Randomised Comparison of a Novel Buprenorphine Oral Lyophilisate versus Existing Buprenorphine Sublingual Tablets in Opioid-Dependent Patients: A First-in-Patient Phase II Randomised Open Label Safety Study.

Aims: To test the safety of new buprenorphine oral lyophilisate wafer ("bup-lyo") versus standard sub-lingual buprenorphine ("bup-SL").

Design: Randomised (2:1) open-label study; opioid-dependent subjects; subsequent partial cross-over.

Settings: Specialised clinical trials facility and addictions treatment facility.

After the randomised injectable opiate treatment trial: post-trial investigation of slow-release oral morphine as an alternative opiate maintenance medication.

Introduction And Aims: To establish if slow-release oral morphine (SROM) is an acceptable maintenance medication in heroin users currently being prescribed injectable diamorphine, who are intolerant to supplementary methadone.

Design And Methods: Case note review of interviews and medication details before and after change in medication in 12 treatment-resistant chronic heroin users attending a supervised injecting clinic twice a day for prescribed injectable diamorphine plus supplementary oral methadone to ensure 24 h stability. SROM was substituted for oral methadone by cross-titration.