Inclusion Criteria

The therapeutic relationship begins during the initial contact with the patient. Whether in person, by telephone, or other correspondence, it provides an important opportunity to begin to build a foundation of trust, as well as to assess the patient’s eligibility for ibogaine therapy.

The most basic considerations for inclusion in therapy are establishing a significant degree of consent. Ibogaine has been generally observed to be ineffective in patients who are not personally committed to therapeutic process. That excludes all forms of intervention-based treatment, state-incentivized treatment models, or any other way that patients may be coerced to participate in the therapeutic process.

The basic considerations for inclusion are as follows:

• Has understood the basic scope of the treatment and what it involves.
• Has a strong desire to take ibogaine and realistic expectations about possible outcomes.
• Is willing to be a part of a process that includes adhering to provider and clinicians’ requests to attend appointments, submit a comprehensive application, and complete other preparation protocols thoroughly and honestly.
• Takes the responsibility of engaging with other services of the options that have been referred to, and continues with ongoing self-care.
• Accepts the Responsibilities in the Ibogaine Patient’s Bill of Rights.

Application

Careful screening is the most important factor in minimizing risks associated with ibogaine-assisted detoxification. The considerations below reflect the known psychological and biological risk factors, and should be taken into careful consideration for every patient prior to intake.

Sufficient personal information and medical history, particularly that regarding psychological diagnoses and drug or mediation use, prior to intake is crucial in making an informed assessment. Interpretation of this information for screening is discussed throughout the rest of this chapter.

Personal Information & Medical Overview

Basic personal information should include: name, personal contact information, emergency contact person information, height, weight, assigned and preferred gender identity, a complete history of accidents, hospitalizations, and surgical procedures, as well as a complete history of previous illnesses, heart conditions, and other diagnoses, including psychiatric diagnoses.
Drug Use Profile

Clinicians should review a complete history and current use of all medications, prescriptions, over-the-counter drugs, street drugs, vitamins, supplements and herbs. This should include dosages and usage patterns. Information about the nature of use including overdoses, at-risk behavior, and any previous experience with psychotropics should also be taken into consideration.

Medical Tests

The following medical tests should be considered in relation to the medical history:

• Resting 12-lead electrocardiogram
  • Taken while not wearing metal objects, while not under the influence of stimulants (including coffee), and while not in withdrawal, etc.
• Stress echocardiogram, valium stress testing, or 24 halter monitor
  • In the case of arrhythmias, extrasystoles, ST segment changes indicating myocardial ischemia/infarction, significant cardiac history, or cardiac risk factors.
• Complete Metabolic Panel (Chem 12 or Chem 18)
  • Including creatinine and electrolytes, sodium, potassium, serum magnesium, and liver functions.
• Complete Blood Count (CBC)
• Complete Thyroid Function Test
  • In the case of a history of thyroid disease or currently prescribed a thyroid-stimulating hormone (TSH) test is not sufficient.
• Complete Physical
  • Conducted when necessary to consider the context of certain pre-existing heart conditions.

Cytochrome P450 2D6 Phenotype

Some preclinical data suggests that dosing regimens should be altered according to CPY2D6 phenotype, especially for Poor Metabolizers and Rapid Metabolizers, the extreme outliers on the spectrum (Glue 2015). This is later addressed in the discussion about dosing (Ch. 14).

Absolute Exclusion Criteria

In the presence of any of the following criteria patients should be excluded from ibogaine-assisted detox due to the gravity of the associated risks. The nature of some of these risks have been previously discussed; others are explained here for clarity. Where possible, these issues should be addressed, and then reassessed, prior to intake.

Certain psychiatric conditions

• Schizophrenia
• Bipolar disorder for which patient has been hospitalized or medicated
• Depersonalization and/or Derealization Disorder
• Cerebellar dysfunction
• Epilepsy
  • Rule out the possibility that benzodiazepine or alcohol withdrawal related seizures have  been misdiagnosed as epilepsy.
• Psychosis or acute confusional state
• Organic brain disease
• Dementia

Certain pre-existing heart conditions

• Prolonged QTc Interval
  • The FDA considers prolonged QTc to be: 450 milliseconds for males and 470 milliseconds for females
• History of heart failure, enlarged or hypertrophic heart
• Active blood clots
  • Pulmonary embolism
  • Deep vein thrombosis

Certain major respiratory conditions

• Low oxygen levels and required steroid treatments lead to excessive risks.
• Emphysema
• Chronic Obstructive Pulmonary Disorder
• Cystic Fibrosis

Severe or chronic gastrointestinal issues

• Bleeding ulcer
• Leaky gut syndrome

Other criteria

• Abnormal blood test results:
  • If potassium or magnesium are outside normal ranges they should be corrected.
• Impaired Kidney or Liver function
  • Any patient with liver enzymes greater than 2.5 times normal levels, on dialysis for kidney failure, or with abnormal Blood Urea Nitrogen (BUN) or creatinine levels may not be able to metabolize ibogaine properly, and might experience toxicity.
• Active infection or abscess
• Within 6 months of major surgeries. Get physician approval.
• Pregnancy

Cardiac Risk Factors to Consider

In the presence of any of the following conditions, a risk benefit analysis should be conducted by a cardiologist that is knowledgeable about ibogaine’s pharmacodynamics if patients are to be considered.

Certain pre-existing heart conditions

• Borderline QTc interval
  • The FDA considers borderline QTc to be: 430 milliseconds for males and 450 milliseconds for females
  • Ibogaine also extends the QT interval. This should be carefully monitored to make sure that it does not become prolonged. Monitor electrolytes.
• Irregular heart rhythms (Arrhythmias)
  • Atrioventricular heart blocks
  • Any history of ventricular arrhythmias
  • Atrial Fibrillation (clot risk)
• Childhood congenital heart defects
• Heart attack (Myocardial Infarction, Coronary Vasospasm)
• Murmur
  • Use echocardiogram to rule out significant Valvular Heart Disease (Valve Stenosis, Regurgitation, Prolapse)
    History of Pericarditis/Endocarditis
  • Call for an echocardiogram.
• Family history of heart attack/sudden cardiac death before 50 years of age
• Major heart/vascular/pulmonary surgery i.e. transplant, Coronary Artery Bypass Grafting, artificial heart valves, childhood Coronary Heart Disease, surgeries.
• Internal or External Pacemaker
• History of blood clots
  • Stroke or transient ischemic attack should only be accepted with sufficient time since event and pre-clearance.
  • Pulmonary embolism or deep vein thrombosis should only be considered if these previous issues have been sufficiently resolved.
• Abnormal Heart Rate/Rhythm
  • Resting heart rate of ≥120 beats per minute or higher; or ≤50 beats per minute.
• High/Low blood pressure
  • 170/105 or higher or 90/60 or lower, while not taking blood pressure medication.

Other cardiac disease risk factors

Including: Hypertension, hypotension, diabetes, nicotine use, high cholesterol, peripheral vascular disease, chest pain/shortness of breath with or without exertion, frequent indigestion, and unexplained fainting.

Other Risk Factors to Consider

The rest of this list includes non-cardiac-related risk factors that should be considered during the application phase by a knowledgeable physician. In some cases preparation protocols can help to resolve these issues prior to treatment, and success with these protocols should be considered prior to acceptance.

Certain psychiatric conditions

• Without proper therapeutic support, ibogaine may exacerbate or re-traumatize patients with some conditions.
  • Bipolar disorder
  • Post traumatic stress disorder (including sexual or violent trauma)
  • Borderline personality disorder
  • Beck depression inventory score ≥24
  • Suicide attempts, ideations and/or intents

No accessible veins for IV port access

In this situation a central line should be inserted prior to treatment. Although other options exist for emergency meds, a central line is the only way to provide fluids, which are primary to several emergency interventions (Ch. 14).

Irregular Thyroid

Hypothyroid leads to increased bradycardia, while hyperthyroid leads to increased risk of tachycardia. Make sure that thyroid medication has stabilized thyroid function.

Major respiratory conditions

• Sleep Apnea
  • Sleep Apnea makes it difficult for people to breath when they are in a sleep state. Saturation or flood doses of ibogaine put people into a sleep-like state, and apneic breathing can cause oxygen saturation to fall dangerously low, which in extreme cases could put the patient at risk for life-threatening hypoxia.
  • Patient should use their prescribed respiratory device during ibogaine administration, and oxygen levels should be monitored closely.
• Asthma, COPD (Chronic Obstructive Pulmonary Disease), emphisema, history of greater than 30 pack/day for 30 years
  • Check for severity of the condition. If the patient has been hospitalized or has had multiple severe attacks in the last 2 years, they should be considered a poor candidate.
  • Check for preparation requirements with prescribed steroid inhalers (Ch. 8).
  • Review Asthma Attack Intervention (Ch. 15).
• Pulmonary Fibrosis
  • Typically patients will be oxygen dependent. Should be considered a poor candidate.
  • Check for preparation requirements with prescribed steroid treatment (Ch. 8).
• Sarcoidosi

Metabolism, Diet, and Gastrointestinal Issues

• CMC or Metabolic Panel results outside of normal ranges
  • Preferred ranges for potassium (4.5-5.5 mEq/L) and magnesium (1.5-2.5 mEq/L) are ideal.
• Constipation or Impaction
  • Movement of the diaphragm can be compromised, leading to lower blood-oxygen saturation, and subsequently hypoxia and left ventricular dysfunction. Hypoxia may precipitate angina or tachycardia. Observe for dizziness and hypotension.
  • Can impede metabolism of medications.
• Obesity
  • In addition to significant concerns about energy metabolism, ibogaine is stored in fat tissue. Obesity will greatly affect metabolism of ibogaine.
  • At a BMI of 35+, risk of blood clot and stroke are dangerously high. These patients can be put on mini-heparin or lovanox (blood thinners that don’t change coagulation factors) during treatment.
• Eating disorders
  • It can be extremely dangerous to treat with anorexia or bulimia. These patients must be stabilized with electrolytes prior to treatment, and must remain under constant observation to make sure they are not purging or binging prior to administration.
• Malnutrition
  • Noribogaine is stored in fat tissue and released back into the blood plasma, and by some accounts this may have an effect on lasting benefits.
• Crohn’s disease, Irritable bowel syndrome, biverticulosis, biverticulitis
  • Patient should be cleared by a gastroenterologist if the condition is stable. Discuss considerations with mediation.
    Pancreatitis
• Other considerations
• Chronic infectious diseases (i.e. Tuberculosis, Hepatitis B or C, HIV)
• Overdose history
• History of head trauma with loss of consciousness for a significant amount of time
• Age 60+
  • Recommended to obtain a stress ECG test.
• Family history of certain psychiatric conditions, which may have a risk of expressing, primarily in patients under 30 years of age
  • Bipolar disorder
  • Schizophrenia
  • Depersonalization and/or Derealization disorder
  • Cerebellar dysfunction
  • Epilepsy
  • Psychosis
  • Organic brain disease
  • Dementia

Drug Interactions to Consider

Common prescription drugs and drugs of abuse which pose major complications, or for which treatment is frequently sought, are listed in the following chapters:

Chapter 3: Opioids
Chapter 4: Benzodiazepines
Chapter 5: Alcohol
Chapter 6: Stimulants
Chapter 7: Antidepressants
Chapter 8: Steroids
Chapter 9: Other Medications

Here are listed broad classifications of other medications and their considerations:

QT prolonging medications, foods and supplements

Ibogaine causes bradycardia, hypotension, and prolongation of the QT interval. Each of these symptoms may be in conjunction with or independent of the others. Other QT prolonging drugs exacerbate these effects, which can put a patient at greater risk for lethal cardiac arrhythmias. All other medications that prolong the QT interval should be assessed.¹

Diuretics

Can lower potassium and sodium levels. It is important that serum electrolyte levels are checked after discontinuing diuretics.

CYP2D6 Metabolism Interactions

This enzyme is the channel by which ibogaine is metabolized in the liver. Other drugs in the body that are metabolized by this enzyme² could interfere with a patient’s ability to efficiently metabolize Ibogaine.

Centrally Acting Drugs

All centrally acting drugs should be avoided or managed with extreme vigilance. Interactions with ibogaine are not well understood. This classification includes blood pressure medications, benzodiazepines, non-benzodiazepine hypnotics (i.e. Z class drugs), barbiturates, muscle relaxants, antipsychotics, anticonvulsants and general anesthetics.

Serotonin Increasing-Medications

Examples of medications that increase the level of serotonin in the body include: SSRIs, SNRIs, NRIs, MAOIs, buspirone (anxiety tx), trazodone (depression & insomnia tx), certain migraine medications, certain pain medications (fentanyl, meperidine, pentazocine and tramadol), dextromethorphan (cough suppressant), certain anti-nausea medications (granisetron, metoclopramide, ondansetron), cocaine, and some dietary supplements like St. John’s Wort.

Ibogaine also causes an increase in serotonin, and extreme levels can cause serotonin syndrome with symptoms of acute confusional state (see Ch 7 for Antidepressants).

Calcium Channel Blockers or Beta Blockers

Calcium Channel Blockers are prescribed for high blood pressure and for arrhythmias. Beta Blockers  (see Ch. 9) are primarily prescribed for high blood pressure and tachycardia. Carefully consider these underlying conditions, and whether the medications are necessary. These medications can lower blood pressure and heart rate dramatically, and alter electrical conduction through the heart.

Anti-Arrhythmic Medications

Patients with arrhythmias that require medication should be considered poor candidates.

Birth Control

Some forms of female birth control are slightly higher risk for blood clots. This should be noted wherever other clot risks are present.

A Note About the Calculation of Half-Lives

Throughout the rest of this document, when calculating the period of time to recommend that people stop taking certain medications prior to treatment, calculate from at least four to seven times the listed half-life of the medication. This is variable depending on the drug and how critical it is. In some cases more specific considerations will be noted.