Feasibility of Double-Blind Clinical Trials with Oral Diacetylmorphine: A Randomized Controlled Phase II Study in an Inpatient Setting
European Addiction Research, 07/31/2012
Farran JC et al. – This study shows the feasibility of double–blind clinical trials using b.i.d. immediate–release oral diacetylmorphine (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.Methods
- 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.