Ketamine Therapy Informed consent

Last revised on July 5, 2024

Preparation Instructions:

FASTING

Having an empty stomach ​greatly​ reduces the risk of discomfort, nausea, and vomiting during your ketamine experience. It is important that you do not eat any food for 4 hours and liquids for 2 hours before the dosing session. You will be able to eat with us at the end of your session.

Please take your usual medications with sips of water more than 4 hours before the start of the dosing session. (If you really need to have caffeine in the morning, please go ahead, but keep in mind the 4-hour fasting guideline.) 

SUBSTANCES

Please avoid using ​alcohol​, ​benzodiazepines​, cannabis, opioids, Benadryl, stimulants, sedative-hypnotics, and/or muscle relaxants, lamotrigine for ​24 hours PRIOR​ to your session. (If you are a frequent alcohol or benzodiazepine user, discuss this with your doctor; abrupt discontinuation of either can be dangerous.) These medications and chemicals interfere with the effectiveness of the medicine.  If you wish to have the full effect of the ketamine therapy, you will need to avoid these medications and chemicals for 24 hours FOLLOWING your session as well.

We also advise that you not ingest any other psychoactive/psychedelic medicines for seven days before or after a ketamine session, as we want your body and psyche to have enough time to process your experiences. Please plan your schedule accordingly.

Please check in with us about all other prescribed medication and dietary supplement use during your initial medical assessment for more specific directions. If you have any questions about medications or interactions, please ask us!

HEALTH AND WELL-BEING PREPARATION

We encourage you to start paying attention to your physical and emotional self on the night before and the morning of the session. This could mean making time for journaling, meditation, a ritual bath, relaxation techniques, or any other way that you might prepare to enter a deep and sacred internal space. Make sure to get a normal night’s sleep prior to any session. 

Make sure you are well hydrated and fed the day before so as to prepare you for fasting, and get as much restorative sleep as possible. Please notify us if you have any changes in your health or physical condition (fever, accidents, falls, chills, productive cough, flu-like symptoms, etc.).

We also recommend taking time off from work on the day of the ketamine dosing, which may increase the benefits and allow you for a deeper phase of reflection and integration.

YOUR FIRST KETAMINE SESSION

On the day of your ketamine administration, it is very important to follow the directions given to you by us. Prior to the first session, we will check your blood pressure, pulse and pulse oximetry (if needed) before and, if indicated based on your medical situation. These vital signs may be checked again during and after the ketamine session.

For the very first session, you should split the lozenge in half and place the halved tablet under the tongue or between your gums and cheek. It will dissolve slowly, and as the ketamine is being absorbed through the lining of your mouth, hold it for at least 15 minutes, and spit it out. It is safe to swallow ketamine, although it may not be absorbed as well if you do so, resulting in less bioavailable medicine.  It also may cause prolonged nausea and dizziness after a session. 

We recommend taking the prescribed anti-nausea medication (eg. ondansetron), 30 minutes before the first session to avoid nausea. If you did not experience any nausea during the first session, you can skip this step from the second session onwards. 

After the session is over, please email your clinician (mai@isha.health) to let her know how your first session went so that she can evaluate your dosing protocol. Namely, please answer the following questions:

  • How was your first session? 
  • Did things seem to be moving in slow motion?
  • Did things seem to be unreal to you, as if you were in a dream?
  • Did you feel disconnected from your own body?
  • Did you feel that your body was larger or smaller than usual?
  • Did you lose track of what was going on? 
  • Did you have gaps in your memory?

THINGS TO PREPARE WITH YOU

❏  Dress in loose-fitting and comfortable clothing

❏  Journal/notepad for reflection notes, or art supplies if you prefer expression in imagery

❏  Water bottle or a cup of water

❏  Important items related to your intention

❏  Your prescribed ketamine

❏ Your blood pressure cuff

❏ Eye mask

❏ Music playlist

 Please make sure to have your designated support person nearby during your sessions. 

Aftercare Instructions:

NO DRIVING

Driving or engaging in any hazardous activities should not be undertaken within 12 hours of the administration, and not until all effects have stopped, as reflexes may be slow or impaired. You are required to have a chaperone or ride share service drive you home from any ketamine therapy session to ensure your safety and security. 

SUBSTANCES

As mentioned previously, we advise that you avoid alcohol, benzodiazepines, cannabis, opioids, Benadryl, stimulants, sedative-hypnotics, and/or muscle relaxants for 24 hours FOLLOWING your session. (If you are a frequent alcohol or benzodiazepine user, discuss this with your doctor; abrupt discontinuation of either can lead to serious health consequences, including possible death.) You may continue your other prescribed medications as usual.

HEALTH AND WELL-BEING AFTERCARE

We highly recommend journaling about your experience, thoughts, and feelings after the session in the form of writing or drawing within 24 hours after the session. We have found that this immediate recording can help you recall your experiences with richer detail, and can be useful information for later integration sessions on how to bring these insights into your daily life.

We also advise you to be thoughtful of the environment that you return to after the treatment, given that such experiences can leave us more open and permeable to influence. This is a wonderful opportunity to foster change, and so we recommend that you choose a landing place that is both interpersonally and physically nurturing. 

Plan to have a restful, relaxing recovery day, without significant obligations or plans. Some may feel activated after treatment; this is temporary. You may engage in calming activities (rest, meditation, exercise), and remind yourself that this will pass.

We again stress the importance of treating your body well while you go through ketamine treatment to maximize results. Physical activity can assist with general well-being. Massage or bodywork following your session can greatly enhance your sense of embodiment.

Be sure to get adequate sleep, especially on nights before a ketamine administration. Sleep is a restorative process that assists in regulating mood, body chemicals, the stress response, and inflammation.

Thanks for reading, and we look forward to assisting you through this treatment. 

ISHA HEALTH 

Ketamine Therapy Informed consent 

Last revised on September 1, 2023

Introduction

This disclosure and consent form contains information about the use of medically prescribed ketamine taken sublingually, while simultaneously engaging in psychotherapy, known as “ketamine therapy.” This informed consent document is designed to provide you with information to help you decide whether to engage in ketamine therapy. It is only part of the information that you need to make an informed decision since it focuses on the therapeutic aspects of ketamine therapy. All other information about general aspects of the therapy services offered, including but not limited to policies and procedures, fees for services, cancellation policy, and confidentiality, and consent for treatment are contained in separate documents provided to you.  By signing this document, you indicate that you understand the information provided herein 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.

What is ketamine? Introduction

Ketamine is a synthetic pharmaceutical compound, classified as a dissociative anesthetic. It is one of the most widely used drugs in modern medicine and is on the World Health Organization’s List of Essential Medicines. It was developed in 1962, FDA approved in 1970 and adopted by many hospitals and medical offices because of its rapid onset, proven safety, and short duration of action. Ketamine is classified as a Schedule III drug by FDA and is legal at the state and federal level. 

As an anesthetic, ketamine is most commonly used in surgical settings, including pediatric surgery, due to its excellent safety profile, particularly around breathing/airway management. It has also been utilized successfully in managing acute and chronic pain conditions due to its analgesic properties. 

When a new drug is approved for medical use, the manufacturer produces a “label” to explain its use as approved by the FDA. Once a medication is approved by the FDA, physicians may use it “off-label,” meaning for purposes other than what is listed on the label, as long as the use is based on sound medical evidence. In the last two decades, ketamine has been increasingly used off-label to treat various chronic and treatment-resistant mental health conditions, such as depression, alcoholism, substance dependencies, post-traumatic stress disorder, anxiety disorders, and other psychiatric diagnoses. In addition, several ongoing FDA approved clinical trials are demonstrating promising results for mental health conditions related to the therapeutic use of ketamine, or similar substances. Given these emerging data, ketamine therapy is considered an experimental treatment at this time. While transformative responses are possible, we cannot guarantee any particular outcome. 

This consent form contains information about the use of subanesthetic doses of ketamine for psychiatric purposes including depression, anxiety, and PTSD. 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. 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.

How Does Ketamine Work?

The current understanding of ketamine’s mode of action is as an NMDA receptor antagonist and an AMPA receptor upregulation working through the glutamate neurotransmitter system. This is a very different pathway than that of other psychiatric drugs such as SSRIs, SNRIs, lamotrigine, antipsychotics, and benzodiazepines. However, there is no consensus on the mode of action. Other mechanisms may well be found central to ketamine’s effects. 

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. More recent work has demonstrated the possibility of an antidepressant response to low doses of ketamine—administered intravenously, intramuscularly, intranasally, sublingually, and orally—which produce minimal psychedelic effects; this antidepressant effect tends to be more sustained with repeated use—a cumulative effect. Although some clinicians believe that psychedelic experiences are instrumental in providing a more robust effect, the correlation between the degree of subjective experience of patients when administered ketamine and the efficacy of ketamine as an antidepressant is controversial . We may employ both methods 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 two hours, which tends to be dose and method of administration related. Relaxation from ordinary concerns and the 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. We act as guides to the experience and process the experience and its impacts on our patients before and after the sessions.

Dosing Strategies

Research has demonstrated an antidepressant response to low doses that are minimally psychoactive or sub-psychedelic. This effect tends to be cumulative, requiring repeated administrations over periods of time. Though experiences vary greatly, it is generally thought that lower doses provide empathogen-like (heart-opening) responses, while higher doses create dissociative, psychedelic, out-of-body, ego-dissolving peak experiences. 

There are a variety of dosing protocols in practice. Our typical patient starts with 100mg - 200mg  ketamine lozenge 2 times a week for 30 days. Every 30 days, we reevaluate the dosing to find the optimal dosage for you. Once we reach the optimal dose, you stay on the regimen for 4 - 6 months after which we may adjust to less frequent dosing. Some patients need weekly dosing, and others require occasional boosters. 

Ketamine Experience

The ketamine experience is characterized by the relaxation of ordinary concerns and usual mindset. This tends to lead to a disruption of negative feelings and preoccupations. Some ketamine providers feel that this interruption, and the exploration of other possible states of consciousness, can lead to significant shifts in overall well-being. 

At low doses, you will likely experience mild anesthetic, anxiolytic, antidepressant, and psychoactive effects. You might experience increased sensitivity to light and sound, as well as an altered sense of time. Some people experience empathogenic effects in this dose range. This state may also enhance participation in psychotherapy, as defenses are relaxed, yet communication with others is still possible. 

Even within the range of low doses that we employ, some people may experience psychedelic, dissociative states that are largely internal journeys away from the external world. Body sensations are greatly diminished. Some clinicians believe that such journeys may provide a more robust treatment effect. The correlation between dissociation and treatment efficacy is not well understood. 

Sensory effects of ketamine may include distorted visualization of colors, feeling suspended in space or floating, experiencing out-of-body sensations, vivid imagery, and changes in visual, tactile, and auditory processing. Synesthesia (a mingling of the senses) may occur. Familiar music may not be recognizable. An ordinary sense of time may morph into time dilation. 

Occasionally people report psychic experiences, which they perceive as bizarre or frightening, while others describe them as pleasurable, joyful, or fascinating. We have found that even frightening experiences can be of great value to your recovery process. Our team is trained in providing stability for those experiencing extreme states, and you will receive psychotherapeutic help and ongoing guidance as to how to make the best use of these experiences.

The effects of ketamine typically start  10 to 15 minutes after ketamine dosing. The peak effects typically last 20 to 30 minutes, and then slowly diminish for the next hour. Some alterations in sensory perception, speech, and motor ability may continue for approximately 5 hours. 

Driving an automobile or engaging in hazardous activities should not be undertaken for at least 12 hours after the administration of ketamine, and not until all effects have stopped. 

Monitoring

It is essential that you be followed very closely while you go through this treatment. This may include blood pressure and pulse measurements before and after the dosing, and psychological assessment tools administered before your first and subsequent sessions to measure effects. Follow-up will be by telephone, video chat, email, or text message as needed. You will need to meet virtually with our doctor every 30 days as per the regulatory requirement.

We encourage you to work with your psychotherapist or enter our psychotherapy program which will assist you in integrating your experience(s) afterward. This program emphasizes the possibilities for change and the seriousness of your effort and our effort to assist you. For most people entering ketamine-assisted psychotherapy, there will be a sustained period for therapy to continue to benefit emotional healing and growth. Support from family, partners, and close friends is desirable.

Why Ketamine Therapy?

Traditional treatment such as antidepressant and psychotherapy takes a long time before you start to feel any difference. Ketamine effects start shortly after the time of dosing when you feel relaxed and dreamlike and last up to a week due to its longer-acting metabolites. The sublingual method is equivalent in effect to the intravenous (IV) method and much less expensive and cumbersome. The literature indicates a 70% response rate to ketamine, as well as a remission rate for treatment-resistant depression of 40–50% using multiple sessions of either the low-dose IV drip method or the sublingual method.

Ketamine may not decrease or relieve symptoms of mental and emotional distress and/or disorders. If your symptoms do respond to ketamine therapy, you may still elect to be treated with other psychiatric medications and other ongoing non-specific therapy to try to reduce the possibility of relapse. Over time, you may also need additional KAP treatments or other therapies to maintain your improvement or remission. 

Our Treatment Process 

When You First Start

Our treatment team consists of trained therapists and doctors. All the interactions are online using telemedicine. You will meet with your doctor for the medical evaluation where she goes over your medical and psychiatric history, current symptoms, and treatment history, and answers any questions you may have. She will also get in touch with your existing treatment team so that we can coordinate to maximize the treatment efficacy. When the doctor decides that ketamine therapy can be beneficial and safely provided to you, she will write a prescription for your medication. All the medications will be shipped to your home. 

Day of Ketamine Treatment

On the day of your ketamine administration, it is very important​ to follow the directions given on your Ketamine Therapy Preparation and Aftercare Instruction about food and medication intake. 

You must identify a support person who can be available during the sessions in case you need additional support for any reason including but not limited to helping you to feel grounded, assisting you to go to the bathroom and in the event of a crisis or emergency. 

If you have never had ketamine before, you must split the lozenge in half and place the halved tablet under the tongue or between your gums and cheek. It will dissolve slowly, and as the ketamine is being absorbed through the lining of your mouth, hold it for 15 to 30 minutes, and split it out. It is safe to swallow ketamine, although it may not be absorbed as well if you do so, resulting in less bioavailable medicine. 

You will continue taking the same dose at least for the first month. It will give us a measure of your responsiveness to ketamine, and enable us to witness the effectiveness of the lozenges and adjust the dose if needed. Some people experience empathogenic effects in this dose range, and engaging in therapeutic exploration can be quite fruitful. Others find speaking too difficult and prefer an internal focus. 

We recommend putting an eye mask on and playing soothing music to facilitate and enhance the experience, and to help you maintain an internal focus. 

You must agree to not drive any vehicles or operate any machinery after each session for the remainder of the day and at least 12 hours after administration of the medicine. Depending on your treatment needs, it may be required to have a brief phone and/or secure email check-in the following day. We encourage you to schedule a follow-up psychotherapy and integration session on a regular basis. 

Obligation to Work with a Therapist

You agrees to work with a separate therapist or other qualified clinician to prepare for and integrate your ketamine sessions. To the extent you ignore the obligations in this section, Client does so at their own risk. 

Chaperone and Emergency Protocol 

If you are engaging in a ketamine session remotely or self-guided, you agree that you will have a therapist, friend or family member present for the duration of your ketamine session and you understand that you should not proceed with a ketamine session if a chaperone is not present. You agree that the Chaperone will monitor your physical wellbeing and contact emergency services in the case of a medical emergency. You agree you will not have a minor child in your care during any ketamine session. 

You acknowledge and agree that if a medical emergency occurs during your ketamine session, your chaperone will call 911. 

USE OF TOUCH

There are two types of “touch” considered during a ketamine therapy session, safety and support. Regarding touch for safety: If there is an issue in which the medical provider determines that touch is required for your safety, you acknowledge and consent to being touched, e.g., holding your arm to avoid falling, or to provide support to walk to the restroom. Regarding touch for support: If, during your ketamine therapy session, a supportive touch, e.g., placing a hand on your shoulder or forearm, appears that it could be helpful, the medical provider will offer this supportive touch to you. You may verbally or non-verbally (shake your head yes or no) decline this offer or accept at any time during your session. You may also change your mind. For example, if you request or prefer supportive touch at one point in your session, you may decline to do so later. Before your session, the medical provider will engage you in a discussion about your preferences for supportive touch during your session, including but not limited the differences between touching during the ketamine therapy session for safety and for support, your choice for engaging in supportive touch and your right to change your mind. 

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. 

Ketamine treatment can result in a number of benefits, and there are now many studies demonstrating its efficacy; however, it is still a relatively new and experimental psychiatric intervention, and there are no guarantees of your outcome. 

Ketamine is distinguished from other psychotropic medications by its rapid onset, often producing relief in as soon as a few hours. The literature indicates a 70% initial response rate to ketamine, as well as a remission rate (return of symptoms) for people with treatment-resistant depression of 40-50%. The effect of ketamine in your brain lasts for about a week and it is cumulative. 

If you do not respond to the initial dose, we will adjust the dosing accordingly. There is an optimal dose for each individual. Once we reach the optimal dose, we will maintain that dose for a few months after which we may reduce the frequency of the treatment over time.

Ketamine can beThis is an effective medicine, and it is even more so when you work with psychotherapy. We encourage you to continue working with your psychotherapist. We’d be happy to offer psychotherapy sessions with our trained and experienced psychotherapist as well. 

Eligibility for Ketamine Therapy

Before participating, you will be carefully interviewed to determine if you are a good candidate for ketamine treatment. This will include discussing your medical and psychiatric history, a review of your medical and psychiatric records, and a consultation with your existing care team. 

Some medical and psychiatric conditions need to be treated before you can safely take ketamine. These conditions include hallucinations, untreated mania, unstable angina (chest pain/heart disease), uncontrolled hyperthyroidism, increased intracranial pressure, or evidence of liver disease. A previously demonstrated allergy to ketamine excludes one from treatment. 

An EKG may be required for those with a history of arrhythmia or a history of cardiovascular issues. Untreated or uncontrolled hypertension is a contraindication to ketamine use, as the substance causes a rise in blood pressure. This increase is typically comparable to normal increases in blood pressure that occur with exercise. 

Pregnant and nursing people are not eligible because of undetermined potential effects on the fetus or nursing child.

Those with a history of cystitis or other bladder issues may need to be cleared by urological consultation, due to the rare but potentially significant adverse effect of cystitis. 

Those with a primary psychotic or dissociative disorder or who are currently in a manic or mixed episode are not eligible for treatment with ketamine. Please consult your treating clinician if you are taking Lamotrigine (Lamictal) or an anxiety medication such as benzodiazepines, pregabalin, or gabapentin as they may blunt the antidepressant effects of ketamine. 

Information on ketamine’s interaction with other medicines is only partially available; any possible interactions will be assessed to help determine your eligibility for ketamine treatment. 

Potential Risks of Ketamine Therapy

Ketamine has an extensive record of safety and has been used at much higher doses for surgical anesthesia, without respiratory depression. As with any other medication, there are also some potential risks and side effects to be informed of and consider. 

The most common physical side effect is a short-term increase in blood pressure, pulse, or heart rate, which may be a risk to those with heart disease, and can be misinterpreted as a symptom of anxiety. 

Other possible side effects include dizziness/lightheadedness, sedation, impaired balance and coordination, 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, headache, anxiety, nausea, vomiting, and diminished awareness of physical functions such as respiration. These effects are transient and resolve as the active phase of the medication ends (generally within 4 hours). 

Repeated, high dose, chronic use of ketamine has caused urinary tract symptoms and even permanent bladder dysfunction or cystitis in individuals using the drug too frequently. These adverse effects are much less likely in medically supervised ketamine treatment populations but might include more frequent, painful, or difficult urination. Please inform your providers immediately if you notice any of these side effects. 

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. 

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 blood pressure. Similarly, a history of heart 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.

SPECIAL NOTE ON SUICIDAL IDEATION. Psychiatric illnesses (especially, depression), chronic pain, and addictions carry the risk of suicidal ideation (thoughts of ending one’s life). Any such thoughts you may have now, at any time during the weeks of your ketamine infusions, or at any point in the future, which cannot immediately be addressed by visiting with a mental health professional should you to seek emergency care at an ER or to call 911.

Management of Adverse Effects 

Our setting and our client instructions (see Ketamine Therapy Preparation and Aftercare Instructions for details) are intended to minimize ketamine's adverse side effects as much as possible. 

It is very important to abstain from eating or drinking in the 4 hours​ prior to your treatment so as to avoid nausea or vomiting. Additionally, due to possible blurred and altered vision, we advise keeping your eyes closed or using the eye mask provided (as long as you are comfortable doing so) until the main effects have worn off. Excessive movement can exacerbate nausea and dizziness, so it is best to lie still during the active phase while balance and coordination are impaired. 

Driving an automobile or engaging in hazardous activities should not be undertaken within 12 hours from the administration, and not until all effects have stopped. 

Please check your vital signs before and after the administration, write them down, and let our doctor know during your appointment. Transient increase of blood pressure is normal. If you have any concerns, email us during the normal business hours (9am - 5pm PST).  

In case of an emergency, please call emergency response systems (such as calling 9-1-1). 

Potential for Ketamine Abuse and Physical Dependence

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 are classified as hallucinogens (also known as 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 the 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(psychological dependency). Therefore, ketamine should only be used under the direct supervision of a licensed prescriber.

Alternative Procedures and Possibilities

Ketamine may not decrease or relieve symptoms of mental and emotional distress and/or disorders. If your symptoms do respond to ketamine therapy, you may still elect to be treated with other psychiatric medications and other ongoing non-specific therapy to try to reduce the possibility of relapse. Over time, you may also need additional KAP treatments or other therapies to maintain your improvement or remission. 

Psychotherapy without ketamine is available and can be effective. Major Depression (MDD), PTSD and Bipolar Disorders are usually treated with antidepressant medications, tranquilizers, mood stabilizers, and psychotherapy. PTSD is often also treated with Eye Movement Desensitization and Reprocessing (EMDR). Electroconvulsive therapy (ECT) and Transcranial Magnetic Stimulation (TMS) are also in use for treatment-resistant depression. 

Confidentiality

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. The results of this ketamine therapy may be published in clinical literature. Published reports will not include your name or any other information that would identify you.

LIABILITY RELEASE AND HOLD HARMLESS PROVISION

 

Being fully informed as to risks laid out above, by signing this Consent, you forever release, indemnify, and hold harmless Isha (and all of its principals, employees, agents, contractors, or assigns) from any and all claims, counterclaims, damages, defenses, setoffs, recoupments, debts, demands, causes of action, suits, obligations, losses, costs, expenses, and liabilities of any nature whatsoever, in law or in equity, whether known or unknown, fixed or contingent, including but not limited to those arising from the ketamine therapy services. You covenants not to sue the undersigned doctor, or any of doctor’s principals, employees, contractors, or agents, and waives any right of recovery, whether known or unknown, that you may have to bring a claim or a lawsuit against the undersigned doctor for any personal injury, death, damage to personal property or other injury arising from the ketamine therapy services, whether arising from a theory of any tort, including negligence, or any other theory in law or equity. This release shall inure to the benefit of any member of Isha’s agents’ family, spouse, heirs, assigns, attorneys and personal representatives. The release shall be construed broadly to provide a release and waiver to the maximum extent permissible under applicable law. Isha assumes no responsibility for any claims or damages caused by the your failure to disclose or misrepresentation of any medical or mental health information. In no event shall Isha’s liability, if any, exceed the amount paid for the services by you. 

MEDIATION/ARBITRATION OF DISPUTES

Prior to initiating any action under this Agreement, the Parties agree to engage in mediation to resolve any disputes. If mediation does not resolve the dispute, any remaining dispute, claim, interpretation, controversy, or issues of public policy arising out of relating to this Agreement, including the determination of the scope or applicability of this Section, will be determined exclusively by mandatory binding arbitration held in San Francisco, California, and will be governed exclusively by Arbitration Act of California. The Parties waive (i) any right of removal to the United States federal courts and (ii) any right in the United States federal courts to compel arbitration, to confirm any arbitration award or order, or to seek any aid or assistance of any kind. If either Party brings an action to enforce the provisions of this Agreement, or claim a breach thereof, the substantially prevailing party in any action will be entitled to recover its reasonable attorneys’ fees and expenses incurred in such action.

The Open Payments database

The Open Payments database is a federal tool used to search payments made by drug and device companies to physicians and teaching hospitals. It can be found at https://openpaymentsdata.cms.gov.

Voluntary Nature of Participation

Your decision to undertake ketamine therapy is completely voluntary. Once you indicate that you have understood the benefits and risks of this treatment, you will be asked to sign the Informed Consent Agreement in order to participate. 

Please ask us 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. 

Informed Consent Attestation

By signing this form, I agree to the following:

1. I have fully read this informed consent form describing ketamine therapy.

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

5. I understand the risks and benefits, and I freely give my consent to participate in ketamine therapy as outlined in this form, and under the conditions indicated in it.

6. I understand that I may withdraw from ketamine therapy at any time up until the lozenge has been given.

Patient Printed Name:

Patient Signature: 

Date:

DOCTOR STATEMENT:

 I have carefully explained the nature of Ketamine treatment to

                                                                                                                                .

 I hereby certify that, to the best of my knowledge, the individual signing this consent  form understands the nature, conditions, risks, and potential benefits involved in participating in ketamine treatment.

 A medical problem or language or educational barrier has not precluded a clear understanding of the subject’s involvement in ketamine treatment.

 

Signature of Doctor                                              Date

 

 

Clinician Printed Name:  

Clinician Signature:

Date: 

Isha Health

4255 18th Street, San Francisco, CA 94114

415.501.0812