Ketamine Treatment Informed Consent

Background

Ketamine is a Schedule III medication that has been used safely as an anesthetic and analgesic since it was FDA-approved in 1970 for that purpose. It is increasingly prescribed “off-label” for treatment of anxiety, depression, post-traumatic stress disorder (PTSD), chronic pain, and other indications. Off-label prescribing is both legal and common. About one in five prescriptions are written for an off-label use.

Ketamine has an extensive historical safety record and has been used at much higher doses for surgical anesthesia and procedural sedation. As with any medication, it is not without risks (discussed in more detail below), and these must be kept in mind when determining whether ketamine is the right treatment for you.

How it Works

Ketamine is an NMDA receptor antagonist working through the glutamate neurotransmitter system, and at low doses, it is believed to exert its antidepressant effects through the 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., SSRIs, SNRIS, lamotrigine, antipsychotics, benzodiazepines), which is part of what makes ketamine’s antidepressant effects so novel and unlike any other known form of treatment. However, our understanding of ketamine’s mode of action is incomplete, and we may find other mechanisms that contribute to its antidepressant effects in the future.

Ketamine is classified as a dissociative anesthetic that produces a sense of disconnection from one’s ordinary reality and usual self. At the dosage level administered to you, you will likely experience mild anesthetic, anxiolytic, antidepressant and, potentially, psychedelic effects. Relaxation from ordinary 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 45-60 minutes following administration.

Benefits

Ketamine has been shown to alleviate symptoms across a variety of mental health issues, as listed above. For people who have responded to ketamine in clinical trials, the initial antidepressant effects are often detectable within hours of administration, with peak antidepressant effect occurring approximately 24-48 hours after injection, on average. The duration of ketamine’s antidepressant effect varies from person to person and can range from a few days to two weeks or longer following a single treatment.

While the benefits of ketamine have been demonstrated across modalities (e.g., sublingual, intravenous, intramuscular, oral), clinical trials have most often focused on intravenous (IV) administration. Studies have shown that a series of IV treatments over 2-3 weeks can extend the antidepressant effects of ketamine to anywhere from weeks to months after the final treatment. Prior to your initial treatment, you and your Choose Ketamine clinician will determine the initial treatment regimen that has the greatest likelihood of achieving your treatment goals.

Eligibility

Before participating in ketamine treatment, our medical team will carefully review your intake information (including medical history and assessment responses) and may conduct an in-person physical and psychiatric consult to confirm your diagnosis and eligibility for treatment. Clients must be 18 years old and not meet the exclusion criteria below:

Ketamine allergy
Ongoing alcohol or substance abuse or dependence
History of opioid use disorder
Active psychotic symptoms, manic symptoms, or a history of a primary psychotic disorder (e.g., schizophrenia, schizoaffective disorder)
Active suicidal ideation with method, intent, or plan
Suicide attempt within the past year
Untreated high blood pressure
Congestive heart failure or other serious heart problems
Severe breathing problems (e.g., COPD)
Unstable thyroid disease
Elevated intraocular pressure (e.g., glaucoma)
Elevated intracranial pressure
Other serious medical illness not listed above
Pregnant, nursing, or currently trying to become pregnant

Notify your provider immediately and discontinue treatment if there are any changes to your physical or mental health that impact your eligibility for treatment.

Preparation for Treatment Requirements

Choose Life clients must strictly comply with the guidelines below for all ketamine treatment sessions.

Continue to take most morning medications, particularly antihypertensive medication, given ketamine’s tendency to increase arterial blood pressure
Refrain from taking stimulants the day of treatment to avoid mild agitation and/or blood pressure elevation (these may be resumed following your ketamine session)
Benzodiazepines may diminish your response to ketamine, so you may want to skip them on treatment day if this doesn’t pose any risks to your health/safety
Avoid hangovers or alcohol on the day of treatment for best experience and clinical response
Refrain from consuming solid foods within 3 hours prior to treatment and liquids within 1 hour prior to treatment to mitigate the risk of nausea (note: your clinician may prescribe anti-nausea medication, if appropriate)
Do not operate a vehicle (e.g., car, motorcycle, bicycle) or heavy machinery following treatment until you’ve had a full night of sleep

Ketamine Treatment

During your initial video consultation, your Choose Ketamine clinician will conduct a psychiatric evaluation, determine whether you have a diagnosis that qualifies you for treatment, review the Informed Consent and Remote Ketamine Treatment Agreement, provide an opportunity for you to ask any questions about your treatment, and (if indicated) prescribe medication.

Choose Ketamine clinicians prescribe sublingual ketamine tablets. These are placed under your tongue or in between your cheek and gums for 7 minutes without swallowing and then spitting out any saliva that has accumulated. Swallowing is not a problem, but ketamine ingested orally has a slightly longer onset time and often extends the time required for you to return to your baseline physical and mental states.

You’ll likely start to feel the effects of the ketamine about 10 minutes after placing it under your tongue, and the peak experience will last approximately 30-45 minutes thereafter. About an hour after taking the medication, effects of ketamine will begin to diminish. The side effects of ketamine, such as dissociation, dizziness, headache, anxiety, or nausea, may persist for several hours following treatment.

Side Effects & Risks Associated with Ketamine Treatment

Ketamine 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, excitability, loss of appetite, loss of balance or unsteady gait, mental confusion, nausea/vomiting, nystagmus (rapid eye movements), restlessness, slurred speech, synesthesia (a mingling of the senses). When these occur, they are time-limited and tend to resolve spontaneously as the acute effects of the ketamine wear off.

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While ketamine has been reported to produce adverse outcomes including but not limited to those outlined below, lasting adverse side-effects are rare when medical protocols are carefully followed. By signing this informed consent document, you agree to adhere to Choose Life’s treatment guidelines, which are designed to minimize the risk of adverse outcomes associated with the use of ketamine and to maximize its potential benefits.

While ketamine has not been shown to be physically addictive, it has been shown to cause moderate psychological dependency in some frequent recreational users
In rare cases, frequent, heavy users have reported increased frequency of urination, urinary incontinence, pain urinating, passing blood in the urine, or reduced bladder size
Ketamine may worsen problems in people with schizophrenia, severe personality disorders, or other serious mental disorders; users with a personal or family history of psychosis should be cautious using any psychoactive substance, including ketamine, and discuss potential risks with your Choose Ketamine clinician before proceeding with treatment
The dissociative effects of ketamine may increase vulnerability and the risk of accidents
People with a personal history of Schizophrenia, Schizoaffective disorder or other primary psychotic illness are not eligible for ketamine therapy, due to the risk for ketamine to exacerbate psychotic symptoms in susceptible individuals

Choose Ketamine Guides

As part of your program you may work with a Choose Ketamine Guide. Your Guide can help navigate your Choose Ketamine program, set intentions for your journey, develop your integration plan, and hold you accountable to your plan. All of our Guides are trained in preparation and integration practices for working with psychedelic medicine, and many have experience and certifications in life coaching and other healing modalities.

While your Guide may be able to support you in changing unwanted thoughts or behaviors and achieve the goals you set for your Choose Ketamine program, Choose Ketamine Guides are not therapists or clinicians, so they are not licensed to treat anxiety, depression, or other diagnoses. That’s the role of your Choose Ketamine clinician or other licensed mental healthcare providers you may work with inside or outside of the Choose Ketamine program.

Choose Ketamine guides do not provide 24/7 support.

Consent to Telehealth

Telehealth involves the use of electronic communications to enable healthcare providers at different locations to share individual patient medical information for the purpose of improving patient care. Telehealth services offered by Choose Ketamine may also include consultations by video or by phone, chart review, remote prescribing, appointment scheduling, health information sharing, and non-clinical services, such as patient education. The information you provide may be used for diagnosis, therapy, follow-up and/or patient education, and may include any combination of the following: (1) health records and test results; (2) images and asynchronous communications; (3) live two-way audio and video; (4) interactive audio with store and forward; and (5) output data from medical devices and sound and video files.

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The electronic communication systems we use will incorporate network and software security protocols to protect the confidentiality of patient identification and imaging data and will include measures to safeguard the data and to ensure its integrity against intentional or unintentional corruption.

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Choose Ketamine providers (our “providers”) are an addition to, and not a replacement for, your primary care physician and/or primary mental health provider. Responsibility for your overall medical care should remain with your local primary care doctor, if you have one, and we strongly encourage you to locate one if you do not.

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Expected Benefits:

Improved access to care
More efficient care evaluation and management
Obtaining expertise of a specialist as appropriate

Possible Risks:

Delays in evaluation and treatment could occur due to deficiencies or failures of the equipment and technologies
In rare events, our provider may determine that the transmitted information is of inadequate quality, thus necessitating a rescheduled telehealth consult or a meeting with your local primary care doctor
In very rare events, security protocols could fail, causing a breach of privacy of personal medical information
In rare events, a lack of access to complete medical records may result in adverse drug interactions or allergic reactions or other judgment errors

Alternative Treatments

Before deciding to proceed with ketamine treatment, you should consider the benefits and risks of available mood and anxiety disorder treatment options, such as other antidepressant and anti-anxiety medications, mood stabilizers, or psychotherapy. You should also consider alternatives to telehealth consultation, such as in-person services, before choosing to participate in a telehealth consultation.

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 form.

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By electronically signing this document, I confirm that:

I have fully read and understand this agreement. I understand the potential benefits, risks, and alternative treatment options, and I freely give my consent to participate in ketamine treatment and receive services via telehealth from medical providers unaffiliated with Choose Ketamine.
I will abide by all of Choose Ketamine’s guidelines and requirements outlined in this document and/or those that have been communicated by my Choose Ketamine clinician.
I meet the eligibility criteria and do not meet the exclusion criteria listed in the “Eligibility” 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 understand that Choose Ketamine providers are not able to connect me directly to any emergency services. If I am in a life-threatening situation, I will call the National Suicide Prevention Line at +1 1-800-273-8255, call 911, or go to the nearest emergency room.
I understand it is up to the Choose Ketamine provider to determine whether or not my specific clinical needs are appropriate for a telehealth encounter.
I understand that my healthcare information may be shared with other individuals for the purposes of treatment, scheduling, billing, and other healthcare operations.
I understand that my data may be used for research purposes, and any personal information that could identify me will be removed or changed before it is shared with other researchers or results are made public.
I give Choose Ketamine’s providers permission to access information regarding my historical medical data through their electronic health record system.
I understand that if I participate in a consultation, I have the right to request a copy of my medical records.
I understand that I may withdraw from treatment and/or the use of telehealth at any time.
I have had the opportunity to review this document with my clinician and ask questions, and I have received satisfactory answers to my questions.

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Note: we’ll send you a link to electronically sign this document prior to your first session.