Ketamine Informed Consent to Treatment

Aspire Medical Group (hereinafter referred to as “Practice”) is an independently owned and operated psychiatric medical practice, which provides psychiatric treatment services using telehealth and in-person services. As part of these psychiatric treatment services, you may be prescribed a medicine named ketamine, which has been shown to have positive effects for the treatment of anxiety, depression and other indications. Your clinician may prescribe ketamine in the form of tablets or liquid that are compounded by pharmacies under Section 503A of the federal Food, Drug, and Cosmetic Act (FDCA), and therefore do not require FDA approval; as such, the FDA has not determined that the compounded ketamine prescribed is safe and effective for mental health conditions. Other drugs containing ketamine have been approved by the FDA for use in anesthesia and analgesia; however, the FDA has not evaluated the safety and efficacy of ketamine for the treatment of depression, anxiety, and other mental health conditions. Ketamine is a Schedule III medication that is not clinically appropriate for all people, and has risks (discussed in more detail below) that must be considered when determining whether this treatment is right for you.

During your initial 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 sublingual ketamine tablets. The tablets are administered by placing them under your tongue or in between your cheek and gums for 7 minutes without swallowing, and then any saliva that has accumulated is spit out. Clinicians advise against swallowing the ketamine because ketamine ingested orally may have a longer onset time, increase the adverse effects listed below, and/or extend the time required for you to return to your baseline physical and mental states. 

Your clinician may also recommend compounded liquid ketamine, which may be combined with vitamins B6 and B12, and is administered through intravenous or intramuscular injection at our office with continuous monitoring of vital signs throughout the treatment. Dosages will be adjusted as needed based on the patient's response to ensure optimal effectiveness.

For patients new to ketamine therapy, intramuscular injections are typically given in two or more smaller doses to assess tolerance and minimize the risk of adverse reactions from a single, higher dose. Treatment sessions generally last between 40 to 55 minutes. If necessary, additional medications may be provided to manage side effects such as nausea or agitation.

Proper storage and handling are essential to ensure the safety of both the patient and others. Patients should refrain from driving or operating hazardous equipment after use and avoid consuming alcohol or other substances during the treatment period. In case of severe side effects, emergency contact with the healthcare provider is advised.

Ketamine may also be administered in intranasal formulations for maintenance therapy or at-home use. These formulations are intended to sustain the therapeutic benefits following in-clinic treatments and must be taken exactly as prescribed. Patients are expected to maintain regular follow-ups and communicate with their healthcare provider to monitor efficacy and potential side effects.

The effects of the ketamine can typically be observed about 5-10 minutes after administration, and the peak experience lasts 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.

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 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 novel and unlike other known forms of treatment. However, the medical community's 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.

Ketamine has been shown to alleviate symptoms across a variety of mental health issues. For people who have responded to ketamine in clinical studies, the initial antidepressant and anxiolytic effects are often detectable within hours of administration, with peak antidepressant and anxiolytic effects typically occurring approximately 24-48 hours after administration. The duration of ketamine’s antidepressant and anxiolytic 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, subcutaneous, oral), clinical studies 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 and anxiolytic effects of ketamine to anywhere from weeks to months after the final treatment. Prior to your initial treatment, you and the Practice’s clinician will determine the initial treatment regimen that has the greatest likelihood of achieving your treatment goals.

Before participating in ketamine treatment, the Practice will carefully review your intake information (including medical history and assessment responses) and will require a physical and/or psychiatric consult, telehealth or in person, to confirm your diagnosis and eligibility for treatment.

Clients must be at least 18 years old and cannot meet the exclusion criteria below:

• Ketamine allergy
• Ketamine use disorder, mild, moderate, or severe; active or in remission
• 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

While clinical studies have demonstrated the effectiveness of ketamine for treating the conditions below, they may indicate you are not a good fit for our treatment model. The clinician will determine eligibility on a case-by-case basis, and confirmation of regular, ongoing therapeutic support outside of Aspire Medical Group may be necessary to move forward.

• Active substance use disorder
• History of severe trauma
• Acute suicidality

**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.

1. Identify a Peer Treatment Monitor (partner, family member, close friend, roommate, or other trusted adult) that will be present for your treatments
2. Avoid stimulants on the day of treatment to avoid mild agitation and/or blood pressure elevation (these may be resumed following your ketamine session)
3. Avoid benzodiazepines on the day of treatment if this doesn’t pose any risks to your health/safety, since these medications may diminish your response to ketamine
4. Avoid alcohol, cannabis, or a hangover on the day of treatment to promote your safety and the likelihood of a strong clinical response
5. Continue to take antihypertensive medication as prescribed
6. Refrain from consuming food for 4 hours prior to treatment to mitigate the risk of nausea (your clinician may prescribe anti-nausea medication, if appropriate)
7. Refrain from consuming liquids for 2 hours prior to treatment to avoid bathroom breaks that may disrupt your treatment
8. Do not proceed with treatment if your blood pressure is above 150/100 or your heart rate is above 100 beats per minute (prior to treatment, you will have to purchase a digital blood pressure monitor)
9. Set aside at least 2 hours for your treatment and avoid moving around until you return to your baseline physical and mental states (ask your Peer Treatment Monitor to assist you if you need to get up for any reason, e.g., to use the restroom)
10. Do not operate a vehicle (e.g., car, motorcycle, bicycle) or heavy machinery following treatment until you’ve had a full night of sleep
11. Additionally, you may not receive ketamine treatment from an Aspire Medical Group clinician at the same time as you receive ketamine treatment from another provider. If you are receiving ketamine treatment from another provider, you must disclose it to your Aspire Medical Group clinician during your initial consultation. Receiving ketamine treatment from another provider during the course of your Aspire Medical Group program will result in the discontinuation of your treatment.

Ketamine may cause serious side effects, including but not limited to risks of: sedation; dissociation; psychiatric events or worsening of psychiatric disorders, including problems in people with schizophrenia, severe personality disorders, or other serious mental disorders; dependence, abuse and misuse; anxiety; increases in blood pressure or heart rate; respiratory depression (breathing becomes slower and shallower and the lungs fail to exchange carbon dioxide and oxygen efficiently); lower urinary tract and bladder symptoms, including frequency of urination, urinary incontinence, pain urinating, passing blood in the urine, or reduced bladder size; altered sense of time; dry mouth; elevated intraocular or intracranial pressure; loss of appetite; confusion; nausea/vomiting; blurred vision; and slurred speech. When these occur, they tend to resolve spontaneously as the acute effects of the ketamine wear off.

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 Aspire Medical Group's treatment guidelines, which are designed to minimize the risk of the side effects listed above and adverse outcomes, and to maximize its potential benefits. You agree to take ketamine only as directed by your clinician.

Ketamine has been found to cause moderate psychological dependency in some 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.
• The dissociative effects of ketamine may increase vulnerability and the risk of accidents.
• People with a personal history of schizophrenia, schizoaffective disorder, other primary psychotic illnesses, or severe personality disorder are not eligible for ketamine therapy, due to the risk for ketamine to exacerbate psychotic symptoms in susceptible individuals.
• Worsening symptoms of depression, anxiety, or suicidal ideations may occur. If you experience worsening symptoms, notify your treatment team. If you are experiencing suicidal thoughts and feel unsafe, contact the National Suicide Prevention Hotline by dialing 988, call 911, or go to the nearest emergency room.

• Ketamine may offer rapid relief of depression, bipolar disorder, PTSD, and chronic pain symptoms, as well as reduce cravings for drugs and alcohol. Results are not guaranteed and often require ongoing maintenance treatments to maintain benefits.

• Hallucinations
• Anxiety
• Flashbacks
• Vivid dreams and nightmares
• Nausea and vomiting
• Increased heart rate and blood pressure during treatment
• Dizziness
• Dissociation
• Blurred vision
• Increased saliva production
• Change in motor skills

• Rash
• Double vision
• Pain and redness at the injection site
• Increased pressure in the eye
• Jerky arm movements resembling a seizure

• Allergic reactions
• Arrhythmia
• Hypotension
• Irregular or slow heart rate
• Low blood pressure
• Bladder cystitis: inflammation, ulcers, and fibrosis

• Ketamine can trigger symptoms such as flashbacks, hallucinations, feelings of unhappiness, restlessness, anxiety, insomnia, and disorientation.
• There is a rare risk of a dosing error or unknown drug interaction that may require medical intervention, including intubation (putting in a breathing tube), or hospitalization.
• Starting an IV may cause temporary discomfort from the needle stick, bruising, or infection. Fainting may also occur.
• Risk of medication interactions with ketamine. It is crucial that you disclose all medications (both prescription and over-the-counter) and supplements that you are taking.
• Ketamine may not alleviate your depression, bipolar disorder, PTSD, anxiety, or other mental health condition. 

• Psychotherapy
  Cognitive Behavioral Therapy (CBT) or other forms of talk therapy can help patients address underlying mental health conditions such as depression, anxiety, and PTSD by changing negative thought patterns and behaviors.
• Pharmacotherapy
  Medications such as antidepressants (e.g., SSRIs, SNRIs), mood stabilizers, antipsychotics, or other conventional psychiatric medications may provide symptom relief for depression, anxiety, bipolar disorder, PTSD, and substance use disorders. These medications are often used as first-line treatments and may be combined with other therapies.
• Electroconvulsive Therapy (ECT)
  ECT is an established treatment for severe depression, bipolar disorder, or schizophrenia, especially in patients who do not respond to medications. It involves electrical stimulation of the brain under anesthesia and has been shown to be effective for certain individuals.
• Transcranial Magnetic Stimulation (TMS)
  TMS is a non-invasive procedure that uses magnetic fields to stimulate nerve cells in the brain. It is commonly used for treatment-resistant depression and may be an option for patients who do not respond to medications.
• Mindfulness-Based Stress Reduction (MBSR)
  Mindfulness and meditation-based therapies, such as MBSR, help individuals improve emotional regulation, reduce anxiety, and manage symptoms of mental health conditions without the use of medication.
• Lifestyle Changes
  Regular exercise, a healthy diet, good sleep hygiene, and stress management techniques can improve overall mental health and alleviate symptoms of depression and anxiety.
• Complementary and Integrative Therapies
  Some patients benefit from acupuncture, yoga, or other integrative approaches to support their mental and physical well-being. These approaches may be used alongside other medical or therapeutic treatments.

• Fasting: Do not eat or drink for at least six hours before each infusion. You may drink clear liquids up to two hours before the infusion or injection.
• Psychiatric care: Maintain regular contact with a qualified mental health professional throughout your ketamine treatments to monitor your overall mental health and treatment progress.
• Medication management: Take your usual morning medications with a few sips of water before an infusion, except for specific medications such as Lamictal, benzodiazepines, and sedatives, including narcotic pain medications. Inform the clinic about all medications you are currently taking, especially narcotic pain relievers, benzodiazepines, stimulants, lamotrigine, and anticonvulsants.
• Substance use: Refrain from consuming alcohol or other substances before and for 24 hours after each infusion.
• Driving and activities: Do not drive a car, operate hazardous equipment, or engage in hazardous activities for 24 hours after each treatment due to potential impaired reflexes. Arrange for another adult to drive you home after the infusion. Avoid conducting business or making important decisions for the rest of the day after ketamine therapy.
• Monitoring side effects: Be aware of potential side effects such as hallucinations, vivid dreams, nausea, dizziness, blurred vision, and changes in heart rate or blood pressure. If you experience troublesome side effects after leaving the clinic, contact Aspire Medical Group or seek medical assistance promptly.
• Medical contact information: Keep contact information readily available for Aspire Medical Group or your primary care provider in case of emergencies or severe side effects.
• Psychiatric emergencies: If you experience suicidal thoughts or any other severe mental health crisis during or after ketamine therapy and cannot immediately reach your mental health provider, seek emergency care at the nearest emergency room or call 911.
• Pregnancy and breastfeeding: Ketamine use is not recommended during pregnancy or breastfeeding. A negative pregnancy test is required before initiating ketamine therapy.
• Restrictions on business and decision-making: Do not conduct business or make any important decisions for the remainder of the day after ketamine therapy. 

• Ketamine infusion therapy alone is not a comprehensive treatment plan for depression, anxiety, or any psychiatric symptoms.
• Ketamine infusions are meant to augment, not replace, a comprehensive treatment plan. We strongly advise you to be under the care of a qualified psychiatric provider while receiving ketamine infusions and for the duration of your psychiatric symptoms. If you currently do not have a psychiatric provider, our psychiatric nurse practitioner, Betty Yu, can take over your care, but this is not a requirement to receive ketamine infusion therapy at our clinic. You are free to seek psychiatric care elsewhere.
• We do not provide ketamine infusions for pain management at Aspire Medical Group.
• Ketamine use during pregnancy or breastfeeding is not recommended. We require a negative pregnancy test result prior to initiation of ketamine therapy but do not provide pregnancy testing as part of the initial screening process.

• Psychiatric conditions (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 while you are receiving ketamine infusions, or at any point in the future, which cannot immediately be addressed by visiting with a mental health professional, you should seek emergency care at an ER or call 911.

• You have the option to accept or decline the ketamine infusion. Please let our staff know if you choose not to proceed with treatment.

• Your provider reserves the right to stop the infusion at any time, with or without your consent, as deemed necessary.

• Ketamine is FDA-approved for use as an anesthetic, but its use for treating conditions such as depression, anxiety, chronic pain, OCD, and substance abuse is considered off-label. This means that while there is clinical evidence supporting ketamine’s efficacy for these conditions, the FDA has not specifically approved ketamine for their treatment.
• By consenting to this treatment, you acknowledge and accept that ketamine is being used off-label in your care, and that Aspire Medical Group does not make any guarantees regarding its efficacy for your particular condition.

By providing my electronic signature below, I agree to the terms and conditions outlined in this agreement. I agree to the use of electronic records and signatures. I acknowledge that I have read the related consumer disclosure.

The parties acknowledge and agree that this financial agreement form may be executed by electronic signature, which shall be considered as an original signature for all purposes and shall have the same force and effect as an original signature. Without limitation, “electronic signature” shall include faxed versions of an original signature or electronically scanned and transmitted versions (e.g., via PDF) of an original signature.

•  I have been provided with ample opportunity to ask questions about the treatment, and I am satisfied with the answers given. The provider has fully explained alternative treatment options, the risks involved, and the potential complications associated with ketamine infusion therapy. 

• I have informed my healthcare provider of all my medical conditions, known allergies to drugs or other substances, and any past adverse reactions. I have also provided a full list of all medications and supplements I am currently taking.

• I understand and accept the risks, conditions, and terms of the proposed treatment as presented. I acknowledge that my prescriber reserves the right to discontinue or adjust the treatment plan as necessary. I understand that failure to comply with the terms of this agreement may result in the discontinuation of my ketamine therapy and/or termination from the practice.

• I acknowledge that no guarantees have been made to me regarding the outcome of this treatment. I certify that I have read this form in its entirety and fully understand its contents. I have been given the opportunity to ask questions, and all my questions have been answered to my satisfaction.

• I agree to remain under the care of a qualified mental health professional while receiving ketamine therapy. I authorize Aspire Medical Group to access my mental healthcare information and to discuss my treatment with my healthcare team as necessary for coordination of care.

• I understand that the use of ketamine for treating conditions such as depression, anxiety, chronic pain, OCD, and substance use disorders is off-label and not FDA-approved. I acknowledge that my participation in this treatment is voluntary, and I can withdraw from treatment at any time without penalty.

• I understand that ketamine therapy may not alleviate my symptoms and that there are no guarantees regarding the results of this treatment. Additionally, I recognize that the provider has the authority to stop the infusion without my consent if deemed medically necessary for my safety.

• I certify that I have read and fully understand the contents of this form. I have had all my questions answered, and sufficient opportunity was provided to clarify anything unclear to me.

• By signing this form, I voluntarily consent to treatment and agree to the use of electronic records and signatures.

• I release Aspire Medical Group from any and all liability related to my receipt of ketamine therapy.

• I consent to the use of ketamine as part of my treatment. I understand that my treatment will be governed by the terms of this agreement, and I accept the risks, conditions, and terms as presented. I am signing this form voluntarily and confirm that I have the full legal right and authority to be bound by this agreement.