Ketamine Assisted Psychotherapy (KAP) - Informed Consent

This consent form contains information about the use of ketamine therapy for various
mental health conditions. Ketamine has been approved by the Food and Drug
Administration (FDA) for use as an anesthetic agent for many years. The use of generic
ketamine to treat mental health conditions is a newer, mostly off-label, use of ketamine. This
means the FDA classifies such uses as investigational. Ketamine is not a first-line treatment
for mental health conditions and is usually used after other treatments have been
unsuccessful.
While it is not formally approved by the FDA, there are now many studies that demonstrate
it may be a safe and effective treatment option for depression, post-traumatic stress
disorder (PTSD), alcohol abuse, and other conditions. Benefits may occur after only one
treatment, though typically an initial course of several treatments are required for a more
robust response. If your symptoms respond to this initial course of ketamine therapy, you
may benefit from receiving further treatments. You may still elect to be treated with other
medications and ongoing psychotherapy to try to reduce the possibility of relapse. Over
time, you may also benefit from additional periodic ketamine treatments or other therapies
to maintain your remission. Ketamine therapy works best when part of an integrated
treatment program that may include other medications, psychotherapy, and lifestyle
changes. It may or may not permanently relieve depression, traumatic memories, or
substance abuse.
In order for you to make an informed decision about whether you should undertake this
therapy, you should understand enough about its nature, purpose, potential risks and
benefits, as well as reasonable alternatives. After being offered the opportunity to ask
whatever questions you may have, you will be asked to sign this form in order to participate.
This process is known as informed consent. By signing this document you indicate that you
understand the information and that you give your consent to participate in ketamine
treatment.
How does ketamine work?
Ketamine is a medication that has long been used safely as an anesthetic and analgesic
agent in both adults and children. Among anesthetic agents, ketamine is known for not
depressing respiration or reducing blood pressure. Ketamine is classified as a dissociative
anesthetic, with dissociation referring to a reduction in input from many of the body’s
senses as well as some disconnection from one’s ordinary reality and usual self. The current
understanding of ketamine's neurobiological mechanism of action is as an N-methyl-D-
aspartate (NMDA) receptor antagonist working through the glutamate neurotransmitter
system. Modulation of glutamate is potentially significant in that glutamate is involved in a
significant number of synapses in the human brain, and is implicated in learning among
other tasks. This is a different pathway than that utilized by other psychiatric drugs such as
the selective serotonin / norepinephrine reuptake inhibitors (SSRI’s / SNRI’s), mood
stabilizers, anti-psychotics, benzodiazepines, etc.
Ketamine is a relatively new and innovative psychiatric treatment—the primary positive
studies have been with depression, PTSD, and substance use disorders. Psychiatric use of
ketamine has become relatively widespread in recent years. In addition to the
aforementioned conditions, ketamine has shown some efficacy in addressing existential,
psychological, and spiritual crises. Ketamine has been studied and promoted by the

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National Institute of Mental Health (NIMH), and American Psychiatric Association (APA).
What is the ketamine experience like?
Ketamine induces an altered state of consciousness which is sometimes compared with a
dreamlike state. This state usually lasts from 30 to 120 minutes, depending on the dose and
personal sensitivity to ketamine. Experiences vary from one person to the next, however,
commonly reported effects include: loss of sense of self, changes in the perception of time,
dreamlike visions, changes in perception of sound and color, and feelings of connection, joy,
and peace. Relaxation from ordinary concerns and 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. It is our view
that this relief and the exploration and experience of other possible states of consciousness
are singularly impactful to overall mental health. As co-facilitators, we act as guides to the
experience and process the experience and its impacts with our clients before and after the
sessions. To get the most out of this experience, we highly encourage you to take at least a
few hours break from your daily obligations before and after your sessions.
At the dosage level administered to you, you are likely to experience mild anesthetic,
anxiolytic, antidepressant and, potentially, psychedelic effects. Recent scientific evidence
suggests the possibility of an antidepressant response to low doses of ketamine that
produce minimal psychedelic effects, with this effect tending to be more sustained with
repeated use – in other words, a cumulative effect. It is our view that psychedelic,
'dissociative' experiences may well be instrumental in providing a more robust effect. This
may well include a positive change in outlook and character that we term a 'transformative'
response. We employ both sublingual (under the tongue/oral) and IM (intramuscular
injection) approaches to ketamine administration.
Overview of Ketamine Assisted Psychotherapy (KAP) session:
The ketamine assisted psychotherapy (KAP) session will be scheduled for either two or three
hours. Please anticipate the presence of two facilitators - a lead therapist, and a scribe /
sitter.
Sessions will begin with an overview of the treatment, addressing of concerns or questions,
and opportunity to revoke this informed consent if you so choose. If you choose to move
forward you will be provided an eye mask, light music will commence, and a previously
agreed upon intention and invocation will be read to you or by you. You will then be
provided with ketamine, either orally or by intramuscular injection; dosage and route of
administration shall be determined prior to your session in consultation with your doctor,
and shall depend on numerous variables such as sensitivity to ketamine and body weight. If
you are receiving ketamine by lozenge we recommend that you place it under your tongue
and allow it to dissolve, and to refrain from swallowing for ten (10) minutes if possible. This
allows the ketamine an opportunity to be absorbed via the mucosal lining of your mouth. If
you are receiving ketamine via IM injection this will be delivered to the deltoid unless
otherwise agreed upon.
The intensity and duration of ketamine’s effects depend on the individual unique
metabolism, the dosage, and the route of administration. Experiences vary from person to
person, and may vary for the same person from experience to experience. However, you will
likely be primarily internally focused for the first 45 to 90 minutes. Following this period you
will likely remain under the noticeable influence of ketamine for another 60 to 90 minutes.

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Regarding the KAP session itself, you will be asked to make two (2) agreements with the
therapist(s) and/or medical provider(s) and/or their staff to ensure your safety and well-
being:
1. You agree to follow any direct instructions given to you by the provider(s) until it is
determined that the session is safely over, and,
2. You agree to remain at the location of the session until the provider(s) believe you are
safe and ready to leave.

Vital Sign Monitoring:

It is essential that you be followed closely during and after your treatment. This will include
blood pressure, pulse, and temperature measurements before each session, and possibly
afterwards if clinically indicated.
How long will it take to notice improvement?
You may experience important positive changes in personality, mood, and cognition during
treatment and in the days and weeks that follow. The ketamine experience will enable you
to access your own healing wisdom. The psychotherapy support will aid you in
understanding the value of your experience.
This program emphasizes the integration of your experience(s) afterwards as well as
emphasizing the possibilities for change. Our expectation is that you will have one formal 30
to 45 minute integration session with an appropriate practitioner, within one week, if
possible, of each KAP session.
Routes of Administration:
Sublingual ketamine lozenge sessions are intended to generate a mood benefit and to
determine your personal sensitivity to ketamine. This enables us to make a decision about
the effectiveness of the lozenge and to adjust the dose. Please be aware that ketamine
lozenges are created at specialty compounding pharmacies. Our practice is not legally
permitted to have a supply in the office from which we administer to patients. Thus, some
time prior to the ketamine session, your provider will send a prescription to the
recommended local compounding pharmacy for you to pick-up. Your signature of this
consent document implies agreement that you will bring all of the prescribed ketamine
lozenges upon return to our office at the predetermined time for the KAP session. These will
then be administered to you, and any excess unused lozenges will be discarded as medical
waste as per DEA regulations. You agree to not divert ketamine lozenges for any other
purpose. If the lozenges are not brought to the KAP session it will be canceled, future
sessions and prescriptions may be prohibited, and a fee of $300 will be incurred.
Intramuscular (IM) ketamine sessions aim to create an altered state of consciousness in
order to facilitate profound healing experiences. IM sessions may also be helpful for those
that find oral ketamine difficult to tolerate due to taste or gastrointestinal upset. This will be
given as an injection by your medical provider, typically in the shoulder (deltoid) muscle. The
IM ketamine will be provided from an intra-office supply, and will not require a separate
prescription and visit to the compounding pharmacy.
Eligibility for Ketamine Treatment:
You will be carefully interviewed to determine if you are eligible for ketamine treatment,
including a medical history, current medication list, review of your medical and psychiatric

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records, and any other relevant information. If we determine a physical exam or lab work
may be necessary, we will refer you to a primary care provider or specialist.
Pregnant women and nursing mothers are not eligible for treatment because of potential
effects on the fetus or nursing child.
Ketamine is not recommended for individuals with psychotic disorders or those currently or
recently experiencing a manic episode.
Ketamine is not recommended for individuals with prior history of hypersensitivity to
ketamine or esketamine.
Those with untreated high blood pressure are not eligible for treatment as ketamine causes
a temporary rise in blood pressure. Additionally, a history of heart disease or
hyperthyroidism may make you ineligible for treatment.
Potential Risks of Ketamine Treatment:
You will be asked to lie still during the ketamine session because your sense of balance and
coordination will be affected until the drug’s effect has worn off. This can last from two to
four hours. Other effects may include blurred vision or double vision, slurred speech,
headache, mental slowing, anxiety, nausea, elevation of pulse, and loss of appetite.
Please refrain from eating at least four (4) hours prior to the session. Failing to fast
beforehand can limit the benefit of ketamine and increase your chances of experiencing
nausea and vomiting. You may drink water up until the time of the session, although aim to
keep the volume low so as not to arrive with an already distended stomach. If you become
nauseous you may be offered anti-nausea medication, sometimes even before the ketamine
treatment. Blood pressure may rise mildly, and anti-hypertensives may be offered to
alleviate this effect. In rare situations, if anxiety becomes severe, you may be offered
medication to help you relax.
Repeated, high dose, chronic use of ketamine has caused urinary tract symptoms and even
permanent bladder dysfunction in individuals abusing the drug. This does not commonly
occur within the framework of studies using ketamine as a medical treatment procedure.
Please refrain from making any major legal decisions within 24 hours of ketamine
treatment.
Potential Drug Interactions:
There is a risk of interaction between ketamine and members of the following classes of
drugs. Please be advised this list is not exhaustive, and the medical and psychiatric
evaluation will include a comprehensive review of your specific medication list:
1. Central Nervous System (CNS) depressants, such as alcohol, opioids, and
benzodiazepines. Concomitant use with ketamine may increase levels of sedation.
2. Psychostimulants such as amphetamine, methylphenidate, modafinil, armodafinil, and
caffeine. Concomitant use with ketamine may increase blood pressure.
3. Monoamine oxidase inhibitors (MAOI’s). Concomitant use with ketamine may increase
blood pressure.

Please be advised to avoid the use of these substances for at least 24 hours prior to
ketamine treatment. They may generally be resumed the day following ketamine treatment.
However, please consult with your medical provider about specific instructions regarding

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these and other drugs.
Driving and Transportation:
Due to ketamine’s effects we require that you not drive or operate heavy machinery for the
remainder of the day after taking any form of ketamine. Although we will make sure you are
OK to leave, you may not necessarily be back to your normal state of consciousness; some
slight effects can linger for several hours. Please plan for a ride home from a friend or
family member – you will be asked to provide this person’s name and contact information
to your provider prior to treatment, and prior to commencing a KAP session contact with
said friend or family member will need to be made by the provider. Due to safety reasons,
we cannot allow your transportation home to be via rideshare (e.g. Uber, Lyft, taxi, etc). It is
not recommended to return to work the same day.
Is There Potential for Abuse or Dependence of Ketamine?
Ketamine belongs to the same group of chemicals as Phencyclidine (Sernyl, PCP, ‘Angel
Dust’). This group of chemical compounds is known chemically as arylcyclohexylamines.
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 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. Therefore,
ketamine should never be used except under the direct supervision of or prescription from
a licensed physician.
ALTERNATIVE PROCEDURES AND POSSIBILITIES
No other medical procedure is currently available that produces ketamine's effects. Major
Depressive Disorder, Post-Traumatic Stress Disorder, and Substance Use Disorders are
usually treated with antidepressant medications, tranquilizers, mood stabilizers,
psychotherapy, and behavioral change. Electroconvulsive therapy (ECT), and the more
recently introduced Transcranial Magnetic Stimulation (TMS) therapy are also in use for
treatment resistant depression.
Although not necessarily recommended, you have the option of forgoing treatment
completely. Although prognosis depends on numerous individual factors, mental health
conditions do sometimes improve with time and without intervention. The opposite is also
true - conditions sometimes worsen over time when untreated.
Cost
$900 per 3 hour KAP session, or $600 per 2 hour KAP session.
Please note the $300 fee for cancellation less than 24 hours prior to the scheduled KAP
session, or for arrival at KAP session without prescribed ketamine lozenges.
If you are feeling sick or ill prior to treatment please share this information with your
provider, the fee will be waived and treatment rescheduled.
Voluntary Nature of Participation

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Your decision to undertake Ketamine Assisted Psychotherapy (KAP) is completely voluntary.
Your signature of the consent to treatment indicates that you have read the information in
this document, understood the potential benefits and risks of this treatment, and that any
questions or concerns you have regarding this treatment have been answered and resolved
to your satisfaction. You are welcome to revoke this consent, in writing, at any time.
INFORMED CONSENT
1. I have fully read this Informed Consent form 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 with my participation in KAP. No oral or written statements,
representations, or inducements have been made to cause me to enter into this agreement.
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. l give my consent to the use of medications to be provided by a licensed psychiatrist if
deemed necessary for agitation, for nausea, and for high blood pressure.
5. I have been given a signed copy of this Informed Consent form, which is mine to keep and
will become a record for our treatment file.
6. I understand the risks and benefits, and I freely give my consent to participate in KAP as
outlined in this form, and under the conditions indicated in it.
7. I understand that I may withdraw from KAP at any time, up until the medication has been
given.
8. I understand that I may not divert ketamine lozenges that have been prescribed for the
express purpose of use in the in-office KAP session. I agree to fill the provided prescription
at the recommended compounding pharmacy, and to bring the entire prescribed supply to
the KAP session. Excess unused lozenges will be discarded as medical waste as per DEA
regulations.
I voluntarily sign my name evidencing acceptance of the provisions of this agreement.

Client

Hope Fulkerson Mooney

Signed by Hope Fulkerson Mooney
September 27, 2023 at 7:06 pm
IP address: 172.124.104.142

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