Title:
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Feasibility of Double-Blind Clinical Trials with Oral Diacetylmorphine: A Randomized Controlled Phase II Study in an Inpatient Setting
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Author:
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Colom, Joan (Colom Farran); Casas, Miquel; Pérez de los Cobos Peris, José C.; del Río, Miquel; Roncero, Carlos; Castells, Xavier; Valero, Sergi; Eiroá Orosa, Francisco José; Batlle, Francisca; Trujols, Joan
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Other authors:
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Universitat de Barcelona |
Abstract:
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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. |
Subject(s):
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-Drogoaddicció -Opi -Desintoxicació de les drogues -Drug addiction -Opium -Drug detoxification |
Rights:
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(c) Karger, 2012
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Document type:
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Article Article - Accepted version |
Published by:
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Karger
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