not what one might hope for

Probuphine-3-25-13Somehow, I missed the buprenorphine implant until a comment on yesterday’s post.

Yesterday’s post pointed to dropout issues with buprenorphine. Of course, an implant would address that issue. However, the outcomes for the implants are, “not what one might hope for”.

Probuphine was evaluated in two placebo-controlled trials. In terms of efficacy, researchers found that patients on the active implant were more likely than those given a placebo implant to have opioid-negative urine samples on more occasions, and were less likely to need sublingual buprenorphine for treating of symptoms of withdrawal or craving.

But the response “was not what one might hope for, given that the product ensures compliance with medication for 6 months,” the researchers wrote. “It prompts speculation that the dose is simply not high enough.”

For instance, only 32% and 27% of patients in the respective trials had opioid-negative samples for half of all their urine tests, and 40% to 62% needed supplemental buprenorphine.

Of course, their theory is that the dose is too low.

The drug was rejected by the FDA. Here is one advocate’s case for the drug:

“If these patients could just start each day without having to decide whether or not to take a pill, I firmly believe we could help a greater number of patients achieve long-term sobriety.”

I see his point, but these outcomes make me wonder if this cuts both ways. What if their outcomes suffered because patient’s role is passive and they don’t make that decision on a daily basis?

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2 responses to “not what one might hope for

  1. I agree, passivity will likely be an issue here. I think what’s also forgotten with these types of treatment is that while they may subdue withdrawal symptoms they don’t produce the same “high” as heroin, which obviously isn’t as much of a factor as physical withdrawal, but is still relevant.

  2. chuck gehrke

    Since my first involvement with addiction and addiction treatment, getting the disease of addiction accepted as a disease and into the mainstream of medical thinking seemed to be a major effort and goal. Now, when we are getting some traction in this direction, we seem to forget some of the principles applied to other illnesses. The studies cited in today’s blog may illustrate this. I wonder how many of the patients in the studies cited were receiving their first treatment and how many were multiple relapse patients? To place a first time treatment opioid addict on long term implant therapy seems to be similar to placing the newly diagnosed diabetic on an insulin infusion pump without first trying less intensive therapy. Certainly some diabetics need intensive treatment of their disease first off but this is not true for all. There is a treatment selection process based on clinical information. Speaking to the question of “passivity” what were each of the individuals expected to do to support their abstinence (recovery ?), other than get the implant e.g 12 Step Program involvement, individual or group therapy, periodic follow-up with their physician or other healthcare provider? Diabetics with infusion pumps additionally are instructed in diet, exercise, and other health maintenance activities, get periodic blood sugar checks and see their physician or healthcare provider periodically. In fairness to the addict, as a patient, the same standards of care should be applied to them as applied to other patients.