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EXCLUSION CRITERIA

 

In order to begin to address the safety of persons being treated with ibogaine, the following indications will exclude clients for 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 will 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

 

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