Minimal Standards of Care in Ibogaine Therapy

1. Minimal Standards of Care in Ibogaine Therapy Global Alliance of Ibogaine Therapy Providers (GITA) Barcelona 2010

2. Introduction Rationale/Intended Purpose A document produced for the Global Ibogaine Therapy Alliance (GITA) in an attempt to standardize the key practices necessary to reduce risks and solidify the potential benefits of ibogaine-assisted therapy. It is an independent addendum to the Manual for Ibogaine Therapy, Second Revision, 2003 produced by Howard Lotsof, Boaz Wachtel, et. al, and has been updated with new information compiled since that manual's publication. The intention of this document is to provide recommendations for increasing the safety of ibogaine therapy. It is intended to assist providers by offering a basic framework for safety and emergency protocols grounded in ethics and recommendations for best practices. It will outline known and suspected risks associated with ibogaine therapy and contain general guidelines for minimizing risk and preventing adverse events. It also includes recommendations for optimum scenarios, background and/or supportive information, links to further info and general considerations.

3. Intended Audience Whilst the following recommendations have come from a variety of sources, types and styles of ibogaine therapy; a large part of the focus is on protocols for drug detoxification therapy as it is a complex issue and deserves much attention because ibogaine is increasingly used for this purpose. It should be noted however, that some basic guidelines in this document are relevant to any kind of ibogaine-assisted/enhanced therapy and therefore we highly recommend that anyone taking ibogaine for any purpose take heed of the general safety advice contained in this document and in the above-mentioned Manual for Ibogaine Therapy.

4. Contributors This document is being compiled and edited by GITA on the basis of recommendations made by ibogaine therapists. These therapists include a wide spectrum of providers from informal lay therapists and underground providers through to medical doctors operating clinical type settings. These individuals have participated in ibogaine-therapy for reasons including drug detoxification/treatment, personal psychotherapy, traditional/cultural, medicinal, religious/spiritual use and a wide range of other therapeutic applications. It is also informed by medical and scientific findings, guiding policy documents regarding treatment, harm reduction and research, discussion forums and mailing lists.

5. Intention Our intention is to provide a framework for minimal standards of care and safety whilst respecting diversity in therapeutic style, program structure, setting and ethos. We understand that if proper care is taken to protect the physical, psychological, emotional and spiritual well-being of the individual undergoing therapy, then the potential for beneficial outcomes is increased. We encourage contributions, general feedback and updates.

6. Contents Orientation Training Ethical Considerations Team/Staff Structure Intake Dosing Monitoring Emergency Protocol Post-therapy Considerations Follow-Up Record Keeping Feedback and Evaluation

7. Orientation • Ibogaine Therapy Providers (TP’s) should demonstrate a capacity to work with compassion and care, even under challenging situations, throughout the course of therapy • The TP’s primary motivation should be the physical and psychological safety of any individual under their supervision • They should approach their work with positive intentions, respecting ethical considerations collectively agreed upon by ibogaine therapists and take into consideration the multifaceted individual needs and expectations of those in their care • They should have a commitment to keeping abreast of recent developments and findings about ibogaine therapy especially those relating to safety • They should recognize that ibogaine therapy is experimental in nature and be prepared to be constantly vigilant in the evaluation, updating and evolution of their own processes, procedures and protocols • They should be committed to demonstrating transparency and be candid about their qualifications, experience and knowledge in their communications with individuals applying to be under their care • They should take into consideration their own level of health and wellbeing and its impact on their capacity to provide an appropriate level of care and support

8. Training Ibogaine Therapy Providers (TP’s) should read and understand the Manual for Ibogaine Therapy, and keep their knowledge as up to date as possible through and communicating with other TPs They should read and understand the Ibogaine Patients' Bill of Rights They should understand the rationale for exclusion criteria and recognize the importance of detailed and effective screening They should understand what fully informed consent consists of They should have a clear understanding of the resource requirements They should have a minimum of training in Cardio Pulmonary Resuscitation for Health Care Providers (CPR-HCP). Ideally TPs should also be certified in assisted cardiac life support, and some level of electrocardiogram interpretation or be prepared to hire someone with these qualifications as an Emergency Medical Responder

9. Training Tp ‘s should learn and make an effort to understand as fully as possible what is known about ibogaine’s mechanisms of action and pharmacology They should learn about ibogaine’s potential effects and side effects They should understand what the potential risks are and how to prevent adverse events. They should also learn how to promptly and effectively respond to adverse events They should learn about contraindicated conditions, medications, drugs, herbs and foods They should have an understanding of the variability in individual clients They should undergo in-depth training with at least one but preferably several experienced therapy providers who have established their ability to provide services in a safe, conscientious and therapeutic manner

10. Ethical Considerations Tp’s should have a commitment to safeguarding the health, safety and dignity of their clients by following ethical guidelines intended to prevent problems and optimize potential therapeutic benefit. They should have an understanding of the ethics surrounding the provision of services to vulnerable individuals and consumer groups. The following ethical guidelines are internationally recognized in therapy and research: • Beneficence: Promotion of wellbeing • Non-malfeasance: Avoid potential harms • Dignity: Respect for the person • Informed Consent: The person's right to information, to ask questions and to weigh the risks and benefits before making a decision to undergo therapy • Confidentiality: Respect for privacy • Feedback: The person’s right to provide feedback, whether positive and/or negative and to file a grievance or incident report

11. Team/Staff Structure TP’s should not conduct sessions alone Emergency Medical Responder is necessary Having staff job/role descriptions helps All team members should sign a confidentiality agreement regarding client’s sensitive info Establish a conflict resolution process Feedback questionnaire for staff helps inform development and evolution of policies and procedures Regular staff meetings help with organization

12. Facility/Setting The TPs should make every effort possible to create a clean, quiet and comfortable therapy environment. Preferably with soft lighting options. Earplugs or headphones, eye covers, and a variety of music may be useful Phone should be available to be used if/when needed. Non-slip stick-ons for bathtub/shower, safety grab bar if possible, flashlight, etc.. Conduct fire drills with team, emergency escape route shown to client before therapy or otherwise clearly marked. Sharps container on site if any needles being used to administer drugs such as anti-nauseant, also in case if needles are found during search procedures. Posted info: emergency contact #'s, escape route, other signs such as hand washing reminders. Advisable to not use soaps in the form of bars, pump style dispensers reduce the risk of transmitting colds and infections.

13. Equipment TPs should have on location a minimum of the following equipment: CPR - First Aid Kit Pulse and Blood Pressure Monitor Thermometer Pulse Oximeter (SP02 – which monitors oxygen saturation in the blood) Ideally they should also have: an AED (Automated External Defibrillator), a Cardiac Monitor (EKG/ECG - electrocardiogram) Oxygen tank All Emergency Medical Responders (EMR) should be fully trained and confident in their ability to use and/or promptly and effectively deploy to prevent or treat any potential adverse events. The TP is responsible for regular maintenance, testing and sanitization of all the above-mentioned equipment.

14. Intake Process Informing Screening Tools (ie: application form) Medical Screening Pharmacological Screening Psychological Screening Other important data gathering File keeping and data storage Decision-making and acceptance process Rejection process Preparation and informing of client prior to therapy Please share your process and any suggestions or insights

15. Contraindicated Conditions Active infections including Peptic Ulcers (such as Gastric, Duodenal, Esophageal), Pneumonia, or Skin Abscess Cancer (there is no information regarding how ibogaine will affect this condition and interact with medications or otherwise affect disease progression) Cerebellar Dysfunction including Cerebral Palsy, Multiple Sclerosis and Stroke Cluster Headaches, Severe Migraines Epilepsy or history of seizures Heart disease or problems such as arrhythmias, heart irregularities, murmur, palpitations, history of heart attack, Myocardial Infarction, Pericarditis, Prolonged QT Syndrome, Alcoholic Cardiomyopathy, etc... High Blood Pressure - untreated (unmedicated hypertension) Gastrointestinal disorders such as Inflammatory Bowel Disease, Crohn's Disease or Irritable Bowel Syndrome Kidney disease including kidney stones and other compromised kidney function such as Urinary Infection Liver disease (dependent on condition - liver enzymes more than 400% above normal indicate compromised liver function and possibility of toxicity ) Lung disease such as Asthma, Bronchitis, Emphysema or other respiratory problems Pregnancy Stroke Tuberculosis uncontrolled Diabetes Vascular disease such as Venous Insufficiency, Deep Vein Thrombosis, Arteriosclerosis, Lymphedema, Phlebitis, Blood Clots or coagulation abnormalities, etc... Serious Psychiatric disorders

16. Dosing Many different dosing regimens have been developed, please contribute your findings; include rationale, benefits and challenges. Clients should also be informed of dosing regimen and any changes that arise during course of therapy

17. Monitoring • Record baseline vitals • Pulse, BP, Temp, Stress test, SP02, ECG (if available) • During Therapy - Post Admin • Pulse, BP, Temp, SP02, ECG (if available) • Every 15mins during first 2 hrs, every ½ hour thereafter for 8 hrs, every hour until resolution (at least 36hrs) • Check for signs of trouble or distress in other ways (ie: watch/listen to breathing, try to make eye contact occasionally, simple dialogue /check-in, etc…) • Record all results and observations in a legible, comprehensible and organized fashion

18. Emergency Protocol Have one!!! Minimum: call emergency services 911, 061, etc… Optimal: Have an EMR: Doctor, Nurse, Paramedic, EMT… Be prepared to employ AED Prepare emergency protocol with your local Hospital/Paramedics/Emergency prepared clinic Send information and updates to Poison Control Center or equivalent in your country Have a crash cart onsite List of emergency contact #’s should be posted in facility, near the phone. Consider setting up protocol with local emergency psychiatric services (if available)

19. Post-therapy • Inform client of reduced tolerance and potential for overdose or other potential adverse effects • Provide contact information • Maintain contact if possible – Follow Up • Consider giving them a package of information to help support them: • ie: referrals/copy of tx notes, consent form, contact info, follow up schedule, info for family and friends, links for further support and information, self care…

20. Follow Up • Try to maintain some form of contact with client • Collect Data if possible • Share resulting data if possible • Considerations: • Be aware of client-therapist dynamics • pay attention to your boundaries • Prepare for what to do if someone is in crisis

21. Record Keeping Some suggestions: Experience Report Measures/Questionnaires Staff Evaluation Forms Clinical Discharge Report File Checklist Store files securely

22. Feedback and Evaluation Elements th help to improve services Take time to collect feedback and consider suggestions for improvement from clients, staff , other providers and yourself Create some form of evaluation process