This consent form contains information about the use of sub-anesthetic dosages of ketamine for psychiatric purposes including depression. Ketamine is a Schedule III medication that was approved by the FDA for medical use in 1970. It has long been used safely as an anesthetic and analgesic agent. In recent years, psychiatrists and other practitioners have been administering ketamine in lower, sub-anesthetic doses to treat pain, depression, PTSD, anxiety, and other psychiatric diagnoses. This “off-label” clinical application of ketamine for psychiatric use has become relatively widespread and has been studied by prominent research bodies including the National Institute of Mental Health. Promising early research showing that ketamine may provide rapid relief of depression symptoms has garnered front-page publicity as the newest potential antidepressant for use after other treatment approaches have been unsuccessful. Ketamine is now increasingly clinically applied as an off-label treatment for a variety of chronic, “treatment-resistant” conditions, including chronic pain, depression, substance dependencies, and PTSD. In these applications, it is commonly administered by intramuscular (IM), intravenous (IV), sublingual, and intranasal routes.  At present, long-term safety and efficacy data on antidepressant use of ketamine is promising.

Ketamine is classified as a dissociative anesthetic, often producing a sense of disconnection from one’s ordinary reality and usual self. Due to this, you may experience anxiolytic, antidepressant, mild anesthetic, and psychedelic effects from this session. In the deepest state you may connect to the beautiful state of “oneness”.

This antidepressant effect tends to be more sustained with repeated use - in other words, a cumulative effect. It is our view that psychedelic, ‘dissociative’ experiences may well be instrumental in providing a more robust antidepressant effect. This may well include a positive change in outlook and character that we term a ‘transformative’ response. A sense of relaxation from ordinary concerns and typical cognitive states, while maintaining conscious awareness of the flow of mind under the influence of ketamine, is characteristic. This tends to lead to a disruption of negative feelings and obsessional preoccupations. It is our view that this relief, along with the exploration and experience of other possible states of consciousness, are singularly impactful. For the treatment of depression, 6 IM sessions, performed 1-2 x a week, followed by less frequent maintenance therapy and ongoing psychotherapy is the optimal approach to prevent relapse.

The literature indicates an approximate 70% response rate to ketamine, and a remission rate for patients with treatment-resistant depression with multiple sessions. Relapses do occur and may require periodic additional sessions. Over time, a certain number of patients may become unresponsive to further ketamine sessions. Again, we encourage combining ketamine with ongoing psychotherapy to enhance these response rates. We are happy to have your therapist collaborate with us and can share records from sessions here with your permission.

Transcranial magnetic therapy is another therapy that can be combined with ketamine to improve outcomes. Working with Dr. Grover to optimize hormones and nutrition can be a powerful adjunct as well.

 

Preparation for a ketamine session requires assessment by Dr. Grover or our nurse for your readiness of your experience. This can be done by zoom prior to coming to office. Together, we are creating an intentional “set and setting” - a relaxed and prepared state of mind in a safe and conducive environment.

On the day for your session, we will check your blood pressure and pulse ox and may take it again during the session if appropriate.  We may recommend psychological assessment tools before your first and subsequent sessions to measure effects. Follow-up is recommended for integration, and may be provided by zoom, phone, email, and/or in-person contact, as needed.

IM: The intramuscular route is the preferred route for ease of administration and efficacy This method can create a non-ordinary (“altered”) state of consciousness in order to facilitate profound transpersonal (i.e., “transcendental”, “mystical”, “spiritual”, or “religious”) peak experiences. These may prove to be auspicious in resolving existential problems, accelerating psycho-spiritual growth, and leading to a deep personal transformation and optimization of lifestyle. Such change is best facilitated within a structured supportive psychotherapeutic milieu in connection with therapists who have a view of a patient’s issues, hopes, desires, and struggles. As a byproduct of your experience, you may well feel improvement in your emotional state and reduction in symptoms that bother you such as depression, anxiety, and post-traumatic manifestations. You may well notice that you are a bit different after a ketamine experience, and that difference may well be liberating and allow for a greater sense of mindfulness and new behavior.

The injection is given into the shoulder or buttocks at doses of 50 mg to 100 mg (130mg maximally). The choice of dose will depend on prior exposure to ketamine and other psychedelics, body weight, and sensitivity.

Individuals experienced with psychedelics may benefit from a higher initial dose. IM ketamine creates an unusual experience of formlessness and a dissolving of boundaries and has novel effects on the mind. Onset is typically in 5-10 minutes, followed by a deep journey lasting approximately 20-30 min, after which over the next hour you will find yourself slowly grounding back into this world.

 

SUBLINGUAL: The purpose of the sublingual ketamine lozenge session is to generate a robust anti-depressant effect or other psychological benefits that often occurs over time with repeated administration of the lozenges. For many individuals, only the lozenge experience may be utilized and may well be sufficient for healing. Lozenges dissolve slowly and we ask you not to swallow your saliva until after your lozenge has dissolved, typically in five minutes. Ketamine will penetrate the oral mucosa—lining of your mouth—and will be absorbed rapidly in that manner. During a sublingual experience you may be able to share more subconscious thoughts with your facilitator or therapist allowing for deeper psychotherapeutic counseling. Sublingual can be used as a maintenance therapy after IM in office therapy or as a stand-alone.

 

IV: This is recommended primarily for those suffering from severe depression with suicidality, or can be an option when you receive NAD+ therapy prior to ketamine therapy. The same calculated dose for IM is placed in normal saline solution and given at rate to complete in 40 min. The onset is more rapid than IM, as is the resolution after the IV is finished. It is a more expensive route to administer, and there is a possibility that the IV may come out during session if you move around excessively during session.

The length of ketamine sessions varies from person-to-person and from experience-to experience. You will be more internally focused for the first 30 minutes and for the following hour you will be more aware of your surroundings.  With sublingual you will be more aware of surroundings during entire session, and it may last closer to 2 hours.

1.      You will be taken to one of our treatment rooms to receive the Ketamine injection. If you would like to enjoy sound therapy or Pandora star, we can provide this in the Mind Spa. Please mention your preference when you book your appointment with front desk.

2.      This medication will often be given in conjunction with our Brain Refuel™ protocol, which is the combination of NAD+ IV followed by FastVitamin IV™.  If so, an IV will be started to begin administration of the fluids. Adding Brain Refuel™ may provide synergistic benefits to the Ketamine treatment. This will be given prior to Ketamine therapy if desired.

3.      As mentioned, we prefer to do Ketamine intramuscularly, given its gentle but very effective uptake.  It can be given via a small needle in your arm or buttock. The dose given is calculated based upon your weight.

4.      Music is strongly recommended during the session, and we’ll discuss a variety of playlists that work well with the session. We typically select an appropriate one, or you can choose one of several available depending on the genre you may be looking for. Headphones are typically worn and we can also use the sound table to enhance the experience further.

5.      Healing touch or sound therapy is an option to help assist you in healing. This can include holding your hand, feet, or resonating a crystal bowl on your chest.  Please initial consent for this element below and let your facilitator know if you’d like this.  You can also hold out your hand or point to forehead if you would like touch to that region when ready.

6.      A sleep mask will be offered to place over your eyes during the procedure to prevent possible dizziness and support comfort in the experience.

7.      We will monitor your pulse, blood pressure, and pulse oximetry during the procedure if there are any concerns.

8.      You can get up and go to the bathroom with assistance if needed towards the end of the session. Please visit the bathroom just prior to its start to minimize this need.

9.      You will be monitored and then released to the care of a family member or friend for a ride home. You may also choose to take an Uber or Lyft home, but this is discouraged over a private ride with family

Any procedure has possible risks and discomforts. This procedure may cause all, some, or none of the risks or side effects listed. Rare, unknown, or unforeseeable (unexpected) risks may also occur. Side effects typically depend on the dose. The dose administered may last for 30-60 minutes. Common side-effects (greater than 1% and less than 10%: between 1 out of 100 and 10 out of 100)

·      Vivid dreams, psychedelic experience

·      Nausea and vomiting- rare

·      Increased saliva production with lozenge

·      Blurred vision in deep part of session

·      Dizziness/light-headedness during 90 min session possible.

·      Out-of-body experience during the 30-60 minute effect

·      Disrupted motor skills (difficult to move arms and legs)

·      Increased blood pressure and increased heart rate

(approx. 20% of the normal rate is usual)

·      Mild discomfort at site of injection

·      Increased pressure in the eyes.

·      If you are female and think you could be pregnant or are not sure, please inform the staff. A pregnancy test must be done if unsure before your appointment, as pregnancy is a contraindication to this treatment.

·      Untreated hypertension is a contraindication to ketamine use as ketamine can bump blood pressure by 10 points. Similarly, a history of heart disease may make you ineligible to participate. We can give you a blood pressure medicine, Clonidine to lower it prior to session if needed. Be sure to take your blood pressure medication if prescribed regularly and on day of procedure.

·      On the day of treatment, you should NOT engage in any of the following: Driving, alcohol, marijuana, recreational drugs, conducting business, or participating in activities that require you to rely on motor skills and memory.

·      Because of the risk of nausea and vomiting, please refrain from eating and drinking for at least 3 (best is 4) hours preceding the session. Eat lightly when you do. Make sure you are well hydrated in that same time frame.

·      Repeated, high dose, chronic street abuse of ketamine has caused urinary tract symptoms and even permanent bladder dysfunction in individuals abusing the drug. This has not occurred within the framework (low, calculated dose) employed by clinicians for therapeutic benefit in a medical setting.

·      If you have any worsening depression, concerning side-effects, or suicidal thoughts after treatment, you agree to call your doctor, therapist, or go to the ER

By signing this document, I recognize that Ketamine is not an FDA approved treatment for depression or other mental health conditions. It has been safely given for off-label use as an effective therapy by providers across the country. I know that my taking part in this procedure is my choice. I know that I may decide not to take part or to withdraw from the procedure at any time. I know that I can do this without penalty or loss of treatment to which I am entitled. I also know that the doctor may skip giving the IM injection, sublingual, or stop the infusion without my consent for my protection. I have had a chance to ask the doctors and clinical staff questions about this treatment. They have answered those questions to my satisfaction. The nature and possible risks of a ketamine infusion have been fully explained to me. The viable alternative methods of treatment, the risks involved, and the possibility of complications have been fully explained to me. No guarantees or assurances have been made or given by anyone regarding the results that may be obtained. I state by my signature below that I have read the information above. I know the conditions and procedures of the treatment. I know the possible risks and benefits of taking part in this treatment.

 

By signing this agreement, I verify that I have reviewed Dr. Grover’s Notice of Privacy Practices on the website.