Manual for Ibogaine Therapy
Screening, Safety, Monitoring & Aftercare
Marc Emery, Geerte Frenken, Sara Glatt
Brian Mariano, Karl Naeher
Martin Polanko, Marko Resinovic
Nick Sandberg, Eric Taub
Samuel Waizmann, Hattie Wells
Table of Contents
Introduction to the Second Edition Preface Treatment
Intake and Safety Issues
Dose and Effect
Opioid Withdrawal Opioid withdrawal tables Post Ibogaine Treatment Therapy Discussion
Overview
Inclusion Criteria
Exclusion Criteria
Treatment Regimen and Dose
Product Identity
Post Ibogaine Therapy Invitation to Contributing Authors Appendices
Selections NIDA Draft Ibogaine Protocol
Related Protocol Bibliography
Additional Document links
Introduction to the Second Revision
The Second Revision of the Ibogaine Manual follows a year and a half after the publication of the First Revision providing new information to the field. This revision of the manual offers additional information on ibogaine therapy as well as, differing philosophies of ibogaine providers and their approaches to therapy. There is consensus as to the benefits of post ibogaine therapy but, no agreement that any one therapy offers benefits over others to a majority of subjects. Many authors feel the exclusion criteria indicated in the draft protocol of the National Institute on Drug Abuse (NIDA) are not realistic to allow treatment of today's chemically dependent drug users who may be depressed or display other psychiatric disorders nor does it allow for the prevalence of HCV and/or HIV to allow those individuals to be treated with ibogaine. The authors review broader ibogaine dose regimens and their advantage than were presented in the First Revision of this manual. The new material is principally found in the Discussion Section that may be referenced from the links of the Table of Contents above though some changes and corrections have been made throughout the text as a whole. Opinions of authors remain diverse.return to contents
Links to a medical encyclopedia as well as, both the home edition and Centennial/Professional edition of the Merck Manual are included in the Additional Documents section. "The Merck Manual, the textbook of medicine most widely used by health care professionals provides vital information about diseases, diagnosis, prevention, and treatment." The Ibogaine Manual now also contains a link to a redacted version of the Diagnostic and Statistical Manual of Mental Disorders (DSM IV) to allow better understanding of mental disorders that may be concurrently seen in persons who are chemically dependent.
Though the Internet allows rapid publication it also has a component of rapid disintegration with web pages linked to the manual being withdrawn from the web by original authors. Therefore the authors of this manual have included where possible multiple links to any particular subject in the appendices so as to maintain information access for the reader.
All links that will take the reader outside of the Ibogaine Manual will highlight on mouseover with most but, not all browsers. These links are found only in the Additional Document section. Links that will take the reader outside of the Ibogaine Dossier web page will appear in separate windows with the Manual remaining visible in the background.
Preface
It is the responsibility of those treatment providers to safely conduct the procedure despite possible limitations of clinical knowledge, patient compliance, money, time etc. The safety of Ibogaine treated patients is the primary objective of this document. Reported Ibogaine-related problems or fatalities might very likely be avoided if simple screening, dosing and monitoring guidelines are adhered to. However, this must be taken in some context as, in 1999 there were 116,000 drug related fatalities in United States hospitals associated with FDA approved medications.
This manual includes selected portions of the National Institute on Drug Abuse (NIDA) Draft Ibogaine Clinical Protocol obtained under a Freedom of Information Act (FOIA) request. Selections are principally directed towards safety issues. Aspects of the therapeutic sessions from the NIDA protocol are included as well as, bibliographical citations relevant to the sections from the protocol. More recent reports providing updated information are included in the Additional Documents section.
Any comments of the author(s) within the selected protocol text are indicated by "[ ]" brackets. The "*" asterisk is used to indicate tests procedures or surveys not included in NIDA's 1993, draft protocol but, suggested either in discussion with the FDA or by later publication.
In a memorandum dated March 10, 1995, Dr. Curtis Wright, Medical Review Officer, Pilot Drug Evaluation Unit, FDA wrote, "I think that ibogaine research will be propelled forward by its advocates, as it will be very hard to make a case that it is unsafe to take a drug into man when there is such substantial documented human experience. I agree with the speaker [March 1995, NIDA Ibogaine Review Meeting] that it is a risk-benefit analysis, but all such development decisions are finally reduced to this basis. The Development question is if ibogaine can be given safely, and if so, will it provide some benefit."
Ibogaine has been propelled by its advocates since then, and administered in many countries often outside the medical establishment. Unfortunately, safety issues are not frequently addressed or evaluated properly. Our objective is to provide basic guidelines and improve patient safety with information. This information is made available for the benefit of the treatment provider and their patients.
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Treatment
Intake and Safety Issues
Needless to say, it is evident that most persons outside of a research institution would not be able to undertake the testing presented in the NIDA ibogaine protocol. The primary issue the authors are attempting to address is that no medical testing is the norm for many persons receiving ibogaine therapy. This leaves both providers and patients at risk. Risk cannot be eliminated but, as inferred by Dr. Curtis Wright in the introduction to this article, risks must be weighed against benefits. It is apparent from the actions of both ibogaine providers and chemically dependent persons who seek treatment that the benefits are significant. However, with no less than three documented ibogaine-related fatalities, so are the risks. Having safety procedures in effect are not for the benefit of the majority of the patients who will go through ibogaine therapy with no problems but, to assure the survival of a small minority of the patients who may experience some form of adverse medical event that may be life threatening.
One of the recorded fatalities was reported to have taken place in 1989 in France. The patient, a forty year old woman was provided a dose of 8 mg/kg of purified ibogaine for purposes of psychotherapy from which she died approximately four hours after administration of ibogaine. The dose given was the lowest dose associated with an ibogaine related fatality that has been recorded and the autopsy found significant blockage of the main arteries to the heart. It was indicated that the patient had a history of cardiovascular disorders that may not have been investigated. This immediately indicates two areas that should be given priority attention by ibogaine providers: 1) A medical history and 2) an electrocardiogram (EKG).
The most common form of a medical history is usually a questionnaire required of every patient visiting a doctor for the first time and your doctor's office is an excellent source of such a document. Among the information required on such forms are issues relating to heart disease and these questions if honestly answered will provide an alert to the existence of a cardiac disorder. As, previously stipulated because medical conditions may not be known to the patient an electrocardiogram (EKG) should be included in any basic intake for ibogaine therapy. Information on electrocardiograms can be found in documents #6 and #7. Any history of heart attacks should be a reason not to treat a patient with ibogaine.
Whether in a hospital or outside of a medical environment the patient's safety can be best provided for by continuously observing the patient. A nursing assistant or other trained person should observe the patient continuously for 48 hours or longer if the patient response to ibogaine requires it. During this period pulse and blood pressure should be monitored at regular intervals and at any time that patients indicate discomfort or the observer has concern. The regular intervals may be as short as 30 minutes for the first four hours or until blood pressure and pulse are stable and then at time points of 1 hour to 4 hours thereafter. Observers should have training in cardiopulmonary resuscitation and be prepared to call a hospital or emergency medical services should the patient's pulse drop below 50 beats per minute. If you are not prepared to call for emergency medical help you should not be providing ibogaine therapy. A hospital should be called at any time if a patient loses consciousness. The emergency number to be called should be available to all provider personnel at all times. Observing the patient is more work then one person can realistically accomplish. In a hospital setting nursing staff would normally rotate on 8 to 12 hour shifts.
The evaluation of blood chemistry is a standard means of assessing the health of a patient and is often used in medical evaluations of patients during annual physicals or to determine the health of a patient at any time for any purpose. The SMA-20 (a series of tests to evaluate blood chemistry) along with a CBC (complete blood count) with differential now appear to be the tools of choice to provide a wide range of information relating to blood chemistry that includes a liver profile but, does not include a hepatitis or HIV screen. Excellent resources concerning the SMA-20, CBC and definitions to allow an understanding of the associated terminology can be found in #3, #4, and #5 of the document section. The second recorded fatality was that of a woman in her mid twenties in the Netherlands who received 29 mg/kg in a split dose of 23 mg/kg and an additional 6 mg/kg approximately 3 hours later. The patient died 16 hours after the administration of ibogaine. The autopsy did not determine the cause of death. The unanswered question of the cause of death brings us to another important safety issue. Ibogaine has been shown to increase the effects of opiates as well as opiate toxicity. Ibogaine may also increase the potency and toxicity of stimulants. Therefore patients should be warned that concurrent drug use during ibogaine therapy may be fatal. It does not mean that concurrent drug use will always be fatal as an early report of an ibogaine experience, Reflections on an Ibogaine Experience found in document #8 of this manual indicates concurrent heroin use that did not result in a fatality. It must be recognized that the response to drugs is individual and that each patient may present a dramatic or not so dramatic distinction in how they respond to ibogaine or other drugs. Ibogaine providers should attempt to minimize danger to the patient by eliminating the use of unauthorized drugs by the patient while under the influence of ibogaine. Good luck on that matter in circumstance where you are treating experienced and dependent drug users. This is why it is very important to let the patient know that drug interaction may be fatal.
The third fatality of record occurred in 2000, in the UK. The patient was a 38 year old male who was administered a total of 5 or 6 grams of a 15% total iboga alkaloid extract over a period of six hours. The patient appeared fully recovered, had eaten breakfast, gone to the toilet and suddenly died approximately 38 hours after the administration of the plant extract. The patient had hepatitis C but, exact data on the state of the disease is not available. The subject had been using heroin for 15 years. The most troubling issue relating to this fatality is that it occurred after the apparent recovery of the subject and quite suddenly. The extract has been widely used and there appears to be no greater fatality-related issues associated to it than to purified ibogaine.
NIDA in its draft protocol and the FDA in the protocol it approved in 1993, excluded patients with hepatitis C. One of the authors believes this was not so much a safety issue but, one that would allow a determination of the transformation of ibogaine into its metabolites by the liver and the associated plasma levels to be validated in pharmacokinetic studies within ranges that would be normal and not to have them skewed by a diseased liver. It is reported that the St. Kitts facility excludes HCV and HIV patients. NDA International, Inc. in its work in The Netherlands and Panama accepted HCV and HIV that were not symptomatic for the diseases. As many chemically dependent drug users test positive for HCV and as there has been no known correlation of fatalities with HCV, it does not seem that this is a reasonable exclusion criteria in the real world of chemical dependence. Non-symptomatic HIV patients have also been treated without apparent medical events. NIDA chose to exclude patients with liver enzyme values exceeding 400% above normal from a later study design. A decision to follow NIDA's footsteps on this matter may be reasonable until more information is available.
Ibogaine appears to be a very safe drug in terms of psychiatric events. One of the authors is aware of a single event from a report where a patient apparently regressed, acted in a childlike manner and urinated in bed for a period of two days, thereafter recovering. An early patient who had been hospitalized on a number of occasions for glue-sniffing related psychosis became paranoid during his first treatment and exhibited behavior distinct from any other ibogaine patient during a second treatment episode. Ibogaine providers should be aware that chemically dependent or not, many persons are going to come to them with underlying and in some cases significant underlying psychiatric disorders. NIDA's exclusion criteria for "patients with a history of active neurological or psychiatric disorders, such as cerebellar dysfunction, psychosis, bipolar illness, major depression, organic brain disease or dementia, that require treatment", may be well thought out and these patients should be avoided by persons not having professional skills in psychiatry and psychopharmacology. These matters are further reviewed in the Discussion section of this manual.
Anything that can be learned about the patient prior to treatment is valuable. And, anything learned before treatment will most likely allow a greater interpretation of events after treatment. To this end the Beck Depression Inventory, document #9, linked in the Additional Documents Section may be valuable as may the Minnesota Multiphasic Personality Inventory-2 (MMPI-2) document #10. The tests are generally only available to persons who are professionally involved in psychology or testing who then provide them to patients. Once provided with a diagnoses it is necessary to understand those disorders. To that extent the Diagnostic and Statistical Manual of Mental Disorders, 4th. Edition, better known as the DSM-IV, document #11 is published by the American Psychiatric Association is a standard in the field.
Taking this broad ranging discussion to a brief conclusion, every ibogaine patient should receive an SMA-20 and CBC blood test and an EKG. These discussions are made in the hope of initiating greater associations between non-medical ibogaine providers and medical professionals who can assist them in increasing the safety of ibogaine treated patients. Questions coming out of the London Ibogaine Conference held in December of 2001, concerned the required testing, how to obtain it and how to understand it. The International Coalition for Addict Self-Help (ICASH) in their work in the late 1980s and early 1990s faced the same problems. Their solution was to have the patient walk into an emergency room or community health service with a friend and to have the friend inform the staff that the person with them had a pain in the chest and passed out and when unconscious appeared to go into convulsions. This usually resulted in the patient obtaining a blood chemistry, an EKG and EEG to investigate the possibility of epilepsy and cardiovascular disorders. ICASH would then obtain a written authorization to obtain the medical records from the patient and request the tests results and reports of the results from the hospital where the patient was evaluated indicating that the patient was to be included in a research program. The tests and reports were then usually reviewed by a doctor who had some interest in ibogaine therapy. In any case, with the basic medical testing accomplished there is at least a place to begin in offering safe ibogaine therapy. Patients who could afford to pay for testing and did not want to indicate their chemical dependence would inform a doctor that they were going on a trek in some physically taxing geographical location and that medical testing was required to participate.
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Dose and effect
After years of review of reports of hundreds of ibogaine patient treatments, the effective dose for the treatment of chemical dependence, including opioid dependence, has been seen to be between 15 mg/kg and 20 mg/kg of ibogaine. It has been reported by some researchers that lower doses are effective but, this has been disputed. Effects of ibogaine generally will make themselves evident within 45 minutes to as long as, three hours after administration. In most cases opioid withdrawal signs will be reduced within 45 minutes of ibogaine administration. Ibogaine is usually administered in place of what would be the next scheduled dose of narcotics. This would provide for an ibogaine administration schedule 8 hours after the last dose of heroin, morphine or demerol and 24 hours after the last dose of methadone. It is expected that the patient would be exhibiting minor withdrawal signs at the time of ibogaine administration. There is no experience with ibogaine in the treatment of LAAM dependence.
Another issue pursuant to dose is that of dose increases, should anticipated effects including the diminishment of opioid withdrawal not be seen. Modification upwards of ibogaine doses have been used occasionally within medical environments and commonly by some lay providers as well as, within the African religious context. The issues remain of ability to respond to medical emergencies and of the experience of the provider to determine the safety at any time of the patient. It may be prudent to allow the primary dose of ibogaine to run its course and then provide a second dose a week later if required. That is, if the patient is still chemically dependent or exhibiting drug craving?
Once ibogaine has been administered, effects follow. The patient will usually want to lay prone and should be encouraged to remain still as nausea and vomiting as well as, being systemic have been seen to be motion related. The skin tends to become numb. Patients will report an initial buzzing or oscillating sound. A period of dream-like visualization lasting for 3 to 4 hours in most but, not all patients is considered to be the first prominent stage of ibogaine effects. This stage ends abruptly should it occur at all. Another aspect of ibogaine effect that is common are random flashes of light that appear everywhere with eyes open. This may last for hours or days. Visualization on the other hand is most common with eyes closed.
The second stage that follows visualization has been described as one in which the subject principally experiences cognitive evaluation or a review of issues that are important to the subject. These may cover every possible scenario from early childhood experiences to current health issues. This period may last for as few as 8 hours or for 20 hours or longer.
The third or final stage of ibogaine effects is that of residual stimulation. This stage, because it tends to leave the subject/patient exhausted is somewhat uncomfortable. Subjects may remain awake for two or more days. Most patients will sleep within 48 hours of ibogaine administration. Some within 24 hours of administration. Usually, there is a long term long term diminishment of the need for sleep over weeks or months. Some patients may require or request sedation. Sedatives that have been used include benzodiazepines, barbiturates and melatonin.
The effects herein described are those of single administration high dose ibogaine regimens. Ibogaine has also been given in regimens of small daily doses of 25 mg to 300 mgs/day and in small daily doses where the dose is increased on a daily basis until the desired interruption of drug dependence is accomplished. These low dose modalities have not been validated for efficacy to the same extent as have the full therapeutic doses of ibogaine. However, these low dose regimens can be traced back some decades to the work of Leo Zeff who in the case of a single patient provided ibogaine on an "as needed" basis via nasal administration to a cocaine dependent patient to substitute for his cocaine use. Lines of ibogaine were somewhat equivalent to lines of cocaine and the patient ceased cocaine use after a week of this daily self-regulated ibogaine regimen. Additionally, reports from Canadian sources indicate multi-week low dose ibogaine therapy 20 mg/day following a therapeutic dose of ibogaine in the treatment of cocaine dependence. Further, reports throughout the ibogaine provider community indicate the use of multiple dosing of varying strength doses over varying time periods in the treatment of opioid dependence. As with all determinations in medicine, decisions must be made on observations of the patient and knowledge of the disorder(s) and the medication(s) used. return to contents
Opioid Withdrawal
An issue that all ibogaine providers treating opioid dependent patients will have to address is discomfort due to opioid withdrawal signs, real or imagined by the patient. To this end it may be helpful during a patient intake interview to ask what withdrawal signs the patient has had in previous withdrawal experiences. During ibogaine therapy this information will be more useful if the provider has had experience observing opiate withdrawal signs as well as, observing patients given ibogaine who were not opiate or chemically dependent. The reason being that certain effects of ibogaine may mimic opiate withdrawal. These signs may include inability to sleep, nausea, a feeling of being cold or vomiting. It is the skill of the provider that will enable the provider to determine whether withdrawal signs are real or imagined and to assist the patient in understanding the difference. It must be recognized that elimination of withdrawal signs are not necessarily isolated ends in themselves to heroin or other opioid dependent patients. Being sick is a rational justification for relief and the simple presentation by the patient that they are exhibiting opiate withdrawal to a significant other or peer or other person in their environment has probably been used by the patient to obtain opiates or the money to do so. The conditioned response of obtaining gratification and/or attention by exhibiting opioid withdrawal signs or claiming to exhibit opiate withdrawal signs has been a successful behavioral mechanism for some patients and should be expected. Generally, if the complaint of withdrawal is made it can be expected between the 14th and 24th hour of treatment and may continue through recovery from ibogaine effects.
Two useful surveys that should be included in ibogaine therapy are the Objective Opiate Withdrawal Scale (SOWS) and the Subjective Opiate Withdrawal Scale (SOWS). Examples of these diagnostic tools follow.
