Traditionally, healthcare practitioners seek to prescribe the lowest practical dose
of a medication to “get the job done,” believing this will help reduce unwanted
side effects. However, in the case of methadone, inadequately low doses often have
been prescribed more for philosophical, moral, or psychological reasons than for
sound pharmacological and clinical ones.
These misguided practices stemmed from stigmatization of methadone as “evil,” and
a belief that patients should be administered the lowest possible amounts and then
discontinue methadone as soon as possible. It also was falsely believed that it
would be easier to eventually withdraw patients from lower rather than higher doses.
However, there is no evidence of lower doses being truly adequate for the vast majority
of patients. Just how large a dose is “enough” depends on individual patient needs.
Numerous clinical trials through the years have compared various doses of methadone
for MMT. A consistently reported finding is that patients receiving higher doses
exhibit superior outcomes, compared with those at lower dose levels. Trials have
looked at such outcome variables as illicit-opioid abstinence, retention in treatment,
psychosocial rehabilitation, and others. Doses compared have ranged from placebo
(0 mg/day) up to 780 mg/day.
It is important to note that clinical trials to date have rarely examined doses
above 100 mg/day, even though there is considerable evidence to demonstrate that
this only might be an average adequate dose for a great many patients. Those studies
that have looked at higher doses found that many patients thrive on and are more
successful in MMT on vastly higher daily doses.
Minimum and maximum doses decided by clinic policy rather than by medical criteria
are contrary to best practices in MMT mandated by federal regulations. Although
individual state requirements may vary, federal regulations do not require special
permission for doses above specific levels; nor are there limits on levels of methadone
for dose increases or amounts provided for take-home.
Sources:
Donny EC, Brasser SM, Stitzer ML, Bigelow GE, Walsh SL. Relatively high doses of
methadone are necessary to suppress heroin self-administration in the human laboratory
Paper presented at: CPDD (College on Problems of Drug Dependence) 65 th Annual Meeting;
June 2004; San Juan, Puerto Rico.
Federal Register. Narcotic drugs in maintenance and detoxification treatment of
narcotic dependence; repeal of current regulations and proposal to adopt new regulations.
Federal Register. July 22, 1999;64(140):39809-39857. 21 CFR Part 291; 42 CFR Part
8.