Ketamine Assisted Psychotherapy–New Informed Consent and Sub-Lingual Lozenge and IM Protocol

Ketamine Assisted Psychotherapy–New Informed Consent and Sub-Lingual Lozenge and IM Protocol

 

The Center for Transformational Psychotherapy 

 

       PHILIP E. WOLFSON, MD                                  JULANE ANDRIES, LMFT

                       415-550-1700                                                      415-497-2911

CA G-33570                                                           MFT #45303

Contents: Scroll Down for Sections on Fees, Informed Consent, Protocol, IJTS Journal 

FEES

Ketamine Assisted Psychotherapy
Comprehensive Medical/Psychiatric Assessment and Screening

Intake and Initial Evaluation $375.00

Ketamine Sessions (Duration: Two and 1/2hours or more) $1000

Lozenges: Prescription to Formulating Pharmacy: fee is determined by pharmacy. Lozenges are prescribed on a personal programmed basis for at home use under supervision.

At-home monitoring fees are pro-rated by practitioner time spent

Follow-up Integrative Session: $375.00 

Additional Integrative/Psychotherapy Sessions:
with JA
$150.00 per hr.  (90837/90838)

with PW
$300.00 per hr.  (90837/90838) 

An Intake Form and other measures will be sent to you at the time of making your appointment.

Because of the complexity of scheduling long sessions, we ask that you give at least 48 hours notice for a cancellation. Otherwise, charges will apply. Thanks for understanding.

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The Center for Transformational Psychotherapy

 

PHILIP E. WOLFSON, MD                        124 Pine Street

415-550-1700                                                          San Anselmo, CA 94960

CA G-33570                                                             Fax 415-721-0895 

 

JULANE ANDRIES, LMFT                                    transformationalpsych@gmail.com

415-497-2911

MFT #45303                                                                                                                   

KETAMINE ASSISTED PSYCHOTHERAPY (KAP)

 INFORMED CONSENT

Introduction

Ketamine is now an increasingly clinically applied “off-label” treatment for various chronic “treatment-resistant” mental conditions. Ketamine is a Schedule III medication that has long been used safely as an anesthetic and analgesic agent and now, often effectively for treatment of depression, alcoholism, substance dependencies, PTSD and other psychiatric diagnoses.

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How Does It Work?  The current, most probable, understanding of ketamine’s mode of action is as an NMDA antagonist working through the glutamate neurotransmitter system. This is a very different pathway than that of other psychiatric drugs such as the SSRIs, SNRIs, lamotrigine, anti-psychotics, benzodiazepines, etc. However there is no consensus on mode of action. Other mechanisms may well be found central to ketamine’s effects.

Ketamine is classified as a dissociative anesthetic, 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, psychedelic effects. More recent work has demonstrated the possibility of an anti-depressant response to low dosages of ketamine–administered intravenously, intra-nasally and sublingually (orally)–that produce minimal psychedelic effects;. this anti-depressant 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 may employ both methods together as will be described herein. 

Essential to both methods is a time-out of usual experience, this period being of varying duration, usually 30 minutes to 2 hours, that tends to be dose and method of administration related.  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.  As therapists we act as guides to the experience and process the experience and its impacts with our patients before and after the sessions.

Monitoring: 

It is essential that you be followed very closely during and after your treatment. This will include blood pressure and pulse measurements–as appropriate, and psychological assessment tools administered before your fist and subsequent sessions to measure effects. Follow-up will be by telephone and/or email and in-person contact as needed.

You will be entering a psychotherapy program that will prepare you for your ketamine session(s) and assist you in integrating your experience(s) afterwards.  This program emphasizes the possibilities for change and the seriousness of your and our effort to assist you. For most people entering KAP, there will be a sustained period for therapy to continue to benefit emotional healing and growth. Support from family, partners and close friends is desirable and they will be included in sessions or parts of sessions as deemed appropriate by you and us as your therapists.

How Long Will It Take Before I Might See Beneficial Effects? You may experience important changes in personality, mood and cognition during treatment, in the aftermath, and in the days and weeks that follow.  Some experiences may be temporarily disturbing to you. The ketamine experience itself is designed to enable your own healing wisdom to be accessed and beneficial to you.  The psychotherapy support you will receive will aid you in making your experience(s) valuable and understandable to you. We will endeavor to assist you in changing patterns of mind and behavior that are of concern and cause you difficulty.

Why Ketamine Assisted Psychotherapy?

The purpose of the intra-muscular ketamine experience is to create a non-ordinary (“altered”) state of consciousness in order to facilitate profound transpersonal (“transcendental”, “mystical”, “spiritual”, “religious”) peak experiences.

These may prove to be auspicious in resolving your existential problems, accelerating your psycho-spiritual growth and leading to a deep personal transformation and optimization of your lifestyle.  Such change is best facilitated within a structured supportive psychotherapeutic milieu in connection with therapists who have a view of your issues, hopes, desires, and struggles.  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 well notice that you are a bit different after a ketamine experience and that difference may well be liberating and allow for new mindfulness and new behavior.

With respect to IM ketamine, we are asking that new patients make a commitment for three IM sessions as a minimum exposure to ketamine. Additional sessions may occur if deemed appropriate and beneficial. We undertstand that you are able to withdraw from our treatment at any time.

Your experience will be unique to you. And if you and we decide to have additional sessions using ketamine, each of your sessions will be different.  All such journeys are adventures that cannot be programmed.  They evolve from your own being in relation to this substance.  While it is best to form an intention for your journey, you may or may not be able to hold onto that. Indeed, no holding on is best and the journey will flow whether or not you hold on and resist, or follow the path that unfolds and relax into it.  Holding on is the main source of anxiety in this and other related journeys.  A ketamine session can be light, dark, or both.  There will be concepts, visions, encounters, and you may well deal with your own death, mortality, and immortality.  Not everyone enjoys the journey, but everyone comes through it.

The purpose of the sub-lingual ketamine lozenge sessions is to generate a robust anti-depressant, or other (PTSD, etc.)  benefit that often occurs over time with repetition of administration of the lozenges, for some, in concert with the IM sessions.  For many individuals, only the lozenge experience may be utilized and may well be sufficient and healing.

We generally begin with assessing repsonsiveness to the lozenge. This enables us to make a decision about the effectiveness of the lozenge and to adjust the dose. You will be given lozenges to take at home for designated evening ketamine sessions, in between IM sessions, or on their own—lozenges only.  Such sessions will be supported with periodic psychtoherapy sessions in which you will meet with us. Please understand that if you prove to be responsive to the ketamine experience, treatment may well continue for a period of time based on your continued response and benefit, as well as prevention of relapses. We will work out a schedule appropriate to your needs, history and responsivity–in concert with you.

The literature indicates a 70% response rate to ketamine; and a remission rate for patients with treatment ressistant depression (using the low dose IV drip method, or the sublingual method) of 40-50%–the percentage of patients having remissions from their symptoms, this with multiple sessions. Relapses do occur and may require periodic additional sessions.  Over time, a certain number of patients may become un-responsive to further ketamine sessions. Based on our growing experience, the sub-lingual method (which is equivalent in effect and much less expensive and cumbersome than the IV method) on its own, or with the IM sessions==both within a framework of intensive psychotherapy designed explicitly for the ketamine experience–we believe will exceed this rate of response.

 

ELIGIBILITY FOR KAP

 

This consent form contains information about the use of sub-anesthetic dosages of ketamine for psychiatric purposes including depression. Ketamine was approved by the FDA for use as an anesthetic agent several decades ago.  The administration of ketamine in lower, sub-anesthetic doses to treat pain, depression, or other psychiatric diagnoses is a newer, off-label use of ketamine. Psychiatric use of ketamine has become relatively wide-spread in recent years, has been studied and promoted by researchers at the National institute of Mental Health, and has had front-page publicity as the newest anti-depressant with its own novel pharmacological mechanism of action. Ketamine has been administered by intravenous (IV), intramuscular (IM), sub-lingual, oral, and intra-nasal routes.  Often, it has been used after other treatment approaches have been unsuccessful.

Once you indicate that you have understood the benefits and risks of this treatment, you will be asked to sign this form at your first visit in order to participate in this treatment. 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 to the medical procedure to be performed during your participation in ketamine treatment. 

Please read this consent form carefully, and feel free to ask questions about any of the information in it.

ELIGIBILITY FOR KETAMINE TREATMENT

Before participating in ketamine treatment, you will be carefully interviewed to determine if you are eligible for ketamine therapy, including a medical/psychiatric history, review of your medical/psychiatric records if necessary, and administration of brief psychological tests to assess your state of mind.

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 our policy that you protect yourself 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 BP.  Similarly, a history of heart disease may make you ineligible to participate.

Information on ketamine’s interaction with other medicines is only partially available and it will be assessed as to your eligibility for KAP.

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.

OVERVIEW OF KETAMINE THERAPY–KAP

During the Ketamine administration session, you will be asked to make two (2) agreements with the therapist(s) to ensure your safety and well-being:

1.   You agree to follow any direct instructions given to you by the therapist(s) until it is determined that the session is over, and

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

The length of ketamine sessions varies from person-to-person and from experience-to-experience. You will be mostly internally focused for the first 30 minutes to one-hour or more. With the sub-lingual lozenges we refer to this state as a light trance. Following IM administration of ketamine, the experience is much deeper and yet you remain conscious of your experience. With either method or in combination, you will continue to remain under ketamine’s influence at a lesser level for at least one hour.  Under my care, ketamine will be given as an intramuscular injection into the shoulder or buttocks at doses of 50 mg to 100 mg (130mg maximally). The choice of dose will depend on prior exposure to ketamine and other psychedelics, body weight, and sensitivity.  Naïve subjects will receive a lower dose initial session. 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. 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. Ketamine IM creates an unusual experience of formlessness and a dissolving of boundaries and has novel effects on the mind.  Therefore, it is much better to have an initial learning experience.

The initial IM injection may be preceded by administration of a sublingual lozenge(s) containing 50 or 100mg of ketamine. Or we will elect to do lozenges only, to begin your ketamine treatment, Lozenges dissolve slowly and we ask you not to swallow your saliva until after your long has dissolved, typically about five 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 responsivity to ketamine. Additional lozenges may be given to you during the session to enable optimal effect for you. At the end of the session you will be given lozenges, a prescription will be called-in to our formulating pharmacy for additional lozenges, and a plan created with you for their use at home. We suggest you use the lozenge in the evening at least two hours before your usual bedtime; that you lie in a quiet, comfotable space, assuming a meditative attitude, listen to gentle non-lyric containing music of your choice; not watch television or use the computer; and not drive afterward or operate potentially hazardous machinery.  We advocate that you do not use alcohol preceding ketamine sessions as this may have negative emotional and physiological consequences. If you are unable to do evening sessions, daytime sessions are fine with the same provisos–no food intake for at least 3 hours prior to a lozenge session–to prevent nausea and enable absorption from ketamine that reaches the alimentary tract. And. please refrain from using stimulants the same day. If ketamine causes you to experience an increase in your energy that affects sleep, please change your timing to earlier in the day.

Preparation for a ketamine session requires assessment by your therapist of your readiness and a sense of connection between you and your therapist. We are engaging in a therapeutic endeavor to benefit you and those who are affected by you.  Together, we are creating a state of mind (set) in safe and conducive setting. After ketamine IM and sub-lingual use, you will have follow-up sessions that focus on integration of your experience and may lead to further sessions, if you so wish, and if that is in accord with your therapist’s view of your treatment.

You may ask the therapist(s) any questions you may have concerning the procedure or effects of ketamine at any time. Your consent to receive ketamine may be withdrawn by you, and you may discontinue your participation, at any time up until the actual injection or lozenge has been given.

POTENTIAL RISKS OF KETAMINE KAP THERAPY

You will be asked to lie still during the ketamine administration because your sense of balance and coordination will be adversely affected until the drug’s effect has worn off–generally two and up to four hours after the injection. It is possible you may fall asleep, though this is a rare event.  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 acccurately including one’s own body, anxiety, nausea and vomiting. Visual, tactile and auditory processing are affected by the drug.  Music that may be familiar may not be recognizable.  Synesthesia—a mingling of the senses may occur. Ordinary sense of time will morph into time dilation.

Because of the risk of nausea and vomiting, please refrain from eating and drinking for at least the 3–best is 4– hours preceding the sessionAnd eat lightly when you do.  Hydrate well in that same time frame. 

If you are unduly nauseated, you may be offered an anti-nausea medication—odansetron—in an oral dissolving tablet form.

Ketamine generally causes a significant but not dangerous 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.There is also avery small risk of lowering BP and Pulse rate.

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.This too is a rare event in our experience.

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 surgical anesthesia. The dose to be used in this sub-anesthetic ketamine therapy is much lower (2mg/kg or less).

Driving an automobile or engaging in hazardous activities should not be undertaken until all effects have stopped–and if for any reason they continue a driver may be necessary.  You will be assessed for safety prior to leaving the office premises.

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 and Dissociative Disorders.

During the experience itself, some people have reported frightening and unusual experiences. These frightening experiences, however, may be of paramount value to your transition to recovery from the suffering that brought you to your KAP work.  They will stop! You will receive psyhotherapeutic help and ongoing guidance from your therapist.

POTENTIAL FOR KETAMINE ABUSE AND PHYSICAL DEPENDENCE

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 (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 within the framework of our study.

You will be provided or prescribed just the amount of lozenges necessary for your treatment between sessions with us. They have no street value.

We and our colleagues doing clinical ketamine work have not had patients become dependent on ketamine.

ALTERNATIVE PROCEDURES AND POSSIBILITIES

No other procedure is available in medicine that produces ketamine’s effects. Major Depression (MDD), PTSD and Bipolar Disorders are usually treated with anti-depressant 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. Ketamine has also been used in the treatment of addictions and alcoholism as part of comprehensive and usually residential treatment programs, primarily abroad.

CONFIDENTIALITY

Your privacy and all therapy records will be kept confidential. 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 published in clinical literature. Published reports will not include your name or any other information that would identify you.

VOLUNTARY NATURE OF PARTICIPATION

Please be aware that the Food and Drug Administration (FDA) has not yet established the appropriateness of Ketamine Assisted Psychotherapy and its use is considered off-label, the only official ’indication’ for use of ketamine being anesthesia.  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.  That 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 Ketamine Assisted Psychotherapy, you may still elect to be treated with medications and ongoing psychotherapy to try to reduce the possibility of relapse and anxiety.  Over time, you may also need additional ketamine treatments or other therapies to maintain your remission.

I PRACTICE PSYCHIATRY /PSYCHOTHERAPY AND MAY OFFER TO ASSIST YOU WITH OTHER MEDICATIONS, TO CONSULT WITH YOUR THERAPISTS AND MDS, AND MAKE RECOMMENDATIONS TO YOU ABOUT YOUR TREATMENT IN ADDITION TO OUR KETAMINE WORK. YOU MAY ON YOUR OWN DESIRE TO CONSULT WITH ME ABOUT THESE TREATMENT ISSUES.

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.

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.

I understand that I am to have no food or drink at least 3 and preferably 4 hours prior to my Ketamine session

I understand that I may need to have someone drive me home from the sessions, and not engage in any driving or hazardous activity for at least 6 hours or more– depending on the continued presence of effects after my session has concluded.  

INFORMED CONSENT ATTESTATION

By signing this form I agree that:

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

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.  I give my consent to the use of lorazepam if deemed necessary for agitation, to odansetron for nausea, and for clonidine for high blood pressure.

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 actual injection, or lozenge has been given.

 

SIGNATURE

 

DATE_

 

PRINTED NAME

 

PHYSICIAN/ THERAPIST STATEMENT

I have carefully explained the nature of Ketamine Assisted Psychotherapy to _________________________. I hereby certify that 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.

A medical problem or language or educational barrier has not precluded a clear understanding of the subject’s involvement in KAP.

Signature of Physician                                                        Date

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Ketamine Sub-lingual, IM and Psychotherapy Protocol

KAP—Ketamine Assisted Psychotherapy 

Three Paths

A)    Sublingual Lozenges–The Path of Ameliorating Depression, PTSD, Reducing Obsessional States and Improving Mood

Method: Sublingual Lozenges:

50   or 100 mg formulations
Reliability of dosage is verified by independent laboratory analysis

BP. P before, and if deemed necessary, during, and after

We begin with an assessment session consisting of intake, informed consent, psychiatric history, BDI II and MADRS and other measures as deemed appropriate and answering concerns—followed by a 50 or 100mg sublingual session with BP and P monitoring if necessary, looking for responsivity, and side effects. We do not feel that lower dosages are necessary to determine safety.  Our lozenges dissolve in 4-5 minutes and we ask that patients retain the saliva content without swallowing for at least that duration.

We make a decision on dosage (generally up to 200 mg) and distribute lozenges with a schedule and a return visit within two weeks.  We prefer six at home sessions–generally two sessions consecutively—as we feel this intensifies the experience– –in the evening—two hours before usual sleep time, with four-hour food cessation and no alcohol, TV or distractions. We suggest a two to three-day break thereafter We ask for gentle music—without lyrics, lying down under comfortable circumstances, with a responsible party near by or on call. No operation of machinery or driving during or afterwards.  No mj or other substances during the treatment period.

This initial session may well run for 2 hours or more.

We call these sessions ‘ketamine influenced sessions’ and encourage these to be internal, meditative experiences.  We ask for journaling of effects, duration, side effects, problems, insights, experiences including the psychedelic and a follow-up the next morning for self-report of effects and aftermath. We ask for reports on problems and successes as the process continues.This can be by telephone or email.

We are on call for help, feedback, modifications and encouragement.

At about the one to two-week mark, we reassess with BDI and MADRS (etc.), examine for efficacy and problems, consider the appropriateness of adding IM sessions, and plan for an additional two weeks or more, generally with two at-home sessions/week, another follow-up session and then a plan for maintenance if appropriate. We may repeat in-office lozenge sessions to promote efficacy and sustain response and provide additional psychotherapy.

The follow-up Integrative sessions last for approximately one-hour. We may well repeat the lozenge sessions in the office as needed.

Our view is that there may well be positive effects with these sessions as a result of cumulative use. They represent a significant commitment to a process of change and an experience of a meditative nature which has the tendency to provide a mild time-out from ordinary consciousness. The alteration of consciousness is essential to the possibility of positive outcomes.  The occurrence of psychedelic experiences is not essential to the potential for a positive effect, but may well be beneficial.  However, minimally, it is the internalization of consciousness and the partial interruption of the usual state of mind that is the psychological mechanism of action. Without this, we do not believe there can be a successful treatment as the dose of ketamine will be too low and there is a null experience threshold. The causation of the cumulative effect of multiple sessions on a molecular, or neurocognitive level remains unknown.  Explanations involving neuroplasticity and impact on the glutametergic system have been made, as well as others, but the basis for understanding the success of ketamine over time remains speculative at best.

B)    The IM Method–The Path of Transformation—Coming Back A Bit Different Each Time—Which May Well Ameliorate Depression, PTSD, Reduce Obsessional States, Enliven Character and Attitude and Improve Mood

Method: Intra-Muscular Ketamine Injections

50-100mg

Odansetron (Zofran) lozenges for pre-session, or as anticipated by history, nausea.

BP, P before, during, and after as necessary.

BDI and MADRS at baseline and at intervals

We ask for a three session commitment and may begin with a 50 mg injection in naïve individuals or at a higher dose for those with prior experience.  We use up to 100 mg per session as beyond that there generally is more difficulty with recollection of the experience because of increasing anesthetic effect as dosage increases.  All patients have significant experiences.  These experiences may be recalled or not. Having the experience itself is beneficial for the transformation that usually occurs, whether remembered or not.  Recollection tends to improve with the next session, even at higher doses.  Dose is increased in succeeding sessions, or not, depending on the tolerability of the effect (anxiety and agitation) and the depth of the experience.  Generally, succeeding sessions are experienced with less anxiety as familiarity with the general boundaries of the experience occurs.

Psychotherapy is not possible during the peak of the experience as patients are internal and not conversational. During the experience, the observational self persists and there is conscious following of the unfolding experience.  Inasmuch as there is synesthesia, we use our own musical mix to evoke experience and to provide an anchor. Generally, we use eye shades and headphones to aid the process of internalization.  Some individuals wish to be more cognizant of their surroundings, may be afraid (especially initially) of letting go, or don’t like our music.  We move to ambient music of a meditative nature such as Tibetan bells and flutes. For occasional agitation, we prefer to provide physical support such as hand-holding or shoulder-touch to reassure and anchor, along with verbal support that is attentive to the individual’s specific fears and trauma and encourages the letting go that takes the individual into the deep experience. This is pre-arranged as a possibility to avoid intrusiveness and to encourage connection as needed.

The deep experience tends to last from 25 minutes to up to an hour, generally in the neighborhood of 45 minutes.  To the patient, there is a lack of timefulness and a dissolution of form.  Hours seem to pass without measure.  A sense of being as an energetic format is a frequent motif. Generally, within the experience there is an absence of the ordinary mind with its depression and obsessional content.  There may well be mystical, spiritual and cosmic experiences with a loosening of the constraints that bind in usual consciousness.  This may be felt as liberating, novel and beneficial to a new format for life.

The point of the integrative portion of the session is to consolidate and anchor the new view of self. While, the ketamine experience has been compared to ECT, the only relationship is the interruption of ordinary mind.  Unlike ECT which is a black hole, ketamine offers the possibility for constant consciousness, and for a new attitude towards self and its expression in living.  This is not a simple task as the maintenance of character and its expression tends to rigidity and continuation of self-structure—change is difficult to obtain—which is why the integrative and subsequent sessions are so important to finding a new balance

The recovery period in which the anesthetic effect subsides and conversation occurs may take an additional hour.  Stability in walking can occur at two to three hours from inception.  Whenever possible, we ask our patients to have transportation home as we do not wish to have them risk driving.  We keep patients within our clinic until they appear safe to us. Working as a co-therapy team enables us to have a division of labor, although this is often difficult to perform as our patients tend to wish us to stay together, rather than separate for portions of the procedure.

The commitment to the three IM sessions can be abrogated by either the patient, or by the therapists if there is a sufficient experience to achieve the desired effect, or if there are effect/side effect problems that make continuation undesirable.  The number of IM sessions may be increased by agreement, should there be an indication that more benefit is achievable.

The session lasts for two to three hours.

C)    The Combined Path—Sublingual lozenges and IM injections–Seeking to Optimize Treatment Outcomes by Integrating the Sub-lingual and IM Paths.

Sublingual lozenge—50 mg-and 100 mgs (up to 200 mg/session) and IM injections 50-100mg/session

Odansetron as needed

BP and P before, during, and after as necessary.

Method:  Initiate with a lozenge experience, allow 15 minutes or so for effect; then follow with IM injection—generally 50mg—for the first experience, or higher as clinically determined.

BDI and MADRS at baseline and at intervals along with other measures.

We begin by assessing the impact of the lozenge on its own and to make decisions about at-home dosing.  The lozenge’s effect is to provide a gentle entry for the much larger experience of the injection that follows–when the patient is ready. We provide the same procedure as with the IM on its own.  At the conclusion of the integrative portion of the session, we dispense and prescribe lozenges for the interval period until the next combined session.

We often prefer the combined path as this follows the same distribution pattern as for the sublingual path and the IM sessions, in our experience, further the anti-depressant, etc. effects providing a cumulative effect that reinforces the reciprocal impact of combining both approaches.

The commitment to the three IM sessions can be abrogated by either the patient, or by the therapists if there is a sufficient experience to achieve the desired effect, or if there are effect/side effect problems that make continuation undesirable.  The number of IM sessions may be increased by agreement, should there be indication that more benefit is achievable.  The sublingual route may be continued for a maintenance format.

Sessions tend to last for two to three hours.  Follow-up is essential.

Modifications to this protocol will occur with time and experience.  We welcome others’ contributions and critiques.

PW 5/4/16

 

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IJTS Ketamine Journal

For the full text go to:
http://www.transpersonalstudies.org/current_issue.html 

Dear Friends,

          I am pleased to announce the publication of the Special Topics Section on Ketamine Assisted Psychotherapy put online by the International Journal of Transpersonal Studies, edited by my friend and colleague Glenn Hartellius. An expanded version will be published as a MAPS book this fall with the title of The Ketamine Papers.  

Phil Wolfson MD

International Journal of Transpersonal Studies, Volume 33(2):

Table of Contents

The Imperative for Diversity in a Transpersonal Psychology of the Whole Person

(Editor’s Introduction)Glenn Hartelius

Engagement in a Community-Based Integral Practice Program Enhances Wellbeing

Cassandra Vieten, Mica Estrada, Adam B. Cohen, Dean Radin, Marilyn Mandala Schlitz, & Arnaud Delorme

Implications and Consequences of Post-Modern Philosophy for Contemporary

Transpersonal Studies, III. Deleuze and Some Related Phenomenologies of Felt Meaning:

Psychosis and Mysticism as Inherent “Structures of Thought”Harry Hunt 

SPECIAL TOPIC: Psychedelic Ketamine as Antidepressant

Introduction to the Special Topic Section: Ketamine—Its History, Uses, Pharmacology, Therapeutic Practice, and an Exploration of its Potential as a Novel Treatment for DepressionPhilip E. Wolfson

Ketamine and Depression: A Review

Wesley C. Ryan, Cole J. Marta, & Ralph J. Koek

 

Ketamine for Depression: A Mixed Methods StudyPhilip E. Wolfson 

 

Ketamine Psychedelic Psychotherapy: Focus on its Pharmacology,

Phenomenology, and Clinical ApplicationsEli Kolp, Harris L. Friedman,

Evgeny Krupitsky, Karl Jansen, Mark Sylvester, M. Scott Young, & Anna Kolp

 

Making Ketamine Work in the Long RunTerrence S. Early

 

Regarding the Transpersonal Nature of Ketamine Therapy:

An Approach to the WorkJeffrey Becker

 

Psychedelic Experiential Pharmacology: Pioneering Clinical Explorations

with Salvador Roquet—An Interview with Richard YensenPhilip E. Wolfson

 

Ethnographic Accounts of Ketamine Explorations in Psychedelic Culture

Kenneth Ring, Ralph Metzner, & Philip E. Wolfson

Ketamine (IM) Assisted Psychotherapy (KAP): A Model for Informed Consent

Philip E. Wolfson

 

The Transformative Power of Ketamine: Psychedelic States

and a Personal History of Self-TransformationPhilip E. Wolfson

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