There were two related and important developments in addiction medicine this week. Walter Ling has a paper in the Journal of the American Medical Association showing that a buprenorphine implant is effective at reducing drug craving and use in opioid addicted patients, and the FDA has approved an extended-release formulation of naltrexone for the treatment of opioid addiction. In both cases, the usual challenge of oral medication — namely that one needs to decide each morning whether or not to take it — is surmounted by a single decision made in advance that keeps the medication present in the body for a month or so.
A minority of people reacts to the existence of these medications by expressing a well-meaning but fuzzy-headed concern that they are inherently “coercive”, for example they might be used to give a opioid dependent person who is leaving prison an injection that will constrain his drug use after he goes into the community. This makes sense only if one assumes that a person who is scrambling to score and shoot heroin several times a day is at the maximum of his or her freedom. Note also that the risk of death to opioid addicted men leaving prison is as high as 1 in 200 in the first fortnight in some places (e.g., Scotland) and death does tend to crimp one’s liberty.
More importantly, it also overlooks how many people, addicted or not, want the power to coerce their future selves. Thomas de Quincey, in one of the many revisions of his spellbinding Confessions of an English Opium Eater, tells the story of how Samuel Coleridge hired a working class assistant to tie him into a chair to stop him from using opium. Coleridge warns the assistant that once in the chair for a few hours, he will begin shouting abuse and saying he didn’t mean what he was saying back then, and he should be untied right away. This captures a basic human dilemma, we fear the urges of our future selves and want to confine them while our present self is at peak capacity. Hence we do not buy the double-chocolate-fat-enriched-salt-loaded pretzels at the store because we worry that in a day or a week or a month we will be tired or stressed enough to eat them.
Anyone who has ever met a person in early recovery from addiction who is desperately afraid of relapsing in a day, or a week, or a month, or on a special occasion (e.g., getting drunk at their child’s wedding) will understand how warmly greeted extended release medications will be by many addicted people and their families. That’s why the development of these medications represents an expansion rather than a restriction of human freedom.
Usage note: "maxima" is the plural form of the word. I suppose someone could simultaneously be at "the maxima of his or her freedom", assuming that they had more than one, but it suggests the possibility of being in more than one place at the same time. This is something that is usually impossible for we mere mortals, unlike the possibility of being at more than one time in the same place.
warns the assistant that once in the chair for a few hours, he will begin shouting abuse and saying he didn’t mean what he was saying back then, and he should be untied right away
The essential triviality of my nature is spotlighted by the fact that this affecting description immediately recalled to me Gene Wilder in Young Frankenstein.
Thanks Marcel for catching that, I have made the change. I wonder if I got the wrong thing in my head because I once almost bought a Nissan Maxima.
I find it difficult to interpret trials with enriched enrollment like this one. Participants were not randomized until they had first been shown to tolerate the experimental intervention. It is still possible to have an unbiased comparison between the two randomized groups, but the trial may results may give an overoptimistic estimate of what will happen when the implants are introduced into general use. Although only 1 participant was excluded during induction for not tolerating buprenorphine, 60 were lost to follow-up, withdrew consent, or failed induction criteria. Enriched enrollment is a very common design for clinical trials these days. They can show therapeutic effects that may work in only a portion of patients, but still it is tough to decide to whom the results actually apply.
There was also considerable attrition during the trial; of the 108 who were randomized to buprenorphine, only 71 completed the trial. While it is significant that the buprenorphine group had a mean of 40% clean urines vs. 28% in the placebo group, that still means 60% dirty urines in the buprenorphine group vs. 72% in the placebo group. This study makes a contribution to the field, but extended-release buprenorphine still allows many people to wriggle out of the ropes that bind them to the chair.
I wonder why ER formulations of drugs like naltrexone haven't been around for decades. Naltrexone and Antabuse are both old, and so are depot shots. They seem like a natural fit.
sr: It's a broader problem that ER, there are only 4 FDA-approved medications for alcoholism, which is amazing given its prevalence and impact. Part of the problem is there are few MDs in the addiction field, which makes it less attractive to pharma because their potential market is smaller. And the lack of meds in turn makes many MDs uncomfortable with addiction care and leads them to avoid it, reinforcing the problem.
For buprenorphine an XR preparation is especially desirable (if it is effective) because of its potential for diversion (unlike Antabuse, for example). That is part of what makes the Ling study important.
The absolute effect size in Ling shows that there is still vast room for improvement, even if the results hold up when the study is repeated. Positive studies tend to be published earlier, and less rosy studies tend to appear later. So this is a contribution, but not a "breakthrough."
Who says they are coercive? Can you cite some examples?
Dr. Arthur Caplan, an eminent bioethicist an an excellent article on Ethical Issues Surrounding Forced, Mandated, or Coerced Treatment (Journal of Substance Abuse Treatment 31 (2006) 117-120. He states: "People who are addicted really do not have the full capacity to be self-determining or autonomous because their addiction literally coerces their behavior. They cannot be autonomous agents precisely because they are caught up in the behavior vice that is addiction".
He goes on to say: "Methadone seems to be a drug that might work. However, methadone may not break the addictive spell that is person is under - it only substitutes a more socially acceptable form of addiction. There are some treatment model out there giving out free heroin and trying to make that form of drug abuse safer. Such programs exist in the UK, Switzerland, Holland and Australia. But again, these programs, while reducing social cost, do nothing for the drug-addicted individual who has lost some or much capacity for self-determination.
Then there is naltrexone. It looks safe …Thus, doesn't it make sense to use the drug that both reduces the social cost of addiction and removes the barrier that addiction creates to self-determination?"
I may add that depot injection of buprenorphine also does the same.