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Article

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Accepted version

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2012-10

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Please use this identifier to cite or link to this item: https://hdl.handle.net/2445/119879

Feasibility of Double-Blind Clinical Trials with Oral Diacetylmorphine: A Randomized Controlled Phase II Study in an Inpatient Setting

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https://doi.org/10.1159/000336849

Abstract

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

Drogoaddicció, Opi, Desintoxicació de les drogues

Subject (English)

Drug addiction, Opium, Drug detoxification

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Articles publicats en revistes (Psicologia Clínica i Psicobiologia)

Citation

COLOM, Joan (Colom Farran), et al. Feasibility of Double-Blind Clinical Trials with Oral Diacetylmorphine: A Randomized Controlled Phase II Study in an Inpatient Setting. European Addiction Research. 2012. Vol. 18, num. 6, pags. 279-287. ISSN 1022-6877. [consulted: 14 of August of 2026]. Available at: https://hdl.handle.net/2445/119879

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