Generic ketamine, a Schedule 3 drug FDA approved for use as an anesthetic, has an established role as an off-label treatment in mental health care. Its use has shown promise in the treatment of depression and acute suicidality. However, issues related to off-label prescribing, over-prescribing, safety, ethics, marketing, manufacturing, and training are surfacing, necessitating a call for professional excellence and robust training for ketamine-assisted therapy (KAP) providers.
A critical oversight in many mental health uses of ketamine is the neglect of the subjective effects. Under ketamine, patients can have profound experiences ranging from terrifying to blissful, yet often receive no professional support in understanding or integrating these experiences into their lives. This gap in patient care is a serious concern, especially for those already in psychological distress.
At Fluence, recognizing this gap, we developed a KAP training program. Our initiative stemmed from a commitment to harm reduction and an understanding that the therapeutic potential of ketamine is at least in part due to its psychological effects. Fortunately, there is a large body of research literature on the use of psychedelics in the context of psychotherapy which can inform practitioners using this off-label treatment. The psychological care component of ketamine therapy is not merely supplementary; it is its backbone.
The FDA’s recent warning over ketamine misuse underscores the complexities in this field. The agency’s alert distinguishes between the controlled, research-informed, off-label use of ketamine and the hazards of practices in which patients receive excessive doses for consumption in unsupervised settings, often after only brief assessments by telemedicine. This warning is a stark reminder of the potential for dangerous psychiatric reactions and other health issues that any responsible ketamine prescriber or therapist must avoid.
This situation challenges us to use existing research, clinical wisdom, and ethical guidelines to inform our training and practice. It is a delicate balance of applying emerging knowledge while meeting our patients’ needs responsibly, especially when other treatments fall short.With ketamine, we have the opportunity to learn to implement high-caliber training and professional standards for other psychedelic therapies on the horizon.
Accordingly, training programs should address not just the pharmacological aspects, contraindications, and addiction potential of ketamine but also—critically—the psychotherapeutic skills required to support patients effectively through their experiences.This training is vital for two primary reasons: First, it protects patients. The psychedelic experience, catalyzed by substances like ketamine, can be profoundly disorienting and, without proper guidance, potentially distressing and even, such as when used alone in a hot tub, deadly. Training can enable professionals to ensure these experiences are integrated in a way that promotes healing and personal growth. Second, the credibility and future of the psychedelic therapy industry hinge on the professionalism and ethical standards we uphold today. Missteps in this nascent stage could jeopardize the immense therapeutic potential that ketamine treatment holds, and the same will be true for other psychedelic therapies if and when an FDA approval allows for broad on-label access.
In summary, as we embrace the potential of ketamine-assisted psychotherapy and look towards the future of psychedelic therapy, let us do so with a commitment to ethical care and a dedication to science-based practices. The public deserves nothing less.