Information For Providers

What is the Joyous treatment?
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We prescribe ketamine at very low doses (10-120 mg troches - buccal absorption of ~25% bioavailability). These doses are not psychedelic, not dissociative, and very safe. 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 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.
 

What makes this treatment safe?
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‍As a medicine, ketamine is very 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:
1. Only admitting patients who meet medical and psychiatric criteria for care
2. Requiring daily checkins from patients in order to monitor side effects, symptoms, suicidality, and relevant medical conditions.
3. Monitoring for controlled substance prescriptions4. Requiring medical clearance for patients with certain medical conditions 
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How are patients monitored?

Patients answer daily check-ins about side effects such as nausea, anxiety, dizziness and sleep disruption, as well as on outcomes measures 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.

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.
 

‍What doses does Joyous use, and how do they compare to other ketamine treatments?

Joyous prescribes doses between 10-120 mg, buccal, with a bioavailability of 20-25%. Based on work with thousands of 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.

‍What is the bioavailability of these dose (and what does bioavailability mean)?

‍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.

‍Are there medication interactions to consider?

‍Ketamine has no major drug-drug interactions. It doesn’t work on the serotonin system, so there is no concern for serotonin syndrome if patients are on other psychiatric medication.

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What are medical contraindications for ketamine use?

‍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 accepts 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 than over telehealth.

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.

‍Is there a risk of addiction to ketamine?

‍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 in fact been found to be a promising treatment for addiction in several studies.

‍Is ketamine a risk factor for high blood pressure? 

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.

‍‍Is there any risk of negative effects on the liver?

‍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.

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How does Joyous prevent abuse and diversion?

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 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.

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‍Why do patients stop treatment?

‍About 20-30% of patients don't experience improvement in their symptoms. Many other patients stop due to financial concerns. 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.

‍What side effects may my patient experience?

‍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. 

How does Joyous differ from other ketamine providers?
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‍We prescribe psycholytic, consistent dosing of ketamine as opposed to infrequent psychedelic dosing. This approach uses ketamine more as a medicine than as a catalyst for mystical experience. Patients do not dissociate or enter into a psychedelic state. Instead, they experience a state of ease and relaxation, and the neuroplasticity inherent to ketamine locks in some of this ease to make them more predisposed to positive, even mood on the whole.

Why is Joyous a telehealth company?
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‍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.

‍Is ketamine safe for at home use?

‍Recent research has shown that ketamine is safe and effective when use in a home setting.

‍What is the half life of ketamine?

‍The half life of medication is approximately 2.5 hours.

‍What dose qualifies as psycholytic dosing?
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Psycholytic dosing is considerably lower than psychedelic dosing. For ketamine, a buccal psychedelic dose is likely 300 mg or more, whereas a psycholytic dose is usually between 20-120 mg buccal.
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‍What does the psycholytic state feel like?
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The psycholytic state is relaxed and open. Patients experienced reduced anxiety and reduced resistance. They often report much mental quiet and fewer thoughts, especially negative thoughts. However, they are fully oriented and lucid. It is not a dreamlike state, without instability or hallucination.

What is psycholytic as opposed to psychedelic dosing?
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In terms of effects, a psychedelic dose often involves visual hallucinations and strong alterations from normal perception. At higher psychedelic levels, ego-death and mystical experiences can occur. These can be very positive experiences for many patients, but can also be fearful or traumatic. 

Psycholytic dosing, on the other hand, is a gentle experience. Patients remain completely oriented during the entire period of effects. They usually report experiences of spaciousness and openness, as the dissociative properties of ketamine lead to expanded states and diminish contracted states associated with stress, depression, or trauma. Patients experience lessened resistance and are better able to process material that may usually be too difficult to process. In therapy, patients often report more insights due to “softening of the ego experience,” which allows them to gain new perspectives about their life. Due to blurred boundaries of the ego as well as reduced resistance, therapists report higher levels of integration are possible.

The following is a list of psycholytic mechanisms of action as defined by Dr. Stansilas Grof:
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• Activation of affect and sensory perception• Loosening of psychological defenses
• Personally meaningful symbolic visualization of affects
• Therapeutic splitting of ego functions with a preserved “reflective ego capacity”
• Broadening of associations
• Exceptionally vivid reliving of disavowed conflicts and memories
• Age regression with great depth of experience
• Pronounced affective abreactions
• Intensification of transference experienced and observable in the here and now on the therapist
• Spontaneous introspective insights

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‍What are the risks of destabilization with psycholytic dosing?

‍While few approaches are completely risk free, psycholytic dosing is highly unlikely to destabilize patients or to lead to retraumatization. Within the first few weeks of use, many patients report an emotional catharsis (a bout of crying, an experience of anger or sadness) that is typically easily recovered from and viewed favorably. Even when it is not experienced favorably, patients do not report this to be destabilizing. 

‍‍Which kinds of therapies pair well with psycholytic ketamine?

‍No therapies are incompatible with psycholytic ketamine, as the patient is fully oriented and lucid, and typically experiences lower levels of resistance, which can aid most therapies. However, some therapy approaches are especially well-suited to the psycholytic state. These include psychodynamic or insight oriented therapies, somatic therapies (due to increased capacity to explore difficult somatic sensations),and ACT and mindfulness-based therapies.

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‍Is psycholytic ketamine safe for patients with trauma?

‍Yes. Because psycholytic ketamine does not distort reality or lead to ego-dissociation, it is considered safe for patients with PTSD and C-PTSD. The degree of impairment has been compared to a “glass of wine” (De Gioannis, 2019), and is typically found to be relaxing rather than distressing.