1. Context of Care

Informed Consent

The World Medical Association’s Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects outlines specific requirements for informed consent when working with an experimental treatment. Whether or not patients explicitly demonstrate the presence of risk factors listed in these guidelines, they should be provided complete and accurate information regarding:

The legal status of ibogaine in the region where the treatment is taking place,
The experimental status of ibogaine-assisted detoxification in scientific literature,
The risk factors involved in ibogaine treatment,
The level of experience and qualifications of the caregiver that will be present during ibogaine administration,
A realistic assessment of any possible benefits,
Possible limitations of the particular method and protocol to be used,
Information about alternative options that may be available,
And, The Ibogaine Patient’s Bill of Rights.

This information should be available to the patient at least two weeks prior to arrival, if possible, and should be reviewed and signed in person with a staff member prior to treatment.

Care Providers

The John’s Hopkins University research team’s Human hallucinogen research: guidelines for safety suggests that the most important quality in a therapist, rather than medical or psychological credentials, is empathic skill (Johnston 2008). We carry forward the same recommendation, however even if the primary care provider is not medically credentialed, in order to effectively manage medical risks a minimum level of medical supervision should also be present.

The John’s Hopkins team and others in the psychedelic therapy community widely recommend the presence of a male/female therapist dyad (Johnson 2008, Grof 2000). In the absence of this, we recommend, at minimum, a same gender therapist. This has therapeutic value, but also practical considerations. The ataxia brought about by ibogaine makes it difficult to walk, and a therapist may be needed to assist the patient in the bathroom.

Medical Supervision

Whether as a primary care provider, or in a supportive role to another therapy provider, medical supervision ensures preparedness in the rare case of cardiac emergency, even after thorough screening has been conducted.

It is highly recommended that all care providers have a minimum of a Basic Life Support (BLS) certification, and are well versed in the treatment of status epileptics seizures and maintaining an airway.

In addition, ACLS trained and equipped medical staff that are knowledgable about the pharmacodynamics of ibogaine and appropriate emergency responses should be available on hand throughout the treatment episode. Preference is given to medical staff certified through an ACLS for Ibogaine Therapy course offered by GITA.

The equipment generally considered necessary to minimize the risks as outlined in this manual is listed in Appendix B.

In cases where medical professionals are the primary care providers, we strongly recommend formal training in working with patients who are undergoing altered states.¹

Emergency Preparedness

Unless the treatment is conducted in a hospital setting, the treatment location should take place within a 15-minute range for fully equipped emergency responders, and ideally no further than 30 minutes from a fully equipped 24-hour hospital.

A thorough emergency plan should be in place, and staff should be well versed in their role in carrying it through.

Set & Setting

Since early days of psychedelic research attention has been drawn to the factors of set & setting (Leary 1964). It is crucial that the therapeutic team understands and displays an acute sensitivity to the development of therapeutic relationships and a therapeutic space.

Set

This term refers primarily to the internal preparations, the state of mind and the intentions of the patient. It can be helpful to review expectations, concerns and hopes prior to the session, as well as to review the general psychological and physiological terrain that might emerge during the experience so that the patient feels a sense of openness and preparedness for what they are about to undergo. Developing a therapeutic relationship can be integral to this supporting the patient in this process.

Setting

This refers to considerations in the immediate environment, and can be extended to include such things as decoration, incense, and music selection. It is important to ensure that the space is as comfortable and clean as possible, with a bed, easy access to a bathroom, and that it will be free of interruption for the duration of the treatment episode.

With other psychotherapeutic aids therapy is often conducted in direct conjunction with administration. However, with ibogaine it is strongly advised that during the acute phase of the experience conversations be limited only to necessities, such as checking in quietly, or coordinating physical movements or medical assistance. It may be appropriate to offer a quite tip if prompted, but otherwise, therapeutic conversations should be limited to pre and post administration, and patients should be given as much space as possible to benefit from the internal process.

Patients become extremely sensitive to light and sound during the course of treatment. The external space should be quiet, and if necessary aids such as earplugs or music through earphones should be available. It should also be easy to darken the space. Comfortable eye masks (such as Mindfold Relaxation Masks) can be effective at blocking all or most of the external light. Ideally, lighting in the room should be ambient and non-intrusive, such as candles or soft lamps.

There are various schools of thought regarding the timing of sessions. Some therapy providers have preferred late afternoon and early evening because there are naturally fewer distractions. However, it is generally easier to access medical support or emergency services during daytime hours. Risk reduction should be a primary consideration.

Music

In psychedelic therapy, music has widely been regarded as beneficial both therapeutically, as well as in reducing psychological risks, by helping the internalization of the process (Grof 2000). Researchers from the Maryland Psychiatric Research Center observed that, “Music appears to be involved significantly in the crucial extra-drug variables of both set and setting” (Bonny 1972).

In general, considerations about the music in psychedelic sessions are also relevant for ibogaine therapy. It is strongly advised that appropriate high fidelity music is available through comfortable headphones.

It is highly recommended that the music selection playing during the peak effects is non-verbal, or that it be in a language not understood by the patient. Appropriate music can be found throughout cultures in which there were efforts to use music meditatively, or in order to access transcendental spaces. Examples include Indian ragas, Sufi chants, Mongolian throat singing, etc. There are also extensive libraries of music by traditional pygmy and Bwiti villages that can be very useful to incorporate. The polyphonic singing of some pygmy communities is one of the most advanced known examples of natural overtones. However, the patient’s music preference, and their response to what is played should be a main concern.

Adjunct Therapies

Ibogaine can be a powerful tool in detoxification and treatment of substance abuse disorders. Both ibogaine (He 2006) and noribogaine (Carnicella 2010) have the capacity to increase the expression of GDNF, a protein that stimulates the growth of new dopamine neurons. It has been shown to produce a valuable state of neuroplasticity that can improve ability to learn new information (Popik 1996), and potentially to ingrain new habits and patterns of thinking.

Neuroplasticity can also be an opportunity to further ingrain negative patterns if positive ones are not enforced. There are practices that in conjunction with ibogaine can help to ensure that the lifestyle changes it initiates are positive and health affirming. This is a non-comprehensive list of adjunct therapies that many have incorporated into their treatments with positive results, including:

Psychotherapy

Various psychotherapeutic techniques provide valuable guidance after ibogaine therapy. This can include CBT, which has been shown to have strong efficacy in the treatment of addiction (Hofmann 2012). Others such as Hollotropic Breathwork, Gestalt therapy, and others have been shown to be valuable tools when applied in conjunction with psychedelic therapy.

Nutrition

Nutrition not only promotes overall health, but can also be a source of important precursors for neurotransmitters that can be very helpful in the recovery process. Diets are often extremely deficient when people are struggling with SUDs and not tending to their basic needs. The period following ibogaine detox can be an important time to re-learn an appreciation for proper nourishment.

Bodywork

Bodywork and physical therapy not only can provide relaxation, as well as relief for people who suffer from discomfort or chronic pain, but it can help people to connect with their body in a new way, which can be grounding and affirming.

Exercise

Exercise has been shown to increase beta-endorphin levels, which has a positive effect on many underlying conditions that are common amongst those with SUDs.

Meditation

Simple mindfulness practices have been shown to help balance brain hemispheres, and generally promote clarity, focus and relaxation. It is not necessary to encourage any elaborate practice, but the foundations of simple meditation techniques can be helpful both during and after the ibogaine experience.

Neurofeedback & Brain Stimulation Devices

Some brain stimulation devices have been FDA approved to treat a variety of conditions, including anxiety, insomnia, depression and chronic pain.

Caution Regarding Detoxifying Therapies

Detoxifying therapies can include colonics, enemas, ozone therapy, castor oil, etc. These methods have all been included for various reasons, some in order to deal with constipation or compaction for opioid users, which constitute a risk factor during treatment.

It should be noted that any therapy that has the potential to deplete electrolytes should be avoided. However, after any major procedure that might affect electrolytes, blood tests and liver panels should be re-taken.

Furthermore, therapy that might release toxins into the body should be avoided in close proximity to ibogaine therapy as this might have an overall effect on energy metabolism.

Record Keeping

Working with an experimental medication requires rigorous record keeping for many reasons. Most obviously, detailed records can provide useful statistical information on how successes were achieved.

In relation to risk management, however, it is much easier to learn and to share information about well documented cases in which treatment goals were not achieved or the treatment episode resulted in an adverse event. Without records, important details can be easily missed and these mistakes are liable to be repeated.

It is highly recommended that extra care be taken in documenting every aspect of the treatment process described in the rest of this document.

i. Introduction

2. Patient Criteria & Considerations