INFORMED CONSENT FOR KETAMINE ASSISTED PSYCHOTHERAPY (KAP)

Nanct Goodman, LCSW

12157 W Cedar Dr. Suite 200

Lakewood, CO 80228

309-916-6929

www.nancygoodmanlcsw.com

 

 

What is Ketamine?

Ketamine is a validated "off-label" treatment for various chronic "treatment-resistant" mental illnesses (Dore et al. 2019 Ketamine is a Schedule III medication that has long been used safely (Jaitly, 2013, Collins et al. 2010) as an anesthetic agent and in the past decade as a treatment for depression (Ryan, Marta, and Koek 2016), anxiety (Kolp, et al. 2007), substance dependencies (Sullivan 2018), Post Traumatic Stress Disorder (Feder et al. 2014) and other psychiatric diagnoses as well as for existential, psychological and spiritual crises and growth (Krupitsky and Grinaneko 1997).

 

 

How Does Ketamine Work?

The current, most probable, understanding of ketamine's mode of action is as an NMDA antagonist working through the glutamate neurotransmitter system in addition to other "downstream effects" such as cholinergic, monoaminergic, kappa opiod, and GABAergic functions(Wallach 2018). This is a very different pathway than that of other psychiatric drugs such as the SSRIs, SNRIS, anti-psychotics, benzodiazepines, etc.

Ketamine is classified as a dissociative anesthetic (Mathew and Zarate 2016), dissociation meaning a sense of disconnection from one's ordinary reality and usual self. At the dosage level administered to you, you will most likely experience mild anesthetic, anxiolytic, antidepressant and potentially, mild- moderate psychedelic effects.

While recent research has demonstrated the possibility of an anti-depressant response to low dosages of ketamine administered intravenously, or self-administered intra-nasally and sublingually (orally) that produce minimal psychedelic effects, the effects tend to be more cumulative and may require continued use (Feder et al. 2014). It is your KAP therapist's view that relational and somatic psychotherapeutic interventions may well be instrumental in providing a more robust psychotherapeutic effect (Van Der Kolk 2014). This may well include a positive change in outlook and character that could be termed as a 'transformative' response.

Recent research conducted in FDA clinical trials of MDMA and Psilocybin indicate a disabling of the "Default Mode Network" (the usual neuronal firing patterns) in subjects minds which allows the rest of the brain to think and perceive in novel ways (Scheidegger 2012). It is possible that Ketamine may have the same effect but more research is necessary in this area. Psychedelic therapy research studies also indicate significant benefit in subjects who have transpersonal (transcendental, mystical, spiritual, religious) experiences (Luckenbaugh et al 2014, Griffiths et al. 2011). A recent research study of Ketamine effects in mice showed "neurogenesis" (Soumier et al. 2016) the creation of new neural networks; this may explain the benefits to clients with depression but again, further research is needed.

 

Why Ketamine Assisted Psychotherapy (KAP)?

The purpose of KAP is to create a non-ordinary, altered state of consciousness in order to facilitate the working through of trauma, limiting beliefs, dysfunctional thinking and behavioral patterns and attachment-related distress. This may include profound transpersonal peak experiences that may be beneficial in resolving your existential problems, accelerating your psycho-spiritual growth and lead you to a deep personal transformation and optimization of your lifestyle. Such change is best facilitated within a structured supportive psychotherapeutic milieu in connection with a therapist who has a view of your issues, hopes, desires, and struggles. Ketamine often facilitates the loosening of psychological "defenses" which can clear the way for the accessing and healing of dysfunctional states and limiting beliefs. As a byproduct of your experience you may well feel improvement in your emotional state and reduction in symptoms that bother you such as depression, anxiety, and post-traumatic manifestations. You may notice that you are a bit different after a ketamine experience and that difference may well be liberating and allow for increased acceptance, awareness, and new functional behaviors. It is frequently the case that a ketamine experience may promote happiness, empathy, loving-kindness to self and others, and a sense of greater self-acceptance and peacefulness. Your experience will be unique to you. Each of your sessions will be different. All such journeys are adventures that cannot be pre- programmed. They evolve from your own being in relation to this substance.

 

 

What happens in a KAP Session?

Before beginning KAP you and your therapist will have already discussed and agreed upon a treatment plan including, but not limited to, purpose and intentions for KAP, frequency and duration of KAP, preparation for sessions, and integration methods. The scheduled length of the session is between 2 and 3 hours. Eligibility for KAP work requires psychological/emotional assessment by your KAP therapist and medical assessment by your prescriber. Initially the session begins with a check-in period and orientation toward the mindset of the psychological content and purposes of the session. You will sub- lingually (under your tongue) self-administer oral ketamine (lozenges) at doses of 75 mg up to 200 mg maximum. The dose will depend on prior exposure to ketamine and other psychedelics and also upon discussions and agreements made between you and the prescriber. It is always better to start with a lower dose to reduce anxiety and become familiar with what a substance may produce in you. There is always an opportunity to make a choice for a larger dose at a future date-if appropriate. As you ingest the medicine, you will ideally place a sleep mask on and recline in any manner comfortable to you. Music will be playing and you will usually experience 60 - 120 minutes of time under the direct influence of the ketamine. The length of the effects of ketamine varies from person-to-persor and from experience to experience. You will continue to remain under ketamine's influence at a lesser level for the rest of the session. You may feel mild effects of the medicine after you leave. This is why it is imperative that you not operate any transportation modalities for the rest of the day (car, bike, scooter, etc...).  While under the influence of the ketamine often a relaxation of ordinary concerns and usual state of mind will occur, while maintaining conscious awareness of the flow of mind as well as where you are and who is in the room with you. There will be concepts, visions, encounters, and you may well deal with your own death, mortality, and immortality. Some sessions are enjoyable and filled with awe and some are difficult. Ketamine creates an unusual experience of formlessness and a dissolving of physical/spatial boundaries with novel effects on the mind. Often during this time, you will be with yourself and your internal experience. Also, during this time, you and your therapist may talk and, relational/somatic psychotherapeutic interventions may take place. As you increasingly come back to normal consciousness further verbal processing, psychotherapeutic interventions, integration and grounding re-orienting will take place. After the KAP process and, sometimes in-between, additional follow-up sessions that focus on integration of your experience are recommended. Time for integration and planning for self-directed integration methods will be made in your session before you leave. Finally, the therapist and client will determine if you are safe to leave the office and will discuss how you have arranged for transportation home afterwards. At this time clients may still be mildly dizzy or disoriented so you should not drive yourself home or operate any transportation mode for the rest of the day. If your ride does not show up you agree to arrange to have someone else pick you up or to use public transportation. You will be welcome to use the waiting area as long as you need to make arrangements and/or feel grounded and safe. Your KAP therapist is a legally mandated reporter and also has a duty to warn if it is revealed in a session that a client plans to harm themselves or anyone else.

 

Preparation for KAP Therapy

Before participating in KAP you will have been carefully interviewed by your licensed prescriber to determine if you are eligible for ketamine therapy, including a medical history, review of your medical/psychiatric records, a psychiatric history, a physical exam and in some cases administration of brief psychological tests to assess your state of mind. Dosages and frequency will be determined by your prescriber. Your signature of this consent form indicates that you have undergone these processes, are medically cleared and, have been given approval to participate in KAP by your prescriber. Because of the risk of nausea and vomiting, please refrain from eating and drinking for at least 4 hours preceding the session. On the day of treatment, if you eat prior to the 4-hour fasting period, eat lightly. Hydrate well prior to the 4-hour fasting period. While it can be helpful to form intentions for your KAP session, you may or may not be able to hold on to that intention while journeying therefore, it is helpful to remain open to whatever arises is the course of the session.

 

 

Potential Side Effects, Risks, and Contraindications of KAP

You will be asked to lie down during the KAP session because your sense of balance and coordination will be adversely affected until the drug's effect has worn off. Other possibilities of adverse effects include blurred and altered vision, 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 in rare cases vomiting. If nausea/vomiting is an issue for you, you can communicate with your prescriber about possible anti-nausea medicines which can be used during the sessions. Visual, tactile and auditory processing are affected by the drug. Familiar music may appear quite different to you, even unrecognizable. Synesthesia, a mingling of the senses, may occur. Ordinary sense of time may become distorted. Anxiety may be experienced, albeit often from a different perspective. Clients are encouraged and supported by their KAP therapist to not resist, but to allow, any difficult experiences to move through. Ketamine generally causes a significant increase in blood pressure and in some cases elevated pulse rate (Tachycardia Agitation and anxiety may occur during the course of a ketamine session. Some clients complain of headaches after the sessions, and Ketamine has in some cases caused/stopped migraines. Diplopia (double vision), nystagmus (rapid eye movements), elevation of intraocular pressure (feeling of pressure in the eyes), and anorexia (loss of appetite) may also occur (These reactions have been observed to occur 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 The dose to be used in this sub-anesthetic sub-lingual KAP is much lower (2 mg/kg or less You may experience changes in personality, mood and cognition during treatment, in the aftermath, and in the days and weeks that follow. 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 personality disorders. If you have been or are presently diagnosed with similar severe mental disorders, you may not be a candidate for KAP. Repeated, high dose, chronic use/abuse of ketamine has caused urinary tract symptoms and even permanent bladder dysfunction in individuals abusing the drug. This does not occur within the framework of KAP. 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 contra-indication to ketamine use as the substance causes a rise in blood pressure. Similarly, a history of heart disease may make you ineligible to participate. Ketamine should not be taken if you have hyperthyroidism. There have also been reports of some decrease in immune function in patients receiving surgical doses of ketamine. You prescriber will assess you for any medications you are already taking and any possible adverse interactions. You should never discontinue the use of medications that you are already taking, or add any new medications without first consulting with your KAP prescriber. Your KAP therapist is in no way qualified to determine medical readiness for KAP, this happens between you and your prescriber only.

 

How Long Will It Take Before I Might See Beneficial Effects?

The number of sessions varies based on personal needs and treatment responses. Some clients report immediate beneficial results after KAP. Often clients undergo a series of sessions and follow-up sessions over periods of weeks and months. Just as with traditional psychotherapy, results can vary widely and there is no guarantee of results.

Potential for Ketamine Abuse and Dependency

Ketamine belongs to the same group of chemicals as Phencyclidine (Sernyl, PCP, "Angel dust"). This group of chemical compounds is known chemically as Arylcyclohexylamines and is classified as Hallucinogens ("Psychedelics"). 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 the history of heavy use of "psychedelic" drugs. In addition, ketamine can have effects on mood (feelings), cognition (thinking), and perception that may make some people want to use it repeatedly. Therefore, ketamine should never be used except under the direct supervision of a licensed prescriber and KAP therapist. If you have issues or concerns with addiction you are encouraged to discuss this with your therapist and prescriber prior to enrolling in KAP.

 

Voluntary Nature of KAP Participation

Please be aware that the Food and Drug Administration (FDA) has not yet established the appropriateness of Ketamine Assisted Psychotherapy (KAP) and its use is considered "off-label.' The only officially approved use of ketamine from the FDA being as an anesthesia and more recently a nasal spray for depression. Your awareness of this situation is key to understanding any liability associated with your use of ketamine. Your informed consent indicates you are aware of this situation.

Ketamine is a new psychiatric treatment-the primary studies have been with depression, bipolar disorders and alcoholism. It is not yet a mainstream treatment, though there are now many studies that demonstrate that it may be an effective treatment. There is an expanding array of ketamine clinics across the country, primarily administering ketamine intravenously, and usually without a therapy component-ir other words, as a drug. That therapeutic effect generally occurs with more than one treatment and is most robust when part of an overall treatment program. It may not permanently relieve depression. If your depressive symptoms respond to KAP 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 need additional ketamine treatments or other therapies to maintain your benefits.

Your decision to undertake KAP 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. Even after agreeing to undertake KAP you may decide to withdraw from treatment at any time prior to ingesting the lozenge.

 

 

Use of Therapeutic Touch

Research shows that trauma is stored in the body/nervous system. The body and mind are inseparable and by incorporating the body into psychotherapy healing can be accelerated. Your KAP therapist is trained in mindfulness-based experiential somatic psychotherapy which can include the use of safe non- sexual touch as a therapeutic intervention. Your KAP therapist will always ask your permission before such an intervention is made. Touch is never essential or mandatory and will not be initiated or continued if you are at all uncomfortable with it. You are encouraged to ask your therapist for examples if you have any questions about what safe touch could include. You are asked to exercise your boundaries in expressing if touch is not okay with you at any time either before or during KAP sessions.

Understand that your consent given for therapeutic touch may be revoked verbally by you at any time. Please sign below indicating if you consent/do not consent to the therapeutic use of touch during KAP

I consent to the therapeutic use of touch during KAP.

I DO NOT consent to the therapeutic use of touch during KAP.

Agreements

You are asked to make 5 agreements with your KAP therapist to ensure your safety and well-being:

1. You agree to follow any safety-related instructions given to you by the therapist(s) until it is determined that the session is over. Initials {initials15}

2. You agree to remain at the location of the session until the therapist(s) decides you are ready to leave. {initials15}

3. You agree to not engage in any driving or hazardous activity for the rest of the day after your KAP session. {initials15}

4. You agree to not ingest ketamine until you are directed to do so by your KAP therapist during the session. {initials15}

5. You agree to schedule for and to complete integration sessions with your therapist. You agree to practice self-directed integration methods in-between sessions as explained by your therapist.

Informed Consent

By signing this form, I agree that:

1. I have fully read this informed consent form describing Ketamine Assisted Psychotherapy (KAP) 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.

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

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 time which I actually ingest the lozenge.

8. I understand that my KAP therapist is bound by mandatory reporting and duty to warn statutes just as they are in normal therapy sessions.

9. I agree to adhere to any previously determined fee and cancelation policies explained in my KAP therapist's general psychotherapy informed consent forms.

10. I understand that this consent form does not replace or supersede any other consent forms I may have signed with my therapist previously.

I voluntarily sign my name evidencing acceptance of the provisions of this agreement.

Therapost Statement

I {printedName} have carefully explained the nature of Ketamine Assisted Psychotherapy (KAP) to {printedName}. I herby certify to the best of my knowledge, the individual signing this consent form understands the nature, conditions, risks and potential benefits involved in participating in KAP. To the best of my knowledge a medical problem or language or cognitive/educationa barrier has not precluded a clear understanding of the subject's involvement in KAP or their ability to give informed consent.