INDUCTION PROCESS FOR BUPRENORPHINE (AND METHADONE): WHERE’S THE EVIDENCE?

In a recent exchange a colleague from Europe asked about switching from methadone to buprenorphine maintenance – and vice versa. Regarding the former, the common wisdom is that patients should be “tapered” to no more than 30 mg or so of methadone because of concern over precipitated withdrawal. However, some clinicians have advised that they switch medications even when patients are receiving as much as 70 mg methadone without significant problems reported by the patients.

But there’s the other side of the coin: what if any evidence-based guidelines are there for patients moving from buprenorphine maintenance to methadone? Any special cautions, side effects to anticipate, issues to which patients should be alerted? And regardless of anecdotal reports of “in my experience . . . “(which often translates to: in the one case I treated), or “in my series of patients” (which often means in those 2 or 3 patients I’ve observed), are there data supporting one approach over another for most patients?

As someone with as much experience in the field of methadone as anyone, it suddenly occurred to me – as a shock! – that I can’t think of a single controlled trial that compared different induction regimens for methadone maintenance either - after 40plus years! We (and for sure, I include myself!) speak of rules of thumb- “start low, go slow” – and make pronouncements that “starting doses over 30-40 mg can be lethal,” and state with conviction that increments of 5 mg every 2-3 days, or 10 mg every other day, or whatever . . . are optimal for most patients. But are there studies supporting one protocol over another?

A practical illustration of the problem of lacking data: a central Asian colleague asked recently whether 5 mg tablets of methadone were essential. Having this dosage (in addition to others) available would increase cost, could lead to far greater number tablets being administered/dispensed to patients, more difficulty in places where law requires the solid tablets to be crushed and dissolved before administration, etc. What evidence guides the answer? 35 years ago the NYC MMTP admitted roughly 15,000 patients to maintenance, and about 25,000 (!!) for ambulatory detoxification before dosages of 5 mg were available - and it seemed to work just fine (as Vince Dole used to say, “patients vote with their feet”, and they sure voted emphatically that these were programs they liked!).

So - can anyone suggest reasonably solid studies that allow us to go beyond the anecdotal to true evidence-based recommendations on induction (let’s stick to induction for now, and perhaps when we’ve solved that issue we can go to the withdrawal protocols)?

AND THEN THERE'S A MORE FUNDAMENTAL QUESTION, just pointed out to me by a colleague in Pittsburgh - do we really want to go down this path? "Guidelines" tend - especially when it comes to addiction medicine - to rapidly become transformed into rigid demands that preclude individual clinical judgment. Nothing's easy!

Comments and references will be appreciated greatly.