Suchergebnisse

<i>Background/Aims:</i> In recent years, quality of life (QoL) assessments have proved useful for evaluating and comparing drug treatment programs. To compare QoL of patients maintained on methadone versus slow-release morphine, a prospective, randomized, double-blind, double-dummy, cross-over study was conducted. <i>Methods:</i> Over two 7-week study phases, participants received either oral slow-release morphine capsules followed by methadone oral solution or vice versa. QoL status was assessed at baseline, week 7, and week 14 using the German version of the Lancashire Quality of Life Profile. <i>Results:</i> No statistically significant difference was found between methadone and slow-release morphine in any QoL domain. A significant time effect for nearly all QoL domains was observed after 14 weeks of opioid medication, independent of the chosen drug (general well-being, p < 0.001; mental health, p = 0.001; general state of health, p = 0.018; leisure time at home, p = 0.034; leisure time out of the home, p = 0.008). Furthermore, this study revealed that even short-term maintenance yields significantly higher QoL scores in the important domain of general well-being. <i>Conclusion:</i> These results indicate that slow-release morphine has effects comparable to methadone on patient-reported QoL data and is thus a promising option for treatment of opioid-dependent subjects.

<i>Aim:</i> To investigate the mortality rate in a cohort of 269 opioid-dependent patients and the outcome of survivors meeting DSM-IV criteria for opioid dependence. <i>Design:</i> Retrospective cohort study. <i>Participants:</i> Patients enrolled in synthetic opioid maintenance therapy during a time frame from 1998 to 1999 originally at the Addiction Clinic and then discharged to general practitioners. <i>Methods:</i> Structured interviews (Europ-ASI), urinalysis at time of interview as well as autopsy findings from deceased patients. <i>Results:</i> After six mailings, information from 147 (54.6%) patients was gained. 85 patients (31.6%) were interviewed. From these 76.5% (n = 65) were still enrolled in maintenance therapy, 18.8% (n = 16) were drug-free and 4.7% (n = 4) relapsed. From 29 fatalities, 37.9% died of intoxication with illicit substances, 34.5% related to AIDS and 27.6% of somatic complications. The Standardized Mortality Ratio (SMR) was 29.13 (95% CI = 19.27–44.04). A higher lifetime frequency of hospitalization, less working days and a lack of social relationships were factors associated with high mortality. <i>Conclusions:</i> The study confirms the high mortality rate in this patient group and supports the importance of maintenance therapy. Although great efforts were undertaken in locating patients, about 45% of the target group could not be located.

<i>Background:</i> Prenatal nicotine exposure is associated with increased neonatal mortality, low birth weight, and smaller head circumference. Opioid-dependent pregnant women show a particularly high prevalence of tobacco smoking and are at greater risk for additional adverse events. However, little is known about the impact of tobacco smoking on opioid-maintained pregnant women and neonatal outcomes. <i>Patients and Methods:</i> This study examined the effect of cigarette smoking on 139 opioid-maintained pregnant women and their neonates. Forty-five percent of the participants were maintained on slow-release oral morphine (SROM), 39% received methadone maintenance, and 16% received buprenorphine. Participants were divided into two groups: (1) women who reported a low cigarette consumption of ≤10 cigarettes/day (56.8%) and (2) those reporting heavy consumption of ≥20 cigarettes/day (43.2%). Neonatal outcome measures were assessed, and a standardized Finnegan score was applied to determine the neonatal abstinence syndrome (NAS). <i>Results:</i> Fifty-two percent of the newborns did not require treatment for NAS (54% of neonates born to methadone-maintained mothers, 30% born to SROM-maintained mothers, and 95% born to buprenorphine-maintained mothers; p < 0.001). Heavy cigarette consumption was associated with significantly lower neonatal birth weight (p < 0.001), smaller birth length (p = 0.017) as well as with the severity of NAS (p = 0.03). With regard to concomitant consumption of opioids (p = 0.54), cocaine (p = 0.25), amphetamines (p = 0.90) or benzodiazepines (p = 0.09), no significant differences between heavy or low nicotine consumption were noted. <i>Conclusion:</i> Heavy tobacco smoking in opioid-maintained pregnant women is associated with adverse medical and developmental consequences for the newborn. Future treatment programs for this target group should focus on an individualized approach to opioid maintenance therapy in addition to offering specially tailored counseling for smoking cessation.

<i>Background:</i> Multi-center trials enable the recruitment of larger study samples, although results might be influenced by site-specific factors. <i>Methods:</i> Site differences of a multi-center prospective double-blind, double-dummy randomized controlled trial (7 centers: Central Europe (Vienna)/USA (3 urban/3 rural centers)) comparing safety and efficacy of methadone and buprenorphine in pregnant opioid-dependent women and their neonates. <i>Results:</i> Urban US women had the highest rate of concomitant opioid (p = 0.050) and cocaine consumption (p = 0.003), the highest dropout rate (p = 0.001), and received the lowest voucher sums (p = 0.001). Viennese neonates had significantly higher Apgar scores 1 min (p = 0.001) and 5 min after birth (p < 0.001) and were more often born by cesarean section (p = 0.024). Rural US newborns had a significantly shorter neonatal abstinence syndrome treatment duration compared to Viennese and urban US sites (p = 0.006), in addition to other site-specific differences, suggesting a more severely affected group of women in the urban US sites. <i>Conclusion:</i> This clinical trial represents a role model for pharmacological treatment in this unique sample of pregnant women and demonstrates the clinical importance of considering site-specific factors in research and clinical practice.