelines to encourage providers to work within the current standard of care.
“The ethical ketamine clinician practices within the scope of their professional license, and they recognize their limitations with respect to their professional training and experience,” reads the guidelines. “They actively seek consultation as needed, and they make referrals to other professionals as needed.”
In addition to supporting the process of due diligence for those seeking a provider of therapeutic ketamine, Bennett notes that the guidelines can be cited in future research studies and by senior clinicians in the field who are consulted in cases where members of a state medical board investigate complaints against licensed practitioners.
“It is no longer acceptable for providers from an anesthesia background to provide a bag of ketamine for a mental health reason without consulting with a mental health professional, because this is not consistent with the published standard of care,” says Bennett.
Ketamine Used to Treat Numerous Psychiatric Indications
Ketamine has long been used as a surgical and procedural anesthetic and is regulated as a Schedule 3 substance that can be legally prescribed off-label by medical professionals for certain indications. Numerous studies have established that racemic (generic) ketamine is also an effective treatment for multiple psychiatric indications, including unipolar and bipolar depression.
The FDA has approved the use of esketamine (which is one component of racemic ketamine) for treatment-resistant depression in the form of a nasal spray called Spravato developed by Janssen Pharmaceutical Companies of Johnson & Johnson. An increasing number of clinicians also offer generic ketamine “off-label” as a mental health treatment.
In their commentary on the guidelines presented in their paper, Ryan and Bennett note that while the number of clinics offering ketamine-assisted therapy is growing rapidly, not all follow ethical practices. “A not insignificant minority of clinics offer ‘package deals’ on ketamine, grossly misrepresent the treatment by suggesting it is a ‘cure’ for depression or make unsubstantiated and exaggerated claims about efficacy,” write the authors. “Such abuses are unfortunately prevalent and undermine the real but measured benefits possible with ketamine.”
In regards to clinics marketing their services, the guidelines advise that ketamine clinicians should be honest and transparent and adhere to FDA guidelines. Clinic operators are also advised to ensure that their “clinical and advertising claims are supported by the research literature.” The guidelines also recommend that ketamine clinicians should try to make therapeutic ketamine accessible to people who cannot afford to pay for treatment.
According to the authors of the paper, the guidelines are intended to begin examining barriers to ketamine therapy based on the costs of treatment. In their commentary, the authors note that there is no FDA approval for racemic (generic) ketamine for a psychiatric indication – and no incentive for companies to seek this approval because ketamine is generic and cannot be patented. As a result, insurers are not obligated to cover the cost of this treatment which remains an out-of-pocket expense for patients exacerbating the present lack of parity with access to mental health care.
The authors note that a recent clinical trial has found that racemic (generic) ketamine, which costs $1- $2 per dose, provides the same benefit in the treatment of depression as a dose of esketamine, such as Spravato, that costs $600-$900 per dose. “Perhaps with time and further study,” write the authors, “insurers will decide to instead cover the much less expensive generic parent compound; a policy that several large health care organizations including the [Department of] Veterans Affairs and Northern California Kaiser Permanente have tried.”
Training Ketamine Providers
The Ethical Guidelines for Ketamine Clinicians are intended to help guide patients and practitioners through the uncharted waters of this new treatment. One of the components of the guidelines is a call for appropriate training. The guidelines note that there are different approaches to ketamine treatment and that each have their advantages and drawbacks. They recommend that an ethical ketamine clinician should be familiar with established forms of ketamine administration, including dosing strategies and paradigms for treatment. These clinicians are also advised to explain to patients the different ways that they can receive psychiatric and psychological care and help patients access these resources in their own community.
Those providing ketamine treatment are also advised by the guidelines that they have a duty to uphold the responsibilities required by their professional license in regards to the clinical practice. These requirements include “informed consent, record-keeping, professional boundaries, confidentiality, and general professional conduct” – in addition to being “compassionate, thoughtful, honest, and forthright” in their communications.
In their commentary on the guidelines, the authors of the paper note that while anesthesiologists are among the most qualified to provide and monitor high doses of ketamine for pain management and sedation, providing ketamine at lower doses for mental health conditions requires training to address possible existing mental health conditions and the potential for suicide which is noted on Spravato packaging.
“The importance of longitudinal experience in working with such individuals, and of suicide risk assessment in particular, cannot be underestimated,” write the authors. “While studies have demonstrated ketamine to have anti-suicidal benefit, cases with such tragic outcomes unfortunately still do exist and are actually increasing in frequency arguably in part as a consequence of sub-par provider qualification.”
Because ketamine has a long history of generic use and is now being used off-label without formal FDA approval, the authors of the paper note in their commentary that requirements for psychotherapy skills among ketamine providers – and training programs of various quality, duration and depth – are now emerging. These trainings attempt to help clinicians understand how to work with psychedelics and include topics like set and setting, the unique effects of ketamine and creating a container for the therapeutic experience.
Gold says that because many providers offer “therapeutic ketamine” without training or experience in psychiatric or psychological treatment, or in the psychedelic effects of the medicine, “The support clients receive is therefore limited and sometimes the treatment can be more damaging, such as when trauma surfaces and client needs support with processing, or when transpersonal material emerges and the client does not know how to make sense of it.”
“ In transpersonal therapy we talk about the guiding principle of Inner Healing Intelligence – inner capacity to heal,” says Gold. “This perspective honors and trusts that what is coming up in the session is significant and requires witnessing and processing. Sometimes this material can be distressing. Some clients have shared that during an IV administration by a provider unfamiliar with these concepts and therapeutic approaches, the provider administered ‘rescue medication’ to ‘calm the client down.’ This sedating strategy then interrupted the working-through process related to the specific emerging psychological issues.”
The authors argue that the best qualification for physicians working with patients receiving therapeutic ketamine is a multi-year post graduate medical specialization psychiatry residency. They note, however, that these kinds of residency programs are only beginning to provide instruction in the use of therapeutic ketamine.
Related treatments using MDMA and psilocybin are now only being briefly covered in medical training programs. The authors say they expect that appropriate training will become more accessible over time as these treatments are more widely accepted. In the meantime, they note that providers must have the training to explain to patients what the pros and cons are for different kinds of ketamine treatment so that those receiving care can provide informed consent.
“This concern over practitioner training and scope of practice is well founded; it is simply not possible to provide a truly informed consent, including risks if the provider does not have psychiatric training,” write the authors, “It is unrealistic for anesthesiologists, for example, to meaningfully comment upon the use of monoamine oxidase inhibitors, tricyclic antidepressants, electroconvulsive therapy (ECT) or various psychotherapy modalities, because it is outside the scope of their training.”
The guidelines advise that clinicians providing ketamine therapies receive special training or mentorship which includes a substantial education in the medical, psychological and psychedelic properties of the substance. As there is significant new research about ketamine emerging, the guidelines also recommend that clinicians keep up on the literature and stay informed about this rapidly emerging area of care. In their commentary, the authors endorse some form of specialized training. As an example of the importance of specialized instruction, they point to the clinician training program developed by MAPS as part of their clinical trials seeking FDA approval for MDMA-assisted psychotherapy.
“The guidelines are arguably most important in this regard: in pointing out the need and advocating for not simply a prescriber, but also a clinician well versed in psychotherapy and the nuanced process of maintaining a therapeutic frame for preparation, support, and, ultimately, growth,” write the authors in their commentary. “Without attention to these components – as is done in other psychedelic assisted psychotherapies currently in clinical trials – the beneficial effects of ketamine are not fully realized, and the overall efficacy probably suffers.”
The authors of the paper predict that as more research on the therapeutic use of ketamine emerges, these data will direct both clinical use of ketamine and the expectations that providers have for these treatments. They view the guidelines as a starting point for helping to shape how ketamine is used therapeutically and also a roadmap for how clinicians can be held to standards of care that support the best outcomes for patients.
“Hopefully these Ethical Guidelines will change this exploding field for the better,” says Bennett. “Patients will be able to read this brief document and evaluate their clinical care. And providers will realize that they need to seek some additional training in order to use this tool in a competent way.”