Feasibility of Double-Blind Clinical Trials with Oral Diacetylmorphine: A Randomized Controlled Phase II Study in an Inpatient Setting
Por:
Farran, JC, Casas, M, de los Cobos, JP, del Rio, M, Roncero, C, Castells, X, Valero, S, Eiroa-Orosa, FJ, Batlle, F, Trujols, J
Publicada:
1 ene 2012
Resumen:
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. Copyright (C) 2012 S. Karger AG, Basel
Filiaciones:
Farran, JC:
Govt Catalonia, Programme Substance Abuse, Publ Hlth Agcy Catalonia, ES-08005 Barcelona, Spain
Casas, M:
Univ Autonoma Barcelona, Hosp Univ Vall dHebron, Dept Psychiat, E-08193 Barcelona, Spain
Univ Autonoma Barcelona, Dept Psychiat & Forens Med, E-08193 Barcelona, Spain
de los Cobos, JP:
Univ Autonoma Barcelona, Dept Psychiat & Forens Med, E-08193 Barcelona, Spain
Hosp Santa Creu & Sant Pau, Dept Psychiat, Addict Behav Unit, Barcelona, Spain
del Rio, M:
Univ Barcelona, Dept Psychiat, Hosp Univ Mutua Terrassa, Res Fdn Mutua Terrassa, Barcelona, Spain
Roncero, C:
Univ Autonoma Barcelona, Hosp Univ Vall dHebron, Dept Psychiat, E-08193 Barcelona, Spain
Univ Autonoma Barcelona, Dept Psychiat & Forens Med, E-08193 Barcelona, Spain
Castells, X:
Univ Autonoma Barcelona, Hosp Univ Vall dHebron, Dept Psychiat, E-08193 Barcelona, Spain
Univ Autonoma Barcelona, Dept Med Sci, Clin Pharmacol Unit, E-08193 Barcelona, Spain
Univ Girona, Grp Recerca TransLab, Girona, Spain
Valero, S:
Univ Autonoma Barcelona, Hosp Univ Vall dHebron, Dept Psychiat, E-08193 Barcelona, Spain
Univ Autonoma Barcelona, Dept Psychiat & Forens Med, E-08193 Barcelona, Spain
Biomed Res Ctr Mental Hlth CIBERSAM, Madrid, Spain
Eiroa-Orosa, FJ:
Univ Autonoma Barcelona, Hosp Univ Vall dHebron, Dept Psychiat, E-08193 Barcelona, Spain
Univ Autonoma Barcelona, Dept Psychiat & Forens Med, E-08193 Barcelona, Spain
Batlle, F:
Univ Autonoma Barcelona, Dept Psychiat & Forens Med, E-08193 Barcelona, Spain
Hosp Santa Creu & Sant Pau, Dept Psychiat, Addict Behav Unit, Barcelona, Spain
Trujols, J:
Hosp Santa Creu & Sant Pau, Dept Psychiat, Addict Behav Unit, Barcelona, Spain
Biomed Res Ctr Mental Hlth CIBERSAM, Madrid, Spain
Green Accepted, Bronze
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