This consent form (referred herein as the “Informed Consent Agreement”) contains information about the use of subanesthetic (low dose) ketamine for diagnoses such as PTSD, depression and chronic pain.

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Ketamine has been approved by the FDA for use as an anesthetic agent for decades. It is considered safe and effective enough to be used as a battlefield anesthetic because it does not affect breathing or other automatic functions. It works differently than other anesthetics, in that, rather than inducing an unconscious state, ketamine is a "dissociative" agent. That is, it separates the conscious awareness from the sensory input of the body. In anesthetic doses it also produces amnesia for the event.

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However, with the use of subanesthetic doses it becomes a means of raising consciousness, unblocking defenses, and building new neural connections to allow better psychological functioning going forward. Utilizing ketamine in subanesthetic doses is considered an off-label use of ketamine.

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By signing this Informed Consent Agreement, you acknowledge that you understand all the information contained within it and affirm that you give your consent to the administration of the medicine in the context of a guided treatment. Please read this entire informed consent form carefully. You may ask questions to any of our qualified provider(s) anytime before by contacting them via email at

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email: info@grokingwholeness.info

Telephone: 762-218-2663 (during normal business hours)

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Your query will be forwarded to one of our qualified licensed professionals who will be in contact with you to answer your questions and concerns before signing this agreement. You will also have an opportunities to ask questions on the day of the treatment anytime during your private session or during your attendance at the weekend workshop. 

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If you prefer to supply this information manually offline, you may print out a copy of this entire webpage. You can then mail the completed form via postal mail to 

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Best Medicine Inc.,

8022 Mays Avenue

Riverview, FL 33578.

 

(Groking Wholeness is an agent for Best Medicine, Inc.). All seminars, workshops and individual sessions are lead, administrated and managed strictly by Best Medicine, Inc. its licensed professional(s), agents and designees.

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ELIGIBILITY FOR KETAMINE TREATMENT

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The Eagle's Eye licensed professional(s), (the "Provider(s)") will perform an evaluation of you and, if appropriate, administer the medicine. The Provider(s) will be either a medical doctor, doctor of osteopathic medicine, or certified registered nurse anesthetists, which are permitted to administer this medicine in the state of Florida. The process will involve you filling out your history in advance on the “The Eagle’s Eye Workshop Reservation and Registration" form ("the Registration”), which will become part of your electronic medical record. In addition to the Registration form and the Informed Consent Agreement, you may also be asked to fill out additional questionnaires and surveys, before and after, your experience. These are for research purposes and, unless you expressly request that this information be shared, it falls under professional confidentiality and will not be shared with anyone.

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An evaluation, usually 20-30 minutes long, will happen with the Provider(s) either before the day, or on the day of the private treatment or workshop, to answer questions and to allow you to become acquainted with the Provider(s).

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Please note that it is strongly advised that anyone with a hyperthyroid (overactive) condition should not take ketamine as it may worsen the condition.

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THE FORMAT OF THE TREATMENT

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An additional second guide(s) (from our trained staff) may also be present, especially for at-home treatments or for a group treatment session or weekend workshop.

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Your vital signs will be taken and recorded, before and after the treatment. That includes heart rate, blood pressure and respiratory rate.

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Following the treatment, for another 30-45 minutes, the guide(s) will remain with the participant(s). This will allow for sharing, if desired, and to be sure the medicine has worn off to allow you to leave safely.

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DO NOT EXPECT TO DRIVE HOME afterward your treatment. It is strongly recommended that you not drive for 24 hours. Please arrange for a ride, or we can call an Uber or arrange other transportation for you.

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During the ketamine session, in order to ensure your safety and wellbeing, you are requested to 1) comply with direct instructions from the Provider(s) and guide(s) until it is agreed that the session is over, and 2) you will remain at the location of the session until the guide(s) agree that you are ready to leave.

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The actual session will last approximately 60-90 minutes (longer in a workshop setting).

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THE EXPERIENCE ITSELF

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If you qualify for the off-label use of ketamine, you will be administered an oral form, or an intermuscular injection of ketamine, which will be determined by your preferences depending on your weight and other factors. Remember, an excessive dosage will induce amnesia so you will be unable to remember much from the treatment. The medicine takes 15-20 minutes for the effects to be felt, with either form of administration.

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Eyes open, exes closed, will give different experiences and you are encouraged to try both to see what you prefer. Music may be a part of the experience, and can be chosen in advance, by you or recommended by your guide.

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Many people describe the experience to be very much like the dream state that we are so familiar with. In fact, the pineal gland in the brain makes the chemical DMT, one of the most powerful psychedelic molecules we know!

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The difference in the ketamine session, is that you are consciously aware and can "navigate" through the "dream" like state.

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Even during this dream state, you will be able to communicate. For example, if you need to use the bathroom, you can call out or raise your hand. Please do not try to do anything by yourself, as your balance and coordination may be temporarily affected.

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To minimize the chance of nausea you should not eat solid food for six hours before the session. Clear liquids in moderation (water, tea, broth) are acceptable to drink.

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Adverse events that may occur, include rapid heart rate (tachycardia), double vision, rapid eye movements, elevation of intraocular pressure, nausea, and loss of appetite. These usually occur only at higher doses. Your guide will have medication to calm those reactions if needed. Ondansetron (Zofran), CBD, blood pressure or other medications are also available if needed. Your blood pressure and pulse will be taken before and after the session.

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AFTER THE SESSION

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It is important to remember that you should not drive or engage in any hazardous activity for 24 hours after treatment with ketamine.

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It is recommended that as soon as you can, begin to write down what you remember of the experience. Your recollections will be freshest and you will bring back the feelings you have experienced in a powerful way.

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If you have a therapist, we encourage you to share your experience with that person. If not, we can recommend some therapists of various types that you can choose from. You are encouraged to work with what you have experienced for at least three months before scheduling another session unless your therapist refers you back sooner.

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POTENTIAL FOR KETAMINE ABUSE AND PHYSICAL DEPENDENCE

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Ketamine belongs to the same group of chemicals as phencyclidine (AKA "PCP" or "Angel dust"). This group of chemical compounds is called arylcyclohexylamines and is classified as hallucinogens ("psychedelics"). Ketamine is a controlled substance and is subject to Schedule Ill control under the Controlled Substances Act of 1970. Medical evidence regarding the issue of drug abuse and dependence suggests that ketamine abuse potential is equivalent to that of phencyclidine and other hallucinogenic substances. Occasional use has a very low risk for abuse or dependence.

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With regard to the potential for misuse of ketamine, "cravings" have been reported by individuals with a history of heavy use of ketamine and other "psychedelic" drugs. In addition, ketamine can have effects on mood, cognition (thinking) and perception that may make some people want to use it repeatedly. Therefore, ketamine should never be used except under the direct supervision of a licensed practitioner who is qualified under state law.

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ALTERNATIVE PROCEDURES

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No other known procedure produces the specific effects of ketamine. Major depression is usually treated with medications and psychotherapy. Subanesthetic ketamine therapy is a new option when those treatments are unsuccessful. Electroconvulsive therapy (ECT), transcranial magnetic therapy (TMS) and vagal nerve stimulation have also been used for treatment resistant depression.

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A variety of medications, including opiates, anticonvulsant medications and anti- inflammatory medicines have been used for the treatment of chronic pain. A number of alternative techniques are done such as nerve blocks, physical therapy, infusion pumps and surgical treatment for various types of pain that do not respond to medications alone. Ketamine may reduce the tolerance that often develops with opiate medications and is generally used along with other pain-relieving medicines only after other first-line treatments have failed to control pain.

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CONFIDENTIALITY

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Your privacy and all treatment records will be kept confidential. They will be maintained with the same precautions as ordinary medical records. Only health care providers involved in your care will have access to information contained in your record and only with your written consent. Privacy and confidentiality of the record will be protected to the extent required by law. For more information on privacy and confidentiality please refer to the web page "About Us" (bottom of the page sections are labeled “Disclaimer” and “Privacy Statement”.
 
The results of ketamine therapy are subject to research study. Published reports will not include your name or any other identifying information. Your experience may be used anonymously for teaching purposes, but your name or other identifying information will not be shared.

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VOLUNTARY NATURE OF PARTICIPATION

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You should know that the use of ketamine in this context has not yet been approved by the Food and Drug Administration (FDA). Under the federal Food, Drug and Cosmetic Act ketamine is approved for general use only as an anesthetic agent. This means that the FDA does not endorse the use of ketamine as a psychotherapeutic agent or as a treatment for pain and classifies subanesthetic ketamine therapy as an investigational therapy. This use is considered an off-label use of ketamine.

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Ketamine therapy is a new treatment for depression and is not a mainstream treatment, though several research studies have shown effectiveness for this purpose. The beneficial effects may lessen over time, which may require periodic repeat sessions. You may still require other medications and psychotherapy to maintain treatment for depression. Similarly, for pain, ongoing treatment by a pain specialist, as well as the use of other medicines, may still be required.

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Your decision to undertake ketamine therapy is completely voluntary. Before you make your decision about participating in ketamine therapy, your Provider(s) will give you a chance to ask any questions and any concerns that you may have about the procedure. Even after agreeing to undertake ketamine, you may change your mind up until moment the medicine has been administered.