Safety & Efficacy of 2 Alternative Forms of Oral Buprenorphine (v10)
Research type
Research Study
Full title
A PHASE II, RANDOMISED, SINGLE CENTRE, OPEN-LABEL, TWO-ARM STUDY TO DETERMINE THE SAFETY AND EFFICACY OF BUPRENORPHINE ORAL LYOPHILISATE (XPRENOR ®) IN COMPARISON WITH BUPRENORPHINE SUBLINGUAL TABLETS (SUBUTEX®)IN OPIOID-DEPENDENT PATIENTS
IRAS ID
114096
Contact name
John Strang
Sponsor organisation
Macarthys Laboratories t/a Martindale Pharma
Eudract number
2012-003560-49
ISRCTN Number
No number provided
Clinicaltrials.gov Identifier
No number provided
Research summary
This study is designed to determine the safety and efficacy of a new oral wafer form of buprenorphine (Xprenor)at clinically effective doses compared with sublingual buprenorphine tablets (Subutex) in opioid-dependent patients. Xprenor has been specifically developed to provide clinicians and patients with a formulation of Opioid Substitution Therapy which will reduce the risks of diversion and abuse but will continue to provide an effective treatment. It is a single centre, 2-arm, open-label study to be undertaken at a nationally recognised centre. The study will comprise screening, pre-randomisation treatment, titration to an effective dose, maintenance at that dose and extension back to a conventional treatment. Safety will be monitored by measuring blood oxygen levels and respiration rate during Titration and at end of the Maintenance Periods, adverse events (AEs)s will be monitored throughout the study. Efficacy will be evaluated by in-patient reported opioid withdrawal symptoms from baseline to end of study between Subutex and Xprenor using assessment scales. Blood drug concentrations will be measured at selected times during the study. The time required for test medication disintegration / complete disappearance will also be measured.
REC name
London - Brent Research Ethics Committee
REC reference
12/LO/1490
Date of REC Opinion
2 Oct 2012
REC opinion
Favourable Opinion