Karen Wise, MS, LPC
1532 N. Emerson #302
Denver, Colorado 80218
(720) 231-2459

About This Informed Consent Document:

This consent form contains information about the use by psychotherapy clients of medically prescribed ketamine taken sublingually while simultaneously engaged in psychotherapy. This procedure is called “ketamine assisted psychotherapy,” KAP in short. Please be aware that the Food and Drug Administration (FDA) has not yet established the appropriateness of KAP and its use is considered off-label, the only official indication for the use of ketamine being anesthesia. KAP is thus considered an experimental treatment. This informed consent document gives you information that may be helpful to you in deciding whether to engage in KAP. The information contained in this form pertains only to the therapeutic aspects of KAP; information about other general aspects of the psychotherapy that I offer, such as office policies and procedures, fees for services, cancellation policy, and confidentiality, and your consent to them are contained in a separate informed consent document.

Background on the Medical and Psychiatric Use of Ketamine:

Ketamine is only available by prescription from a medical provider, a physician or nurse practitioner. It is a drug regulated by the Drug Enforcement Agency (DEA) as a Schedule III medication and as such has long been used safely as an anesthetic and analgesic agent. Ketamine is also approved for use by the FDA, which has conducted evaluations of the risks and benefits associated with its use.

The administration of ketamine in sub-anesthetic doses to treat depression, alcoholism, substance use disorders, post-traumatic stress disorder, obsessive compulsive disorder, and other psychiatric diagnoses is a relatively new, off-label use of ketamine. Ketamine is increasingly used as a treatment for various chronic treatment-resistant mental and emotional conditions, often used after other treatment approaches have been unsuccessful. While the scientific data is not completely clear, research suggests ketamine may help grow new neural connections once diminished by chronic stress, leaving many people feeling relief. The literature indicates a 70% response rate to ketamine of patients with treatment resistant depression, and a remission rate of 40-50%.

Ketamine as a Current Psychopharmacological Treatment:

Ketamine for depression has become popularized through medical infusion clinics. At infusion clinics, a patient is administered ketamine through intravenous (IV), intramuscular (IM), or intra-nasal routes. Symptoms can be relieved through this process alone, but the underlying issues that caused the symptoms may persist. Ketamine treatment is generally considered inappropriate for persons with a history of psychosis, personality disorders, mania or schizophrenia, or who are currently taking benzodiazepines, stimulants, or MAOI’s.

Pregnant women and nursing mothers are not eligible because of potential effects on the fetus or nursing child. The effects of ketamine on pregnancy and the fetus are undetermined and therefore it is advisable to protect against pregnancy while exposing yourself to ketamine or in the immediate aftermath of its use. Untreated hypertension is a contraindication to ketamine use as the medicine causes a rise in blood pressure. Similarly, a history of heart disease may make you ineligible to participate. Information on ketamine’s interaction with other medicines will be assessed by your medical provider (not your KAP therapist) to determine your eligibility. Ketamine should not be taken if you have untreated hyperthyroidism. There have also been reports of some decrease in immune function in patients receiving surgical doses of ketamine.

Ketamine has an extensive record of safety and has been used at much higher doses for surgical anesthesia without respiratory depression.

Ketamine Taken During Psychotherapeutic Treatment, aka KAP: 

Interested in providing the most advanced and effective care for their clients, psychotherapists as well as physicians have studied the science and benefits related to ketamine. Some psychotherapists have begun integrating ketamine into their psychotherapeutic practices as an effective adjunctive path for healing, with the benefits of ketamine enhanced by a personalized approach and the support of a trusted psychotherapist.

While ketamine administered without psychotherapeutic assistance has helped with symptoms of mental and emotional problems, it is the belief of many clinicians that KAP with a skilled and experienced therapist can enhance the benefits of ketamine so that healing occurs at a deeper and longer lasting level. The use of ketamine within a personal therapeutic relationship can help the client better identify and work through difficult experiences and behavior patterns, providing new insights and healing that might not have been possible otherwise. Ketamine assisted psychotherapy may allow a person to gain access to the causes of their struggles that were previously outside their awareness.

Becoming a KAP Client:

Your medical provider, a physician or nurse practitioner who practices independently from your KAP therapist, will medically assess you to diagnose you and to ensure your safety when using ketamine. Your medical provider will also ask you to read and sign an informed consent document, much like this one, but with additional information about the physical and medical effects and potential side effects of ketamine. If in the judgment of that medical provider, you are assessed as an appropriate candidate for treatment with ketamine and KAP, you will then authorize your KAP psychotherapist to begin KAP sessions. The licensure and competence of your KAP psychotherapist is in providing psychotherapy including KAP, but not in prescribing or administering medications such as ketamine.

The KAP Experience:

Two hours will be reserved for your KAP session. After you self-administer your prescribed sublingual ketamine in the office, your KAP psychotherapist will support and guide you as you encounter and explore emotional issues that arise during the KAP session. You agree to follow any direct instructions that your psychotherapist gives to you until the therapist determines that the session is over, and to remain at the location of the session until the therapist decides that you are ready to leave.

You will receive a lower dose during the initial session. It is always better to start with a lower dose to reduce anxiety and become familiar with how the medicine affects you. There is always an opportunity to make a choice for a larger dose at a future date. It is more difficult to correct a bad experience because of too high an initial dose and the anxiety it may engender. Individuals experienced with psychedelics may receive a higher initial dose.

Administration will be through one or more sublingual lozenges each containing 50-100mg of ketamine. It will dissolve slowly and we ask you not to swallow your saliva for around 15 minutes. Ketamine will penetrate the oral mucosa~ lining of your mouth~ and will be absorbed rapidly in that manner. This will give us a measure of your sensitivity to ketamine. The therapist will watch the time and let you know when to spit or swallow.
Ketamine is formally classified as a “dissociative” anesthetic, dissociation meaning a sense of disconnection from one’s ordinary experience of reality and self. At the dosage typically self- administered during KAP, most people experience mild anesthetic, anxiolytic (anxiety reducing), antidepressant and, potentially, psychedelic effects though these latter effects are typically minimal. The antidepressant effect tends to have a cumulative effect, that is, be more sustained with repeated use. It has been speculated that dissociative experiences are associated with greater and longer lasting beneficial effects. This may also include a positive change in outlook and character that some describe as profound and transformative.

You should be aware that some emotional and other experiences that arise during KAP may be temporarily disturbing to you. Visual, tactile and auditory processing may be altered. A mingling of the senses and emotions may occur. Your ordinary sense of time may become dilated, meaning your perception of the passage of time may be different than the actual passage of time.

When the session ends you may still be under the influence of ketamine so leaving with a friend or family member is strongly recommended. Driving an automobile or engaging in hazardous activities should not be undertaken until all effects have stopped. The therapist will schedule a time for you to call the following day in order to help you process your KAP experience.

Potential Risks of Ketamine Therapy:

You will be asked to sit or lie down during the ketamine administration because your sense of balance and coordination will be adversely affected until the drug’s effect has worn off. It is possible you may fall asleep. Other possibilities for adverse effects include blurred and uncomfortable vision (you are advised to keep your eyes closed until the main effects have worn off), slurred speech, mental confusion, excitability, diminished ability to see things that are actually present, diminished ability to hear or to feel objects accurately including one’s own body, anxiety, nausea and vomiting. Visual, tactile and auditory processing are affected by the drug. Synesthesia, or mingling of the senses, may occur. Ordinary sense of time will be altered.

Because of the risk of nausea and vomiting please refrain from eating and drinking for at least 4 hours preceding the session and eat lightly when you do. Hydrate well the night before. If you are prone to nausea you may take anti-nausea medication~ odansetron~ in pill or oral dissolving tablet forms.
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.

The administration of ketamine may also cause the following adverse reactions: Tachycardia (elevated pulse), double vision, nystagmus (rapid eye movements), feeling of pressure in the eyes and loss of appetite. The above reactions were noted in the literature after rapid or high doses of ketamine (5 mg/kg used for surgical anesthesia). The dose to be used in this sub- anesthetic ketamine therapy is much lower (2 mg/kg or less).

Confidentiality:

Your therapy records will be kept confidential. To allow others access to your records, you will have to provide a signed release form.

Chaperone:

If you are engaging in a KAP session remotely, you agree that you will have a friend or family member present for the duration of your KAP session and you understand that your therapist will not proceed with a KAP session if a chaperone is not present. For sessions conducted in the office, it is strongly recommended that you have a chaperone present to take you home after your session is complete. You will provide your therapist with the name and contact information for your chaperone. You acknowledge and agree that, if you choose to proceed with KAP in the office without a chaperone, you acknowledge that you are acting against clinical advice and waiving liability related to your decision.

Emergency Protocol:

You acknowledge and agree that, if a medical emergency occurs during your remote or in-office KAP session, your therapist will call 911. You further acknowledge and agree that, if you are receiving KAP services remotely or self-guided, your chaperone also may reach out for emergency medical assistance through 911 in the event of a medical emergency.

Movement During KAP Session:

You acknowledge and agree that your therapist will advise you on whether it is safe to leave a session, such as to use the restroom or to seek fresh air. If your therapist determines that it is safe, if your session occurs in our office, your therapist will accompany you. If your session occurs remotely or in your home, your chaperone will accompany you. You acknowledge and agree that you will comply with your therapist’s instructions unless you feel unsafe in doing so. If you choose to leave a session against the advice of your therapist, you release our practice and any therapists providing services to you for any liability related to your actions in leaving the session.

Use of Touch:

You acknowledge and agree that your therapist may use touch therapy during your KAP sessions with your full consent if you participate in KAP, unless you object orally or in writing to the proposed use of any touch therapy. Your therapist will discuss the proposed use of touch therapy with you prior to initiating any use of touch therapy and will comply with your wishes if you choose to refrain from using, or discontinue the use of, touch therapy. You retain at all times the ability to revoke any consent for the use of touch therapy.

Disposal:

You acknowledge and agree that you will follow the applicable state disposal guidance for any ketamine in your possession that will not be used.

The Effectiveness of KAP:

KAP is a new treatment, still considered experimental and not yet mainstream, though there are now many studies that demonstrate that it may be effective. It does not necessarily permanently relieve symptoms of mental and emotional disorders however. If your symptoms respond to KAP, you may still elect to be treated with other psychiatric medications and other ongoing non-specific psychotherapy to try to reduce the possibility of relapse. Over time, you may also need additional KAP treatments or other therapies to maintain your improvement or remission.

Your Agreement:

Please read this consent form thoroughly and carefully, and feel free to ask questions about any of the information in it. Once you indicate that you have understood the benefits and risks of this treatment, you will be asked to sign this form in order to participate in this treatment. You will be given 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 and that you give your consent. Withdrawal from KAP is always your option. Even after agreeing to undertake ketamine assisted psychotherapy you may decide to withdraw from treatment at any time up until ingestion of the lozenges.