- High Dose Best Dose for Many
- Managing Clinic Growth
- From the Editor
- Events to Note
- Change as a Challenge
- Reader Survey Responses
- Where to Get Info
High Dose Best Dose for Many
The original protocol of Dole and Nyswander (1966) recommended maintenance methadone doses of 80 to 120 mg/d – an average 100 mg/d. Over the years, however, this became distorted and in some clinics was viewed as an exceptionally high dosage regimen on average. By 1992, survey research by D’Aunno & Vaughn found that over half of American MMT patients received doses inadequate to curtail illicit narcotic use and/or retain them in treatment.
Recent research by Marc Shinderman, MD and Sarz Maxwell, MD of the Center for Addictive Problems (CAP) in Chicago found that average methadone doses in excess of 100 mg/d are not only safe, but are effective and absolutely necessary for some patients to prevent continued illicit drug use. He suggests that while methadone blood serum levels are useful as a guide to therapy, objective signs and subjective symptoms of withdrawal, and the continued illicit use of drugs, are primary indicators of the need to increase dosages in MMT patients and achieve optimal daily dosing.
CAP, a private organization founded in 1976, currently treats about 1200 patients. The research project treated 77 patients with methadone doses in excess of 100 mg/d – the average was a little over 200 mg/d (range 110-580 mg/d). This high dose (HD) group was compared to a control group of patients randomly selected from the clinic population.
There were some unique qualities of the HD group: 73% had comorbid psychiatric diagnoses (major depression in 40% of those being the major illness) versus a third of the control group. At intake, the HD group had larger heroin requirements ($170/day versus $90/day in the controls).
The results achieved by a high dose regimen were exceptional. Urine tests positive for illicit drugs in the HD group dropped from 91% before the dose increases to only 5% afterward. This compared favorably to the control group, which went from 52% “dirty urines” down to 30% during the same period. Of interest, the average methadone dose among control group patients, who were all allowed to self-determine their dosages, was merely 65 mg/d.
Program retention in the HD group was 85%, and there was some evidence that such doses also decrease cocaine use among patients. As another benefit, Shinderman observes that other psychotropic medications (e.g., antidepressives) will start working more effectively when adequate methadone levels are reached.
Clinical Assessment of Adequate Dose
According to Shinderman, the higher doses were necessary to achieve optimum methadone blood plasma levels. Various researchers have found that minimum trough methadone plasma concentrations (i.e., usually the low point before the next dose is taken) of 400 ng/ml are required to provide stabilized maintenance; trough levels between 200 and 400 ng/ml are associated with subjective patient complaints, while those below 200 ng/ml produce objective signs of abstinence syndrome.
The continued use of illicit drugs is the most obvious sign of the need for increased methadone dose. Subjective symptoms (i.e., patient complaints) have the most utility for fine tuning dose.
Peak (maximum concentration) plasma levels for effective MMT are generally higher than 500 ng/ml; peak levels above 1000 ng/ml should be watched closely for possible toxic effects. However, plasma levels of methadone and their effects can be highly variable among individuals, so adequate dose is most often achieved by closely monitoring clinical response. For this, regular patient contact with staff physicians is required.
Shinderman says his research found that once the trough level reaches 400ng/ml most patients stop asking for increases in dose. However, the exact methadone dosages to achieve that plasma level can vary by hundreds of milligrams per day!
Interactions with certain medications – e.g., phenytoin, carbamazepine, rifampin, some protease inhibitors, and others [see Addiction Treatment Forum, Spring 1997] – can influence metabolism and require higher doses of methadone. Furthermore, while the average high dose in the CAP study was about 200 mg/d, 18% of patients (representing 1.10% of the total clinic population) required in excess of 250 mg/d; some with liver disease, malabsorption syndrome, or other illness inhibiting metabolism.
Yet, Shinderman has found that patients almost never ask for dosage increases resulting in toxic serum levels and nearly a third require encouragement to accept adequate doses resulting in cessation of illicit substance abuse. He believes that, if allowed to set their own methadone doses, a significant number of patients will tend to under-dose themselves.
Breaking Through “Glass Ceilings”
Shinderman concedes there were several barriers keeping his group from instituting high dosing programs much earlier. For one thing, like many clinic operators, he didn’t fully appreciate that the federal regulations readily allow take home doses above 100 mg/d. Hence, both patients and staff erroneously perceived that going beyond that “glass ceiling” was an exception to the rules, rather than a perfectly acceptable and appropriate everyday medical regimen for many patients.
Arriving at optimal higher dosages requires more active participation by staff physicians to work with patients and observe their clinical responses on a frequent schedule. Shinderman’s group finally accepted that challenge, but he believes some clinics may not have sufficient staff or otherwise be reluctant to institute such measures.
Also, he says some clinical staff believe that methadone can only go so far in preventing continuing drug abuse and then patients must assume responsibility for their own behaviors. Shinderman admits he was making this same error in thinking until he discovered that appropriately higher methadone doses alone could completely eliminate continued opiate abuse, which is just what MMT was intended to do.
Managing Clinic Growth
A Formidable Assignment
Here’s your assignment: more than double the patient population of your MMT clinic in just two years, while holding the budget constant and reducing per patient costs, and improve treatment outcomes while you’re at it. That was the challenge undertaken several years ago by Charles Seaman, MD, medical director and his staff at the VA Northern California Health Care System, Berkeley.
In 1991 this government institution had 70 patients in an MMTP. By 1994 that number had more than doubled to 150 patients and a new plan to accommodate further growth was needed. Consequently the program grew to over 300 patients by 1996.
In developing the plan Seaman decided that retention in treatment was the most important factor in achieving positive outcomes. “Spending all of a program’s resources on a limited number of patients over a shorter time-frame just creates a revolving door situation,” he says. “It can take a long time for addicts to recover and become productive citizens, and anything that can extend their time spent in treatment can help achieve that goal.”
Previously, the program had focused on quickly achieving complete abstinence from illicit substances and alcohol. There was also an emphasis on a “more is better” philosophy in providing an abundance of intensive services. These were pitfalls to be avoided, Seaman recalls: “Putting the patient in an intensive, expensive, and short-term program in the hopes of achieving long-lasting abstinence just isn’t practical or a good use of resources.”
As one element of the new program, rapid patient intake was considered essential. Seaman says research has demonstrated that merely a 3-day wait causes reductions in retention later on.
At the same time, Seaman’s program switched from a high intensity to a low intensity approach. Whereas, patients had attended clinic programs several hours every weekday, with therapy groups attuned to many specific patient needs, the group sessions were reduced to just a few each week covering broader topics. Along with this the staff developed a large-group discussion format – 20 to 30 patients – with smaller break-out groups to focus on individual concerns.
In 1994, patients had mandatory weekly individual counseling, which was confrontational in nature and focused on abstinence.
By 1996, individual counseling was provided on an “as needed” basis, and it was non-confrontational and more flexible regarding compliance.
Along with this, the staff was reduced from 19 employees per 150 patients to 14 staff for over 300 patients. Among those eliminated were social workers and registered nurses; dosing was done by licensed practical nurses. A computerized dosing system was also implemented, which helped save on staff time and made it more feasible for LPNs to do the dispensing. The program also made better use of community resources and 12-step groups to augment clinic services.
By 1996, the clinic had completely switched to a more patient-friendly approach:
*intake was on a “walk-in” basis, without a waiting period;
*during certain hours, patients could just drop by to see a psychiatrist without an appointment;
*introduction-to-treatment groups and dose assessments were held daily for patients needing them;
* the focus was on retention in the program and long-term treatment success.
The cuts in staff and treatment intensity, and the more liberalized philosophy regarding abstinence would, at first glance, seem to doom a program to failure. But, Seaman reports some startling successes:
* In 1994 the program had a one-year patient retention rate of 50%; this increased to over 80% by 1996.
* In terms of costs, the program went from $6,350/patient/year in 1994 down to $1,989/pt/yr in 1996.
*Morale among remaining staff members improved dramatically, since the prior confrontational approach was stressful for both staff and patients.
Average methadone doses remained at a fairly constant level of 60 to 80 mg/d during the program revisions. “We’ve always been liberal in allowing patients to determine their own dosage ranges, and anyone who wanted an increase got it,” Seaman says. “Our experience has been that we don’t get much further benefit above 80 mg/d for most patients. We have no objection to vastly higher ranges for certain patients who might benefit, but we haven’t as yet established a protocol to examine that issue.”
Abstinence rates appear to have declined in the refurbished, low intensity program. For the original 1994 high intensity program abstinence at six months was 50%, but it had fallen to 25% by 1996.
However, Seaman stresses this needs qualification: “At first, abstinence measured as clean urines is enhanced by a high intensity, abstinence-oriented program, but these rates appear to begin to decline after the first six months patients are in the program. Our current abstinence rates may seem low because we retained a lot of patients in treatment who would have been discharged from the earlier program.”
“If abstinence is a primary goal, a program may show great success among the patients retained in treatment,” he cautions, “but the real question is, How many patients left that program because they couldn’t achieve abstinence in the time allowed? One has to balance the abstinence rate with the risks of a high drop-out rate.”
Finally, Seaman observes that in the long-term it’s more cost-effective to keep patients in treatment longer, possibly with fewer services to save on costs and less abstinence, than to discharge them prematurely and have to readmit them again later after they’ve possibly developed severe medical complications and/or HIV. Insurance companies and managed care organizations need to appreciate that fact and not push for shorter-term treatment.
From the Editor
That was the theme for this year’s AMTA (American Methadone Treatment Association) Conference in Chicago during mid-April, which attracted over 1,100 registrants from 21 nations. In his conference-opening remarks AMTA president Mark Parrino explained the challenging times:
“Public funding for treatment has become increasingly scarce and heroin is more available at purer levels than ever before. Unfortunately, one thing has remained the same; access to methadone treatment is still just as limited as it was twenty years ago.”
Parrino indicated that there are 830 methadone programs in the United States, providing care to 130,000 people. Clinics operate in 42 states, which means eight have no methadone services available.
“The spirit of our treatment program and this conference is founded on the principle of healing,” Parrino said. “America has struggled with the desire to cure rather than the need to treat. . We can only achieve our objectives with the unwavering support of the White House, Congress, and the states.”
Science, Not Ideology
Over the conference’s three days, plenary sessions featured an impressive forum of distinguished speakers who all seemed to center on a single theme: To move forward, the field of methadone treatment must continue to focus on the science of addiction and the benefits of treatment, overcoming the biases and unachievable ideals of misinformed bureaucrats and an uneducated public. Here are excerpts from those sessions:
Bobby Rush, Illinois Congressman
How the field defines itself is critical, “We need to talk about being in the recovery business that will lead to a better reception.”
“Overcoming addiction requires help and intervention. The ‘Just say no to drugs’ approach doesn’t work. People can’t cure addiction with words, it takes a commitment of people, and funds, and resources.”
“We’ve not only been defeated in the war on drugs, but we’re in constant retreat. We need to organize in a political sense for change we need a common will so we cannot be divided or Congress will use such divisions against us.”
General Barry McCaffrey, director, Office of National Drug Control Policy (ONDCP) [via video message]
“Our national drug control strategy is fundamentally based on science, not ideology. Treatment is going to be an essential component of that strategy and methadone in turn is a critical component of addiction treatment.” ONDCP will support the recommendations of the Institute of Medicine (IOM) report, and unequivocally support the science on which methadone is based. The agency will also work with federal and state treatment providers to develop ways of increasing the availability of and access to treatment. “There are currently 600,000 addicts in need of methadone treatment and only 140,000 slots available,” he stated.
Hoover Adjer, MD, deputy director of ONDCP
The case has been made that treatment programs work, but there is a need to convince the general public. However, scare tactics to prevent drug use among our youth won’t work; we need good scientific data.
ONDCP is committed to the use of methadone and LAAM. And, in accordance with the IOM recommendations some form of accreditation program seems to be in the offing. But the impact of several factors must be considered: What will such accreditation cost and who will do it? Will the costs be passed on to patients? Will it alter the quality of treatment?
Avram Goldstein, MD, Professor Emeritus of Pharmacology, Stanford University
Addiction is characterized by overwhelming involvement in substances of abuse and oftentimes relapse after withdrawal. Addressing the science of addiction, he observed that endorphins stimulate the release of dopamine in the “reward pathways” of the brain. Opiates shut down inhibitory neurons, which allows dopamine to run wild leading to addictive tolerance and dependence.
Methadone occupies mu opioid receptors and blocks the heroin high – it is a therapeutic aid, not a panacea – and giving up methadone is not a primary treatment goal. It takes at least 60 to 80 mg/d of methadone to saturate the receptors; low dosage programs are self-defeating.
David Smith, MD, president, American Society of Addiction Medicine
The addiction treatment field is under siege, as Congress reduces budgets. “Public policies that make no sense reflect the attitudes of the policy makers and society.”
The only thing more regulated in our society than methadone is nuclear fuels. The “system” doesn’t trust patients or the providers of services to those patients. At any one time only 5-10% of the opiate addicts at risk are in treatment. The trend is toward increasing numbers of dual-diagnosed and triple-diagnosed (including HIV) patients.
“In order to survive, the methadone maintenance field needs to broaden its base of support outside the field.” ASAM, which was once heavily oriented toward 12-step programs, is now also supportive of MMT.
Yet, no single treatment approach is effective in all cases. Diagnoses-based treatment accepts a variety of modalities. Too often, treatment is program-driven, rather than by what’s best for the individual patient in terms of a broader delivery system and new medications.
Lisa Mojer-Torres, JD, recipient of NIDA’s Public Service Award
There is a need to overcome public ignorance about MMT, but we also need to educate patients regarding methadone as a medication. Addicts come into MMTs in desperation – that is a time to educate them regarding how/why it works and safety considerations.
Even among clinic staff there is sometimes the erroneous belief that after a time patients on methadone are “cured” and no longer need the medication. This only leads to relapse.
Alan Leshner, PhD, director, National Institute on Drug Abuse (NIDA)
“Advances in science have revolutionized our fundamental views of drug abuse and addiction. Drug abuse is a preventable behavior; drug addiction is a treatable disease.”
People take drugs because they like what it does to their brains and prolonged use alters brain function. Some time after the start of drug abuse a “switch” flips and continued drug use is no longer voluntary. It is a brain disease also influenced by environmental and hereditary factors.
The major task of treatment is to change the brain back, and methadone helps compensate for those changes. Behavioral modification is also important.
There is a “great disconnect” between currently appreciated scientific facts and public perception of addiction issues. Bringing these opposing perspectives closer together can be important and has worked for the better treatment of cancer, aging, schizophrenia, and depression.
David Mactas, director, Center for Substance Abuse Treatment (CSAT)
“We need to be educated, so our promotion of the field [MMT] is based on science. We can’t promote the field on the basis of mythology or dogma. We don’t cure anybody, we provide opportunities for people to rehabilitate and recover.” MMT patients exist as part of a society which doubts the efficacy of that treatment.
“We have to promote the idea that treatment is very worthwhile and that we [society] pay very dearly for the absence of it.” We need to lobby Congress to promote the concept of the benefits of addiction treatment as a whole, rather than focusing on individual treatment modalities.
Change Creates Challenges
In summing-up the conference, we agree with Bob Lambert, Program Director for Connecticut Counseling Centers, who commented to us that over the years each AMTA conference gets better in terms of the quality of programming, professionalism of the attendees, and attitudes that are increasingly more favorable toward MMT. The next AMTA Conference will be in New York City, September 27-30, 1998, so mark your calendars now – you won’t want to miss it.
Continuing the theme of the conference, in this issue we examine three aspects of change which create challenges for MMTPs: expanding treatment capacity while containing costs; serving a population of patients requiring “higher than usual” methadone doses; and the impact of switching methadone formulations from tablets to liquid.
As usual, we wish also to share the experiences of our readers, so this issue’s survey questions are:
1. Has your clinic experienced increased stress among patients as a result of some change in overall policies or procedures?
* Yes * No * Don’t Know
2. Were there increased rates of patient relapses or aberrant behavior as a result?
* Yes * No * Don’t Know
3. Did any patients leave your MMT program as a result?
* Yes * No * Don’t Know
Please provide your responses and written comments on the postage-free feedback card in this issue, OR write or fax us, OR visit our Web site to respond via e-mail. As always, your written comments will be very important for helping us explain your checked responses.
Addiction Treatment Forum
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Stewart B. Leavitt, PhD, Editor