Buprenorphine hemiadepate with naloxone in opioid dependent patients

• Research type

  Research Study

• Full title

  A randomised, double blind, placebo controlled, cross over study of the effects of Buprenorphine Hemiadipate Hydrochloride/Naloxone Hydrochloride Dihydrate intravenous co-administration in opiate dependant patients stabilised on sublingual Buprenorphine Hydrochloride/Naloxone Hydrochloride Dihydrate

• IRAS ID

  87451

• Contact name

  James Bell

• Sponsor organisation

  Rickett Benckiser Pharmaceuticals

• Eudract number

  2011-002229-23

• Research summary

  Buprenorphine is used to treat patients with opiate dependency. It is taken under the tongue in tablet form, and is sometimes combined with naloxone (eg as Suboxone©). Naloxone is an antagonist of opioids, and is included in Suboxone© to discourage intravenous misuse. Misuse includes grinding tablets, dissolving them in water and injecting the solution: naloxone blocks the action of buprenorphine when administered in this way, discouraging this dangerous practice. Buprenorphine hemiadipate hydrochloride is closely chemically related to buprenorphine, but is better absorbed when given by mouth and then converted inside the body into buprenorphine, so it is hoped that it will be an improvement on the standard marketed form of buprenorphine. It will be combined with naloxone for the same reason as is the standard buprenorphine preparation, namely to discourage intravenous misuse. This combination is being developed by Reckitt Benckiser Pharmaceuticals., (the Sponsor) and this study is being carried out on behalf of the Sponsor by the South London and Maudsely Hospital. It is not yet known how much naloxone needs to be added to buprenorphine hemiadipate hydrochloride to discourage misuse. The purpose of this present study is to investigate this by measuring the effects of injecting buprenorphine hemiadipate hydrochloride and naloxone both separately and combined in three different proportions in opioid dependent subjects stabilised on sublingual buprenorphine. Other objectives are to assess how the human body handles these drugs and their breakdown products. This will help the sponsor to develop better treatments for opioid dependency.

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  11/LO/1528

• Date of REC Opinion

  23 Nov 2011

• REC opinion

  Further Information Favourable Opinion