Consent for Treatment
Effective Date: February 1, 2023
This form contains information that will help you decide whether to participate in this procedure, it is important for you to know why it is being done and what it will involve. This includes any potential risks to you as well as any potential benefits you might receive as well as alternatives to ketamine therapy.
1. Ketamine
Ketamine is a Schedule III drug that has been widely used as an anesthetic agent since 1970 both in humans and in animals. In the last 25 years, ketamine, in lower subanesthetic doses, has been found helpful for people with pain conditions and psychiatric disorders including, but not limited to, anxiety, depression, post-traumatic stress disorder, and obsessive-compulsive disorder. As a psychiatric treatment, ketamine is considered “off-label” as it is not being administered for the purpose approved by the Food and Drug Administration (FDA). This means that the FDA does not endorse the use of ketamine for mental health purposes or as a psychotherapeutic agent and that all the possible side effects and complications are not known.
The use of ketamine in this therapy involves a different dose and conditions and may change the risk profile of the drug from what is described in FDA literature. While not formally approved by the FDA, there exists a growing body of studies clinically demonstrating its potential as a rapid treatment option for psychiatric disorders.
a. How Does it Work?
Ketamine, based on scientific consensus, blocks the N-methyl-D-aspartate (NMDA) receptor with downstream effects on the glutamate neurotransmitter system. At low doses, there is an enhancement of neuroplasticity, or the ability of brain cells to form new connections with one another. The glutamate pathway is very different from that used by other psychiatric drugs (e.g., antidepressants, mood stabilizers, antipsychotics, benzodiazepines) including classical psychedelics which primarily work through the serotonergic systems. Ultimately, this is what makes ketamine’s antidepressant effects unique and unlike any other known form of treatment. To note, the medical community’s understanding of ketamine’s mode of action may be incomplete and other mechanisms may be found in the future. Ketamine is classified as a dissociative anesthetic that produces a sense of disconnection from one’s usual reality and usual perception. At the oral tablet dosage level that will be administered to you, you will likely experience mild anesthetic, anxiolytic, antidepressant, and potentially, psychedelic effects. Relaxation from usual concerns and usual states of mind, while maintaining conscious awareness of the flow of mind under the influence of ketamine is characteristic. This can lead to a disruption of negative feelings and obsessional preoccupations. The dissociative effects of ketamine are short-lived, and most people return to their ordinary level of awareness and state of mind within 60-90 minutes following administration.
b. Potential Side Effects and Associated Risks
● Administration of ketamine under this procedure may cause adverse effects including, but not limited to: altered sense of time, anxiety, blurred, vision, diminished ability to see/hear/feel, dizziness, dry mouth, elevated blood pressure and heart rate, elevated intraocular or intracranial pressure, loss of appetite, loss or unsteady balance, mental confusion, nausea, vomiting, rapid eye movements (i.e. nystagmus), restlessness, slurred speech, a mingling of the senses (i.e. synesthesia), and increased frequency of urination. If these side effects do occur, they tend to resolve spontaneously as the acute effects of the ketamine wears off. In order to manage common side effects like nausea, your clinician may prescribe pyridoxine (Vitamine B6) for mild nausea, or ondansetron for moderate to severe nausea. The pyridoxine will be compounded with the ketamine (one tablet) for your convenience. Ondansetron is taken separately 1 hour before taking ketamine. In the rare case you experience increased suicidal ideations, your clinician will not be able to connect you to emergency services directly. If you are in a life-threatening situation, immediately call the National Suicide Prevention line at 988, call 911, or go to the nearest emergency room.
● When ketamine is administered in subanesthetic dosing, as used in this therapeutic procedure, addiction remains a possible but very rare outcome. According to a study of 6630 patients treated with parenteral Ketamine, only 9 displayed addiction-like behavior
1 . As per the Lancet, medical journal from the UK, the degree of harm produced by the drug (e.g. drug-specific damage) and its harm to others (e.g. loss of relationships, community) is less compared to benzodiazepines, cocaine, cannabis and heroin
2 . In some recreational users who use ketamine frequently, at doses on average over ten- times the dosage offered by our clinicians, it has been shown to cause psychological dependence. In select cases, when ketamine is abused recreationally, it can lead to pain during urination, passing blood in urine, inability to urinate, and reduced bladder size/bladder damage which could potentially be permanent.
1. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7408561/
2. https://www.researchgate.net/publication/285843262_Drug_harms_in_the_UK_A_multi-cr iterion_decision_analysis
☐ I understand that ketamine addiction is a possible but very rare outcome.
c. Potential and Intended Benefits
Ketamine provided across multiple routes of administration (e.g. oral, intravenous, intramuscular, intranasal, sublingual) has been shown to alleviate symptoms of mental distress in over 70%-80% of people. More specifically one could potentially expect to experience improved general function, reduced suicidal thoughts, reduction in feelings of depression, anxiety, and obsessive-compulsive disorder symptoms which can last from a few days to weeks or longer following a single treatment.
Ketamine therapy is a treatment and not a cure to mental health issues like depression and anxiety. Most clients need a minimum of 6 ketamine treatments to see the benefits and ongoing maintenance treatments may be needed. Prior to your initial treatment, a care plan will be established between you, the clinician, and the coach, with a goal of realizing the greatest likelihood of achieving your treatment goals. There is no guarantee you will experience these intended and potential benefits of ketamine therapy.
2. Oxytocin
Oxytocin is a peptide hormone and neuropeptide that acts as a natural pain reliever and is naturally produced in the hypothalamus. It plays a role in social bonding, childbirth, and sexual reproduction in both sexes. Oxytocin was discovered in 1906 and its molecular structure was determined in 1952. It has been used since the 1950s to induce labor. As a psychiatric treatment, Oxytocin is considered “off-label” as it is not being administered for the purposes approved by the FDA. This means the FDA does not endorse Oxytocin as a mental health or psychotherapeutic agent and that all the possible side effects and complications are not known. The use of ketamine in this therapy involves a different dose and conditions and may change the risk profile of the drug from what is described in FDA literature. While a newer psychiatric therapy compared to ketamine, oxytocin is showing promise at reducing anxiety and depression and there is a growing body of studies with its use of reducing social stress in people with autism.
a. How Does it Work?
Oxytocin binds to its receptors in the brain and stimulates natural opioid release. Furthermore, it lowers cortisol blood levels, which is often called the “stress hormone”. At the intranasal dosage that will be administered to you, oxytocin can improve mood. Oxytocin causes vasodilation and increased blood flow to the genitals. Due to these effects, it may be of beneficial use for sexual dysfunction related to mood disorders. Oxytocin is naturally released into the bloodstream as a hormone in response to stretching of the cervix and uterus during labor and with stimulation of the nipples from breastfeeding. This helps with birth, bonding with the baby and milk production, respectively. Due to these properties, oxytocin has been commonly used acutely to induce labor at significantly higher dosing than its intended psychiatric and psychotherapeutic dosing.
b. Potential Side Effects and Associated Risks
The most common side effects related to oxytocin are reported with the use of intravenous or intramuscular formulations. These adverse effects include nausea, vomiting, hypertension, hypotension, tachycardia, uterine bleeding or contractions. The most well studied alternate dosage form is intranasal which is more bioavailable and thus stronger than the rapidly disintegrating tablets prescribed by our clinicians. The side effects associated with intranasal dosing include stuffy nose, watery eyes, headaches and behavioral changes. In other studies lightheadedness, anxious and “fuzzy” feelings are reported - these effects are limited in duration and if they do occur decrease as the effects of oxytocin wear off. To note, while studies are limited, there are no documented nor reported side effects associated with both the sublingual route which is the route of administration utilized by our clinicians.
c. Potential and Intended Benefits
Oxytocin has been shown to decrease anxiety and depression, increase resilience towards stress, and improve general function. The effects can last from a few days to weeks or longer following a single treatment. Prior to your initial treatment, a care plan will be established between you, the clinician, and the coach, with a goal of realizing the greatest likelihood of achieving your treatment goals. There is no guarantee you will experience these intended and potential benefits of oxytocin therapy.
3. Eligibility for Ketamine Treatment or Ketamine & Oxytocin Treatment
a. Eligibility Determined by Coaches and Clinicians
Before starting Ketamine treatment, your coach and subsequently a clinician will thoroughly and carefully review your intake information (including medical history and assessment responses) as well as conduct a full psychiatric evaluation under the guidance of the clinician to determine eligibility for treatment.
Inclusion Criteria
Referral from a primary mental health provider OR history of previous treatment failure OR a diagnosis of at least one of the following: bipolar depression, generalized anxiety disorder (GAD), major depressive disorder (MDD), obsessive-compulsive disorder (OCD), post-traumatic stress disorder (PTSD) or other psychiatric disorder.
Exclusion Criteria
Clients must be at least 18 years old and cannot meet any of the exclusion criteria below:
● Active psychotic symptoms, manic symptoms, or a history of a primary psychotic disorder (e.g. schizophrenia, schizoaffective disorder, bipolar disorder with psychotic features);
● Active suicidal ideation with method, intent, or plan;
● Suicide attempt within the past year;
● Ketamine Allergy;
● Uncontrolled substance abuse/dependency (e.g. alcohol, opiates, cocaine, ketamine);
● Untreated high blood pressure;
● Severe heart disease (e.g. atrial fibrillation, congestive heart failure);
● Severe respiratory disease (e.g. Chronic Obstructive Pulmonary Disease);
● Unstable thyroid disease;
● Elevated Intraocular pressure (e.g. glaucoma);
● Elevated intracranial pressure;
● Pregnant, nursing or currently trying to become pregnant; or
● Other serious medical illnesses not listed above (e.g. severe personality disorders).
Please notify your provider immediately and discontinue treatment if there are any changes to your physical or mental health that impact your eligibility for treatment.
b. Eric Osterlind’s Guidelines and Requirements for Treatment
You further agree to adhere to the following requirements, and decline to receive the treatment if you fail (or expect to fail) any of the conditions below:
1. Identify a companion monitor (partner, family member, close friend, roommate, or other trusted and physically capable adult) that will be present for your treatment;
2. Avoid stimulants on day of treatment unless indicated otherwise by your clinician in order to reduce or avoid agitation of blood pressure prior to your treatment;
3. Avoid benzodiazepines on the day of treatment unless indicated other by your clinician, which class of medications could reduce responsiveness to ketamine and/or cause oversedation;
4. Avoid alcohol and hangover on the day of treatment;
5. Refrain from consuming food for 3 hours prior to treatment to mitigate the risk of nausea;
6. Refrain from consuming liquids for 1 hours prior to treatment to avoid bathroom breaks that may disrupt treatment;
7. Not proceed with treatment if your blood pressure is above 150/100 or your heart rate is above 100 beats per minute;
8. Set aside at least 3 hours for your treatment and not travel during this period; and
9. Not operate a vehicle or heavy machinery for the remainder of the day following your treatment.
4. Ketamine Treatment
During your initial video consultation, your clinician will conduct a psychiatric evaluation, determine whether you have a diagnosis that qualifies you for treatment using this medication, and confirm that you do not meet any of the exclusion criteria listed above.
If your clinician determines that you are eligible for treatment, they will review this Informed Consent with you and provide an opportunity for you to ask any questions. Your clinician may prescribe oral ketamine tablets. The tablets are to be administered by placing them under your tongue or in between your cheek and gums until they dissolve completely, hold for a total of several minutes primarily at the clinicians discretion, after which the solution in its entirety is to be swallowed.
The effects of the ketamine tablets can typically be observed 20-30 minutes after swallowing. The peak experience lasts approximately 45-60 minutes thereafter. About 90 minutes after taking the medication, effects of ketamine will begin to diminish.
The side effects of ketamine, such as dissociation, dizziness, headaches, anxiety, nausea, and fatigue, although uncommon, may persist for several hours following treatment.
5. Oxytocin Treatment
During your initial video consultation, your clinician will conduct a psychiatric evaluation, determine whether you have a diagnosis that qualifies you for treatment using this medication, and confirm that you do not meet any of the exclusion criteria listed above. If your clinician determines that you are eligible for treatment, they will review this Informed Consent with you and provide an opportunity for you to ask any questions.
Your clinician may prescribe rapid dissolving tablets (RDTs) administration of oxytocin. The RDTs are to be administered sublingual (under the tongue) or in the buccal region (space in the cheek) of the mouth. Depending upon the dose your clinician may prescribe 40IU -120IU (1-3 RDTs) of oxytocin. If oxytocin is prescribed, take the oxytocin first before the ketamine. Take the oxytocin RDTs and place them sublingually (under tongue) in the mouth. The RDTs will dissolve within a minute, and hold saliva for 5 minutes and then swallow your saliva. The effects of oxytocin administration can typically be observed 1-6 minutes after administration. The peak experience lasts approximately 20-40 minutes thereafter. About 90 minutes after receiving the medication, effects of oxytocin will begin to diminish. The side effects of oxytocin, such as nausea, vomiting, hypertension, hypotension, tachycardia, uterine bleeding or contractions, stuffy nose, watery eyes, headaches, behavioral changes, lightheadedness, anxious and “fuzzy” feelings, although uncommon, may persist for several hours following treatment.
6. Coaches
As part of your program you will work with a coach who is affiliated with Eric Osterlind. Your coach will help you navigate your program, set intentions, and develop your integration plan. Coaches are trained in life coaching, best practices for working with psychedelic medicine, and how to best collaborate with your clinician to support your treatment.
7. Consent to Telehealth
a. How Does it Work?
Telehealth involves the use of electronic communications, information technology, or other means to enable healthcare providers at different geographic locations to request information for the sole purposes of providing you the treatment, providing you the Eric Osterlind services, and improving client care.
The electronic transmission of client information may include, but is not limited to: medical records, photo images, personal health information or other data between a clinician and the client, and potentially clients other providers. Moreover, telehealth services offered through the Eric Osterlind platform by the clinicians may include psychiatric consultations by video or, less often, by phone, chart review, remote prescribing, appointment scheduling, health information sharing, as well as client education.
The services provided will be based on the information you provided in order to diagnose, provide therapy, and provide education. The electronic systems used in the Eric Osterlind service will incorporate network and software security protocols to protect the privacy and confidentiality of client identification and imaging data, and will include measures to safeguard the data to ensure its integrity against intentional or unintentional corruption. Your medical information will be kept confidential and may be shared in limited ways according to the confidentiality terms below.
b. Potential Risks of Telehealth
You understand and accept the following risks of engaging in telehealth services:
● The inability of your provider to conduct certain tests/assess vital signs/closely monitor in-person may in some cases, depending on the client's context, prevent a diagnosis from being made and for treatment to be administered;
● The inability of your provider to monitor the acute and post treatment effects may in rare cases prevent the identification of the need for emergency medical care; ● Delays in medical evaluation/treatment could occur due to inadequacies or failures of electronic equipment and information technologies;
● If the clinician deems you clinically unfit due to serious illness you may be required to seek in-person or alternative care;
● Security protocols or safeguards could fail in rare cases causing a breach of privacy;
● The inability for your provider to attain full access to complete medical records may result in inaccurate and/or incomplete medical advise, interactions, or allergic reactions; and
● Given ongoing regulatory processes in certain jurisdictions, your consultation and treatment options, especially pertaining to select prescriptions, may be limited at any point.
c. Potential Benefits of Telehealth
The potential benefits of receiving telehealth services include, obtaining expertise from a distant specialist, more efficient client evaluation and management, and improved access to care.
8. Research Consent
We are committed to improving the field of Mental Health through scientific research. Data gathered from treatment by Eric Osterlind may be used for medical research publication. Any and all personal/identifying information is removed before any information is used for publication. Following HIPAA guidelines, patient visits and information may be recorded and used internally for Eric Osterlind clinician training purposes. By signing this document, I agree to the use of my information in this manner.
9. Acknowledgement of Alternative Treatments
Before deciding to proceed with ketamine treatment and potential adjunct oxytocin treatment, you should consider the risks and potential benefits of available alternative mood and anxiety disorder treatment options, such as antidepressants, anti-anxiety medications, mood stabilizers, psychotherapy, or transcranial magnetic stimulation (TMS). You should also consider alternatives to telehealth consultation, such as in-person services, before choosing to participate in a telehealth consultation. You can discuss these alternative treatments with your clinician or local primary care doctor.
10. Confidentiality
Your privacy is a priority and all treatment records will be kept confidential. They will be maintained with the same precautions as ordinary medical records. If you would like to provide other individuals or organizations with access to your records, contact us for a release of information form. You also understand that your healthcare information may be shared by Eric Osterlind and with its affiliates and service providers for scheduling, treatment and/or billing purposes, as well as in the event of a malpractice suit or other litigation, or for any other purpose to the extent permitted by law. Disclosure of my health information may also be shared with government agencies and other persons and entities described in this consent form for the purposes described in this consent form and as required by law.
11. Acknowledgement of Informed Consent By electronically signing this document, I understand and confirm that:
☐ I have fully read and understand this informed consent document and thus understand the potential risks and benefits, and I understand my receipt of these services and these treatments is not required and is purely voluntary, and I therefore freely give my consent to participate in ketamine treatment with a potential adjunct oxytocin treatment, and I freely give my consent to receive telehealth services from Eric Osterlind.
☐ I will abide by all of Eric Osterlind’s guidelines and treatment requirements outlined in this document and/or those that have been communicated by my clinician; I understand that if I do not abide by all of Eric Osterlinds guidelines I will no longer qualify to receive services or treatments from Eric Osterlind.
☐ I understand that my clinician will determine whether or not my specific clinical needs are appropriate for a telehealth encounter. I understand that my clinician may deny services if misuse is suspected or for any other reason if, in the professional judgment of my clinician, the telehealth encounter is not medically or ethically appropriate.
☐ I meet the eligibility criteria and do not meet the exclusion criteria listed in the “Eligibility for Ketamine Treatment or Ketamine & Oxytocin Treatment” section above. If there are any changes to my physical or mental health that impact my eligibility for treatment, I will notify my providers immediately and discontinue treatment, if necessary.
☐ I will be physically located in my state of residence, as identified in my onboarding application, during my telehealth consultation to comply with healthcare laws and guidelines. I will notify a Eric Osterlind clinician, coach or support team member immediately if I am located in a different state.
☐ I understand that my clinician will not be able to directly connect me to emergency services. I understand that if I am in a life-threatening situation, I will call the National Suicide Prevention line at +1 1-800-273-8255, or call 911 or go to the nearest emergency room.
☐ I understand that the laws that protect privacy and the confidentiality of health information also apply to telehealth, and that no information obtained in the use of telehealth which identifies me will be disclosed to researchers or other entities without my consent.
☐ I understand that I have the right to withhold or withdraw my consent to the use of ketamine, oxytocin, and telehealth in the course of my care at any time. I understand that withholding or withdrawing consent may result in me no longer qualifying to receive services and that such consent will not impact the rights and actions of Eric Osterlind while the consent was in effect.
☐ I understand that I have the right to inspect all information obtained and recorded in the course of a telehealth interaction and may receive copies of this information for a reasonable fee.
☐ I understand that a variety of alternative methods of healthcare and alternative treatments are available to me, and that I may choose one or more of these at any time. My clinician has explained the alternatives to my satisfaction.
☐ I understand that telehealth may involve electronic communication of my personal health information to other practitioners who may be located in other areas, including out of my state of residence.
☐ I understand it is my duty to inform my clinician of electronic interactions regarding my care that I may have with our healthcare providers.
☐ I understand that I may expect the anticipated benefits from the use of ketamine, oxytocin, and telehealth in my care but that no results can be guaranteed or assured, and in some cases my health conditions may get worse.
☐ I understand Eric Osterlind does not condone using ketamine illegally (i.e. “off the streets).
☐ I have had an opportunity to ask questions and all my questions have been answered.
☐ I am aware that data gathered from treatment by Eric Osterlind may be used for medical research publication. Any and all personal/identifying information is removed before any information is used for publication.
I have read the foregoing and agree to receive the treatments and services described in this Eric Osterlind Informed Consent.