‍WELCOME TO THE NOMA THERAPY KETAMINE ASSISTED PSYCHOTHERAPY (KAP) PROGRAM

This form describes what you can expect from the program including:

1. Information about ketamine dosing and psychotherapy
2. Any known potential risks and benefits
3. Patient rights and responsibilities
4. Your consent for treatment

The services of the KAP program will be performed by healthcare providers who are employed or contracted by Noma Therapy of Colorado P.C. (hereafter, “Noma Therapy”). 

Once you indicate that you have understood the benefits and risks of this treatment, as well as alternatives to KAP, you will be asked to sign this form. By signing this document, you indicate that you understand the information provided and that you give your consent for KAP services. You will be given a signed copy to keep for your records

Please read the following information carefully and ask the Noma Therapy team if you have any questions. 

Section 1: Information About Ketamine Dosing & Psychotherapy Sessions

WHAT IS KAP? 

Ketamine 

Ketamine is classified as a Schedule III medication (can be prescribed by physicians or nurse practitioners) and has been used safely as an anesthetic and analgesic agent since 1970. Over the past 25 years, lower doses of ketamine have shown benefits in the treatment of depression, alcoholism, substance dependencies, PTSD and other psychiatric diagnoses. Ketamine allows the brain to develop new neural connections, thus providing a potential “reset” that will allow for new learning of coping and other behavioral health skills to prevent relapse. 

Ketamine can be administered by intravenous, intramuscular (IM), sublingual, oral, and intranasal routes. Only certain forms of ketamine have received FDA approval including the intranasal form Spravato (esketamine).  While there are multiple routes of administration, Noma offers ketamine in the form of a Rapid Dissolve Tablet (RDT). Ketamine RTDs are compounded medications and are not FDA approved meaning the FDA has not evaluated the safety, effectiveness, or quality prior to marketing. Noma Therapy takes the FDA’s guidance and caution seriously and evaluates partner pharmacies to ensure safe, effective, and high quality RDTs are used. 

The Psychotherapy in Ketamine Assisted Psychotherapy

Evidence-based psychotherapies such as cognitive behavioral therapy are effective for treating depression, anxiety, and other mental disorders.  These therapies help patients address psychological difficulties effectively by processing thoughts and emotions and by learning new coping and relapse prevention skills. Adding ketamine sessions to psychotherapy treatment can sometimes provide faster symptom relief. Your psychotherapist will help you define your personalized treatment goals and devise a treatment plan customized to help you reach these goals.

NOMA THERAPY’S KAP PROGRAM

1. The program consists of 4 guide-supported dosing sessions, up to 9 psychotherapy sessions, and access to a prescriber who will personalize your dosing strategy throughout the 14 week program.
2. The program begins with an initial evaluation with a prescriber  to make sure that KAP is right for you. Once enrolled, your guide will support you throughout the program including coordinating all sessions and addressing any issues or questions you may have.
3. You will also partner with a licensed psychotherapist (clinical psychologist, clinical social worker, or masters’ level psychotherapist) who will provide up to 9 sessions of virtually-delivered psychotherapy over the course of the next 14 weeks. Psychotherapy will include establishing your goals for treatment, learning new skills to help cope with symptoms, and planning for relapse prevention. Psychotherapy sessions will be timed soon after dosing sessions in order to optimize ketamine effects as well as additional reinforcing sessions to master the skills and insights you will learn.
4. Ketamine RDTs will be delivered to your home for each of the 4 dosing sessions and will require a signature to confirm receipt.
5. During each dosing session, your guide will be present virtually (via secure video chat) for your entire in-home session.
6. As the program is conducted 100% virtually, you will need to have the necessary capacity (computer/smartphone and broadband connectivity) to fully participate.
7. In addition to secure video chat, Noma Therapy will engage with you by telephone, email, SMS texts, video telehealth, and/or in-person contact for scheduling, psychotherapy and dosing sessions, psychiatric evaluations and follow up virtual visits, and guide check ins.

NOMA THERAPY’S KAP ELIGIBILITY 

You will be evaluated to determine if you are eligible for KAP, including your medical history, physical exam findings, review of historic medical/psychiatric records, a current psychiatric evaluation and administration of brief psychological tests to assess your state of mind. Conditions that may make you ineligible include:

• Being pregnant or nursing 
• Uncontrolled hypertension 
• A history of significant heart disease 
• Negative experiences with ketamine in the past
• Other medications or substances that can have potentially harmful effects when combined with ketamine
• Other psychiatric conditions that are not optimally treated  through ketamine assisted psychotherapy

NOMA THERAPY’S KAP DOSING 

During each in-home ketamine dosing session, you will be asked to make two (2) agreements with your guide to ensure your safety and well-being: 

• You agree to follow all instructions until the dosing session is complete including a period of observation following the dosing period. 
• You agree to remain at the location of your dosing session until your guide informs you that you may safely leave.

The length of dosing sessions will vary depending on the person and their experience with ketamine. For the first 45-90 minutes after dosing, you will very likely be internally focused. Your guide will have assisted you in preparing your environment for this session to ensure a sense of safety and comfort. You may remain under ketamine’s influence for longer than 90 minutes so activities requiring excessive effort, thought or movement immediately following a dosing session are not recommended. 

Development of your personalized dosing strategy will be based on a number of factors that include the best available scientific evidence, your experience with psychedelics, your weight, and more. Following a standardized 1st dose, your individual experience will direct the possibility of dosage increase (or decrease) for your 2nd dosing session.  Presuming tolerance and benefit from the first half of the KAP program, your 3rd dosing session will most likely result in a maintenance of your 2nd session dosage.  Your 4th dosing session dosage will likewise be determined based on your experience with the program and is designed to give a final ketamine experience as you exit the program with new skills and perspective to resume your life. 

Administering ketamine sublingually with RDTs will occur under direct observation and support by your guide during every dosing session.  Your RDTs are to be held in your gum line for no less than 10 minutes while the tablet dissolves.  Absorbing ketamine through your oral mucosa is more effective than ingesting and absorbing the medication in your stomach. It is known that ketamine RDTs have a bitter taste associated with use. Along with our pharmacy partners, Noma Therapy continues to work on finding more tolerable and effective ways to administer ketamine without the cost and risk of IV or IM administration.  Moreover, ingesting (swallowing) ketamine raises the risk of gastrointestinal side effects such as nauseas and vomiting.  To minimize this risk, it is recommended to not swallow any saliva during the dosing period and to spit out your saliva and any remaining RDT after the 10 min dosing period.  Dosing guidance is also subject to change depending on your experience with the dosing sessions. 

You will be asked to lie still or sit comfortably during the dosing session because your balance and coordination may be affected by ketamine. You may fall asleep. Some have reported vision changes while taking ketamine that may be improved by simply closing your eyes (or using an eye mask). Sensory and perceptual changes may also occur that can sometimes be soothed by listening to calming music. Any other possible adverse effects from ketamine will be noted by your  guide and addressed along with your prescriber in order to create a net positive dosing experience. 

Finally, it may be helpful to remember that the effects of ketamine, good and bad, are fairly immediate, but also time limited.  The purpose and mission of Noma Therapy is to leverage these moments in time as opportunities to amplify and sustain the development of new skills and new perspectives to better support your mental wellness.

Section 2: Risks & Benefits of Ketamine

HOW LONG BEFORE I MIGHT SEE A BENEFIT FROM NOMA THERAPY’S KAP? 

You may experience notable positive changes in personality, mood and cognition during dosing, shortly after dosing, and/ or in the days and weeks that follow. It is also possible that ketamine might bring up negative memories or thoughts such as past traumas. Broadly, people typically report that ketamine helps develop an alternative understanding of their past creating an opportunity to process issues more productively . If your depressive symptoms respond to Ketamine Assisted Psychotherapy, you may still elect following consultation with your healthcare provider to be treated with medications and ongoing psychotherapy to try to reduce the possibility of relapse. Over time, you may also need additional intermittent ketamine treatments or other therapies to maintain your remission. 

IMPORTANT PRECAUTIONS 

1. Because of the risk of nausea and vomiting, please refrain from eating and drinking for at least 4 hours prior to your session. And eat lightly when you do. Hydrate well in that same time frame. 
2. If you are unduly nauseated, you may be offered an anti-nausea medication—odansetron—in pill or oral dissolving tablet forms prior to future sessions. 
3. Ketamine generally causes a significant increase in blood pressure but usually not pulse rate. If blood pressure monitoring reveals that your blood pressure is too high, you may be offered clonidine to remedy this.
4. Agitation may occur during the course of a ketamine session. If your agitation is severe, you may be offered lorazepam orally or by injection to help you relax prior to future sessions. 
5. Driving an automobile or engaging in hazardous activities should not be undertaken until all effects have stopped--and if for any reason they continue, you may need a driver if you have to leave your home. The administration of Ketamine may also cause the following adverse reactions: tachycardia (elevation of pulse), diplopia (double vision), nystagmus (rapid eye movements), elevation of intraocular pressure (feeling of pressure in the eyes) and anorexia (loss of appetite). The above reactions occurred after rapid intravenous administration of ketamine or intramuscular administration of high doses of ketamine (in a range of greater than 5 mg/kg used for a surgical anesthesia not with oral tablet administration.
6. In terms of psychological risk, ketamine has been shown to worsen certain psychotic symptoms in people who suffer from Schizophrenia or other serious Mental Disorders. It may also worsen underlying psychological problems in people with severe Personality Disorders. During the experience itself, some people have reported frightening and unusual experiences. You will receive psychotherapeutic help and ongoing guidance from your therapist to help address any uncomfortable or frightening experiences you may experience from ketamine dosing.

KETAMINE POTENTIAL FOR ABUSE AND DEPENDENCE 

Ketamine and other hallucinogenic compounds do not meet criteria for chemical dependence, since they do not cause tolerance and withdrawal symptoms. However, 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 a licensed physician. 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 occur at the levels in which you’ll be prescribed the medication. 

NOMA THERAPY’S KAP COMMUNICATION 

There are both benefits and risks of using video-chat solutions also known as “telehealth” or “virtual” therapy when compared to in-person KAP sessions. Noma Therapy believes the benefits outweigh any potential risks in order to provide a convenient and reliable care option while maintaining safety and privacy.

• Confidentiality still applies for telehealth services, and nobody will record the session without the permission from you.
• Noma Therapy will provide a HIPAA compliant video-chat solution for all virtual sessions, and the Noma Therapy guide will teach you how to use it and address any issues you might have.
• You may communicate with the Noma Therapy by other means as well. Other than text based messaging through the Noma Therapy patient portal, phone/ email/ SMS texts are not HIPAA compliant and including detailed Personal Health Information is not recommended.
• You need to use a webcam or smartphone during each primary KAP session (dosing sessions, prescriber encounters, and psychotherapy sessions) to ensure both audio and video is utilized. Audio or text only communication is permissible in between primary KAP sessions.
• It is important that all KAP sessions be conducted in a quiet, private space that is free of distractions (including cell phone or other devices) during the session.
• It is important to use a secure broadband internet connection rather than public/free Wi-Fi.
• It is important to be on time. If you need to cancel or change your tele-appointment, you must notify your guide in advance by phone or text based message. If you need to cancel and/or reschedule your appointment, we ask that you do so at least 24 hours in advance of your original appointment.
• In the event of technical problems, we may need a back-up plan (e.g., alternative phone or email where you can be reached) to restart the session or reschedule it.
• We need a safety plan that includes at least one emergency contact and the closest ER to your location, in the event of a crisis situation.
• We may determine that, due to certain circumstances, virtual KAP sessions are no longer appropriate and we may refer you to in person treatment options.

ALTERNATIVE PROCEDURES AND POSSIBILITIES 

Major Depression (MDD), PTSD and Bipolar Disorders are usually treated with antidepressant medications, tranquilizers, mood stabilizers and psychotherapy. Electroconvulsive therapy (ECT), and the recently introduced Transcranial Magnetic Stimulation (TMS) are also in use for treatment-resistant-depression. If you have a history of any of these conditions, be sure to discuss these with your Noma Therapy providers.

Section 3: Patient Rights & Responsibilities 

CONFIDENTIALITY 

Your privacy and all documentation will be kept confidential in compliance with Noma Therapy’s Notice of Privacy Practices. They will be maintained with the same precautions as ordinary medical records. To allow others access to your records, you will have to provide a signed release form. The results of this ketamine therapy may be included as part of an aggregate of published clinical results. These published reports will not include your name or any other information that would identify you. Also, we may reach out to you to ask you to participate in our quality improvement efforts. This participation is completely voluntary and will not impact your ability to receive KAP treatment at Noma Therapy.

NATURE OF PARTICIPATION 

Your decision to undertake Ketamine Assisted Psychotherapy is completely voluntary. Before you make your decision about participating in KAP, you may ask and will be encouraged to ask any questions you may have about the process. 

NOMA THERAPY’S KAP VOLUNTARY WITHDRAWAL

Even after agreeing to undertake Ketamine Assisted Psychotherapy, you may decide to withdraw from treatment at any time.

NOMA THERAPY’S KAP DISCLOSURES 

1. The practice of licensed or registered persons in the field of psychotherapy is regulated by the Mental Health Licensing Section of the Division of Registrations. The Board of Psychologist Examiners can be reached at 1560 Broadway, Suite 1350, Denver, Colorado 80202, (303) 894-7800.  As to the regulatory requirements applicable to mental health professionals: a Licensed Clinical Social Worker, a Licensed Marriage and Family Therapist, and a Licensed Professional Counselor must hold a masters degree in their profession and have two years of post-masters supervision. A Licensed Psychologist must hold a doctorate degree in psychology and have one year of post-doctoral supervision.  A Licensed Social Worker must hold a masters degree in social work. A Psychologist Candidate, a Marriage and Family Therapist Candidate, and a Licensed Professional Counselor Candidate must hold the necessary licensing degree and be in the process of completing the required supervision for licensure. A Registered Psychotherapist is registered with the State Board of Registered Psychotherapists, is not licensed or certified, and no degree, training or experience is required. The practice of psychiatry is regulated by the Colorado Medical Board, 1560 Broadway, Suite 1350, Denver, Colorado 80202, (303)894-7800. Nurse-practitioners are regulated by the Colorado Board of Nursing which also can be reached at , 1560 Broadway, Suite 1350, Denver, Colorado 80202, (303)894-7800.
2. You are entitled to receive information from your therapist about the methods of therapy, the techniques used, the duration of your therapy, if known, and the fee structure.  You can seek a second opinion from another therapist or terminate therapy at any time. You are entitled to receive information from your psychiatric prescriber about the medications prescribed, possible side effects, and possible medication benefits and risks.
3. In a professional relationship, sexual intimacy is never appropriate and should be reported to the board that licenses, registers, or certifies the licensee, registrant or certificate holder.
4. Generally speaking, the information provided by and to the client during therapy sessions is legally confidential and cannot be released without your consent.  However, if a team is evaluating you, your provider will need to share some information with that team (this includes the Noma Therapy team). It is important to discuss with your provider what types of information are necessary to share. There are other exceptions to this confidentiality, some of which are listed in Colorado section 12-43-218 and also in the Patients Rights and Responsibilities, and HIPAA forms that you were provided.  For example, mental health professionals are required to report child abuse to authorities.  If a legal exception arises during therapy, if feasible, you will be informed accordingly. 
5. You may be asked to complete health-related psychological assessments to facilitate assessment and treatment planning.  The results of these inventories may then be compiled for research purposes to improve our understanding of the effect of health and emotional issues on our patient’s lives.  Any data used will be prepared in large group form and no specific individual’s data will be identified.  If you so elect, you may refuse to have your personal testing data used for this research purpose by notifying the Chief Medical Officer: Dr. Thomas Kim at tkim@nomatherapy.com

Section 4: Patient’s Consent to Treatment

NOMA THERAPY’S KAP CONSENT TO SERVICE

This Agreement applies to all clinical team members that are part of Noma Therapy and including all contracted health care providers (“Providers”) providing care for Noma Therapy, some of whom are contracted by Noma Therapy.

I acknowledge and consent to the statements made in this form. Changes to this form are not binding on Noma Therapy and/or any of its contracted providers. This form (the “Agreement”) applies for care and treatment now and moving forward, until I sign another version of this Agreement or revoke this one.

By signing this form I agree that: 

1. I have fully read (or it was read to me) this Informed Consent form describing in-home Ketamine Assisted Psychotherapy (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 consent to receive virtual care at Noma Therapy Colorado from their Providers, their employees and their contractors. I consent to services the Providers consider reasonable and necessary for care and treatment including examinations, diagnostic tests, administration of medications, and other health care services. I understand that I have the right to agree to or refuse care in accordance with the law.
4. I understand guarantees about health care outcomes cannot be made.
5. I understand that care and treatment may be provided by Noma Therapy’s physicians, nurse practitioners, licensed psychologists, masters level psychotherapists, licensed clinical social workers, and guides trained in ketamine assisted treatment.
6. I agree to allow the Noma Therapy team to contact me via telephone, email, SMS texts, video telehealth, and /or in person to allow for scheduling, reminders, and other communication related to my treatment.
7. 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.
8. I understand that I am to have no food or drink 4 hours prior to my ketamine session.  I agree that I will not engage in any driving or hazardous activity for at least 4 hours or more-- depending on the continued presence of effects – after my session has concluded.  I understand that if  I need to leave my home in the first 4 hours after my ketamine session, I will need to have someone drive me.
9. 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.
10. I understand that I may withdraw from Noma Therapy’s KAP services at any time. If I withdraw from such services during a ketamine dosing session or within the four-hours after any such session, I understand that I may increase the risk that I will experience negative effects to my health and safety. .  I voluntarily sign my name evidencing acceptance of the provisions of this agreement.
11. If I am trying to become pregnant or become pregnant during the course of my KAP treatment, I will notify NOMA immediately and will immediately discontinue ketamine during the course of my pregnancy and during the postpartum period if I choose to breastfeed.

I have been given a signed copy of this Informed Consent form, which is mine to keep. 

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