Inclusion & Exclusion Criteria

This page includes Inclusion and Exclusion Criteria for those who are considering an Iboga journey at the iBoga Clinic. It has been adapted from the Ibogaine Dossier, which has become an internationally recognised authority on the safe use of Ibogaine.

Potential clients should be aware that this medication has not been through the testing required by the American corporate model of health care, ie the 3 stages of FDA drug trials, 1. Biochemical Testing 2. Animal testing 3. Human testing. Therefore it is considered by many medical authorities to be unsafe for widespread use.

Against this is the fact that many thousands of doses have now been recorded in a diverse number of countries. One good example is a clinic at St Kitts in the Carribean, run by board certified addiction specialist Dr Jeff Kamlet MD. He has now logged over 1800 Ibogaine treatments, with what he states is “zero mortality, and zero morbidity”.

However, the medicine does have some risks for some people, the worst of which can be difficult cardiac arrhythmias, which can – and have – resulted in unexpected mortality. For this reason it is now accepted International practise to have Iboga drug detoxification supervised by a qualified medical practitioner, who is familiar with the Inclusion and Exclusion Criteria listed on the Ibogaine Dossiers site.

INCLUSION CRITERIA

1. Subject participation must be voluntary and not coerced.

2. Subject must sign an Informed Consent that indicates and understanding of the risks and benefits of ibogaine administration.

3. Subject must undergo a general medical evaluation by the iBoga clinic doctor.

4. Subject must supply a copy of their medical history questionnaire.

5. Subject may be required to respond to a Beck Depression Inventory questionnaire.

6. Subject must obtain an ECG (electrocardiogram) and report.

7. Blood tests specified by iBoga Clinic doctor:

8. Upon subject meeting all other inclusion criteria and not being excluded by exclusion criteria, subject will be administered a 400 mg (total) test dose of ibogaine. Should the subject not have an adverse or atypical response, a full therapeutic dose of ibogaine may be considered. See exclusion criteria #4.

9. Ibogaine providers following a medical model may require evaluation of cytochrome P450 enzymes activity. Particularly, P450 2D6 (CYP4502D6) plays a significant role in the metabolism of ibogaine to noribogaine, its active metabolite. Testing allows a determination of whether the patient will be a “poor metabolizer” (PM), “intermediate metabolizer (IM), extensive metabolizer (EM) or “ultra rapid” metabolizer (UM). This testing is now available through commercial laboratories.

EXCLUSION CRITERIA

In order to begin to address the safety of persons being treated with ibogaine, the following indications should exclude treatment with ibogaine.

1. 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.

2. Patients who have a Beck Depression Inventory score greater than or equal to twenty-four.

3. Patients requiring concomitant medications that may cause adverse ibogaine/other drug interactions (e.g., anti-epileptic drugs, antidepressants, neuroleptics, etc.)

4. Patients with a history of sensitivity or adverse reactions to the treatment medication.

5. Patients with a history of significant heart disease or a history of myocardial infarction.

6. Patients with blood pressure above 170 mm Hg systolic/105 mm Hg diastolic or below 80 mm Hg systolic/60 mm Hg diastolic or a pulse greater than 120 beats per minute or less than 50 beats per minute.

7. Patients who have a history of hypertension uncontrolled by conventional medical therapy.

8. Patients who have received any drug known to have a well-defined potential for toxicity to a major organ system within the month prior to entering the study.

9. Patients who have clinically significant laboratory values outside the limits thus specified by normal laboratory parameters.

10. Patients who have any disease of the gastrointestinal system, liver or kidneys, or abnormal condition which compromises a function of these systems and could result in a possibility of altered metabolism or excretion of ibogaine may be excluded. As it is not possible to enumerate the many conditions that might impair absorption, metabolism or excretion, the provider should be guided by evidence such as:

A. History of major gastrointestinal tract surgery (e.g., gastrectomy, gastrostomy, bowel resections., etc.) or a history or diagnosis of an active peptic ulcer or chronic disease of the gastrointestinal tract, (e.g. ulcerative colitis, regional enteritis, Crohn’s disease or gastrointestinal bleeding).

B. Indication of impaired liver function.

C. Indication of impaired renal function.

11. Patients with active tuberculosis.

12. Pregnancy

The Criteria listed above are not universally accepted, as the use of the medicine world wide is still in an early stage of development. The following discussion by various authors is extracted from the Ibogaine Dossiers.

“Regarding the manual I would disagree with some of the exclusion criteria,” says one author. “By excluding patients that are depressed or bipolar you exclude a sizable portion of the addict population. Because ibogaine’s metabolites have been shown to have an antidepressant effect it would probably help these patients. Proper treatment for psychiatric conditions can be administered afterward. You will find below some of the experience we have had with patients taking antidepressants prior to ibogaine and since many patients have psychiatric conditions, we don’t consider it prudent or necessary to suspend psychotropics for longer than 24 hours before treatment. Below are presented three examples of such patients. All of these patients suspended their medications 24 hours prior to treatment and apparently had no different responses to ibogaine or any unexpected side effects.”

1)   22 year old male on Prozac (fluoxetine) 20 mg for 14 months.
2)   38 year old male on Zoloft (sertraline) 100 mg for 2 years.
3)   36 year old female on Paxil (paroxetine) 40 mg for 1 year.

“Since most patients are depressed, a fast acting antidepressant can help in the days after ibogaine. We have found S-adenosyl-L-methionine (SAMe) to be useful. If necessary we also prescribe SSRI’s. These take about two weeks to start working. Another simple but effective therapy is DHA (omega-3 fatty acids). These reduce depression and stabilize mood.”

Commenting on the exclusion criteria, another author states, “I don’t think depression should be taken as a contraindication. I’ve treated a lady with an extreme depression hoping it would help. It didn’t. The condition remained unchanged. Of course, one case – no case. People on Oxycontin often claim depression. No wonder – that’s what the interruption of oxycontin use usually leads to. Ibogaine is needed to eliminate the addiction. I suggest antidepressants be started immediately after ibogaine therapy under the supervision of a physician.”

Further, an author indicates “that Crohn’s disease should not be an exclusion criteria as one patient diagnosed with Crohn’s disease had the disease placed in remission after ibogaine therapy.” While other authors have not had such experience it should be noted that an early report from Dutch Addict Self-Help concerning Hepatitis C being placed in remission resulted in most providers, including then, NDA International, Inc. agreeing to treat patients with HCV whose liver enzymes were not greater than 400% above normal. It must be remembered that we are discussing an experimental medical procedure should that definition be accepted and that medicine itself is diverse in its effects, expectations or adverse events.

A number of authors indicate nonfatal adverse medical events in patients with stomach ulcers. Ibogaine may cause pain and/or bleeding in these patients. Whether this is a matter of irritation to the stomach lining or a more systemic effect is unknown at this time thus, it is unknown whether rectal administration rather than oral administration would ovecome this problem.

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2 thoughts on “Inclusion & Exclusion Criteria

  1. I have graves disease. So can have a fast heartrate and I thknk I have a dodgy rhythm. I have been found to have large amounts of heavy metals. The highest being lead and mercury I have been looking for a good way to detox. Am I excluded from being able to try this treatment

    • Hi Emma – we are not doing any treatments at the moment, but I can still give you some medical advice. Graves Disease is not a contraindication to treatment with iboga, but your thyroid function needs to be in the normal range with medication first. If you are hyperthyroid it you put you at increased risk of cardiac arrhythmias with iboga treatment. of course it is important to get the routine blood tests and ECG done prior to treatment in any case – hope this helps – best wishes

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