Ketamine therapy has certainly gone mainstream, with numerous reports highlighting its transformative potential and many lives changed and saved. Used off-label for over two decades for the treatment of mental health issues and pain, the landscape of ketamine therapy has evolved significantly. Initially offered exclusively in intravenous (IV) form within a monitored clinical setting, patients now have additional options, including oral ketamine, which can be self-administered at home with little to no guidance and oversight.
An arguable advantage of at-home ketamine use is the potential for increased access and affordability. However, this also comes with significant risks, including potential decreases in efficacy and numerous accounts of misuse, abuse, addiction, and even death. Mail-order ketamine providers are putting patient safety at severe risk due to the lack of proper screening, care, and oversight. A recent article highlights the concerning ease of obtaining ketamine online, stating, "Before booking my virtual consultation, I was asked to fill out a short online survey that essentially amounted to: Are you over 18? Are you sad? Do you have any pre-existing medical conditions?"
Furthermore, there is a growing number of stories about severe incidents associated with at-home use of ketamine. These include cases such as an individual who suffered a laryngospasm and died due to self-administering sublingual ketamine at home, as well as instances where individuals vomited and aspirated, which have a high rate of mortality.
Let’s take a closer look at at-home ketamine therapy to better understand its implications for treating mental health disorders such as depression, anxiety, PTSD, substance abuse, and pain.
A good place to start is with the story of Ryan Haight, an 18-year-old honors student from La Mesa, California. In 2001, Ryan purchased Vicodin over the internet without a valid prescription and then died of an overdose. His death underscored the significant issues with the ease of obtaining medications online and the concerning lack of regulation in this sector. In response, his parents campaigned for stricter regulations, leading to the passage of the Ryan Haight Online Pharmacy Consumer Protection Act in 2008. This law made it illegal to deliver, distribute, or dispense controlled substances online without a valid prescription, mandates face-to-face consultations between patients and doctors, and imposes strict requirements on online pharmacies and advertisements.
Due to the COVID-19 pandemic, there have been temporary modifications to the Ryan Haight Act to allow for greater flexibility in telemedicine. The DEA temporarily waived the requirement for an in-person medical evaluation, allowing healthcare providers to prescribe controlled substances via telemedicine under certain conditions. This has enabled the expansion of at-home ketamine treatments, leading to the emergence of numerous online providers that mail oral ketamine directly to the doorsteps of Americans.
The process is often quite straightforward. We recently had a patient come to our facility seeking IV ketamine therapy after experiencing only marginal effects from his at-home ketamine trial. He reported that he was approved for the at-home ketamine therapy after a mere five-minute phone conversation with an online provider, during which he was asked for little more than his home address. This raises concerns about the thoroughness of the evaluation process and the potential risks involved.
Intravenous (IV) ketamine is widely regarded as the superior route of administration, supported by extensive studies and the scientific community. It is considered the safest and potentially most effective method of treatment. Oral ketamine, on the other hand, has been found to be less effective with a delayed onset of antidepressant effects. Studies indicate that “oral ketamine has modest effectiveness in treatment-resistant depression, with only approximately 30% of patients reporting some benefit and about 70% experiencing no change or a worsening of mood.”
Administering ketamine in a supervised setting significantly reduces the risk of serious side effects, which can include acute anxiety, airway issues, and fluctuations in heart rate and blood pressure. The presence of an on-site medical professional ensures swift intervention in case of a medical emergency or adverse reactions, providing a safer and more controlled environment for treatment.
IV ketamine boasts 100% bioavailability, meaning all of the administered ketamine is absorbed into the bloodstream. This allows for the use of the lowest possible dose necessary to achieve the therapeutic threshold for antidepressant effects, thereby reducing the risk of side effects or adverse reactions. In contrast, oral ketamine has a bioavailability of only 20-25%, meaning the majority of the drug does not even reach the bloodstream and thus has no effect.
A significant advantage of IV ketamine is the ability to control the experience. With IV administration, the clinician can temporarily pause or stop the infusion if needed, a level of control that is not possible with oral or nasal ketamine, where the entire dose is ingested or inhaled at once. This control enhances the safety and customization of the treatment experience.
IV ketamine is a mixture of two ketamine molecules: (R)-ketamine and (S)-ketamine. In contrast, the oral formulation of ketamine typically contains only the (S)-ketamine molecule. Studies suggest that (R)-ketamine may have more potent antidepressant effects, while (S)-ketamine is a more effective anesthetic. This implies that both molecules play important roles, and the combined presence in IV ketamine may contribute to its superior therapeutic efficacy compared to (S)-ketamine alone.
Since the commercial availability of oral ketamine is limited, compounding pharmacies create oral formulations by measuring and mixing ketamine with other substances to ensure accurate dosing and optimal absorption. However, the FDA has expressed concerns about compounded ketamine, particularly because these drugs are not FDA-approved. This lack of approval means they have not undergone the rigorous testing and evaluation process required for FDA approval, including assessments of their safety, efficacy, and quality. As a result, compounded ketamine formulations can vary in concentration and purity, potentially leading to inconsistent therapeutic effects and safety profiles.
A major concern is the quality and sterility of compounded ketamine. Medications prepared in compounding pharmacies may not adhere to the stringent manufacturing standards upheld by commercial pharmaceutical companies such as Pfizer and Hikma, which produce IV ketamine. This can increase the risk of contamination or improper compounding, leading to adverse effects or ineffective treatment.
Ketamine is a Schedule III controlled substance, meaning it has a potential for abuse and dependence. The FDA is concerned that compounded ketamine, especially in oral or nasal forms, may be more prone to misuse or diversion compared to the controlled administration of IV ketamine in a clinical setting. This could lead to increased cases of ketamine abuse, addiction, and its associated health risks.
News stories of ketamine abuse, such as the case with actor Matthew Perry’s tragic death, highlight the complexities surrounding mental health treatments. Perry, famously known for his role on "Friends," died from drowning in a hot tub while under the influence of ketamine. His death brought attention to the significant risks associated with the unsupervised use of ketamine outside of a medical setting. The medical examiner's report suggested that Perry might have taken ketamine orally, a method that can be especially dangerous if not properly dosed and monitored .
Juan Pablo Cappello, the co-founder of Nue Life Health, one of the industry's largest providers of at-home ketamine, has since urged caution among patients and providers, withdrawing his endorsement of at-home ketamine therapy. "After being at the forefront of at-home ketamine treatment, recent findings, such as the case study of unintentional overdose via telehealth, have led me to reevaluate," said Juan Pablo Cappello. He also posted on X (formerly known as Twitter), stating, "I can no longer endorse the prescription of ketamine without stricter controls. And I cannot recommend at-home ketamine therapy to my family and friends.”
Whether you’re considering ketamine therapy in a clinical setting, such as Innerbloom, or at home, we urge you to exercise caution and conduct thorough preparation before starting the treatment process. Ensuring safety with directed supervision provided by trained medical professionals and ketamine specialists is always recommended. With the utilization of IV ketamine and thoughtful guidance from a ketamine-assisted psychotherapist, you can maximize the therapeutic potential of ketamine. These are crucial points to consider if you're thinking about using ketamine at home.
If you have questions or concerns please reach out!
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