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10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved. 1 Treatment of Opioid Addiction Educational Grant Provided by: Cebert Pharmaceuticals.

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1 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved. 1 Treatment of Opioid Addiction Educational Grant Provided by: Cebert Pharmaceuticals Inc.

2 Treatment of Opioid Addiction 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved. 2 Where it All Begins The Opium Poppy papaver somniferum "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 1894 – 1963 photo and quote found at Heroin.Org

3 Treatment of Opioid Addiction 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved. 3 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., Excerpts and Pictures from Heroin.Org

4 Treatment of Opioid Addiction 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved. 4 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 Opuiums 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

5 Treatment of Opioid Addiction 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved. 5 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..

6 Treatment of Opioid Addiction 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved. 6 The History of Opium 1600s -- 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.

7 Treatment of Opioid Addiction 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved. 7 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

8 Treatment of Opioid Addiction 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved. 8 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 Gods 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.

9 Treatment of Opioid Addiction 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved. 9 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. Morpheus

10 Treatment of Opioid Addiction 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved. 10 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…

11 Treatment of Opioid Addiction 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved. 11 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.

12 Treatment of Opioid Addiction 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved. 12 The First Opium War "Reality is a crutch for people who can't handle drugs" George Bernard Shaw ( )

13 Treatment of Opioid Addiction 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved. 13 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. Its introduced commercially in 1898 as a safer, less addicting alternative to Morphine.

14 Treatment of Opioid Addiction 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved. 14 Morphine Structure Heroin Structure Acetyl Group Morphine and Diacetyl Morphine (Heroin)

15 Treatment of Opioid Addiction 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved. 15 The History of Opium Early 1900s -- 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.

16 Treatment of Opioid Addiction 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved. 16 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 Yorks Chinatown.

17 Treatment of Opioid Addiction 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved. 17 The History of Opium 1930s -- Most illegal Heroin in U.S. comes from China Burma independent, Opium cultivation flourishes Corsican gangsters dominate U.S. Heroin market. 1950s -- 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, Solomon Snyder and Candace Pert discover opiate receptors in the brain.

18 Treatment of Opioid Addiction 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved. 18 The History of Opium July 1, President Nixon creates DEA. Mid 1970s -- With fall of Vietnam, Mexico main source of Heroin for U.S. until 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 Present -- War on Drugs meets with little success. Heroin and Cocaine readily available and inexpensive.

19 Treatment of Opioid Addiction 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved. 19 I Wonder Why that Nice Man Offered Me So Much Money for my Flowers!

20 Treatment of Opioid Addiction 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved. 20 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.

21 Treatment of Opioid Addiction 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved. 21 The Pleasure Center b The Pleasure Center is located in the limbic system, the emotional center of the brain. b All sensations of pleasure and reward are believed to be mediated by the neurotransmitter Dopamine. bDopamine is secreted in the synapse, then taken back up into the neuron.

22 Treatment of Opioid Addiction 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved. 22 The Pleasure Center b The pathways that modulate the Dopaminergic neurons project from the ventral tegmental area to the nuclear accumbens b These Neurons secrete GABA, which limits the secretion of Dopamine bWhen the opiate receptors on these neurons are stimiulated, GABA secretion is suppressed, resulting in increased Dopamine secretion and the sensation of pleasure

23 Treatment of Opioid Addiction 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved. 23 Its 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)

24 Treatment of Opioid Addiction 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved. 24 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 m 1 receptor Heroin binds to the m 1 receptor and possibly to a variant m receptor to which Morphine does not bind

25 Treatment of Opioid Addiction 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved. 25 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 m 2 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.

26 Treatment of Opioid Addiction 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved. 26

27 Treatment of Opioid Addiction 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved. 27 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.

28 Treatment of Opioid Addiction 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved. 28 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.

29 Treatment of Opioid Addiction 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved. 29 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, its little wonder why people feel desperate for their next fix

30 Treatment of Opioid Addiction 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved. 30 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.

31 Treatment of Opioid Addiction 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved. 31 Mr. Jones, I said I wanted to hear about your heroines experiences, NOT your Heroin Experiences!

32 Treatment of Opioid Addiction 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved. 32 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

33 Treatment of Opioid Addiction 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved. 33

34 Treatment of Opioid Addiction 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved. 34 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

35 Treatment of Opioid Addiction 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved. 35 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

36 Treatment of Opioid Addiction 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved. 36 Why do you Do it? Its the Cheese!

37 Treatment of Opioid Addiction 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved. 37 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.

38 Treatment of Opioid Addiction 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved. 38 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

39 Treatment of Opioid Addiction 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved. 39 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.

40 Treatment of Opioid Addiction 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved. 40 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 addicts 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

41 Treatment of Opioid Addiction 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved. 41 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

42 Treatment of Opioid Addiction 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved. 42 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

43 Treatment of Opioid Addiction 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved. 43 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 addicts 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.

44 Treatment of Opioid Addiction 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved. 44 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.

45 Treatment of Opioid Addiction 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved. 45 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"

46 Treatment of Opioid Addiction 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved. 46 Isnt 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.

47 Treatment of Opioid Addiction 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved. 47 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.

48 Treatment of Opioid Addiction 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved. 48 So, What is Methadone? Methadone was originally synthesized in Germany before WWII. Fearing an impending shortage of Morphine, German scientists created this synthetic, long-acting opiod analgesic. Its 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 dont 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 Methadone Structure

49 Treatment of Opioid Addiction 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved. 49 Where did MMT Begin? By the 1960s, 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!

50 Treatment of Opioid Addiction 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved. 50 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)

51 Treatment of Opioid Addiction 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved. 51 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.

52 Treatment of Opioid Addiction 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved. 52 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 -- theyre not just juice bars!

53 Treatment of Opioid Addiction 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved. 53 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

54 Treatment of Opioid Addiction 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved. 54 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

55 Treatment of Opioid Addiction 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved. 55 How About Graphs and Charts? Dose Response Time Loaded High Normal Range Comfort Zone Sick 0 hrs.24 hrs. Abnormal Normality Subjective w/d Opioid Agonist Treatment of Addiction - Payte Courtesy of Judy Martin Heroin Methadone

56 Treatment of Opioid Addiction 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved. 56 Crime among 491 patients before and during MMT at 6 programs Adapted from Ball & Ross - The Effectiveness of Methadone Maintenance Treatment, 1991 Courtesy of Judy Martin Crime Days Per Year

57 Treatment of Opioid Addiction 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved. 57 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

58 Treatment of Opioid Addiction 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved. 58 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)

59 Treatment of Opioid Addiction 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved. 59 Ref: J. C. Ball, November 18, 1988 Slide adapted from Tom Payte

60 Treatment of Opioid Addiction 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved. 60 Factors Effecting Methadone Levels Several drugs, including Dilantin, Phenobarbital and other Barbiturates, Tegretol, Ethanol, Rifampin, St. Johns 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

61 Treatment of Opioid Addiction 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved. 61 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

62 Treatment of Opioid Addiction 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved. 62 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

63 Treatment of Opioid Addiction 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved. 63 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!

64 Treatment of Opioid Addiction 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved. 64 Effect of Treatment Duration Cerebral Phospholipid Metabolites %PME%PDEPME/PDE Short Term ( weeks) Long Term ( weeks) Control p< p< 0.09 Normalized Value (% Control)

65 Treatment of Opioid Addiction 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved. 65 Relapse to IV drug use after MMT 105 male patients who left treatment Percent IV Users Treatment Months Since Stopping Treatment Opioid Agonist Treatment of Addiction - Payte Adapted from Ball & Ross – The Effectiveness of Methadone Maintenance Treatment, 1991

66 Treatment of Opioid Addiction 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved. 66 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

67 Treatment of Opioid Addiction 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved. 67 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.

68 Treatment of Opioid Addiction 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved. 68 Nurses Dosing Station key elements are water spigot, log book Methadone bottle, cups, Med book Methadone Bottles

69 Treatment of Opioid Addiction 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved. 69 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).

70 Treatment of Opioid Addiction 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved. 70 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!

71 Treatment of Opioid Addiction 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved. 71 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 patients access to taking the medicine at home.

72 Treatment of Opioid Addiction 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved. 72 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.

73 Treatment of Opioid Addiction 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved. 73 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).

74 Treatment of Opioid Addiction 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved. 74 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.

75 Treatment of Opioid Addiction 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved. 75 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 (benzos 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.

76 Treatment of Opioid Addiction 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved. 76 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 hasnt been found, and Methadone, especially in conjunction with counseling and peer-support programs, is well established as the best treatment we have.

77 Treatment of Opioid Addiction 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved. 77 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!

78 Treatment of Opioid Addiction 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved. 78 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 -- dont 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!

79 Treatment of Opioid Addiction 10/15/2003 Copyright 2003 Aegis Medical Systems, Inc. All rights reserved. 79 Please Ask, Please Help!


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