Sacred Roots

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Ketamine is a dissociative anesthetic that has been used since the 1970’s in many different ways. Due to its excellent safety profile and the fact that it does not suppress breathing, Ketamine was used in war times as an anesthetic to help with trauma on the battlefield. It is used extensively in emergency rooms and it also has a role in veterinary medicine. Ketamine is most often used in hospital settings by anesthesiologists during major and minor surgical procedures as an anesthetic. Recently, lower dose (subanesthetic) ketamine has shown great promise in the treatment of mental illness, most notably depression and suicidality. Ketamine is one of the safest and most widely used anesthetics in the world according to the World Health Organization. Researchers at Yale have been studying low-dose ketamine since 2000 in controlled clinical settings for patients with severe depression who are unresponsive to other antidepressants. In several studies, more than half show a significant decrease in depression symptoms in 24 hours and approximately 4 out of 5 went on to find significant improvement. Ketamine is now used extensively for many chronic mental illnesses such as difficult-to-treat depression, suicidality, anxiety, anxious bipolar depression (without mania), post-traumatic stress disorder (PTSD), obsessive compulsive disorder, and chronic pain. Many clinicians, including us at Skylight Psychedelics, classify ketamine as a psychedelic, however it is not a classic hallucinogen like psilocybin, the compound found in psychedelic mushrooms, also with many promising mental health benefits.

The exact mechanism by which ketamine functions as an antidepressant remains largely unknown. So far the medical community has learned that ketamine has an affinity for multiple receptors and it likely affects several different types of receptors in the brain, including N-methyl-D-aspartate (NMDA) receptor, which binds glutamate, the primary excitatory neurotransmitter in the brain as well as Alpha-amino-3-hydroxy-5-methyl-4-isoxazole propionic acid (AMPA) receptor, which is also involved in glutamate neurotransmission. It has been demonstrated that people who suffer from chronic depression and anxiety experience atrophy of neuronal connections in the frontal part of the brain. Ketamine enhances neuroplasticity, the brain cell’s ability to form new connections with one another via expression of brain-derived neurotrophic factor. Not only has ketamine demonstrated the ability to repair neurons that were atrophied from chronic depression, but it also promotes the growth of new neuronal connections! Ketamine’s antidepressant effects may be due to activation of the AMPA receptor by the ketamine metabolite. Furthermore, animal studies have suggested that neuronal vascular endothelial growth factor signaling in the prefrontal cortex region of the brain mediates the rapid antidepressant actions of ketamine. It is also referred to as a “psychoplastogen” which refers to small molecule neurotherapeutics that induce swift changes in plasticity following a single administration. These changes are thought to promote lasting changes in behavior patterns. Ketamine also activates at the level of the anterior cingulate cortex and by increasing connectivity between the insula and default mode network. Note: It remains unclear if the effect ketamine has on the opioid receptors plays a role in its antidepressant effects. Ketamine’s effect on these receptors demonstrates how this medicine also functions as an analgesic (pain medicine) for those with chronic pain

Ketamine is used to treat various illnesses. Notably the following: Depression Suicidality (Skylight Psychedelics refers all suicidal clients for intravenous or intramuscular ketamine in conjunction with therapy) Post Traumatic Stress Disorder (PTSD) Anxiety Obsessive-compulsive Disorder (OCD) Substance abuse co-occurring with a primary psychiatric disorder Relationship and existential issues such as existential distress Bipolar I and II depressive phases (not mania) Psychological reactions to physical illness and life threatening illnesses substance Chronic pain (often requires higher doses of ketamine in a medically supervised settings such as a clinics or hospitals)

There are medical and psychiatric conditions that render people unable to receive ketamine therapy. This includes: Medical Conditions Contraindications Untreated hyperthyroidism Untreated hypertension Epilepsy Aneurysm or dissection Heart disease, including heart failure, heart attacks or arrhythmias Severe breathing problems Kidney disease Advanced liver disease Interstitial cystitis (bladder wall inflammation) Glaucoma (unless cleared by an ophthalmologist) Active illicit substance abuse Pregnant or breastfeeding Psychiatric Contraindications Schizophrenia Psychotic features Mania As an added safety measure we recommend our clients reach out to their primary care physician to ensure they do not have any contraindications to treatment. Additionally, if a client has a psychiatrist we recommend they contact their psychiatrist to ensure they have no contraindications to treatment

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Theophylline or Aminophylline – can lower seizure threshold. Benzodiazepines, opioid analgesics, or other CNS depressants (can cause profound sedation, respiratory depression, coma or death, they can also interfere with the mental health benefits of ketamine). Lamotrigine (trade name Lamictal). Sleeping aids and sedatives such as Ambien, Benadryl, Remeron. There are other medicines that may interact with ketamine and therefore your clients medications have been thoroughly reviewed by Skylight Psychedelics physician team prior to their prescription being authorized. We also recommend clients refrain from using the following substances during treatment as they can interfere with the benefits of ketamine and some can lead to dangerous interactions: - Alcohol - Marijuana - All Illegal substances such as cocaine, etc. We do not recommend mixing ketamine with other medicines including using ketamine with psilocybin, MDMA, Kambo, DMT, ayahuasca, mescaline, iboga, etc. Combining medicines has an increased risk of adverse events, notably hypertension, and is not recommended unless the combination is being studied in a clinical trial. Further, if a client is on a benzodiazepine we may ask them to taper off under the care of their prescriber prior to a prescription for ketamine being authorized. Rapidly tapering off benzodiazepines is NOT recommended and can result in severe withdrawal and potentially death.

There are many studies supporting the use of ketamine for mental illness. Please refer to any of the studies below for further information. Huang YJ et al. New Treatment Strategies of Depression: Based on Mechanisms Related to Neuroplasticity. Neural Plast. 2017; 2017:4605971. Hamilton et al. Depressive Rumination, the Default-Mode Network, and the Dark Matter of Clinical Neuroscience. Biological Psychiatry. 2015 Aug 15;78(4):224-30. Andrade, C. Ketamine for Depression, 1: Clinical Summary of Issues Related to Efficacy, Adverse Effects, and Mechanism of Action. J Clinical Psychiatry 2017 Apr;78(4):e415-e419. Gaynes BN et al. What Did STAR*D Teach Us? Results From a Large-Scale, Practical, Clinical Trial for Patients With Depression. Published online 1 Nov 2009. https://doi.org/10.1176/ps.2009.60.11.1439. Zarate CA, et al. A randomized trial of an N-methyl-D-aspartate antagonist in treatment-resistant major depression.Arch Gen Psychiatry. 2006 Aug;63(8):856-64. Aan Het Rot M et al. Ketamine for depression: where do we go from here? Biol. Psychiatry. 2012 Oct 1;72(7):537-47. DiazGranados N et al. Rapid resolution of suicidal ideation after a single infusion of an N-methyl-D-aspartate antagonist in patients with treatment-resistant major depressive disorder. J. Clin. Psychiatry. 2010 Dec;71(12):1605-11. https://www.nimh.nih.gov/about/directors/thomas-insel/blog/2014/ketamine.shtml Jennifer Dore et al. Ketamine Assisted Psychotherapy (KAP): Patient Demographics, Clinical Data and Outcomes in Three Large Practices Administering Ketamine with Psychotherapy, Journal of Psychoactive Drugs, 51:2, 189-198, DOI: 10.1080/02791072.2019.1587556.

Ketamine hydrochloride, trade name Ketalar, is a Schedule III controlled medicine that is FDA approved for general anesthesia in intravenous or intramuscular formulations. Ketamine is a racemic mixture, made up of two molecules that are mirror images of one another, R-ketamine and S-ketamine. Ketamine does not have FDA approval for any psychiatric illness. S-ketamine, derived from ketamine, called esketamine, trade name Spravato, was approved in 2019 in nasal spray form, for treatment resistant depression in adults with major depressive disorder with acute suicidal ideation or behavior, in conjunction with an oral antidepressant. Most ketamine being used for mental illness is being used legally by healthcare professionals off-label. Sublingual ketamine used by Skylight Psychedelics is off-label.

Ketamine treatments are far less frequent than standard medications for mental health. This in turn results in far fewer side effects. Our clients often begin with 2-3 times weekly administration during their initial six-session program, and then transition to less frequent sessions as needed, if needed. Clinical trials with IV ketamine have shown that an initial course of 4-6 twice weekly treatments can produce antidepressant effects that last several weeks-months. Ketamine also allows you to connect with the deeper root cause of your struggles, your traumas. Ketamine elevates all types of therapy models and allows people to be more open and able to receive the benefits of various therapeutic approaches.

Ketamine has been used since the 1970s as an anesthetic. More recently, it has proven its ability (at a much lower dose) to act as a therapeutic agent for numerous mental health conditions. It has an extensive safety profile and has very few undesirable side effects which are rarely encountered. The doses used in mental health are so low that many of these side effects are ameliorated.

A small percentage of clients will not respond to ketamine, even at higher doses. Additionally, some clients with rigid personality structures, including those with severe OCD or personality disorders and possibly those with profound PTSD, won’t be able to go into a trance-like state and may find it challenging to maintain the benefits of the treatment experience, if they find any relief with the experience at all. We don’t yet know enough about who won’t benefit and recommend attempting this treatment if no contraindications exist as the medicine is incredibly safe and well-tolerated.

Skylight Psychedelics offers two ketamine formulations, a specialized sublingual formulation of ketamine that is rapidly dissolving and an intranasal option. Our protocol was formulated by a multidisciplinary team of physicians board certified in internal medicine, anesthesia, and psychiatry in conjunction with doctors of pharmacy. Our protocol was developed with client safety and the medicine’s efficacy as top priorities. We provide our clients with client specific dosing based on many factors. We chose to work with these formulations of ketamine as, not only are they safe, but they reliably promote communication between client and therapist while the client is in a trance-like state. These formulations also allows people to tap into difficult states of mind with decreased fear. Further, they afford clients the ability to integrate healing after the acute phase of medicine starts to wear off. Our team at Skylight Psychedelics believes that the trance-like state is an ideal state of mind for psychotherapy. We find that most often the peak experience on the medicine lasts approximately 25-60 mins and the medicine becomes much less intense after this initial wave.

The most common side effects from ketamine include: Headache Blurry vision Nausea Vomiting Anxiety Diminished ability to see/hear/feel Dry mouth Lip tingling and/or heaviness Elevated blood pressure Elevated heart rate Elevated intraocular or intracranial pressure Excitability Loss of appetite Confusion Nystagmus (rapid eye movements) Restlessness Slurred speech Synesthesia (overlapping of the senses, for example seeing sounds) Dissociation (feeling out of body) Dizziness Tinnitus (ringing in the ears) Hypoesthesia (partial or total lack of sensation in a body part) Lethargy (fatigue) Sedation (somnolence) Vertigo (room spinning) Feeling drunk Rarely a client can experience a feeling of paralysis Note: There have been no cases of persistent neuropsychiatric sequelae, medical effects, nor increased substance abuse in clinical practice. Note: Skylight Psychedelics firmly believes that the dissociative and/or psychedelic effects of ketamine treatment are a critical piece of the therapeutic process and should not be avoided. We believe this part of the experience can be extremely beneficial to our clients when supported in a trusted healing container.

Many people in a trance-like state from ketamine often describe positive feelings. This has been described as euphoria, empathy, forgiveness, calmness, total relaxation and reduced mind chatter. With intravenous and intramuscular dosing clients more often report dissociative effects and can experience the feeling of falling, flying, feeling out of their body, they can relive a past events, they can feel paralyzed, they often cry, laugh, smile, breathe very deeply and quickly, moan, and rarely, some can kick and scream. Each session is completely different from the one prior and also differs significantly from client to client. There is no way to predict what a session will be like for someone. Experiences with Ketamine can often lead to any one of the following and more: Feelings of gratefulness, calmness, acceptance Feeling of flying Feeling of falling Seeing God Feeling out of body – looking down on oneself Feeling of being reborn Re-experiencing past events, including traumas Ego dissolution/Ego loss – a complete loss of one’s sense of self or self-identity (less likely to occur with sublingual ketamine) Falling asleep Feeling of paralysis is a rare occurrence, but possible

Ketamine-induced cystitis, a bladder pain syndrome due to chronic ketamine use is associated with ulceration of the bladder lining and chronic inflammation. This condition is typically found in people who abuse street ketamine. Studies have demonstrated that certain concentrations of ketamine were toxic to the cells of the bladder wall, causing damage to the urinary barrier. Further there is data to suggest that some factor in urine (rather than something affecting the whole body) is responsible for the ulceration–most likely ketamine itself or its metabolites. Symptoms include pelvic pain, frequent urination, urgency, hematuria (blood in urine), nocturia (frequent urination during the night) and urinary incontinence. This condition is often reversible once the medicine is stopped. For clients who develop this condition complete ketamine cessation is recommended. Ketamine tolerance can also develop. Concerns arise over addiction but when used at low doses and with infrequent dosing models, as used in mental health, this is less likely to occur. Neurotoxicity has been identified in ketamine abusers and rodents impacting brain structure and function and reports of liver toxicity have also been found in the literature.

The duration of benefits is variable and depends a lot on why the client sought out ketamine to begin with. Many clients will return for further courses of treatment, especially those with long standing depression, failing multiple medications.

Ketamine is routinely given in sterile clinical settings for various mental health indications. Oftentimes there is no therapy provided with this service and clients are left trying to make sense of the experience and to navigate challenging experiences on their own. The lack of therapy short changes people seeking ketamine treatment as they are less likely to be able to integrate the experience into their everyday life. In 2015, Stephen Hyde published a paper Ketamine for Depression, demonstrating ketamine’s ability to be used successfully via routes other than intravenous and intramuscular, promoting easier use outside of a clinical setting. Incorporating psychotherapy into ketamine treatment sessions was first described by Wolfson and Hartelius in 2016. By the mid-2000s many clinicians were using ketamine in conjunction with therapy. It has become increasingly more apparent that prescribers aren’t required at the bedside, but someone should be there to guide and hold space for clients on ketamine and that’s you.

When used for mental health, ketamine is typically given six times over a 2-3 week period. After six sessions a patient may reach out to Skylight Psychedelics for further ketamine doses if they had further trauma or other setbacks. Again we do not have patients on a standing autopilot schedule without checking in with them first to ensure they need further treatment. This is a very client specific medicine and the need for booster doses should be determined on a case by case basis by the prescribing physician with input from the patient and their therapist.

Avoid driving, operating heavy machinery, swimming, bathing, and being the sole provider of childcare following medicine sessions

When taking ketamine prescribed by Skylight you will need to take your blood pressure before and after the session. It is not your therapist’s job to take or interpret your blood pressure. This will be explained in detail once you meet criteria for treatment. You will need to purchase your own blood pressure cuff, found at most pharmacies. We do not recommend the use of wrist blood pressure cuffs as the reading is less accurate.

Yes, we recommend using an eye mask for the duration of time you are on the medicine. This promotes an internal journey. We recommend using the Mindfold mask, which can be found on Amazon.

Integration is when you take the experience from your medicine journey and weave it into your daily life. Integration is a critical part of psychedelic medicine. While the medicine sessions are very important, a time where people get many messages, without the integration many of these messages can get lost or be fleeting. Integration is done with your therapist and a key part of this work. Please remember you can always drop into our biweekly therapist zoom call led by Dr. Elizabeth Wolfson, with others on a similar journey for further integration. The link is in your initial welcome email. Join us every other Wed from 5/17 at 3 noon MT.

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