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KETAMINE ASSISTED PSYCHOTHERAPY (KAP)

INFORMED CONSENT

Introduction

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. 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 wide-spread in recent years, has been studied and promoted by researchers at the National institute of Mental Health, and has had front-page publicity as the newest anti-depressant. Ketamine has been administered by intravenous (IV), intramuscular (IM), sub-lingual, oral, and intra-nasal routes. Often, it has been used after other treatment approaches have been unsuccessful.

 

Ketamine is now an increasingly clinically applied "off-label" treatment for various chronic "treatment-resistant" mental conditions. Ketamine is a Schedule III medication that has long been used safely as an anesthetic and analgesic agent and now, often effectively for treatment of depression, alcoholism, substance dependencies, PTSD and other psychiatric diagnoses.

 

Ketamine is classified as a dissociative anesthetic, dissociation meaning a sense of disconnection from one's ordinary reality and usual self. At the dosage level administered to you, you will most likely experience mild anesthetic, anxiolytic, antidepressant and, potentially, psychedelic effects. Recent work has demonstrated the possibility of an anti-depressant response to low dosages of ketamine administered intravenously, intra-nasally and sublingually (orally)-that produce minimal psychedelic effects; this anti-depressant effect tending 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 effect. This may well include a positive change in outlook and character that we term a 'transformative' response. We may employ both methods together as will be described herein.

 

Essential to both methods is a time-out of usual experience, this period being of varying duration, usually 30 minutes to 2 hours, that tends to be dose and method of administration related. Relaxation from ordinary concerns and usual mind, 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 and the exploration and experience of other possible states of consciousness are singularly impactful. 

Monitoring

It is essential that you be followed very closely during and after your treatment. This will include blood pressure and pulse measurements-as appropriate, and psychological assessment tools administered before your first and subsequent sessions to measure effects. Follow-up will be by telephone and/or email and in-person contact as needed. 

How Long Will It Take Before I Might See Beneficial Effects?

You may experience important changes in personality, mood and cognition during treatment, in the 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 psychotherapy support you will receive will aid you in making your experience(s) valuable and understandable to you. We will endeavor to assist you in changing patterns of mind and behavior that are of concern and cause you difficulty. 

Three possible modes of treatment

You may be administered ketamine via one of three methods: oral lozenges, IV or intra-muscular injection. All three of these of these methods are covered in this one consent as your provider at KETER may switch between these methods to give you the best response possible. The preferred method at KETER is IM but the other two remain options in some cases.

 

#1. The purpose of the intra-muscular ketamine experience is to create a non-ordinary ("altered") state of consciousness in order to facilitate profound transpersonal ("transcendental", ' 1mystical", "spiritual", "religious") peak experiences.

 

These may prove to be auspicious in resolving your existential problems, accelerating your psycho-spiritual growth and leading to a deep personal transformation and optimization of your lifestyle. Such change is best facilitated within a structured supportive psychotherapeutic milieu in connection with therapists who have a view of your issues, hopes, desires, and struggles. As a by product 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 new mindfulness and new behavior.

 

With respect to IM ketamine, we are asking that new patients make a commitment for three IM sessions as a minimum exposure to ketamine. Additional sessions may occur if deemed appropriate and beneficial. We understand that you are able to withdraw from our treatment at any time. 

 

#2. The purpose of the sub-Lingual ketamine sessions is to generate a robust anti-depressant, or other (PTSD, etc.) benefit that often occurs over time with repetition of administration of the sublingual dosing, for some, in concert with the IM sessions. For many individuals, only the sublingual experience may be utilized and may well be sufficient and healing.

 

#3. The IV-method involves setting up the intravenous access and then providing a dose of ketamine over 45 minutes while being monitored or in discussion with your provider. This method is more expensive and is also the shortest in duration.

 

The literature indicates a 70% response rate to ketamine; and a remission rate for patients with treatment resistant depression of 40-50%-the percentage of patients having remissions from their symptoms, this 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. We believe that combining ketamine with intensive psychotherapy enhances these response rates. 

ELIGIBILITY FOR KETAMINE TREATMENT

Once you indicate that you have understood the benefits and risks of this treatment, you will be asked to sign this form at your first visit in order to participate in this treatment. 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 if you are eligible for ketamine therapy, including a medical/psychiatric history, review of your medical/psychiatric records if necessary, 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 our policy that you protect yourself 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 BP. Similarly, a history ofheart disease may make you ineligible to participate.

 

Ketamine should not be taken if you have untreated hyperthyroidism. There have also been reports of some decrease in immune function in patients receiving surgical doses of ketamine.

 

Ketamine has an extensive and consistent record of safety when used at much higher doses for surgical anesthesia. 

OVERVIEW OF KETAMINE THERAPY 

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

 

1. You agree to follow any direct instructions given to you by the therapist(s) until it is determined that the session is over, and

 

2. You agree to remain at the location of the session until the therapist(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 30 minutes to one hour or more. With the sub-lingual lozenges we refer to this state as a light trance. Following IM administration of ketamine, the experience is much deeper and yet you remain conscious of your experience. With either method or in combination, you will continue to remain under ketamine's influence at a lesser level for at least one hour. IM ketamine will be given as an intramuscular injection into the shoulder or buttocks at doses of 20 mgto 100 mg (140 mg maximally). The choice of dose will depend on prior exposure to ketamine and other psychedelics, body weight, and sensitivity. Individuals experienced with psychedelics may receive a higher initial dose. Ketamine IM 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.

 

The initial IM injection may be preceded by administration of a sublingual dosing. Or we will elect to do sublingual dosing only, to begin your ketamine treatment, sublingual dosing dissolves slowly and we ask you not to swallow your saliva until after your long has dissolved, typically about five minutes. Ketamine will penetrate the oral mucosa-lining of your mouth-and will be absorbed rapidly in that manner. This will give us a measure of your reaction to ketamine.

 

Preparation for a ketamine session requires assessment by your therapist of your readiness and a sense of connection between you and your therapist. We are engaging in a therapeutic endeavor to benefit you and those who are affected by you. Together, we are creating a state of mind (set) in safe and conducive setting. After ketamine IM and sub-lingual use, you will have follow-up 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 therapist's view of your treatment.

 

You may ask the therapist(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 injection or lozenge has been given. 

POTENTIAL RISKS OF KETAMINE THERAPY 

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 the injection. It is possible you may fall asleep, though this is a rare event. 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. Music that may be familiar may not be recognizable. Synesthesia - mingling of the senses may occur. Ordinary sense of time will morph into time dilation. 

 

Because of the risk of nausea and vomiting, please refrain from eating and drinking for at least 4 - hours preceding the session. And eat lightly when you do. Hydrate well in that same time frame. If you are unduly nauseated, you may be offered an anti-nausea medication - zolfran an oral dissolving tablet form. Ketamine generally causes a significant but not dangerous increase in blood pressure but usually not pulse rate. If blood pressure monitoring reveals that your blood pressure is too high, you may be offered clonidine to remedy this. There is also a very small risk of lowering BP and Pulse rate. Agitation may occur during the course of a ketamine session. If your agitation is severe, you may be offered lorazepam orally or by injection to help you relax. This too is a rare event in our experience. 

 

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 surgical anesthesia. The dose to be used in this sub-anesthetic ketamine therapy is much lower (2mg/kg or less). 

 

Driving an automobile or engaging in hazardous activities should not be undertaken until all effects have stopped-and if for this reason you will be required to have someone pick you up from each ketamine session. 

 

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 and Dissociative Disorders.

 

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

POTENTIAL FOR KETAMINE ABUSE AND PHYSICAL DEPENDENCE 

Ketamine 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 the 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.

 

Repeated, high dose, chronic use of ketamine has caused urinary tract symptoms and even permanent bladder dysfunction in individuals abusing the drug. This has not occurred within this framework (dose) of treatment.

 

We and our colleagues doing clinical ketamine work have not had patients become dependent on ketamine. 

ALTERNATIVE PROCEDURES AND POSSIBILITIES 

No other procedure is available in medicine that produces ketamine's effects. Major Depression (MDD), PTSD and Bipolar Disorders are usually treated with antidepressant 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. 

CONFIDENTIALTIY

Your privacy and all therapy records will be kept confidential. They will be maintained with the same precautions as ordinary medical records. To allow others access to your records, you will have to provide a signed release form. 

VOLUNTARY NATURE OF PARTICIPATION 

Please be aware that the Food and Drug Administration (FDA) has not yet established the appropriateness of Ketamine Assisted Psychotherapy and its use is considered offlabel, 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, you may still elect to be treated with medications and ongoing psychotherapy to try to reduce the possibility of relapse and anxiety. Over time, you may also need additional ketamine treatments or other therapies to maintain your remission.

 

I PRACTICE PSYCHIATRY /PSYCHOTHERAPY AND MAY OFFER TO ASSIST YOU WITH OTHER MEDICATIONS, TO CONSULT WITH YOUR THERAPISTS AND MDS, AND MAKE RECOMMENDATIONS TO YOU ABOUT YOUR TREATMENT IN ADDITION TO OUR KETAMINE WORK. YOU MAY ON YOUR OWN DESIRE TO CONSULT WITH ME ABOUT THESE TREATMENT ISSUES.

 

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

WITHDRAW AL FROM KETAMINE TREATMENT IS ALWAYS YOUR OPTION

Even after agreeing to undertake Ketamine Treatment, you may decide to withdraw from treatment at any time. I understand that I am to have no food or drink at least 3 and preferably 4 hours prior to my Ketamine session.

 

I understand that I need to have someone drive me home from the sessions, and not engage in any driving or hazardous activity for at least 6 to 12 hours or more- depending on the continued presence of effects after my session has concluded.

INFORMED CONSENT ATTESTATION

By signing this form I agree that:

 

1. I have fully read this informed consent form describing Ketamine Treatment.

 

2. I have had the opportunity to raise questions and have received satisfactory answers.

 

3. 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.

 

4. I give my consent to the use of lorazepam if deemed necessary for agitation, to odansetron for nausea, and for clonidine for high blood pressure.

 

5. I have been given a signed copy of this informed consent form, which is mine to keep.

 

6. I understand the risks and benefits, and I freely give my consent to participate in Ketamine treatment as outlined in this form, and under the conditions indicated in it.

 

7. I understand that I may withdraw from Ketamine treatment at any time, up until the actual sublingual dose, or lozenge has been given.

 

8. I agree to be charged a cancellation fee of 50% if I cancel without 24 hour notice.

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