Safety and tolerability of slow-release oral morphine versus methadone in the treatment of opioid dependence.

Opioid substitution treatment (OST) for opioid dependence may be limited by adverse events (AEs). Increasing the range of therapeutic options optimizes outcomes and facilitates patient management. An international, multi-center, two-phase study investigated the efficacy and safety of slow-release oral morphine (SROM) versus methadone in patients receiving methadone therapy for opioid dependence. In phase 1 (two way cross-over, 11 weeks each period) patients were randomized to SROM or methadone oral solution. In phase 2 (25 weeks), patients continued treatment with SROM (group A) or switched from methadone to SROM (group B). In total, 211 out of 276 completed phase 1 and 198 entered phase 2 (n=95 group A, n=103 group B). Treatment with both SROM and methadone was well tolerated. However, the mean QTc-interval associated with methadone was significantly longer than that under SROM. Higher treatment satisfaction, fewer cravings for heroin, and lower mental stress were reported with SROM. This study adds a significant further weight of evidence that SROM is an effective and well tolerated long-term maintenance treatment for opioid dependence with a beneficial risk profile compared to methadone regarding cardiac effects and supports its clinical utility.

Long-term effects of heroin-assisted treatment in Germany.

AIMS: Trials in Switzerland, the Netherlands and Spain have found that heroin-assisted treatment (HAT) as maintenance treatment for opioid-dependent patients reduces illicit drug use. A German trial also found diamorphine treatment to be superior to methadone treatment. The present study describes the association between 2 years of heroin treatment and improvements in health and social stabilization, as well as illicit drug use. DESIGN: A prospective cohort study design. PARTICIPANTS: A total of 515 patients were assigned to diamorphine treatment; 278 patients remained in the study treatment for the entire period of 24 months (54.8%). MEASUREMENTS: The results on physical (Opiate Treatment Index Health Symptoms Scale) and mental (Symptom Checklist 90-Revised Global Severity Index) health and illicit drug use (number of days with drug use within the last month-European Addiction Severity Index) were examined by repeated-measures analyses. FINDINGS: Symptoms of physical (Pillai's trace = 0.837, df = 4, P < 0.001) and mental health (Pillai's trace = 0.450, df = 4, P < 0.001) improved during treatment. Street heroin use declined rapidly (Pillai's trace = 0.836, df = 4, P < 0.001), as did cocaine use (Pillai's trace = 0.280, df = 4, P < 0.001). CONCLUSIONS: HAT is associated with improvements in mental and physical health in the long term.