Naltrexone implants in opioid dependence (version 1)

• Research type

  Research Study

• Full title

  Naltrexone implants in opioid dependence: a pharmacodynamic/pharmacokinetic proof of mechanism study

• IRAS ID

  71444

• Contact name

  Jan Melichar

• Eudract number

  2011-000558-45

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  This study will explore a potentially exciting alternative new approach to the treatment of opiate dependence - the use of a long acting depot preparation of the #230; receptor Antagonist naltrexone following detoxification. Currently the limitation of naltrexone treatment is the need for once daily oral dosing which can lead to escape from treatment. The current project is designed to test a much longer acting preparation that is given as an implant and which releases the active drug over a period of about 6 months. We aim to have fifteen opioid addicts complete an open treatment programme that will allow us to monitor plasma levels of naltrexone and its active metabolite over the 6 months to determine the pharmacokinetics of the implants. In addition the plasma levels of the antagonists needed to provide effective blockade of -on-top- heroin use will be determined by giving test doses of heroin at different times during the 6 months. These data will allow the more general use of implants in randomised controlled efficacy trials, which hopefully will result in a new pharmacological treatment approach to opioid addiction - the first in twenty years.

• REC name

  South Central - Oxford C Research Ethics Committee

• REC reference

  11/SC/0296

• Date of REC Opinion

  21 Dec 2011

• REC opinion

  Further Information Favourable Opinion