3 December 2007

Editorial questions the ethics of naltrexone imlants until they are proven and registered

Degenhardt L, Gibson A, Mattick RP, Hall W. Drug and Alcohol Review 2008 27;1:1-3



Depot naltrexone use for opioid dependence in Australia: large-scale use of an unregistered medication in the absence of data on safety and efficacy.



Dear Colleagues,On page one of Drug and Alcohol Review for January 2008 there is an editorial which condemns the current practice of using customized naltrexone implants before safety and effectiveness data have been obtained. Degenhardt and co-authors reflect the sentiments of many in the field questioning the premature use of various doses of non-standardised pellets of naltrexone sub-cutaneously. After quoting the limited research and normal therapeutic safeguards, they write: �Practitioners who do so run the risk of bringing into disrepute a treatment that we think may well prove to play a useful niche role in the treatment of a small group of highly selected opioid-dependent patients.�In my view it is time to call a moratorium on this treatment. The attractive side of the interest in developing naltrexone implants is that this demonstrates the relentless efforts of researchers to develop more effective, safer and more cost effective treatments for heroin dependence. However, it is important that such a quest follow the basic rules of all medical research, always protecting those taking part in the research.Standard doses of supervised methadone in traditional clinics have always suited a substantial proportion of those addicted to street heroin. Now that we have a second variety of methadone and two types of buprenorphine in Australia, as well as better �matching� of drugs, doses, added supports, etc, these success rates have improved further. Trials utilizing both methadone and buprenorphine as appropriate have shown up to 80% retention at 6 months. About 5% will successfully detoxify each year, still leaving a proportion of drug users either unwilling or unable to cope with existing treatments. Thus these may suit other approaches such as supervised naltrexone tablets, depot injections or implants (or even heroin trials). There are still waiting lists for tradition detoxification services, both medicated and otherwise.Now that John Howard is leaving office Australia may yet get its latter-day drug trial. Even beyond a simple �heroin trial�, we may need some new bold new approaches for alcohol, amphetamine use, depression, suicide and the stresses of modern life. Just as there is some indication that naltrexone may help a certain group of addicts, there has also been some promise in the use of tiagabine, ondansetron, modafinil, long-acting morphine and dexamphetamine. A new drug, varenicline (Champix) is to be released next month on the PBS under similar conditions as Zyban. There is some unconfirmed information that this nicotinic receptor drug may reduce alcohol cravings at the same time.On the subject of the stresses of modern life, I learned of an inspiring talk at the APSAD conference in Auckland last month discussing the �search for wisdom� exemplified by Bob Cloninger in his presentation on "Wellness". This was amplified with great clarity in a lecture on the history of theism by an 89 year old retired professor of theology, Lloyd Geering. He allowed the audience to recognise that in this secular age, we are all now �playing God� ourselves and it is understandably quite stressful. My correspondent said that these �higher themes� spilled out into many of the discussions and set the tone for much of the casual interaction with colleagues at the conference, many of whom were �new� to APSAD being part of the large Kiwi contingent.

Comments by Andrew Byrne ..