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Naltrexone implants after in-patient treatment for opioid dependence: randomised controlled trial

  • Nikolaj Kun⊘e (a1), Philipp Lobmaier (a1), John Kåre Vederhus (a2), Bj⊘rg Hjerkinn (a2), Solfrid Hegstad (a3), Michael Gossop (a4), Øistein Kristensen (a2) and Helge Waal (a5)...
Abstract
Background

Naltrexone has considerable potential in helping to prevent relapse in heroin dependency. A longer-lasting formulation for naltrexone treatment is desirable to further reduce non-adherence and relapse during treatment of opiate dependence.

Aims

To evaluate the safety and effectiveness of a 6-month naltrexone implant in reducing opioid use after in-patient treatment.

Method

A group of 56 abstinence-oriented patients who completed in-patient treatment for opioid dependence were randomly and openly assigned to receive either a 6-month naltrexone implant or their usual aftercare. Drug use and other outcomes were assessed at 6-month follow-up.

Results

Patients receiving naltrexone had on average 45 days less heroin use and 60 days less opioid use than controls in the 180-day period (both P<0.05). Blood tests showed naltrexone levels above 1 ng/ml for the duration of 6 months. Two patients died, neither of whom had received an implant.

Conclusions

Naltrexone implant treatment safely and significantly reduces opioid use in a motivated population of patients.

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Copyright
Corresponding author
Nikolaj Kun⊘e, Norwegian Centre for Addiction Research, Kirkeveien 166, NO-0407 Oslo, Norway. Email: nikolaj.kunoe@medisin.uio.no
Footnotes
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Declaration of interest

None.

Footnotes
References
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Supplementary materials

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Supplementary Table S1

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Supplementary materials

Kun⊘e et al. supplementary material
Supplementary Table S1

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Naltrexone implants after in-patient treatment for opioid dependence: randomised controlled trial

  • Nikolaj Kun⊘e (a1), Philipp Lobmaier (a1), John Kåre Vederhus (a2), Bj⊘rg Hjerkinn (a2), Solfrid Hegstad (a3), Michael Gossop (a4), Øistein Kristensen (a2) and Helge Waal (a5)...
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Re: Naltrexone Implants

Nikolaj Kun�
22 October 2009

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.
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Conflict of interest: None Declared

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Naltrexone Implants

Kathleen I Kelly, Specialist Registrar Psychiatry
30 September 2009

The report by Kuone et al(1) of the first randomised controlled trialof 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 foreach 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 characteristicsof 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 thatthey 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.
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