Treatment of Opioid Addiction

Treatment of Opioid Addiction
Educational Grant Provided by: Cebert Pharmaceuticals Inc. 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved.

Where it All Begins "If we could sniff or swallow something that would, for five or six hours each day, abolish our solitude as individuals, atone us with our fellows in a glowing exaltation of affection and make life in all its aspects seem not only worth living, but divinely beautiful and significant, and if this heavenly, world-transfiguring drug were of such a kind that we could wake up next morning with a clear head and an undamaged constitution-then, it seems to me, all our problems (and not merely the one small problem of discovering a novel pleasure) would be wholly solved and earth would become paradise." ALDOUS HUXLEY – 1963 photo and quote found at Heroin.Org The Opium Poppy papaver somniferum 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved.

Copyright 2003 Aegis Medical Systems, Inc. All rights reserved.
The History of Opium c.3400 B.C.E. The opium poppy is cultivated in lower Mesopotamia. The Sumerians refer to it as Hul Gil, the 'joy plant.' The Sumerians would soon pass along the plant and its euphoric effects to the Assyrians. The art of poppy- culling would continue from the Assyrians to the Babylonians who in turn would pass their knowledge onto the Egyptians. Opium: A History. by Martin Booth Simon & Schuster, Ltd., 1996. Excerpts and Pictures from Heroin.Org 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved.

The History of Opium 1300 BCE -- Egyptians cultivate Opium in Thebes and establish brisk trade 1100 BCE -- Cypriots craft Surgical Quality culling knives. Opium smoking popular, trade brisk 460 BCE -- Hippocrates, acknowledges Opuium’s usefulness as a narcotic and styptic in treating internal diseases, diseases of women and epidemics 330 BCE -- Alexander the Great introduces opium to the people of Persia and India 400 CE -- Opium thebaicum, from the Egyptian fields at Thebes, is first introduced to China by Arab traders 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved.

The History of Opium Ancient Indian medical treatises The Shodal Gadanigrah and Sharangdhar Samahita describe the use of opium for diarrohea and sexual debility. The Dhanvantri Nighantu also describes the medical properties of opium. 1300's -- Opium a taboo subject for those in circles of learning during the Holy Inquisition. Anything from the East was linked to the Devil. The Portuguese, while trading along the East China Sea find the effects of smoking Opium were instantaneous but the Chinese considered it barbaric and subversive. Opium thebaicum compounded with citrus juice and quintessence of gold as the pain-killer Laudanum, the “Stones of Immortality”.. 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved.

The History of Opium 1600’s -- Opium mixtures recreationally consumed in India and Persia. Portuguese merchants direct Opium into China via Macao. Ships chartered by Elizabeth I are instructed to purchase the finest Indian opium and transport it back to England. Opium becomes the main commodity of British trade with China. English apothecary Thomas Syndenham, introduces Sydenham's Laudanum, a compound of opium, sherry wine and herbs. 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved.

The History of Opium The Dutch export shipments of Indian opium to China and to Southeast Asia; the Dutch introduce the practice of smoking opium in a tobacco pipe to the Chinese. Chinese Emperor prohibits all but medicinal use. Britain and the British East India Company dominate the Opium trade from India to China. Linnaeus, the father of botany, first classifies the Opium poppy, Papaver somniferum - 'sleep-inducing', in his book Genera Plantarum. British East India Company fully controls Opium trade out of India 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved.

The History of Opium Chinese emperor Kia King completely banned Opium. German scientist Friedrich Sertürner isolates the active ingredient of Opium -- Principium somniferum -- and names it Morphine for the Greek god of dreams, Morpheus. Morphine hailed as “God’s own medicine” for its reliability, long-lasting effects, and safety. American shippers join the trade of smuggling Opium to China. Thomas De Quincey publishes his autobiographical account of opium addiction, Confessions of an English Opium-Eater. 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved.

The Father of Morphine Morphine was first isolated from opium by Friedrich Wilhelm Sertürner in Sertürner named the bitter white crystalline alkaloid after Morpheus, the Greek god of dreams. 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved.

Into the Arms of Morpheus
Thomas De Quincey originally took Opium for a toothache. He wrote in Confessions of an English Opium-Eater: ...I was necessarily ignorant of the whole art and mystery of opium-taking: and, what I took, I took under every disadvantage. But I took it: -- and in an hour, oh! Heavens! what a revulsion! what an upheaving, from its lowest depths, of the inner spirit! what an apocalypse of the world within me! That my pains had vanished, was now a trifle in my eyes: -- this negative effect was swallowed up in the immensity of those positive effects which had opened before me -- in the abyss of divine enjoyment thus suddenly revealed. Here was a panacea -- a [pharmakon nepenthez] for all human woes: here was the secret of happiness, about which philosophers had disputed for so many ages, at once discovered: happiness might now be bought for a penny, and carried in the waistcoat pocket: portable ecstasies might be had corked up in a pint bottle: and peace of mind could be sent down in gallons by the mail coach… Into the Arms of Morpheus 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved.

The History of Opium E. Merck & Company of Darmstadt, Germany, begins commercial manufacturing of morphine. March 18, Lin Tse-Hsu, Imperial Chinese Commissioner in charge of suppressing Opium smuggling, orders all foreign traders to surrender their Opium stashes. The British send troops, and the First Opium War begins. Due to the heavy importation of Opium into the US, Customs Officials declare a duty fee on its import. China loses the First Opium War to Britain, and loses Hong Kong along with it! Dr. Alexander Wood of Edinburgh first administers morphine by injection. Effects instantaneous and three times more potent. 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved.

The History of Opium The Second Opium War results in the legalization of Opium import into China.. English researcher C.R. Wright boils Morphine and creates diacetylmorphine. In San Francisco, the smoking of Opium is confined to Opium Dens in Chinatowns. Britain passes the Opium Act to limit Opium consumption. The sale of Opium is restricted to registered users in China and India. U.S. Congress taxes on Opium and Morphine. The Bayer Company, in Germany, synthesizes diacetylmorphine and calls it Heroin. It’s introduced commercially in 1898 as a safer, less addicting alternative to Morphine. 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved.

The History of Opium Early 1900’s -- The Saint James Society promotes Heroin as a treatment for Morphine addiction. British and French try to curb Opium production in Southeast Asia, with little success. Heroin withdrawal found to be as harsh as Morphine withdrawal. Heroin addiction rates in U.S. alarming. U.S. Congress bans Opium. Drs. Lambert and Towns promote a 7 day Heroin detox regimen using belladonna and delerium. The U.S. Pure Food and Drug Act requires contents labeling on patent medicines, reducing the availability of opiates. 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved.

The History of Opium U.S. bans the importation of Opium and, at the International Opium Commission in Shanghai, speaks out on the Immoral and evil effects of Opium. Chinese finally convince British to end India-China Opium trade. Dec. 17, Harrison Narcotics Act imposes a tax on doctors who prescribe Opiates, hoping to contain the cocaine and heroin abuse epidemics. U.S. Treasury Department Narcotics Division bans all legal sales of narcotics. Heroin addicts forced to buy from illegal street dealers.. Opium trade booms in New York’s Chinatown. 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved.

The History of Opium 1930’s -- Most illegal Heroin in U.S. comes from China Burma independent, Opium cultivation flourishes. Corsican gangsters dominate U.S. Heroin market. 1950’s -- U.S. efforts to contain Communism result in support for drug warlords in Laos, Burma, and Thailand, thus increasing the flow of illegal flow of Heroin into the U.S. To aid U.S. allies during Vietnam War, CIA assists Corsican gangsters import Heroin via the French Connection Number of addicts in U.S. reaches 750,000. Solomon Snyder and Candace Pert discover opiate receptors in the brain. 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved.

The History of Opium July 1, President Nixon creates DEA. Mid 1970’s -- With fall of Vietnam, Mexico main source of Heroin for U.S. until 1978. Hans Kosterlitz discovers enkalphin, and endogenous opiod. Agent Orange used to destroy Mexican Opium fields. Iran, Afghanistan, and Pakistan become main source. State Department replaces crop substitution programs for Third World countries with drug crop eradication programs. Success is minimal. 1998- Present -- “War on Drugs” meets with little success. Heroin and Cocaine readily available and inexpensive. 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved.

I Wonder Why that Nice Man Offered Me So Much Money for my Flowers!
10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved.

How Opiates Work an Inborn Need
We are ALL naturally dependent on opiates for our emotional health and wellbeing. Our brains produce natural opiates, Endorphins and Enkalphins (meaning “in the brain”) that help us to maintain emotional equilibrium and to handle pain. In fact, pain is one of the main stimulants to the production of these chemicals. They are also stimulated by exercise, sex, food (especially chocolate), and even by receiving a complement. Both natural and external opiates operate in the “Pleasure Centers” of the brain. 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved.

The Pleasure Center The “Pleasure Center” is located in the limbic system, the “emotional center” of the brain. All sensations of pleasure and reward are believed to be mediated by the neurotransmitter Dopamine. Dopamine is secreted in the synapse, then taken back up into the neuron. 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved.

The Pleasure Center The pathways that modulate the Dopaminergic neurons project from the ventral tegmental area to the nuclear accumbens These Neurons secrete GABA, which limits the secretion of Dopamine When the opiate receptors on these neurons are stimiulated, GABA secretion is suppressed, resulting in increased Dopamine secretion and the sensation of pleasure 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved.

It’s All About Chemistry!
"At a purely chemical level, every experience humans find enjoyable - whether listening to music, embracing a lover, or savoring chocolate - amounts to little more than an explosion of dopamine in the nucleus accumbens as exhilarating and ephemeral as a firecracker." (J Madelaine Nash) 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved.

More About Opiate Receptors
There are three main receptor types, m (mu), k (kappa) and d (delta) These receptors couple through pertussis-toxin sensitive G-Proteins There are also non-neuron based “orphan” receptors, such as ORL1 Morphine binds to and works primarily through the m1 receptor Heroin binds to the m1 receptor and possibly to a variant m receptor to which Morphine does not bind 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved.

More About Opiate Receptors
Each classic receptor type has several sub-types, and there are several lesser opiate receptor types as well The periaqueductal grey region (PAG) is a major anatomical locus for opioid activation of descending inhibitory pathways to the spinal cord and is thus an important site for m-receptor-induced analgesia. Stimulation of m2 receptors by Morphine modulates respiratory depression -- a principle danger of opiates. After repeated administration of an opiate, receptor down- regulation and possibly other factors, result in tolerance and dependency. 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved.

Tolerance and Dependency
Tolerance is both a blessing and a curse. Thanks to tolerance, the user can take larger and larger doses without developing respiratory depression. Due to tolerance, the opiate user needs more and more drug to achieve a “high” or to attain adequate analgesia in medical applications. Because of down-regulation, the brain becomes insensitive to endogenous opiates, Endorphins and Enkalphins, and the individual becomes opiate dependant. Homeostasis of the organism can now only be achieved by means of continued exogenous opiate administration. 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved.

Dependency and Withdrawal
The opiate-dependent individual experiences horrendous withdrawal symptoms when a dose wears off -- I.e. when an inadequate percentage of the receptors are being stimulated Though the exact mechanisms of withdrawal are uncertain, an increase in GABA in the nucleus accumbens has been observed. PET scans evaluating regional blood flow have demonstrated multiple areas of cerebral hypoperfusion during both opiate and cocaine withdrawal. 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved.

Withdrawal Symptoms Chills and goose bumps, giving rise to the expression “cold turkey” Running nose, tearing eyes, mucus in the throat and oiling under the eyes may mimic URI or allergy symptoms Sweats, nausea, diarrhea, muscle aches, and joint pains add to the perception of a severe flu-like syndrome In severe withdrawal, involuntary spastic movements of the legs gave rise to the expression “kick the habit” With symptoms like these, it’s little wonder why people feel desperate for their next “fix” 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved.

The Heroin Experience "It's so good. Don't even try it once." -intravenous heroin user Heroin, originally marketed and named by The Bayer Company, is named for the German word for hero heroisch. Fastest acting of all opiates, reaching the brain seconds after injection. Initial extreme euphoric rush, a surge of pleasure that starts in the abdomen and spreads through the body This is followed by a period of tranquility, safety, and general well-being and a dreamy and relaxed state of contentment. 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved.

Addiction vrs. Dependency
Dependency is characterized by withdrawal symptoms when the level of the drug is too low to maintain homeostasis Addiction is a Brain Disease characterized by compulsion and craving The addict will do anything and everything to obtain the drug, regardless of risks to his freedom, health, or life The non-addict is capable of stopping drug use when the risks of continuing become too great, the addict, untreated, is not 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved.

What the Experts Say "Functionally you've moved into a different state, a state of compulsive drug use," says Alan Leshner, Ph.D., former director of the National Institute on Drug Abuse (NIDA). "People have a lot of trouble understanding that addiction is not an issue of choice or will or morality. ” Says Steven Hyman, M.D., director of the National Institute of Mental Health, "An alcoholic taking a drink looks like anyone else engaged in that behavior, but what's happening in his or her head is different. He or she is in the grip of a powerful compulsion that may lead to a binge.” Source: Moyers on Addiction, WNET 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved.

Features of the Addict May come from any walk of life, but lower socioeconomic class predominates Addiction leads to loss of appetite, weight loss, lack of self-attention, rotting teeth, and loss of self-esteem Most active addicts have difficulty maintaining employment or career Crime, especially property crime and prostitution, as well as drug sales, common means of supporting habit Repeated incarceration common Polysubstance abuse, especially cocaine, amphetamines, alcohol, and nicotine quite common 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved.

The addict is trapped in his or her addictions, much as this cat is in the cage. Most addicts seek to hide their addiction from family, non-using friends (if any), from employers and potential employers, and even from their doctors. The addict fears the consequences of addiction, but cannot stop. The addict fears that doctors may be judgmental, unconcerned, or unwilling to treat him. 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved.

Why do People Start Using Drugs?
Environment and Peer Pressure Self-Medication -- Many addicts suffer from depression or anxiety disorders (the so-called “Dual Diagnosis” patient). Stimulation of the pleasure centers helps to alleviate unpleasant symptoms To Escape -- Family situations, unpleasant environment, abuse (especially females) To Experiment To Rebel -- Common among teens Pleasure Seeking -- Just to get “high” 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved.

What About Legitimate Prescription Opiates?
Extremely valuable in the treatment of acute and chronic pain! DO NOT under-treat pain out of fear of addiction. Yes, dependency often WILL develop, but addiction and escalating use is uncommon. Oxycontin -- a long-acting Oxycodone, has become a street favorite. It is crushed, cooked, and injected like Heroin. Only a few real pain patients become addicted. Many questionable prescriptions are obtained and diverted. Methadone -- High incidence of dependency, low rate of addiction when used for pain. 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved.

Societal Impacts of Addiction
Increased crime -- the main source of income for many addicts is criminal activity High costs of incarceration Increased disease rates -- not just for the addict, but for the addict’s sexual contacts High Costs of treatment -- both for addiction and acquired diseases High rates of unemployment and welfare recipients High rates of work absenteeism for those employed 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved.

Complications Encountered by the IV Drug Addict
HIV and Aids Hepatitis B and C -- cirrhosis, liver failure, death Abscesses Wound Botulism Necrotizing Fasciitis Endocarditis Collapsed Veins Lost Relationships and Jobs Prison 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved.

Treatment Modalities for Opiate Addiction
Heroin or Morphine -- for registered addicts, utilized in some European countries Self-Detox -- Painful, dangerous, and with little long-term success 12-Step programs -- AA, NA, MA etc. In-patient or out-patient short-term detox Minnesota Model Inpatient or Outpatient programs -- include 12-step, counseling, dual-diagnosis treatment Therapeutic Communities -- after jail or other detox Opiate Antagonist Therapy -- Naloxone, Naltrexone Opiate Substitution Therapy -- Methadone or LAAM 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved.

Opposing Treatment Paradigms
Abstinence paradigm -- Presupposes that patients can achieve drug-free living as a result of counseling, support, and a favorable environment. Seems to disregard the disease concept of addiction, treating it more as a social disease than a medical one. Programs include Treatment Communities, Minnesota Model, Detox programs. Medical Stabilization paradigm -- Recognizes the disease concept of addiction. Realizes the addict’s brain is NOT normal, that homeostasis off drugs cannot be quickly achieved. Views treatment of addiction as no different from treatment of hypertension or diabetes -- I.e. the Methadone (or LAAM) patient needs his medication just as the others need theirs. 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved.

What Works? The reality is, there is no simple answer to that question. Each paradigm has its adherents, its success stories, and its failures. The TOPS study clearly demonstrates that duration of therapy is a key -- patients in a treatment setting for less than 90 days did no better than those who registered for treatment then failed to follow up! This was true for Methadone, Treatment Communities, Outpatient programs and Residential programs. While different modalities may work better for some patients, the reality is that Methadone Maintenance works best. 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved.

Says Who? When it comes to quitting heroin, the evidence is in. In 1990, the National Academy of Sciences' Institute of Medicine found that "methadone maintenance has been the most rigorously studied [drug treatment] modality and has yielded the most incontrovertibly positive results…The effectiveness of methadone treatment of opiate addicts has been established in many studies conducted over three decades. Methadone- maintained patients show improvement in a number of outcomes...Consumption of all illicit drugs, especially heroin, declines. Crime is reduced, fewer individuals become HIV positive, and individual functioning is improved" 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved.

Isn’t Long-term Treatment Expensive?
According to a fact sheet issued by the CDC published in February, 2002, “Treatment is a high-return social investment that makes financial sense for communities and the nation. Every $1 invested in treatment reduces the costs of drug-related crime, criminal justice costs, and theft by $4 to $7. The average cost of 1 year of methadone maintenance treatment is $4,700. The cost of 1 year of incarceration per person is about $18,700. When health care savings are added in, total savings can exceed costs by a ratio of 12 to 1.” 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved.

OK, but does it benefit the Patient?
The CDC says YES! Starting methadone maintenance treatment (MMT) reduces the mortality rate for opiate addicts to less than one-third of what it would have been before they entered treatment. Substance abuse treatment's effectiveness, particularly methadone maintenance treatment, has been repeatedly demonstrated. By helping a person reduce or stop using drugs, it can have a positive impact on many facets of IDUs' lives. This includes improving their health, their ability to get and hold a job, their family stability, as well as reducing their involvement with crime. Substance abuse treatment is as effective as treatment for other chronic diseases, such as asthma, diabetes, and hypertension. 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved.

So, What is Methadone? Methadone Structure Methadone was originally synthesized in Germany before WWII. Fearing an impending shortage of Morphine, German scientists created this synthetic, long-acting opiod analgesic. It’s trade name, Dolophin was derived from the Latin words for Pain and End. Methadone provides effective analgesia for about 6 hours, but its average hour half life means that withdrawal symptoms don’t occur for up to a day after the last dose. After the war, Methadone was used to detox addicts at Lexington. It was cheap, worked orally, and was longer-lasting than Morphine 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved.

Where did MMT Begin? By the 1960’s, Heroin and Morphine addiction was rampant. There was no treatment known that could cure more than a small fraction of addicts. Dr. Vincent Dole, and expert in metabolic disorders, and his wife Dr. Marie Nyswander, a psychiatrist who had treated addicts at the Public Health Hospital at Lexington, endeavored to find a successful treatment at Rockefeller University in New York. They tried unsuccessfully to maintain and stabilize Heroin addicts using a variety of opiates from Morphine to Dilaudid. After failing in their endeavors, they began to use Methadone to detox the patients. Much to their surprise, after a few days on the relatively high starting doses, the patients began to stabilize and manifest remarkably different behaviors! 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved.

Really? How So? “Whereas for weeks they had spent their days either feeling the effects of the narcotics or complaining of their need for more narcotics, suddenly the focus of their days turned away from drugs. One subject asked the researchers for supplies so that he might resume his long neglected hobby of painting. Another inquired after the possibility of continuing his interrupted education. In short, the addicts- who when admitted to the hospital had looked and behaved very much alike -now began to differentiate. They began to manifest the potential that each had obscured during years of chasing street narcotics.” National Association of Methadone Advocates (NAMA) 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved.

False Messiah The press, in its usual “understated” manner, hailed the results as representing a savior from a national scourge. Unfortunately, although a very effective treatment modality, Methadone was NOT a panacea! Many Heroin addicts are polysubstance abusers, and Methadone, in and of itself, does nothing to help Cocaine, Amphetamine, Alcohol, or Nicotine addiction. However, in the TOPS study it was demonstrated that the Methadone-treated patients who used Heroin less than once a week while on Methadone markedly decreased their use of Cocaine and Amphetamines without increasing Alcohol abuse. Whether this was due to attitude adjustment or counseling is open to speculation. 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved.

How Does Methadone Work?
Constant stimulation of Opiate Receptors prevents withdrawal Long half-life and high affinity for receptors allows stabilization, prevents “highs and lows” Development of tolerance avoids respiratory suppression or undue drowsiness Adequate dosing prevents or markedly limits Heroin craving Programs run according to regulatory standards provide regular counseling services and medical attention -- they’re not just juice bars! 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved.

What are the Side Effects?
Drowsiness (often resolves with development of tolerance) Respiratory suppression (rare due to cross-tolerance from the start) Excessive sweating (often resolves) Constipation (fiber helps) Withdrawal if the patient stops abruptly or tapers too rapidly 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved.

But I Heard… a litany of myths
Methadone rots your teeth and destroys your bones…False Methadone damages your heart and your liver…False Methadone is more addictive than Heroin…False -- Dependency almost always develops but Methadone addiction is uncommon. When the patients crave, they crave Heroin! Methadone withdrawal is worse than that from Heroin…False -- Similar, less severe symptoms, but they do last longer Methadone was really named for Adolph Hitler…False -- Dolophin stands for “Pain End” 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved.

How About Graphs and Charts?
“Loaded” “High” Heroin “Abnormal Normality” Methadone Dose Response Normal Range “Comfort Zone” Subjective w/d “Sick” 0 hrs. Time 24 hrs. Opioid Agonist Treatment of Addiction - Payte Courtesy of Judy Martin 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved.

Crime among 491 patients before and during MMT at 6 programs
Crime Days Per Year Adapted from Ball & Ross - The Effectiveness of Methadone Maintenance Treatment, Courtesy of Judy Martin 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved.

HIV CONVERSION IN TREATMENT HIV infection rates by baseline treatment status. In treatment (IT) n=138, not in treatment (OT) n=88 | Source: Metzger, D. et. al. J of AIDS 6:1993. p.1052 Opioid Maintenance Pharmacotherapy - A Course for Clinicians 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved.

How Much Methadone? Varies from patient to patient Starting doses range from 30 mg to as high as 60 or even 70 mg. If the patient is using 1g or more of Heroin per day, he will easily tolerate a starting dose of 50. Initial doses above 30 mg must be justified on the chart Doses are titrated up, rapidly at first (usually by 10 mg each day), then more slowly as stabilization is approached Stabilization and the abatement of craving almost always requires daily doses of 60 mg or more, and usually requires mg per day 180 mg/day is the maximum dose allowed by CSAT (Center for Substance Abuse Treatment -- a regulatory agency) 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved.

Factors Effecting Methadone Levels
Several drugs, including Dilantin, Phenobarbital and other Barbiturates, Tegretol, Ethanol, Rifampin, St. John’s Wort, Nafcillin, urinary acidifiers used for Calcium type kidney stone formers, and Ultram, hasten the metabolism of Methadone in the liver or increase urinary excretion, and thus shorten its half life and reduces effectiveness. Other drugs, including Tagamet, Elavil, Valium, Luvox, Nizoral, Benemid, urinary alkalinizers, and ethanol can prolong the half-life of Methadone, possibly resulting in undesired effects. Erythromycin, Clarithromycin, Vit. E, and several NSAIDS disrupt Methadone Serum Protein binding, raising Methadone levels 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved.

Factors Effecting Methadone Levels
Severe Liver Disease, especially if combined with significant renal insufficiency, can slow the elimination of Methadone, but since it has a dual route of excretion neither one alone is likely to cause a severe problem Some patients are inherently rapid metabolizers, resultine in a shortened half life of the drug. Addition of medications such as Tagamet or Benemid may be helpful, and split dosing can be arranged with CSAT approval Some patients on take-home doses divert some of their medicine to others 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved.

Drugs to AVOID in Patients on Methadone
Opiate Antagonists and Mixed Opiate agonists/antagonists will precipitate acute sever withdrawal syndrome and should be avoided. The IV antagonists may be used to treat acute Opiate overdose. IV Antagonists: Narcan, Revex PO Antagonist: ReVia (Naltrexone) Agonist/Antagonists: Stadol, Nubain, Talwin, Dalganr, and Buprenex 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved.

How Long is Treatment? Several studies have shown that intervals to post-treatment relapse lengthen as the treatment time lengthens. Treatment for less than 90 days is no more effective at one year than no treatment at all Longer periods of treatment give the patient more time to improve his/her health, immune system, relationships, living environment, financial situation, and outlook Avoidance of the drug environment is a key to recovery Some patients require lifetime therapy to maintain stability, but then again so do most hypertensives, diabetics, and hyperlipidemics Long Enough! 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved.

Effect of Treatment Duration 80 90 100 110 120 130 140 %PME %PDE PME/PDE Short Term ( weeks) Long Term ( weeks) Control p< p< 0.002 p< 0.09 Normalized Value (% Control) Cerebral Phospholipid Metabolites 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved.

Treatment Months Since Stopping Treatment
Relapse to IV drug use after MMT 105 male patients who left treatment Percent IV Users Treatment Months Since Stopping Treatment Adapted from Ball & Ross – The Effectiveness of Methadone Maintenance Treatment, 1991 Opioid Agonist Treatment of Addiction - Payte 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved.

How is Methadone Supplied?
Cebert Pharmaceuticals Inc. distributes Methadone in several forms: 5 mg and 10 mg Tablets, FDA approved For Analgesia Only! 40 mg cross-scored Diskets or “wafers”, easily dissolve in water. Peach colored, orange-pineapple flavored Clear and Cherry Flavored Liquid, 10mg/ml, in 960 ml bottles (cherry liquid also sold by Malinkroft) 50 G and 100 G bottles of powder for dissolution in water or juice 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved.

How is Methadone Administered?
When used for the treatment of Opiate addiction, Methadone is distributed on a daily basis at licensed Opiate Addiction Treatment Clinics, such as the Aegis Clinics. Each daily dose is provided to the patient in a cup, diluted with water or juice (in the case of the clear liquid) to a total volume of 60 cc. Take home doses are diluted to 30 cc and provided in daily-dose bottles which must be transported home in a locked unlabeled box. Take-home privileges are accrued after sufficient time in the program and consecutive months with drug-free urinalysis for employed patients. After 4 years in a program, a patient can be down to 1 clinic visit per week. Exceptions can be made for extenuating circumstances. 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved.

What is LAAM? LAAM, levo-alpha acetylmethadol is a long-acting Methadone-like agent with a hour half life. It is administered either every other day, or on a M-W-F or T-Th-Sat schedule. LAAM may only be used for patients who have failed to respond to Methadone -- it is reserved for second line use due to the risk of fatal arrhythmias. When converting from Methadone to LAAM, the “2 day” dose is 20% greater than the current Methadone daily dose, and the “three day” (I.e. Friday or Saturday) dose is 40% greater than the 2 day dose. It, too, is administered as an oral liquid. It is only indicated for the treatment of Opiate addiction. Aegis is licensed to administer LAAM in its West Covina Clinic only (in Southern California). 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved.

How Prevalent is Methadone Treatment?
There are over 1000 Methadone Clinics in the U.S. About 115,000 patients are enrolled in a Methadone or LAAM treatment program at any given time Unfortunately, this represents less than 15% of the Heroin and Morphine Addict population! 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved.

What are the Obstacles? Attitudes -- Government, Societal, and Medical Community Costs -- Due to funding cuts and governmental “moralistic, not medical” approach to addiction, many addicts have no coverage for Methadone treatment. In most European countries, addicts can get “Methadone On Demand” Regulations -- Methadone and LAAM are the only drugs for which government agencies strictly limit the doses allowed (in Europe, some patients receive upwards of 300 mg Methadone per day), as well as limiting the patient’s access to taking the medicine at home. 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved.

What are the Obstacles? And More Regulations -- Methadone therapy is limited to patients who have failed Methadone detox (a 21 day program, required by the rules, but rarely of any long-term value). All Aegis clinics have a so-called “2+2 waiver” allowing the Program Medical director to use his discretion. Otherwise, patients must have at least a 2 year history of addiction and must have relapsed after detox twice! And Still More Regulations -- The regulations concerning Take-Home doses have far more to do with DEA fears of drug diversion than with treatment efficacy. 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved.

Why do People Relapse? Addiction, like Cancer, is not always curable! Inadequate treatment -- either too low a dose or too short a course of treatment Stress -- As with many conditions, emotional state can hinder recovery Environment -- It has been well documented that exposure to the drug environment (people or places) can induce sudden cravings, especially in the untreated or under-treated patient. Viewing drug-related videos results in similar, albeit weaker, reactions in the brain to taking Heroin for the addict (based on metabolic PET scan studies). 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved.

Why do People Relapse? Personality traits -- although there is no difference in prevalence of Heroin use while on Methadone based upon Axis I (state) psychiatric conditions, there appears to be a trend toward difference based on Axis II (trait or personality) type disorders. Desire -- Some patients get into treatment only to lower the cost of their Heroin needs -- allowing them to use recreationally only. (Adequate Methadone doses will block the “high” of use while on treatment). Others enroll because of the influence of others -- family or law enforcement agencies -- and have no real desire to give up their drug of choice. 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved.

What Can You Do? Be Aware -- Ask your patients about any drug abuse history. Find out if they are on a Methadone Program. Be Armed with Knowledge -- Understand the disease nature of addiction. Be cautious of drug-drug interactions with Methadone when prescribing. Avoid prescribing addictive agents to addicts (benzo’s have a high street value, you know) Be Understanding -- NOT judgmental. These are patients with a Medical Condition, not just a criminal or social problem. Know the Resources -- Be Aware of the treatment programs near your practice. 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved.

What does the Future Hold?
Buprenorphine has been well studied and appears to be nearly as effective as Methadone, about on a par with LAAM. It holds promise as an alternative therapy and should have final FDA approval soon. Naltrexone -- May be useful in the post-treatment patient, after the patient is fully tapered off of and detoxed from Methadone. This drug has a higher affinity for opiate receptors than any opiate, and can completely block any effect of Heroin when taken. Ongoing research is being conducted to find the “magic bullet”. So far, it hasn’t been found, and Methadone, especially in conjunction with counseling and peer-support programs, is well established as the best treatment we have. 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved.

Summary Opiate abuse is a problem almost as old as civilization itself Opiate addiction is a disease state of the brain, with down-regulation of opiate receptors and resultant compulsions and cravings There are several types of treatment available, all of which are imperfect and all of which work for some people Methadone Maintenance Therapy is well established as the most effective modality currently available. The longer in treatment, the better! 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved.

Finally! Addicts, especially polysubstance abusers and addicts, are not easily “cured”, but remission is better than progressive disease and partial cure is certainly better than none. Just as in the treatment of Hypertension, Diabetes, Heart Disease, Cancer, or Depression -- don’t be an absolutist! A failure to completely cure is NOT a total treatment failure, but a failure to recognize or treat a serious medical conditions is a total failure indeed! 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved.

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