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PAPERS:
Nikolaj Kunøe, Philipp Lobmaier, John Kåre Vederhus, Bjørg Hjerkinn, Solfrid Hegstad, Michael Gossop, Øistein Kristensen, and Helge Waal
Naltrexone implants after in-patient treatment for opioid dependence: randomised controlled trial
The British Journal of Psychiatry 2009; 194: 541-546 [Abstract] [Full text] [PDF]
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Electronic letters published:

[Read eLetter] Naltrexone Implants
Kathleen I Kelly, Dr Andrew Mcbride.   (30 September 2009)
[Read eLetter] Re: Naltrexone Implants
Nikolaj Kunĝe, Philipp Lobmaier, Michael Gossop, and Helge Waal   (22 October 2009)

Naltrexone Implants 30 September 2009
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Kathleen I Kelly,
Specialist Registrar Psychiatry
OBMH NHS FT,
Dr Andrew Mcbride.

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Re: Naltrexone Implants

kathleen.kelly{at}obmh.nhs.uk Kathleen I Kelly, et al.

The report by Kuone et al(1) of the first randomised controlled trial of naltrexone implants is of great interest.

The authors identify two inclusion criteria in their methodology:being an in-patient and being 18years or above. Exclusion criteria are given as psychosis,pregnancy and serious hepatic disease. Of 667 possible participants 480 are excluded. In the results,the term "ineligibility" is used to describe not completeing treatment,starting maintenance and transfer to other clinics. Could the authors clarify when these additional criteria were decided upon,and how many were excluded for each reason? Given that all 667 patients were receiving "abstinence- orinated" in-patient treatment,it is notable that only a small proportion of patients were eligible for,or wanted such treatment.The characteristics of the ineligible or refusal group could provide important information about which group of opiate dependent patients are likely to benefit from naltrexone.

Data on opiod use throughout the period of treatment would be of value. In the non-abstainers we would expect both groups to use in the first few days,but behavioural extinction to occur in the naltrexone group.

Participants who had their implants removed were included in the analysis using their last response carried forward. If these patients could not be contacted,would it not be a more conservative assumption that they would have relapsed?

The patient group who were living in controlled environments(prison or clinic),at follow up,were dealt with by using preadmission data. This group is missing from the flowchart.

Re: Naltrexone Implants 22 October 2009
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Nikolaj Kunĝe
Norwegian Centre for Addiction Research; University of Oslo,Norway,
Philipp Lobmaier, Michael Gossop, and Helge Waal

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Re: Re: Naltrexone Implants

nikolaj.kunoe{at}medisin.uio.no Nikolaj Kunĝe, et al.

We are happy to clarify: Of the 667 patients, 265 opioid dependent patients entered inpatient treatment for induction onto agonist maintenance treatment and were therefore excluded. Also, patients who left their respective clinics prematurely were not eligible for participation (n=193). Eleven were excluded due to psychotic symptoms, 8 due to pregnancy, and 17 due to extreme ALT/AST values.

This left n=173 opioid dependent patients as satisfying inclusion criteria. However, the virtually complete novelty of naltrexone implant treatment in Norway at the time of recruitment probably means that these results are a poor basis upon which to base estimates of demand for this form of treatment.

The randomized trial period was followed by an implantation or re- implantation opportunity for all patients, meaning that the proportion of patients who entered inpatient treatment again at the end of the study to detoxify or stabilise is probably higher than future clinical samples. Reporting it as a result or as part of a figure could be regarded as misleading.