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We prescribe ketamine at very low doses (10-120 mg troches - buccal absorption of ~25% bioavailability) and pair the medication with curated treatment courses and content to help our patients process underlying emotions, learn valuable skills based in psychology-based practices, and make gradual and consistent mental health improvements. We work with individuals who suffer from anxiety and/or depression, and who have tried other treatments such as antidepressants or psychotherapy in the past. The doses we prescribe are designed to allow patients to be coherent and able to engage with therapeutic practices. Unlike other ketamine treatments, patients are not dissociated or in psychedelic states. The doses are taken daily until a patient experiences improvement in their symptoms of anxiety and depression, at which point they are encouraged to begin spacing out their doses.
As a medicine, ketamine is considered safe, and has been placed on the list of essential medicines by the World Health Organization. In particular, Joyous approaches safety in the following ways:
Patients answer daily check-ins about side effects such as nausea, anxiety, dizziness and sleep disruption, as well as on outcomes measured, such as energy levels and mood. Weekly, they are asked to complete a PHQ-9 and GAD-7 to monitor symptoms, as well as to provide additional information about any side effects. On a monthly basis, we monitor bladder health, alcohol/tobacco/substance use behavior and BMI/exercise. All responses are tracked and shared with Joyous providers to monitor patient progress and ensure safety.
In addition, patients are invited to message our medical and care staff in every check-in, and their comments, questions and concerns are read and responded to by live RNs and care staff daily.
Joyous prescribes doses between 10-120 mg, buccal, with a bioavailability of 20-25%. Based on data and patient outcomes of over 50,000 patients, we found that in the buccal troche delivery mode there’s not a need to adjust for weight. Anesthetic doses (for surgery) are around 3 mg/kg using IV. For subanesthetic IV dosing usually used for psychedelic pain and depression treatment, the dosing is generally 0.5-1.5 mg/kg. Sprovato by Johnson & Johnson, which has bioavailability of 48% and uses esketamine (which is more dissociative than the racemic ketamine Joyous uses) begins dosing at 28 mg and ends at 84 mg.
Bioavailability refers to the percentage of a medicine that is metabolized in a way that is active in the body. Different delivery modes of medicine have different bioavailability - for example, intravenous (IV) treatments, which enter the bloodstream directly, have 100% bioavailability. Buccal troches, which Joyous uses, have a bioavailability of 20-25%, depending on the conditions of the mouth (wetness, warmth). By contrast, Spravato, the esketamine nasal spray from Johnson & Johnson, has a bioavailability of 48% according to research.
Joyous medical providers review medical history, current medications, and mental health history to assess if Joyous is a safe option for patients. The list of medication interactions with low-dose ketamine is short and providers share the risk assessment and any identified interactions with patients in their initial consultation. Ketamine itself doesn't work on the serotonin system, so there is no concern for serotonin syndrome if patients are on other psychiatric medication like SSRIs.
Psychiatrically, the main concern with ketamine use is psychosis. Even at these low doses, a person with a history of psychosis may be at risk. There are some studies that suggest that ketamine may be a good treatment for bipolar disorder, but more replications are required, as ketamine may also cause cycling up of mania. Joyous accepted patients with a Bipolar II diagnosis, but disqualifies patients with Bipolar I disorder in order to remain safe. We also don't work with patients who have a history of substance use disorder or are currently using suboxone, methadone, Subutex, or Naloxone. While ketamine has actually been found to be beneficial in treating addiction, we feel that it is more appropriate to do so with a provider in person rather than over telehealth. We will request medical consent forms or other documentation from patients if our providers determine the need on a case-by-case basis.
Medically, we do not work with patients who've had strokes, aneurysmal vascular problems, uncontrolled high blood pressure, or current/imminent pregnancy. In patients with a history of liver disease, kidney disease, seizures, or cerebral hemorrhaging, we require that the patient's treating physician approve treatment with ketamine in order to accept the patient into our program.
Ketamine addiction has rarely resulted from a clinically-prescribed course. The doses that Joyous prescribes are low enough that they constitute 10% or less of a typical daily dose for a ketamine addict. Typically, cases of dependence involve daily use of between 1- 4 grams (not milligrams) of ketamine. Ketamine has recently been found to be a promising treatment for addition in several studies.
In patients with controlled blood pressure, there’s low evidence to support states of hypertensive emergencies. At high doses, ketamine can transiently increase blood pressure, but this has not been found at lower sublingual or buccal doses. If mild increases were to occur in patients with controlled blood pressure, it would be similar to the blood pressure increase that comes with exercise.
Ketamine is a weak competitor of the liver enzyme CYP450, but it doesn’t interfere with this enzyme significantly. People without liver disease are not expected to have any negative outcomes due to ketamine use.
The troche form-factor has a very slow absorption rate that does not lend itself well to abuse. The troches cannot be altered by the patient into powder form. Patients are asked about how many troches they have left on a weekly basis, and our pharmacy does not refill earlier than 3 weeks, meaning that patients who use more than their prescribed dose are left without doses until they're eligible for a refill. Refills are not sent until the patient requests them. We use multiple forms of controlled substance monitoring (PDMP/CURES) and require discharge consents from other providers if patients are found to have multiple prescriptions. If our PDMP/CURES report reveals that they have a second active ketamine prescription, we remove them from the program.
Fewer than 10% of patients don't experience improvement in their symptoms. Many other patients stop due to financial concerns, though we do offer financial assistance to prevent financial means from blocking patients from treatment. A smaller percentage stop because of side effects, such as nausea, headaches, or sleep disruptions. Many patients who stop report that they are stopping because they feel much better. Our treatment program is designed for patients to "graduate" from the program; it is designed to help patients process underlying emotions, experience neuroplasticity and learn new coping skills, and build a new mindset that empowers them with tools to handle life's ups and downs far beyond treatment.
Most patients experience at most slight nausea, lightheadedness for not longer than 30 minutes. Unlike traditional treatments there is no change in libido, no weight gain, no emotional numbing.
We prescribe consistent psycholytic dosing of ketamine as opposed to infrequent psychedelic dosing. This approach uses ketamine more as a medicine than as a catalyst for mystical experiences. Patients do not dissociate or enter into a psychedelic state, which may be overwhelming or intense, and may require monitoring and integration coaching. Instead, they experience a state of ease and nervous system relaxation. Ketamine has been found to enhance neuroplasticity, which can lock in some of this ease to make patients more predisposed to positive moods, and also provides a unique and powerful opportunity for therapy and skill-building.
Our mission is to increase accessibility to mental well-being. By operating as a telehealth company, we can provide access to individuals who live far from physicians who prescribe ketamine treatment, as well as individuals who are homebound for various reasons. Telehealth also allows us to keep this treatment affordable, at $129/month, making it available to many patients who can't afford it otherwise.
Recent research has shown that ketamine is safe and effective when use in a home setting. Our multi-layered safety measures and medication form factor helps monitor patients and support safe use of this medication at home.
