New Patient Informed Consent to Treatment

Please read the following form carefully and bring any questions you have to your prescriber and therapist.
Introduction:
Ketamine is used in this context as an “off-label” treatment for a range of treatment-resistant mental disorders.
The DEA has labeled Ketamine a Schedule III substance traditionally used as an anesthetic and analgesic. “Off label” ketamine has been used to treat depression, alcohol and substance dependence, trauma, and several other psychiatric disorders.
Ketamine, as it is currently understood, likely works as an NMDA antagonist in the glutamate neurotransmitter system, quite different from many other psychiatric medications. Medically, it is classified as a dissociative anesthetic. Dissociation is typically understood as the disconnection from one’s self and environment. The higher the dose of ketamine, the more likely you are to experience it’s psychedelic effects. For safety purposes, you will always begin treatment with a lower dose to assess your sensitivity.
At home, virtual sessions, are always conducted with lozenges, whereas sessions conducted in clinic may include lozenges or intramuscular injection, or a combination.
The intention of utilizing ketamine in psychotherapy is to promote an altered state of mind with lowered negative psychological defenses that allows for more efficient healing than traditional talk therapy.
You may withdraw from treatment at any time, except in a session after you have been administered ketamine. After taking ketamine in each session, we will support you if difficult experiences arise.
Eligibility
In order to be eligible for ketamine-assisted psychotherapy, you will undergo a series of screening measures to determine appropriateness. We will assess various indications and contraindications for ketamine in the context of your physical and psychological history and presentation. Depending on our assessment, we may require a review of your medical/psychiatric records, or a physical examination, including bloodwork to move forward with treatment.
We reserve the right based on our medical and clinical judgement to determine if you are not ready yet or simply excluded from this treatment through our services.
Strict exclusions for this treatment include pregnant women and nursing mothers.
Contraindications that require further evaluation to determine severity and treatment to move forward with treatment include:Untreated hypertension History of heart diseaseUntreated hyperthyroidismActive maniaActive suicidalityActive PsychosisAlcohol or substance use disorders in which cessation for treatment would risk severe withdrawal symptomsHistory of severe dissociationSevere personality disorders
Information on Ketamine’s interaction with other medicines is only partially available and will be assessed as to your eligibility for KAP.
Some points for overview:
Before and after KAP treatment sessions, we require preparation and integration work. We consider this as part of the treatment process.
Low dose KAP sessions are generally conducted in more of a talk therapy and interactive fashion, whereas moderate to higher dose sessions are conducted in part with music guidance and eyeshades with longer periods of going inwards due to increase psychedelic and dissociative effects.
Typically, despite dose and route of administration, the effects of ketamine last 45 min to 90 min, with about 5 min onset for Intramuscular Injection and 15-20 min for lozenge.
We ask that you strictly follow the day before, day of, and day after ketamine session instructions for safety and optimum outcomes.
Whether you are in office or at home, you agree to not drive after your ketamine session. If leaving from the office, you must have prearranged transportation home with a trusted person and are not allowed to leave via walking, bicycle, etc. You will also agree to not engage in any driving or operation of heavy machinery for the remainder of the evening.
Because everyone has a unique experience, there is not a one size fits all treatment protocol. Some individuals may need additional treatments to maintain remission of symptoms at various frequencies.
Some potential risks include:
Risks vary between low and high doses of ketamine
The higher the dose, the increased risk of disorientation issues include lack of spatial awareness, recognition of environment and self, and coordination/balance issues. Thus, we ask that you remain stationary during your treatment. It is also possible that you may fall asleep.
Other possible adverse effects include:Blurred/uncomfortable visionSlurred speechMental confusionExcitability/agitationDiminished ability to see things that are actually presentDiminished ability to hear or to feel objects accuratelyAnxietyNausea/vomitingSenses processing is affected by the substanceElevation of pulseDouble visionRapid eye movementsFeeling of pressure in the eyesLoss of appetite
Typically, Ketamine causes a significant increase in blood pressure. This can sometimes be mitigated through blood pressure medication.
As a Schedule III substance, ketamine is understood to moderate to low psychological and physiological dependence. It should only be used under direct supervision of a licensed prescriber to inform treatment and safety planning.
Confidentiality:
Your identification and all medical information is legally protected by HIPAA, the same as any medical or psychiatric clinic. This information will be kept confidential, on HIPAA protected, encrypted programs. If you wish to have others access these records, you must sign a release of protected information form.
We do collect clinical data from your sessions that may be published in clinical literature, with all of your identifying information removed. The purpose of this data collection is to further validate this treatment and bring more evidence to the field of psychedelic-assisted psychotherapy.
If your emergency contact person(s) is contacted without your permission, it is for safety purposes only and only the minimal information will be provided in order for your treatment team or emergency services to ensure your safety.
Voluntary participation in treatment:
As written above, ketamine for treatment resistant mental disorders is currently considered “off label” by the FDA. You are consenting to understanding this designation and liability associated with your voluntary participation in the treatment.
Before moving forward with treatment session, you will be thoroughly screened for risks, but also will be encouraged to ask any questions about the treatment, and it’s potential benefits and risks.
Informed Consent:
After reviewing this document and indicating your understanding, you will be asked to sign before participating in treatment.
You will have access to a signed copy of this form to keep for your own records. This process is known as giving informed consent.
By signing this document, you indicate that you understand the information provided. You thereby give your consent to participate in the ketamine treatment.
You agree that:I have fully read this New Patient Informed Consent describing Ketamine Assisted Psychotherapy and agree to its terms holding harmless the practitioner(s) involved in my care--waiving, releasing and discharging all claims, rights, and or causes of action, which may arise out of or in connection to my participation in this treatment. No oral or written statements, representations, or inducements have been made to cause me to enter into this agreement. I have had the opportunity to raise questions and have received satisfactory answers.I fully understand that the sessions can result in a profound change in mental state and may result in unusual psychological and physiological effects.I give my consent to the use of lorazepam if deemed necessary for agitation, to ondansetron for nausea, and clonidine for high blood pressure.I have been offered a signed copy of this New Patient Informed Consent, which is mine to keep.I understand the risks and benefits and I freely give my consent to participate in this ketamine treatment as outlined in this form, under the conditions indicated in it. I understand that I may withdraw from the ketamine treatment at any time, up until the actual injection or lozenge has been given.