Maintenance treatment for opioid dependence with slow-release oral morphine: a randomized cross-over, non-inferiority study versus methadone.

ABSTRACT: AIMS:To compare the efficacy of slow-release oral morphine (SROM) and methadone as maintenance medication for opioid dependence in patients previously treated with methadone. DESIGN:Prospective, multiple-dose, open label, randomized, non-inferiority, cross-over study over two 11-week periods. Methadone treatment was switched to SROM with flexible dosing and vice versa according to period and sequence of treatment. SETTING:Fourteen out-patient addiction treatment centres in Switzerland and Germany. PARTICIPANTS:Adults with opioid dependence in methadone maintenance programmes (dose ?50?mg/day) for ?26 weeks. MEASUREMENTS:The efficacy end-point was the proportion of heroin-positive urine samples per patient and period of treatment. Each week, two urine samples were collected, randomly selected and analysed for 6-monoacetyl-morphine and 6-acetylcodeine. Non-inferiority was concluded if the two-sided 95% confidence interval (CI) in the difference of proportions of positive urine samples was below the predefined boundary of 10%. FINDINGS:One hundred and fifty-seven patients fulfilled criteria to form the per protocol population. The proportion of heroin-positive urine samples under SROM treatment (0.20) was non-inferior to the proportion under methadone treatment (0.15) (least-squares mean difference 0.05; 95% CI?=?0.02, 0.08; P?>?0.01). The 95% CI fell within the 10% non-inferiority margin, confirming the non-inferiority of SROM to methadone. A dose-dependent effect was shown for SROM (i.e. decreasing proportions of heroin-positive urine samples with increasing SROM doses). Retention in treatment showed no significant differences between treatments (period 1/period 2: SROM: 88.7%/82.1%, methadone: 91.1%/88.0%; period 1: P?=?0.50, period 2: P?=?0.19). Overall, safety outcomes were similar between the two groups. CONCLUSIONS:Slow-release oral morphine appears to be at least as effective as methadone in treating people with opioid use disorder.

SUBMITTER: Beck T 

PROVIDER: S-EPMC4226326 | biostudies-literature | 2014 Apr

REPOSITORIES: biostudies-literature