Ketamine Informed Consent Form

Ketamine is now a validated "off-label" treatment for various chronic "treatment-resistant" mental illnesses. Ketamine is a Schedule III medication that has long been used safely as an anesthetic agent and now, at times, effectively as treatment for depression, alcoholism, substance dependencies, PTSD and other psychiatric diagnoses.

The current, most probable, understanding of ketamine's mode of action is as an NMDA antagonist working through the glutamate neurotransmitter system. It is classified as a dissociative anesthetic. At the dosage level administered to you, you will most likely experience analgesic, anxiolytic, antidepressant, and psychedelic effects. Ketamine also may bring about "transpersonal," "mystical," or "out-of-body" experiences that may also serve to facilitate a shift in your perspective and emotional state.

It is essential that you be followed very closely during and after your treatment. This will include blood pressure and pulse measurements, some psychological measurements before and after your session, close supervision and support during your treatment session with your guide, and follow-up telephone and in-person contact with your treatment team.

You will be entering a comprehensive program that will prepare you for your ketamine session(s) and assist you in integrating your experience(s) afterwards. This program emphasizes the possibilities for change and the seriousness of your and our effort to assist you.

You may experience important changes in personality, mood, and cognition during treatment, in the immediate aftermath, and in the days and weeks that follow. Some experiences may be temporarily disturbing to you. The ketamine experience itself is designed to enable your own healing wisdom to be accessed and beneficial to you. The guiding support you will receive will aid you in making your experience(s) valuable and understandable to you. Some experiences may be temporarily disturbing, but the integration process may greatly help you move to clarity and understanding.

The purpose of the ketamine therapy is to create a non-ordinary ("altered") state of consciousness in order to facilitate profound trans personal ("transcendental," "mystical," "spiritual," "religious") peak experiences that may be beneficial in resolving your existential problems, accelerating your psycho-spiritual growth and lead you to a deep personal transformation and optimization of your lifestyle. Such change is best facilitated within a structured and supportive milieu in connection with guides who have a view of your 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 notice that you are a bit different after a ketamine experience and that difference may well be liberating and allow for new mindfulness and new behavior. It is frequently the case that a ketamine experience may promote happiness, empathy, loving-kindness to self and others, and a sense of greater self-acceptance and peacefulness.

Your experience will be unique to you. If you and we decide to have additional sessions using ketamine, each of your sessions will be different. All such journeys are adventures that cannot be programmed. They evolve from your own being in relation to this substance. While it is best to form an intention for your journey, you may or may not be able to hold onto that. Indeed, no holding on is best and the journey will flow whether or not you hold on and resist, or follow the path that unfolds and relax into it. Holding on is the main source of anxiety in this and other related journeys. A ketamine session can be light, dark, or both. There will be concepts, visions, encounters, and you may well deal with your own death, mortality, and immortality. Not everyone enjoys the journey, but everyone comes through it-and generally with a measure of positive change and a sense of having had a profound experience that may be life changing indeed.

This consent form contains information about the use of sub-anesthetic dosages of ketamine for psychiatric purposes including depression. Ketamine was approved by the FDA for use as an anesthetic agent several decades ago. Ketamine has an extensive record of safety and has been used at much higher doses for surgical anesthesia, without respiratory depression. The administration of ketamine in lower, sub-anesthetic doses to treat pain, depression, or other psychiatric diagnoses is a newer, off-label use of ketamine. Psychiatric use of ketamine has become relatively widespread in recent years, has been studied and promoted by researchers at the National Institute of Mental Health, and has had publicity as the newest anti-depressant with its own novel pharmacological mechanism of action. Ketamine has been administered by intravenous, intramuscular, and intranasal routes. Often, it has been used after other treatment approaches have been unsuccessful.

Once you indicate that you have understood the benefits and risks of this treatment, you will be asked to sign this form in order to participate in this treatment. You will be given a signed copy of this form to keep for your own records. This process is known as giving informed consent.

By signing this document, you indicate that you understand the information provided and that you give your consent to the medical procedure to be performed during your participation in ketamine treatment. Please read this consent form carefully, and feel free to ask questions about any of the information in it.

Before participating in ketamine treatment, you will be carefully interviewed to determine whether you are eligible for ketamine therapy, including a medical history, a physical exam if deemed necessary, review of your medical/psychiatric records, a psychiatric history and administration of brief psychological tests to assess your state of mind.

Pregnant women and nursing mothers are not eligible because of potential effects on the fetus, or nursing child. The effects of ketamine on pregnancy and the fetus are undetermined, and therefore, it is advisable to protect against pregnancy while exposing yourself to ketamine or in the immediate aftermath of its use.

Untreated hypertension is a contra-indication to ketamine use as the substance causes a rise in blood pressure. Similarly, a history of heart disease may make you ineligible to participate.

Information on ketamine's interaction with other medicines is only partially available and it will be assessed as to your eligibility for Ketamine Therapy.

Ketamine should not be taken if you have hyperthyroidism. There have also been reports of some decrease in immune function in patients receiving surgical doses of ketamine. Ketamine has an extensive record of safety and has been used at much higher doses for surgical anesthesia, without respiratory depression, making it an ideal anesthetic agent.

During the Ketamine administration session, you will be asked to make two (2) agreements with the guide to ensure your safety and well-being:

• You agree to follow any direct instructions given to you by the doctor/guide(s) until it is determined that the session is over, and you agree to remain at the location of the session until the doctor(s) decides you are ready to leave. The length of ketamine sessions varies from person-to-person and from experience- to-experience. You will be mostly internally focused for the first 45 minutes to one-hour- and-a half following sublingual administration of ketamine. You will continue to remain under ketamine's influence at a lesser level for at least one hour.
  
  
• Under my care, you will bring the ketamine lozenges, which have been prescribed to you and only you, into the office the day of your session. You will take one lozenge sublingually (under the tongue) at a dose of 100 mg to start. The lozenge will be held in the mouth and swished for 10 minutes before being swallowed. Together we will decide whether to administer a second or third dose, based on your response. The choice of dose will depend on prior exposure to ketamine and other psychedelics. Naive subjects will receive a lower dose in the initial session. It is always better to start with a lower dose to reduce anxiety and become familiar with what a substance may produce in you. There is always an opportunity to make a choice for a larger dose at a future date-if appropriate. It is more difficult to correct a bad experience because of too high an initial dose and the anxiety it may engender. Individuals experienced with psychedelics may receive a higher initial dose. Ketamine creates an unusual experience of formlessness and a dissolving of boundaries and has novel effects on the mind. Therefore, it is much better to have an initial learning experience for familiarization with ketamine and its effects on you.
  
  
• Preparation for a ketamine session requires assessment by your doctor of your readiness and a sense of connection between you and your doctor. We are engaging in a therapeutic endeavor to benefit you and those who are affected by you. Together, we are creating a therapeutic state that is based on rapport and trust (set) in a safe and conducive setting. That will require prior sessions to your use of the drug. After ketamine use, you will have follow­up sessions that focus on integration of your experience and may lead to further sessions, if you so wish, and if that is in accord with your doctor's view of your treatment. You may ask the doctor(s) any questions you may have concerning the procedure or effects of ketamine at any time.
  
  

Your consent to receive ketamine may be withdrawn by you, and you may discontinue your participation at any time up until the actual tab/injection has been taken/given.

You will be asked to lie still during the ketamine administration because your sense of balance and coordination will be adversely affected until the drug's effect has worn off-generally two and up to four hours after taking the lozenge. Other possibilities for adverse effects include blurred and uncomfortable vision (you are advised to keep your eyes closed until the main effects have worn off), slurred speech, mental confusion, excitability, diminished ability to see things that are actually present, diminished ability to hear or to feel objects accurately, including one's own body, anxiety, nausea and vomiting. Visual, tactile and auditory processing are affected by the drug. Familiar music may appear quite different to you, even unrecognizable. Synesthesia, a mingling of the senses, may occur. Ordinary sense of time may morph into time dilation.

Because of the risk of nausea and vomiting, please refrain from eating and drinking for at least the 6 hours preceding the session. On the day of treatment, if you eat prior to the 6-hour fasting period, eat lightly. Hydrate well prior to the 6-hour fasting period.

If you are unduly nauseated, you may be offered an anti-nausea medication, odansetron, orally.

Ketamine generally causes a significant increase in blood pressure but ususally not pulse rate. If blood pressure monitoring reveals that your blood pressure is too high, you may be offered clonidine to remedy this.

Agitation may occur during the course of a ketamine session. If your agitation is severe, you may be offered lorazepam or herbal anti-anxiety medications to help you relax.

The administration of ketamine may also cause the following adverse reactions: tachycardia (elevation of pulse), diplopia (double vision), nystagmus (rapid eye movements), elevation of intraocular pressure (feeling of pressure in the eyes), and anorexia (loss of appetite). The above reactions occurred after rapid intravenous administration of ketamine or intramuscular administration of high doses of ketamine (in a range of greater than 5 mg/kg used for a surgical anesthesia. The dose to be used in this sub-anesthetic ketamine therapy is much lower (2 mg/kg or less).

Driving an automobile or engaging in hazardous activities should not be undertaken for 3 hours after treatment with ketamine and definitively until all effects have stopped if for any reason they continue longer.

In terms of psychological risk, ketamine has been shown to worsen certain psychotic symptoms in people who suffer from Schizophrenia or other serious Mental Disorders. It may also worsen underlying psychological problems in people with severe Personality Disorders. If you have been or are presently diagnosed with similar severe Mental Disorders, you may not be a candidate for ketamine therapy.

During the experience itself, some people have reported frightening, unusual experiences. These frightening experiences, however, may be of paramount value to your transition to recovery from the suffering that brought you to your ketamine work. You will receive support help and ongoing guidance from your therapist.

Ketamine belongs to the same group of chemicals as Phencyclidine (Sernyl, PCP, "Angel dust"). This group of chemical compounds is known chemically as Arylcyclohexylamines and is classified ·as Hallucinogens ("Psychedelics"). Ketamine is a controlled substance and is subject to Schedule III rules under the Controlled Substance Act of 1970. Medical evidence regarding the issue of drug abuse and dependence suggests that ketamine's abuse potential is equivalent to that of phencyclidine and other hallucinogenic substances.

Phencyclidine and other hallucinogenic compounds do not meet criteria for chemical dependence, since they do not cause tolerance and withdrawal symptoms. However, "cravings" have been reported by individuals with a history of heavy use of "psychedelic" drugs. In addition, ketamine can have effects on mood (feelings), cognition (thinking), and perception (imagery) that may make some people want to use it repeatedly. Therefore, ketamine should never be used except under the direct supervision of a licensed physician.

No other procedure is available in medicine that produces ketamine's effects. Major Depression (MDD) and Bipolar Disorders are usually treated with anti-depressant medications, tranquilizers, mood stabilizers, and psychotherapy. Electroconvulsive therapy (ECT), and the recently introduced Transcranial Magnetic Stimulation (TMS), are also in use for treatment-resistant depression. Ketamine has also been used in the treatment of addictions and alcoholism as part of comprehensive and usually residential treatment programs, primarily abroad.

Please be aware that the Food and Drug Administration (FDA) has not yet established the appropriateness of Ketamine Thearpy, and its use is considered off-label, the only official "indication" for use of ketamine being anesthesia. Your awareness of this situation is key to understanding any liability associated with your use of ketamine. Your informed consent indicates you are aware of this situation.

Ketamine is a new psychiatric treatment-the primary studies have been with depression, bipolar disorders, and alcoholism. It is not yet a mainstream treatment, though there are now many studies that demonstrate that it may be an effective treatment. That effect generally occurs with more than one treatment and is most robust when part of an overall treatment program. It may not permanently relieve depression. If your depressive symptoms respond to Ketamine Assisted Therapy, you may still elect to be treated with medications and ongoing psychotherapy to try to reduce the possibility of relapse. Over time, you may also need additional ketamine treatments or other therapies to maintain your remission.

Your decision to undertake Ketamine Assisted Therapy is completely voluntary. Before you make your decision about participating in Ketamine Therapy, you may ask and will be encouraged to ask any questions you may have about the process.

Withdrawal From Ketamine Therapy is Always Your Right! Even after agreeing to undertake Ketamine Assisted Therapy, you may decide to withdraw from treatment at any time.

By signing this form I agree that:

• I have fully read this informed consent form describing Ketamine Therapy.
• I have had the opportunity to raise questions and have received satisfactory answers.
• I fully understand that the ketamine session(s) can result in a profound change in mental state and may result in unusual psychological and physiological effects.
• I understand that I am to have no food or drink for 6 hours prior to my Ketamine session.
• I agree that I will not engage in any hazardous activity for at least 6 hours or longer after my session has concluded, and that I will not engage in any such activities until the effects of the Ketamine-induced state are no longer present.
• I give my consent to the use of lorazepam if deemed necessary for agitation, to ondansetron for nausea, and for clonidine for high blood pressure.
• I have been given a signed copy of this informed consent form, which is mine to keep.
• I understand the risks and benefits, and I freely give my consent to participate as outlined in this form, and under the conditions indicated in it.
• I understand that I may withdraw at any time, up until the actual lozenge/injection has been taken/given.