Feasibility of double-blind clinical trials with oral diacetylmorphine: A randomized controlled Phase II study in an inpatient setting

Joan Colom Farran, Miguel Casas, José Pérez De Los Cobos, Miquel Del Río, Carlos Roncero, Xavier Castells, Sergi Valero, Francisco José Eiroa-Orosa, Francisca Batlle, Joan Trujols

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5 Citations (Scopus)

Abstract

© 2012 S. Karger AG, Basel. The aim of this study was to evaluate the feasibility of conducting double-blind controlled randomized clinical trials using twice-a-day immediate-release oral diacetylmorphine (DAM) in heroin-dependent patients, by means of measuring the capacity of oral DAM to block opiate withdrawal and clinicians' ability to distinguish it from morphine and methadone. This was a randomized, phase II, double-blind, multicenter pilot study comparing immediate-release oral DAM, slow-release oral morphine and oral methadone administered twice a day during 10 days. Forty-five heroin-dependent patients were randomly assigned to these three treatment groups in an inpatient regime. Patients were stabilized with a mean of 350 mg (SD = 193) of immediate-release oral DAM, 108 mg (SD = 46.2) of slow-release oral morphine and 40 mg (SD = 17.9) of methadone. No statistically significant differences were found between any studied medication in clinical outcome. Neither patients nor clinicians were able to identify the administered medication. This study shows the feasibility of double-blind clinical trials using b.i.d. immediate-release oral DAM allowing further phase III clinical trials in the process of introducing oral DAM as a medication for heroin-dependent patients not responding to standard maintenance treatments.
Original languageEnglish
Pages (from-to)279-287
JournalEuropean Addiction Research
Volume18
Issue number6
DOIs
Publication statusPublished - 1 Jan 2012

Keywords

  • Double-blind randomized clinical trial
  • Feasibility studies
  • Immediate-release oral diacetylmorphine
  • Methadone
  • Opiate dependence
  • Slow-release oral morphine

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