London iCAAD 2019 - Dr Jeffrey Kamlet - A PRIMER TO THE TREATMENT OF ADDICTION USING IBOGAINE – WHY HAS ‘THE MOST IMPORTANT MEDICATION DISCOVERY IN THE HISTORY OF ADDICTION MEDICINE’ BEEN OVERLOOKED?
As the world’s leading expert on Ibogaine administration, side effects, risk versus benefit and pharmacokinetics of all forms of Ibogaine, my presentation will begin with a brief history of Ibogaine. How Ibogaine has been used for hundreds of years in Africa as a sacrament by the Bwitti and other tribes in Gabon. How, when it was legal in the United States, it was serendipitously discovered by Howard Lotsoff to ameliorate Heroine and Methadone withdrawal in less than 24 hours.
iCAAD London 2019 - Dr Michael McCann and Sarah Chilton - ADDICTION IN THE W...iCAADEvents
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Similaire à London iCAAD 2019 - Dr Jeffrey Kamlet - A PRIMER TO THE TREATMENT OF ADDICTION USING IBOGAINE – WHY HAS ‘THE MOST IMPORTANT MEDICATION DISCOVERY IN THE HISTORY OF ADDICTION MEDICINE’ BEEN OVERLOOKED?
Similaire à London iCAAD 2019 - Dr Jeffrey Kamlet - A PRIMER TO THE TREATMENT OF ADDICTION USING IBOGAINE – WHY HAS ‘THE MOST IMPORTANT MEDICATION DISCOVERY IN THE HISTORY OF ADDICTION MEDICINE’ BEEN OVERLOOKED? (9)
London iCAAD 2019 - Dr Jeffrey Kamlet - A PRIMER TO THE TREATMENT OF ADDICTION USING IBOGAINE – WHY HAS ‘THE MOST IMPORTANT MEDICATION DISCOVERY IN THE HISTORY OF ADDICTION MEDICINE’ BEEN OVERLOOKED?
1. Ibogaine as an Interrupter of Substance Abuse
Disorders:
Why Has the Cure for Opiate Dependency Been
Overlooked?
***************************************
(Financial disclosures-None)
Jeffrey D. Kamlet, MD, FASAM DABAM FACFE,
DACFM, DACFPS
iCAAD London 2019
Jeffrey D. Kamlet, MD, FASAM, DABAM
2.
3. • Ibogaine is not the cure for addiction. It is the closest thing we have as a cure for opiate
dependency. What takes 90 days in the typical model of “pharmaceutical substitution”
detoxification can be accomplished in 18 - 36 hours following a single oral flood dose of
Ibogaine hydrochloride.
• It has shown promise as an addiction interrupter for a variety of substances from; alcohol,
cocaine, methamphetamines, nicotine and others. It does NOT work for benzodiazepines.
• Yet its effects on opiate dependence are unparalleled and easily objectively quantified while
its success with other drugs is subjectively quantified.
• Opiate withdrawal is a set constellation of very measurable and predictable symptomatology
which is easily studied and cannot be missed by even by the casual observer.
4. • Ibogaine is a monoterpene indole alkaloid from plant sources, principally from the perennial
rainforest shrub root bark of Tabernanthe Iboga which is native to central west Africa,
particularly Gabon.
• Animistic tribal religions like the Bwite use small dosages to treat fatigue,
hunger, and thirst and have traditionally used larger ceremonial dosages for healing and
Initiation rights to meet their ancestors and connect to the forest.
7. BRIEF HISTORY OF IBOGAINE
• Ibogaine was first extracted from iboga root in 1901
• French pharmacologist began to study Ibogaine’s cardiovascular and neurological
effects
• In France laboratory Houdé marketed tablets containing 5 to 10 mgs of Ibogaine as
a drug called Lambarene for fatigue and depression. Lambarene was withdrawn
from the market in 1996 other research groups such as NIMH and CIBA
pharmaceutical were studying Ibogaine’s ability to potentiate morphine’s analgesic
effects.
8. • In 1962, Howard Lotsof, a 19 year old NYU film student, who was living with his
parents in New Jersey, was addicted to heroin, methadone, and abusing
methamphetamines. He purchased Ibogaine legally at a “head shop” in New York
City and then after 36 hours, he noticed he had no desire to use more opiates and
experienced no withdrawal symptoms after years of trying to cut back decrease and
stop his opiate addiction by every means possible.
• Over the course of 8 months Lotsof admitted ibogaine to 20 people, 7 of whom
were using heroine and cocaine. 5 of those 7 related total immediate cessation of
drug use without withdrawals for periods ranging from 16 to 18 months.
• In 1965 Congress passed the “Drug Abuse and Control Amendments” to the Food,
Drug, and Cosmetics Act. Sale and distribution of Ibogaine became regulated in
1967 and was then scheduled in the USA by the DEA as a schedule 1 drug.
9. Su b st an ces h ave n o cu r r en t ly
accep t ed m ed ical u se in t h e Un it ed
St at es, a lack o f accep t ed saf et y f o r
u se u n d er m ed ical su p er visio n an d
a h igh p o t en t ial f o r ab u se.
Su b st an ces in t h is sch ed u le h ave a
h igh p o t en t ial f o r ab u se w h ich m ay
lead t o sever e p sych o lo gi cal o r
p h ysical d ep en d en ce.
Su b st an ces in t h is sch ed u le h ave a
p o t en t ial f o r ab u se less t h an
su b st an ces in Sch ed u les I o r II an d
ab u se m ay lead t o m o d er at e o r lo w
p h ysical d ep en d en ce o r h igh
p sych o lo gical d ep en d en ce.
Su b st an ces in t h is sch ed u le h ave
a lo w p o t en t ial f o r ab u se r elat ive
t o su b st an ces in Sch ed u le III.
Su b st an ces in t h is sch ed u le h ave a
lo w p o t en t ial f o r ab u se r elat ive t o
su b st an ces list ed in Sch ed u le IV
an d co n sist p r im ar ily o f
p r ep ar at io n s co n t ain in g lim it ed
q u an t it ies o f cer t ain n ar co t ics.
h e r oin , LSD, m ar iju an a (ca n n a bis), p eyo t e
(m esca lin e ), m et h aq u al o n e (Qu a a lu de ), 3,4-
m et h yl en ed io xym et h am p h et am in e
(“e cst a sy”) an d “ba t h sa lt s.”
N ARCOTI C: h yd r o m o r p h o n e
(Dila u did), m et h ad o n e
(Doloph in e), m ep er id in e
(Dem e r ol), o xyco d o n e
(OxyCon t in , Pe r coce t ), an d
f en t an yl (Su blim a ze).
N ARCOTI C: co m b in at io n p r o d u ct s
co n t ain in g less t h an 15 m gs o f
h yd r o co d o n e p er d o sage u n it
(Vicodin ), p r o d u ct s co n t ain in g n o t
m o r e t h an 90 m gs o f co d ein e p er
d o sage u n it (Tyle n ol w it h codein e),
an d b u p r en o r p h in e (Su boxon e).
alp r azo lam (Xa n a x), car i so p r o d o l (Som a ),
clo n azep am (Klon opin ), clo r azep at e
(Tr a n xe n e ), d i azep am (Va liu m ), l o r azep am
(At iva n ), m id azo l am (Ve r sed), t em azep am
(Re st or il), an d t r iazo l am (H a lcion ).
co u gh p r ep ar at io n s co n t ain in g n o t m o r e t h an
200 m illigr am s o f co d ein e p er 100 m il lil it er s
o r p er 100 gr am s (Robit u ssin AC,
Ph e n e r ga n w it h Code in e ), an d e zoga bin e.
N ON -N ARCOTI C:
am p h et am in e
(Dexe dr in e, Adde r a ll),
m et h am p h et am in e
(Desoxyn ), an d
m et h ylp h en id at e
(Rit a lin ).
N ON -N ARCOTI C:
b en zp h et am in e (Didr ex),
ph en dim e t r a zin e,
k et a m in e , an d a n a bolic
st er oids su ch as Dep o -
Test o st er o n e.
DESCRI PTI ON EXAM PLESSCH EDULE
DRUG CLASSI FI CATI ON SCH EDULE
Sou r ce: h t t ps:/ / w w w .de a .gov/ dr u g-sch e du lin g
10. • Lotsof, with the help of other activists in New York receives patents for Ibogaine
starting in 1983, as a rapid method for interrupting narcotic addiction syndrome
,which was granted to him in 1985. From 1986 to 1992 Lotsof and his company,
NDA International Inc. received 4 more patents for interrupting cocaine and
amphetamine abuse, attenuating alcohol dependency, attenuating nicotine/tobacco
dependency and interrupting poly-drug dependency syndromes.
• May 1991 the National Institute of Drug Abuse, Medication Development Division
(MDD) starts to study Ibogaine. In 1993 and 1994 four Phase I/II protocol
development meetings for Ibogaine treating cocaine dependency occurred and it
was called; “one of the most promising addiction drugs in the pipeline to combat
addiction”.
• Due to political pressures from politicians and big pharma in March of 1995, MDD
decides to not proactively pursue clinical studies with Ibogaine.
• Frank Vocci, former director of NIDA called Ibogaine a promising “vast uncontrolled
experiment.”
11. • Lotsof, needing scientists with real credentials, brings the idea of Ibogaine to the
University of Miami, specifically Debra Mash, PhD., to assist in clinical trials.
• Immediate patent conflicts existed between Mash and Lotsoff.
• Approximately in 1997 Dr. Mash and myself meet, as she is in need of a physician
who can treat a wide variety of cardiovascular conditions and also has expertise in
addiction medicine.
• Healing Visions, a for profit company doing research on Ibogaine begins in Saint
Kits, BWI, treating 10 to 14 patients per month for approximately 7 years.
• Dr. Kamlet was present for 95% of these treatments from start to finish including
determining who would be accepted, maintaining the patients on opiate
medications while awaiting their “flood dose” of Ibogaine and monitoring the
patients during their Ibogaine treatments to fruition. That’s how we learned how to
treat and how to be careful due to flood dosing side effects.
12. • Myself and all others involved in that project were told we were collecting enough scientific
data to present factual, scientific evidence of safety and efficacy to NIDA and the FDA once
the study was concluded.
• I believed this was going to be what Mash and I called “our gift to the world”. We where
going to give this data away for free as true scientists and healers to save lives.
• After the study was completed and St Kitt’s was closed, the data was never published and Dr.
Mash opened a series of other companies: Healing Transitions Novaneuron DemeRx.
She continued to take out patents and our relationship became estranged.
• DemeRx had over $30 million in investment money to research Ibogaine as Mash continued
to take out proprietary patents on Ibogaine for a myriad of conditions.
• DemeRx resulted in a small study of less than 10 patients (research is expensive and slow in
the US) who received low dose nor Ibogaine in a multiple dosed regimen for opioid
dependency.
• 2017, DemeRx files chapter 11 bankruptcy for over $3 million in debt.
13. Over 16 years after the the St Kitts trials ended and DemeRx is in chapter 11, Mash publishes this data.
? – Why now?
14. • Dr. Mash continues with her efforts to find a drug acceptable to big pharma.
• Research is complicated- profits over saving lives / studying a class –I drug need
DEA approval / the extreme cost of bring out any new Rx in the US system / Big
pharma’s opposition to anything that cuts into their profits.
• Should it not be “principles above personalities”
15. SAFETY ISSUES AND PATIENT SELECTION FOR
IBOGAINE FLOOD DOSE TREATMENTS.
• This lecture is primary focus is about detoxification of patients who are opiate
dependent in a 24 hour period and treating other substance abuse problems, with
a single “flood dose” treatment, using Ibogaine hydrochloride typically at a dosage
of 1 to 2mgs/kgs., in a single dose.
• Much discussion is currently being had about “micro-dosing” with Ibogaine and
studying its metabolites “nor- ibogaine” or the synthetic metabolite “18 MC” (18-
Methoxycoronaridine), in an attempt to find a drug that patients will need to take
repeatedly to satisfy big pharma’s axiom of “no drug is a good drug unless patients
have to continuously take it.
• BIG PHARMA – “we exist to turn profits for our shareholders not to find single dose
cures for diseases.”
16. PATIENT SELECTION
• Patient pre screening: complete psycho-social history and physical exam.
Comprehensive recent blood testing including; CBC, chem-profile 14-18,serum
Mg++ levels, complete thyroid function studies, electrocardiogram and in certain
cases Holter monitoring, echo cardiograms, etc.
• Drug test, drug test, drug test.
• Inclusion and exclusion criteria exist.
• Pre Ibogaine counseling and the need for strict after care planning.
• Standardization of product being given to the patient is critical if protocols for
safety are to exist.
• In this expert’s opinion only 98%+ pure, Ibogaine Hydrochloride should be used.
• Ibogaine is used and purchased on the internet in many different forms from root
bark to extract to total alkaloid and others. Desperate addicts and less than ethical
clinics may turn to the internet to buy sub-optimal products making this a more
dangerous procedure.
17. SPECIFIC SAFETY ISSUES DURING FLOOD
DOSE TREATMENT
• All patients must have good IV access before treatment is initiated and until
treatment ends.
• All patients must be under constant three lead EKG monitoring, constant BP, pulse
and pulse oximetry monitoring and under constant supervision.
• A physician experienced in ibogaine treatments who has a minimum current
certification in Advanced Cardiac Life Support (ACLS) as well as all the drugs and
equipment necessary to treat a “Code Blue” or any adverse event, must be present
at all times.
• The physician must be constantly near the bed side for the 18 to 24 hours (not 15
minutes away) while the patient is under the drug effects and typically an ICU level
nurse should be in the room constantly with the patient monitoring critical vital
signs and attending to the patients needs like going to the bathroom, etc.
18. • Ibogaine causes pronounced bradycardia.
• Patients typically experience nausea and vomiting post ingestion of the drug and certain
medications can be given pre-treatment by experienced providers to make sure the patient
does not throw up any of the drug post ingestion. If that happens we do not know how
much drug was ingested and how much drug was lost making treatment difficult.
• Ibogaine must be given orally.
• Ibogaine is metabolized by the liver to nor-ibogaine through a complex metabolic pathway
called cytochrome P450-2D6 (CYP2D6).
• Currently, researchers have advocated CYP2D6 genotyping prior to the administration of
Ibogaine, to better guide dosing.
• It appears the major risk of serious cardiac arrhythmias begin to peak during the
metabolism of Ibogaine to its nor-ibogaine metabolite with noted changes of their ECG.
Extremely experienced clinicians, can gauge the stage of treatment the patient is in, by the
ecg changes on the monitor.
• Ibogaine is a potent QTc prolonger, predisposing the patients to a specific lethal arrhythmia
called “torsade's de pointes” (TDP). Other arrhythmias have been seen due to what I have
termed “hyper excitable heart syndrome” especially on patients who are abusing
sympatheto-mimetic substances.
19. OTHER SAFETY ISSUES
• Ibogaine causes marked hypotension.
• I was the first to observe and report that Ibogaine flood dosing and it’s metabolism, may
produce bizarre T wave morphology and even total loss of the T wave during treatment
especially while the metabolism of Ibo to nor is occurring. With the help of other scientists
this has recently thought to be due to ”H-erg blockade” (human Ether-à-go-go-Related
Gene).
• This may be used to gauge the phases of treatment and when the T waves return to normal,
the patients risk for serious cardiac arrythmia’s and other cardio-vascular issues appears to
be minimal.
• Long acting opioids like Methadone and Buprenorphine products must be switched to short
acting opiates under careful medical supervision. How long the patient needs to be on S.A
opiate’s,is done by calculating out the half lives of the long acting opiate to ensure non is
left on board before flood dosing occurs.
24. TREATMENT DAY
• Patients are stabilized on short acting opiates until midnight the day prior to treatment. No
taper is necessary but this allows the clinician to quantify the patients 24 hour Opiate need.
• NPO after midnight pre-treatment.
• IV access and ICU monitoring set up. The patient gets an antiemetic and usually a liter of
physiologic fluid + one amp of MgSo4, to keep BP up and help avoid TDP.
• The patient takes their Ibogaine flood dose, always orally, as first pass metabolism is critical
for the production of enough nor- ibogaine to block withdrawal and PAWS.
25. DISCRETE PHASES OF TREATMENT
• Onset phase: 1-2 hours post ingestion.
• The visionary/oneiric “ waking dream” phase with perceptual changes and marked ataxia. At
all times the patient knows who they are, where they are and who I am. They are lying in bed
during this treatment with eye shields on listening to binary beat music via noise cancelling
head phones. Little happens with the eyes open. / lasting 4-12 hours typically.
• The Evaluative phase/ 6-18hours. The patient slowly returns to a normal state, The visions
decrease and the patient begins to process the insights and visions of the prior phase into
abstract thought. It has been called by patient's “a brain reset and a complete life review”
and by myself as, the “ equivalent of getting 10 years quality psychotherapy in one day.
"Patients get insights into their behavior, addiction and often relate a profound spiritual
experience and some, of meeting benevolent spirit teachers of the plant drug. There is
quantifiable commonality to the visions and yet each patent’s experience is very unique.
26. WHAT IS
SUCCESS
• Seeing a patient at end of Ibogaine flood dose treatment with approximately 36 hours off opiates, NOT be in
clinical withdrawal is nothing short of miraculous……
• I too did not believe this until I saw it with my own eyes and from that day forward I have advocated to see,
flood dosing, done as a 23 hours facility admission in the USA and hopefully one day, be the primary
treatment of opiate detoxification in the USA and the world.
• So the patient is now feeling well and usually extremely happy. Is that patient “ cured?”
• Is sustainable recovery the true goal? I believe so !
• Thus, the need for a well though out, contractile like after care plan, prior to treatment is critical in my
protocols i.e.; psycho-therapy, 12 step programs, etc..
• I break it down to two distinct disease processes: “dependency” vs. “addiction and abuse”. Both must be
addressed as separate diseases if we are to truly going to save lives.
27. ENTHIOGENIC PLANT TEACHERS
Many plant and other like substances can be plant teachers and used to facilitate a spiritual awakening
and teach proper behavior while closing past traumas and gestalts.
Only Ibogaine, ameliorates opiate withdrawal in 24 hours. It also assists with other SUD’s. This makes
it very special and I believe the focus on all new research should be for the most observable and easy
to prove quality of stoping opiate withdrawal in it’s tracks, especially in the face of a global opiate
epidemic.
***************************************************
The *Hallucinogenic Quandary*
Hallucinations are wrong associations.
“Entheogenic Drug ” is a better term. There is great commonality to the visions and a true sense of “
traveling to a destination as real as life itself.
28. WHY IN-PATIENT DETOXIFICATION FROM
OPIATES NO LONGER WORKS IN THE USA
MODEL
• Its illegal to detox any opiate addict or give class-II opiates to an addicted patient in an outpatient setting.
Only Buprenorhine containing medications for the diagnosis of opiate dependency can be given for 30-90
days as opposed to the daily methadone (MMT) at a federally licensed methadone clinic
• Buprenorphine is a schedule III drug due to it’s being a mu opioid receptor agonist but a kappa receptor
antagonist. Thus, it is a wide therapeutic index drug with no respiratory depression as a cause of over dose
deaths, occur. Out patient detox with this drug is near impossible and big pharma is pushing “Harm
Reduction” as the best any opiate addict can due.
• In patient and even hospital based detoxes can no longer use class-I and class- II drugs to get patients off
class I and II street or prescription drugs.
• That leaves only Burenorphine containing products like “ Subutex/Suboxone” as the only drug used for in
patient detox.
• So, how can I get a patient addicted to 16+ mgs of suboxone / day for 10 years, off that drug by tapering it
for 5-7 days in a residential detox? Answer is; I can’t ! Its equivalent to cold turkey cruelty.
• Federal drug laws need to be changed and soon in the USA as 80,000 opiate deaths per year occur in my
country annually.
29. IN CLOSING;
• Google should not be your doctor or referral source.
• Caveat emptor.
• Seek a clinic that follows the safety standards, ask questions and have a firm after
care plan to sustain your recovery.
• Addicts stay clean 24 hours at a time.
• We all get a daily reprieve.