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Maintenance Therapy
for Opioid Addiction

In the 1960s the Kennedy administration's Advisory Commission on Narcotic and Drug Abuse recommended researching the utility of dispensing opioids to addicts for maintenance therapy and to, hopefully, then titrate that therapy down. The Nixon administration in the early 1970s responded to increasing opioid crime by spending more to stem the supply of heroin coming into the U.S (starting “the war on drugs”). But, it also increased the funding for methadone maintenance dramatically increasing the number of patients from 9,000 in 1971 to 73,000 in treatment in 1973.

Dr. Vincent Dole's research program in NYS was established in the early 1960s to study the utility of opioid maintenance. A starting concept was the belief that abstinence attempts (without medication), detoxifications, psychotherapy and hospitalizations did not work. A maintenance model was needed. Morphine was ruled out due to it's sedating effects. It is a short-lived drug that would require multiple injections per day, too. More and more would be needed as resistance developed. These same problems ruled out use of codeine, heroin, oxycodone and Demerol. A long-acting opioid was needed, and methadone fit the bill; also, it could be orally administered.

Methadone
With methadone, there were no tranquilizing, euphoric or analgesic effects. Normal socialization and work was possible while taking the drug. Tolerance did not vary or increase, and some people have been maintained at the same dose for 20+ years. Methadone reduced or blocked the euphoric and tranquilizing effects of all other opioid drugs regardless of whether they were injected or smoked. With a half-life of 24-36 hours, patients could take it just once per day. Side effects appeared minimal and it eliminated the "craving" that addicts often describe as the major reason for their relapses.

Dole's findings were independently supported in 1965 at the Manhattan General Hospital where most patients who were stabilized on methadone were able to eliminate illicit opioid use with improved function at school, work and home. California completed a large-scale study of substance abuse treatment in 1994, showing maintenance methods saved $7 for every dollar invested. Methadone treatment was among the most cost-effective. Methadone maintenance patients showed reduction in criminal activity and drug selling on the order of 84% and 86%, respectively. Health care utilization also dropped (e.g. 58% fewer days of hospitalization) across all treatment modalities.

Non-methadone Maintenance Therapies
Levo-alpha acetyl methanol (LAAM) was first developed in Germany in 1948 as an analgesic. In the 1960s it was looked at as an alternative to methadone with 27 separate studies between 1960 and 1981 finding it safe and helpful. However, in 2001 it was reported to affect cardiac function and currently only 3% of maintenance patients in the US take LAAM.

Naltrexone is a pure opioid antagonist, approved by the FDA in 1995 as a prevention treatment for relapse of alcohol use in patients with alcohol dependency. This is the “life-saving drug” that many fire and police departments are now carrying to reverse fatal overdose effects of heroin, oxycodone and morphine. The drug has no effect if there are no opiates in the victim’s body and has no potential for abuse. Naltrexone may help some patients in early stages of opioid use and addiction, and/or provide some additional support to motivated patients who have undergone opioid detoxification. It is a good example of the politics surrounding these drugs, as conservative Republicans like Gov. Paul LePage of Maine refuse to allow legislation expanding the availability of naloxone in his state. The belief seems to be that it would make it easier for addicts to push themselves to the edge by providing a false sense of security by thinking they would be safe from overdose if they knew rescuers with access to naloxone were nearby. There is no research of any type supporting this contorted view. LePage also thought the drug too expensive to spend on addicts, at $20-$50 per dose.

Subutex, buprenorphine, was approved to treat pain via injection in the UK in 1978. While Subutex is an opioid it is also an opioid partial agonist which means it can block the side effects of euphoria and respiratory depression of other opioids like heroin. Subutex and methadone are almost identical in their effectiveness at maintaining drug sobriety, although methadone is more sedating.

Suboxone is a combination of buprenorphine and naloxone at a 4:1 ratio. Injecting Subutex can cause a “high”; however, trying to inject Suboxone can induce withdrawal effects due to the naloxone it contains.

Subutex and Suboxone were approved for opioid addiction replacement therapy in the US in 2002. The makers of Subutex lobbied Congress and helped craft the Drug Addiction Treatment act of 2000 giving the Secretary of Health and Human Services the power to grant a waiver to physicians with special training (8 hours), to allow them to prescribe Subutex or Suboxone for opioid addiction treatment. The initial limit was ten patients per physician, but this has been increased to 100. This may have been the biggest step for helping opioid patients deal with addiction, in the “war on drugs.”

Alcoholics Anonymous
AA has about two million members participating in well over 100,000 groups worldwide, with about half of them are in the US. Professional help is discouraged, in fact no psychologists, physicians or therapists can attend AA meetings unless they have a drinking problem. Scientific American published Does Alcoholics Anonymous Work in 2011, and offered the following findings:

While about 40% of AA members drop out in their first year (some may return) those who remain are likely more motivated to “work” the 12 steps. A 1997 study found that over 12 weeks of intervention, AA worked about as well as cognitive-behavior therapy or motivational enhancement therapy. Participants in all three groups went from drinking 80% of the time before treatment to about 20% of the time a year after treatment. But, without a control group, it was unknown if any of the treatments were better than simply trying to quit on their own.

Another study in 2006 compared problem drinkers’ who tried to quit on their own vs. with AA and/or with professional therapists’ help. After ≥27 weeks of AA meetings in their first year, 67% were abstinent 16 years later compared to 34% who did not use AA. For those who received therapy 56% were abstinent vs. 39% who did not. Those with both AA and therapy typically do the best. Since the subjects chose their own paths (a naturalistic study) rather then being randomly assigned to the treatment types, the effects of pre-motivation and pre-expectations can not be determined. Still, AA does appear to help in alcohol addiction, and there are many thousands of people who swear by it.

Residential Treatment
A sad state of affairs is to be found in residential drug treatment facilities as well as outpatient options in the US, at present. Consider that in the late 1990’s Mayor Rudy Giuliani tried, unsuccessfully, to cut methadone programs serving 2,000 addicts in NY despite the programs’ success because it was “immoral” and did not result in high re-employment among them. Today, medical schools essential ignore addictive diseases, producing few experts willing to use medications. Physicians with mental health training, like psychiatrists, are limited to treating 100 patients via either in- or out-patient settings, combined. So, the vast majority of treatment available in the US is based on Alcoholics Anonymous’ (AA) 12-step orientation. In short, the efficacy of AA models with opioid addiction are far worse than for alcoholism.

On Jan. 28, 2015 the Huffington Post published a remarkably detailed article on the state of addiction treatment in the US, called
Dying to be Free: A 12-step program is, by definition, a drug-free model. Drug abstinence-only treatment works for less then 10% of opiate addicts. Even state courts reflect this bias; e.g., many Kentucky judges will not allow Suboxone or methadone treatment as a part of re-directed (treatment diversion) sentencing. Thus, if you are opioid-free by being on Suboxone, you have to go off that medication and enter an ineffective treatment program or face incarceration. For many years there has been an active black market for methadone, and now for Suboxone, serving addicts trying to stay off opiates. It was only in 2013 that the Hazelden Clinic in Minnesota (maybe the most respected treatment center in the US, which has merged with the Betty Ford Center) announced it would offer Suboxone as part of their treatment program for opioid addiction!

Essentially all of Australia’s heroin addicts in treatment were on either methadone or Suboxone by 2004. In 2005, the WHO added both drugs to its list of essential medicines for all countries. Even in Iranian prisons, addicts have access to methadone programs! In May, the
New England Journal of Medicine called for expanding the use of medication-assisted therapies (MATs).

While there are some positive strides in maintenance approaches to helping people stay off opioids, there is no easy cure in sight that would help people come off drugs altogether. And, sadly the most effective medication-maintenance treatments are rarely being used in typical treatment programs in the US. In sum, the best treatment available today is to avoid becoming addicted in the first place.

Read on for a history of attempts to legislate opiates in the next section.
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History of
Opioid Use
& Abuse

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History of
Opioid Use
& Abuse