Safety and Efficacy of Oral Slow Release Morphine for Maintenance Treatment in Heroin Addicts: A 6-Month Open Noncomparative Study

Abstract

This open-label, noncomparative, single-center trial evaluated the safety and efficacy of once-daily treatment with slow release oral morphine (SROM) capsules for the maintenance treatment of 20 outpatients with heroin dependency over 6 months at the National Institute for Addictions in Sofia, Bulgaria. Doses were individually titrated up to a mean daily maintenance dose of 760 mg (range 440–1,200 mg). SROM was effective in significantly reducing the signs and symptoms of opioid withdrawal and craving for heroin, with stabilization generally evident within two weeks. Nineteen patients completed 6 months of treatment and illicit opioid use was virtually eliminated. One patient withdrew voluntarily at 22 weeks. Validated questionnaires and tests indicated improvements in patients’ well-being from baseline assessments. These included significant improvements with regard to suicidal depression (85%), anxiety and dysphoria (66%), general illness (58%), social dysfunction (54%), sense of hopelessness (34%), attention (25%), and self-reported typical depressive (27%) and disease-related (11%) symptoms. No deaths, serious adverse events, or withdrawals due to adverse events occurred. Five episodes of constipation and one episode of sweating (all nonserious and of mild or moderate severity) were reported. Vital signs were unaffected by SROM and no weight change was evident over the study period. The observations made in this study indicate a promising role for once-daily treatment with SROM in the clinical management of heroin dependency.

Quality of Life in Patients Receiving Opioid Maintenance Therapy

“…These results strongly support previous findings of increased QoL for patients in maintenance treatment compared with patients at admission or those seeking treatment [22,35,43,44] .…”

Evidence-Based Treatment of Opioid-Dependent Patients

“…In contrast, SROM is a promising compound that is complementary to existing substances for maintenance treatment and has been authorized for maintenance treatment of opioid dependence in a few European countries. Several smaller and mostly open-label studies have shown positive results for SROM with respect to retention, reduced heroin use, and (or) improved quality of life (135)(136)(137)(138)(139). Further studies will have to confirm these results before the added value of this substance for the treatment of heroin dependence can be established.…”

Mental Symptoms and Drug Use in Maintenance Treatment with Slow-Release Oral Morphine Compared to Methadone: Results of a Randomized Crossover Study

“…Given the high prevalence rates of psychiatric comorbidity in opioid-dependent patients, the effects of substitution medication on these symptoms in particular are of special interest [11]. Previous studies suggest positive effects of slow-release oral morphine on depression, anxiety or quality of life [9,10,12]. However, only the study of Eder et al [9] had a controlled design, and it failed to show superior quality of life results for slow-release oral morphine compared to methadone [13].…”