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Incident reporting systems or so-called critical incident reporting systems (CIRS) were first recommended for use in health care more than 15 years ago. The uses of these CIRS are highly variable among countries, ranging from being used to report critical incidents, falls, or sentinel events resulting in death. In Austria, CIRS have only been introduced to the health care sector relatively recently. The goal of this work, therefore, was to determine whether and specifically how CIRS are used in Austria. A working group from the Austrian Society for Quality and Safety in Healthcare (ASQS) developed a survey on the topic of CIRS to collect information on penetration of CIRS in general and on how CIRS reports are used to increase patient safety. Three hundred seventy-one health care professionals from 274 health care facilities were contacted via e-mail. Seventy-eight respondents (21.0%) completed the online survey, thereof 66 from hospitals and 12 from other facilities (outpatient clinics, nursing homes). In all, 64.1% of the respondents indicated that CIRS were used in the entire health care facility; 20.6% had not yet introduced CIRS and 15.4% used CIRS only in particular areas. Most often, critical incidents without any harm to patients were reported (76.9%); however, some health care facilities also use their CIRS to report patient falls (16.7%), needle stick injuries (17.9%), technical problems (51.3%), or critical incidents involving health care professionals. CIRS are not yet extensively or homogeneously used in Austria. Inconsistencies exist with respect to which events are reported as well as how they are followed up and reported to health care professionals. Further recommendations for general use are needed to support the dissemination in Austrian health care environments.

Objectives Cognitive behavioural guided self-help has been shown to be effective in mild and moderate depressive disorder. It is not known, however, if it is effective in individuals with partially remitted depressive disorder, which is a serious clinical problem in up to 50–60% of treated patients. This study is the first one to examine the clinical benefit of this intervention in this patient population. Design For the purpose of this study, a single-blind, randomized controlled design was used. Method We randomized 90 individuals with partially remitted depressive disorder either to cognitive behavioural guided self-help plus psychopharmacotherapy (n = 49) or psychopharmacotherapy alone (n = 41). They were clinically assessed at regular intervals with ratings of depressive symptoms and stress-coping strategies over a 3-week run-in period and a 6-week treatment period. Results After 6 weeks, intention-to-treat analysis (n = 90) showed that patients treated with cognitive behavioural guided self-help plus psychopharmacotherapy did not have significantly lower scores on the Hamilton Rating Scale of Depression (17-item version; HRSD-17) and on the Beck Depression Inventory (BDI) compared to patients treated with psychopharmacotherapy alone. When negative stress-coping strategies were considered, there was a significant difference between the two groups at the end of treatment with respect to the BDI but not to the HRSD-17. Conclusions Guided self-help did not lead to a significant reduction in symptom severity in patients with partially remitted depressive disorder after a 6-week intervention. However, the intervention leads to a reduction of negative stress-coping strategies. Practitioner points Cognitive behavioural guided self-help did not significantly improve depressive symptoms measured with the Hamilton Rating Scale of Depression (17-item version; HRSD-17) in patients with partially remitted depressive disorder. Improvements were found in reducing negative stress-coping strategies for those allocated to the cognitive behavioural guided self-help, which significantly improved Beck Depression Inventory but not HRSD-17. These findings suggest that cognitive behavioural guided self-help may offer some assistance in managing negative stress-coping strategies.

(Headache 2011;51:220-225) Objective.— To evaluate the relationship between migraine and eating disorders by applying a special study design. Background.— To date, only a few studies have assessed eating disorders and eating behavior in patients with migraine. Methods.— The distinctive feature of this design is the comparison of sister pairs with one sister suffering from an eating disorder according to Diagnostic and Statistical Manual of Mental Disorders, fourth edition and the other being free of such disease. Results.— We investigated 120 female patients with a median age of 24 years (interquartile range 20-31) as well as their non-eating-disordered sisters with a median age of 24 (20-31) years. Headache was diagnosed according to the International Classification of Headache Disorders, Second Edition. Thirteen sister pairs were concordant for the presence of migraine, 67 were concordant for the absence of migraine and 40 were discordant. Among the latter, 21 patients and 19 controls had migraine. The prevalence of migraine was virtually identical in patients (28%) and controls (27%). Conclusion.— This clinic-based controlled study using a sister-pair comparison design showed no evidence of an increased prevalence of migraine among patients with eating disorder.

EINLEITUNG: Da in Europa wahrend der letzten Jahre ein stetiger Anstieg des Kokainund Crackkonsums beobachtet werden konnte, wurde im Rahmen einer multizentrischen Querschnittuntersuchung der Missbrauch dieser Substanzen in verschiedenen Zielgruppen erhoben. Die Studie wurde an der Universitatsklinik fur Psychiatrie, Medizinische Universitat Wien und neun weiteren europaischen Stadten durchgefuhrt. METHODEN: Die Daten wurden mittels strukturierter Interviews erhoben. Insgesamt wurden 211 KokainkonsumentInnen befragt, wobei diese einer von drei Zielgruppen zugeteilt wurden: (1) der Behandlungsgruppe (BG), die sich zum Zeitpunkt der Befragung in Opioiderhaltungstherapie befand, (2) der marginalisierten Szenegruppe (SG) oder (3) der sozial integrierten Partygruppe (PG). Neben soziodemographischen Daten wurden monatliche Ausgaben fur Kokain/Crack, das Konsummuster, wie auch korperliche und psychische Gesundheit erhoben als auch Fragen zur Selbsteinschatzung den eigenen Kokainkonsum betreffend. Zudem wurden toxikologische Analysen hinsichtlich der Veranderung des Kokainkonsums in der BG als Indikator herangezogen. ERGEBNISSE: Von den drei Zielgruppen war die Szenegruppe mit durchschnittlich 29,35 Jahren die alteste und wies innerhalb des letzten Monats die hochste Arbeitslosigkeit (im Mittel 25,11 Tage) und die langste Dauer des Kokainkonsums (im Mittel 5,80 Jahre) auf. Im letzten Monat hatten sie den hochstfrequenten Kokainkonsum mit durchschnittlich 22,32 Tagen und verbrauchten durchschnittlich 1969 Euro/Monat fur den Erwerb. Die Behandlungsgruppe hingegen hatte mit durchschnittlich 10,36 Jahren die geringste Schulbildung, wohingegen die Personen der Partygruppe am jungsten waren (durchschnittliches Alter 25,64 Jahre), am wenigsten fur die Beschaffung des Suchtgiftes ausgaben, immerhin aber durchschnittlich 588,99 Euro/Monat, und die schlechteste Selbsteinschatzung durch die Kokain- bzw. Crackproblematik abgaben. Uber den Zeitraum von 1996–2002 findet man zudem in der Analyse kokain-positiver Harnanalysen bei PatientInnen in einer Opioiderhaltungstherapie (BG) einen signifikanten Anstieg (1996: 33,1%; 2002: 40,2%; p = 0,044). DISKUSSION: Der europaische Trend des steigenden Kokainkonsums bestatigt sich auch in Wien. Eine der grosten Schwierigkeiten in der Behandlung dieser Substanzabhangigengruppe besteht darin, die betroffene Population zu erreichen. Als Hauptcharakteristikum der KokainkonsumentInnen ist das haufige Auftreten eines polytoxikomanen Substanzmusters zu nennen, wobei diesem Aspekt in der Behandlung eine wesentliche Rolle zukommen sollte (SG u. BG – Zusatzkonsum von Heroin und Benzodiazepinen; PG – Zusatzkonsum von Alkohol). Die Wiener Ergebnisse spiegeln im Wesentlichen die europaische Situation wieder, jedoch stellen Crack-Konsum und Binge-Abusus, im Vergleich zu beispielsweise Hamburg oder London, in Wien derzeit kein vorrangiges Problem dar.

Aims: In addition to methadone, other synthetic opioids are now available for the treatment of opioid dependence. The study investigated the treatment satisfaction of oral slow-release morphine for maintenance therapy in opioid-dependent patients in an open-label 3-week study. Design: We evaluated the treatment satisfaction of oral slow-release morphine hydrochloride for 3 weeks in 110 patients meeting the diagnosis of opioid dependence (DSM-IV 304.0) or polysubstance dependence (DSM-IV 304.9). Measurements: Primary outcome measures were the study retention rate, urinalysis for additional illicit consumption other than heroin, cravings and withdrawal symptoms 24 h after the last intake of the medication (duration of action of treatment). Findings: In total, 103 patients completed the study, representing a retention rate of 94%. Patients reported significant improvements in somatic complaints, as well as significant reductions in heroin and cocaine cravings (p < 0.0001) and in additional consumption of cocaine in supervised urinalysis (p = 0.0083). Additional illicit consumption of benzodiazepines remained unchanged. Conclusions: The high study retention rate implies a good acceptance of slow-release acting oral morphine. However, randomised, double-blind, double-dummy studies with a longer investigational period are needed to meet criteria for evidence-based medicine.

Aims: To assess the influence of methadone and buprenorphine maintenance treatment on the driving aptitude of opioid-dependent patients. Design: Prospective, open label, outpatient maintenance, single-blind (investigator) study. Participants and Setting: Thirty opioid-dependent patients maintained on either methadone or buprenorphine were recruited from the drug-addiction outpatient clinic in Vienna. Measurements: The traffic-relevant performance dimensions of the participants were assessed 22 h after receiving synthetic opioid maintenance therapy, by a series of seven tests constituting the Act & React Test System (ART) 2020 Standard test battery, developed by the Austrian Road Safety Board (ARSB). To test for additional consumption of illicit substances, blood and urine samples were taken at the beginning of the tests. Findings: The patient group only differed from control subjects in two of the ART 2020 Standard tests. During a task to test the subject’s attention under monotonous circumstances (Q1 test), patients had a significantly greater number of reactions (p = 0.027) and a significantly higher percentage of incorrect reactions than control subjects. When driving in a dynamic environment (DR2 test) patients had a significantly longer mean decision time (p = 0.029) and mean reaction time (p = 0.009) compared with control subjects. Interestingly, when separated into treatment groups, the mean decision and reaction times of buprenorphine-maintained patients in the DR2 test did not differ from controls, whereas patients maintained on methadone showed significantly prolonged mean decision (p = 0.009) and reaction times (p = 0.004). In this same test, patients who had consumed additional illicit drugs had a longer mean reaction time compared with control subjects (p = 0.036). Conclusion: The synthetic opioid-maintained subjects investigated in the current study did not differ significantly in comparison to healthy controls in the majority of the ART 2020 Standard tests.

Aim and Setting: The drug addiction out-patient clinic at the University Hospital for Psychiatry in Vienna performed a study to identify the prevalence of hepatitis C virus (HCV) infections in a group of opiate-dependent patients, to detect the distribution of HCV subtypes and to calculate the comorbidity of human immunodeficiency virus (HIV) and hepatitis B virus (HBV). Design and Participants: We consecutively investigated unselected patients (n = 173) during an observation period of 2 months with the diagnosis of opioid dependence (DSM-IV: 304.0) and polysubstance dependence (DSM-IV: 304.9). Measurements: Blood was investigated focusing on liver enzymes and on viral status including HIV, hepatitis B and hepatitis C, followed by subtyping of the virus. Findings: In 80.3% hepatitis C antibodies were found, 66.5% were HCV RNA (PCR) positive. 3a was the most frequent subtype (35.6%), followed by 1a (28.8%) and 1b (22.0%). Four patients had both subtypes 1a and 1b (6.8%), 3 were 2b positive (5.1%) and 1 patient had subtypes 2a/2c (1.7%). No significant difference in aspartate (AST) and alanine aminotransferases (ALT) concerning the different subtypes (AST: p = 0.290; ALT: p = 0.260) could be calculated; 11.6% showed co-infection with HIV, 2 patients had a chronic infection with hepatitis B. Conclusions: The rate of HCV infection in substance-dependent patients at our drug addiction out-patient clinic is extremely high. The distribution of subtypes showed a relatively homogeneous distribution of the types 1a, 1b and 3a. The recommended therapy with α-interferon should be initiated in drug-dependent patients under considerations of an enrollment in oral maintenance with synthetic opioids.

The efficacy of buprenorphine in opioid dependent patients (n = 20) was compared to methadone maintained subjects (n = 20) in a randomized comparison trial. Sublingual application of buprenorphine as an alternative synthetical opioid is being compared to methadone during a 24 week study period. A trend (p = 0.06) could be found in the retention rate of investigated patients being maintained on a mean dosage of 63 mg oral applicable methadone (racemat of L- and D-methadone) in comparison to the group on a mean dosage of 7.3 mg buprenorphine (sublingual tablets). The dropout-rate of 11 subjects at the end of the study in the buprenorphine group was higher when compared to the dropout-rate of 5 in the methadone group. There was no significant difference between the two groups over the treatment period in respect to additional consumption of opiates, benzodiazepines and cocaine as evaluated through urine toxicology. The result in regard to compliance over the study period demonstrates that methadone appears to be the more successful oral opioid (p = 0.04). Nevertheless, efficacy of buprenorphine in maintenance could be demonstrated in the remaining subjects, and further studies with higher daily doses and a higher number of subjects have to be performed.

The fetal consequences of drug abuse during pregnancy remain underestimated. Obstetrical complications of cigarette smoking include growth retardation, spontaneous abortion and sudden infant death syndrome; alcohol abuse leads to nutritional deficiencies and fetal alcohol syndrome. Heroin and cocaine consumption result in medical, nutritional and social neglect; cocaine and amphetamine cause hypertension, abruptio placentae; all three drugs of abuse cause preterm labor, with neonates being small for gestational age. Intravenous abuse also increases the risk of contracting infectious disease. The recommended treatment standard is to maintain pregnant, opioid-dependent women on synthetic opioids such as methadone, but newer substances like slow-release morphine and buprenorphine may also be beneficial. Treatment should be interdisciplinary and consider the high prevalence of substance dependent partners. Programmes should be initiated to identify women at risk and provide early treatment to improve the outcome for mother and child. Care must be provided in a supportive, proactive and non-judgemental fashion.

Aims. To investigate whether the neonatal abstinence syndrome (NAS) is different in children born to women maintained on slow-release morphine, compared with those maintained on methadone, and to compare additional drug consumption in these groups of women . Design, Setting and Participants. An open, randomized trial was conducted in an established clinic. Forty-eight pregnant women who presented to the clinic as opiate or polysubstance abusers were enrolled and maintained on either methadone (24 women) or slow-release morphine (24 women) up to and following delivery. The programme included psychosocial therapy and support for their opiate-addicted partners . Measurements. Standard urinalysis methods were used to measure consumption of cocaine and benzodiazepines during pregnancy. Injection sites were monitored to indicate additional opiate use. NAS was measured according to Finnegan score and the amount of phenobarbiturates prescribed to alleviate the symptoms . Findings. No difference was found in the number of days that NAS was experienced by neonates born to methadone or morphine maintained mothers (mean = 16 and 21 days, respectively). All children were born healthy and no serious complications arose. Fewer benzodiazepines ( p 0.05) and fewer additional opiates ( p 0.05) were consumed by the morphinemaintained women compared with those who took methadone, but no difference was seen in cocaine consumption. Nicotine consumption was reduced significantly in both groups during pregnancy ( p 0.02) . Conclusions. Both methadone and morphine are suitable maintenance agents for pregnant opiate addicts. Maintenance agents that result in a less prolonged NAS should be studied in further trials.

Aims: Drug addiction in females requires special attention when the woman is pregnant. In opioid dependent pregnant addicts early intervention during the prenatal period is highly desirable for maintaining the health of the woman, the fetus, and her infant after birth. The aim of our study was to perform an analysis of different variables to determine which factors are responsible for stabilizing the mother so that she could keep the child.

In an open study design, 50 opioid-dependent subjects (DSM-IV: 304.0) were investigated in a gradual detoxification treatment with buprenorphine. The study was performed at the drug addiction outpatient clinic of the Department of General Psychiatry at the University of Vienna. Subjects had to contact the outpatient clinic on a daily basis and buprenorphine was administered according to their clinical status. Withdrawal symptoms were evaluated by applying the WANG scale. Urine samples were screened for drug toxicology to exclude additional consumption. In this investigation buprenorphine was applied sublingually in a free dosage scheme aimed at completing detoxification treatment within 10 days by reducing buprenorphine on a daily basis. A mean daily dosage of 2.3 mg buprenorphine was required by patients on day 1 of the treatment period. The highest mean daily buprenorphine dosage was given on day 2, followed by a daily reduction over the study period. The result of this open study design revealed that a gradual daily reduction of buprenorphine might be a successful alternative outpatient detoxification treatment in opioid-dependent subjects. Compliance was 70%, the reported and evaluated withdrawal symptoms during the study period were moderate.

To evaluate the relationship between migraine and eating disorders by applying a special study design.To date, only a few studies have assessed eating disorders and eating behavior in patients with migraine.The distinctive feature of this design is the comparison of sister pairs with one sister suffering from an eating disorder according to Diagnostic and Statistical Manual of Mental Disorders, fourth edition and the other being free of such disease.We investigated 120 female patients with a median age of 24 years (interquartile range 20-31) as well as their non-eating-disordered sisters with a median age of 24 (20-31) years. Headache was diagnosed according to the International Classification of Headache Disorders, Second Edition. Thirteen sister pairs were concordant for the presence of migraine, 67 were concordant for the absence of migraine and 40 were discordant. Among the latter, 21 patients and 19 controls had migraine. The prevalence of migraine was virtually identical in patients (28%) and controls (27%).This clinic-based controlled study using a sister-pair comparison design showed no evidence of an increased prevalence of migraine among patients with eating disorder.

The treatment of opioid dependence during pregnancy is a major challenge for doctors, social workers and gynaecologists. Continuous drug abuse during pregnancy can lead to a variety of complications in the mother, fetus and neonate. lt is recommended practice to maintain pregnant opioid-dependent women with synthetic opioids and according to international guidelines, methadone is the recommended substance so far. However, a neonatal abstinence syndrome (NAS) of varying severity is observed in 60 - 80 % of the neonates with even a longer course of duration in comparison to the NAS after heroin consumption during pregnancy. NAS is characterised by tremor, irritability, hypertonicity, vomiting, sneezing, fever, poor suckling, and sometimes convulsions. Recent studies have investigated the safety and efficacy of other synthetic opioids like sublingual buprenorphine for the treatment of pregnant patients. We present a 22 year old opioid-dependent woman, who has been maintained continuously on buprenorphine for 3 years. During the treatment episode she delivered two healthy newborns and both did not show any symptoms of NAS. The maintenance therapy with buprenorphine proved safety and efficacy during pregnancy, the mother was free of continuous heroin abuse, verified through supervised urine-toxicology. The quantitative and qualitative difference in NAS may be explained by the partial mu-receptor agonist and kappa-antagonist receptor profile of buprenorphine compared to pure mu-agonist action of methadone or heroin.

To evaluate driving aptitude and traffic-relevant performance at peak and trough medication levels in opioid-dependent patients receiving maintenance therapy with either buprenorphine (mean: 13.4 mg) or methadone (52.7 mg) and a medication-free control group, the Addiction Clinic at Medical University Vienna conducted a prospective, open-label trial where 40 opioid-dependent patients maintained either on buprenorphine or methadone were assessed regarding their traffic-relevant performance. Using the standardized Act and React Testsystem (ART) 2020 Standard test battery, traffic-relevant performance was analysed 1.5 h (peak level) and 20 h (trough level) after administration of opioid maintenance therapy. Results showed that patients at trough level had a significantly higher percentage of incorrect reactions (p = 0.03) and more simple errors (p = 0.02) than patients at peak level as well as methadone-maintained patients at peak level tended to perform less well than buprenorphine-maintained patients in some of the test items, e.g. methadone-maintained patients at trough level had a higher number of delayed reactions in the RST3 phase 2 test (p = 0.09) and answered fewer questions correctly in the visual structuring ability test (p = 0.04). This investigation indicates that opioid-maintained patients did not differ significantly at peak vs.trough level in the majority of the investigated items and that both substances do not appear to affect traffic-relevant performance dimensions when given as a maintenance therapy in a population where concomitant consumption would be excluded.

As cocaine consumption seems to have increased over the last decades, the EU has funded this multi-center, cross-sectional survey to investigate cocaine consumption in three different target groups. The study was conducted by the Addiction Clinic, Department of Psychiatry, Medical University Vienna and other nine European cities.Data were collected by structured face-to-face interviews. The sample was composed of 211 cocaine abusers out of three target groups: (1) treatment group undergoing opioid maintenance therapy, (2) marginalized scene group and (3) integrated party group. Sociodemographic data such as age, education, employment, monthly expenses on cocaine/crack, data on consumption patterns, physical and mental health and personal needs regarding cocaine consumption were evaluated. Urine toxicology results for cocaine in the treatment group completed the analysis.The marginalized scene group was the oldest with a mean age of 29.35 years, with the highest unemployment rate (mean 25.11 days) and the longest duration of cocaine consumption (mean 5.80 years). They had the highest cocaine consumption pattern with a mean of 22.32 days within the last month. On average 1969 Euros/months was spent for their addiction. The treatment group had the lowest school education with a mean of 10.36 years, but showed a sufficient insight in their cocaine problem. However, the party group (with the lowest mean age, 25.64 years) highly underestimated their drug problem, the mean amount of money they spent for their addiction was 588.99 Euro/months. Structured urine toxicology between 1996 and 2002 in patients undergoing opioid maintenance therapy ("treatment group") revealed a significant increase of concomitant cocaine consumption (1996: 33.1%; 2002: 40.2%; p = 0.044).The European trend of increased cocaine use could also be observed in Vienna. One of the greatest barriers for establishing adequate treatment settings for this target group is the difficulty to reach this population. In addition, multiple substance abuse seems to be one of the predominating patterns of cocaine consumption and this aspect should be integrated within treatment (in the treatment and scene groups additional heroin and benzodiapzepines abuse is observed, in the party group intensive alcohol consumption). The Viennese results are in line with those of the other European cities; however, it could not be confirmed that consumption of crack cocaine and binge play a similarly significant role as in cities such as Hamburg or London.

This is the first trial to compare the relationship of opioid plasma concentrations in methadone-versus buprenorphine-maintained subjects. Sixty subjects (19 females and 41 males) seeking treatment who met Diagnostic and Statistical Manual version IV (DSM-IV) criteria for opioid dependence were recruited and treated at the Drug Addiction Outpatient Clinic at the University of Vienna. Of these, 44 (11 female and 33 male) were included in the analyses of plasma concentrations. Subjects received either daily sublingual buprenorphine (2 mg or 8 mg tablets; maximum daily dose: 8 mg) or oral methadone (racemic R-/S-methadone) and were maintained on a stable dose after an induction period of 2 weeks. Mean dose and mean plasma concentrations were correlated on an individual and collective basis. Correlation was 0.51 for buprenorphine, whereas the score for methadone was 0.69. Intra-individual variation was much higher for buprenorphine (p

Aims Slow-release morphine may represent a much-needed new pharmacological treatment for opioid dependence. Design In a 14-week randomized, double-blind, double-dummy, cross-over study oral slow-release morphine was compared with methadone as a treatment for opioid dependency. During two study periods, each consisting of a 1-week titration and a 6-week fixed-dose treatment phase, medication was administered daily under supervised conditions. Setting The study was carried out at the Addiction Clinic, Department of Psychiatry, Medical University Vienna. Participants Sixty-four subjects (56 males, eight females) with opioid dependence participated in the trial. Measurements Efficacy was evaluated on the basis of retention, use of illicit substances based on urinalysis, extent of drug cravings, withdrawal symptoms and general wellbeing. Safety was assessed on the basis of adverse events and clinical and physical examination. Demographic and baseline characteristics were assessed using the European Addiction Severity Index. Findings Fifty-five patients (86%) completed the study, with a mean methadone dose of 85 mg and a mean slow-release morphine dose of 680 mg. No significant differences in retention or use of illicit substances (opioids, benzodiazepines, cocaine) were observed, irrespective of treatment group or medication. However, patients receiving slow-release morphine had significantly lower depression (P

In Austria, methadone, buprenorphine as well as oral slow-release morphine are used for the treatment of opioid dependence. This controlled examination marks the first time that oral slow-release morphine hydrochloride is applied for maintenance therapy in opioid dependent subjects.In order to evaluate the effectiveness of this psychopharmacological medication, we examined patients over a three-week period. Outcome measures were retention rate, additional consumption and the evaluation of opioid withdrawal 24 hours after the last oral medication.Sixty-seven patients were included; sixty-four patients completed the study, representing a retention rate of 94%. During the three-week period, a significant improvement in well-being and a significant reduction in heroin, cocaine and benzodiazepine craving (p0.0001) was evaluated. Furthermore, there was a significant reduction of additional consumption of benzodiazepines in supervised urinalysis. Additional consumption of cocaine remained unchanged. Laboratory results showed a significant reduction of CK over the course of investigation.The high retention rate of 94% implies a good acceptance and efficacy of the substance. The reduced CK is consistent with a reduction in intravenous application of illegal substances. However, randomized double-blind, double-dummy studies with oral slow-release morphine are needed in order to meet criteria for evidence based medicine.

To assess the effects of maternal buprenorphine treatment at conception and during pregnancy on neonates in terms of birth outcomes and neonatal abstinence syndrome (NAS).Prospective, open-label, out-patient maintenance, case report study, conducted at the drug addiction out-patient clinic at the University Hospital Vienna.Two buprenorphine-maintained pregnant women who had conceived during buprenorphine treatment. Both patients had previously given birth to healthy neonates following induction on to buprenorphine maintenance therapy in the second trimester.Mothers: urinalysis. Neonates: gestational age at delivery, Apgar scores, birth weight, length and NAS (Finnegan Scale).Urinalyses were negative for both women for 25 and 38 months, respectively, during the pregnancy period. There were no complications during the course of the pregnancy. The newborns delivered by both women were healthy, birth outcomes were within normal ranges and there were no NAS symptoms requiring treatment.To our knowledge this is the first report detailing the pregnancies of women treated with buprenorphine at the time of conception and investigated in a prospective study. The NAS noted in neonates born to buprenorphine-maintained mothers appears to be less severe than the NAS observed in neonates born to methadone-maintained mothers. These preliminary data indicate that, in our patient cohort, buprenorphine maintenance at the time of conception and during pregnancy did not seem to affect birth outcome measurements such as pregnancy complications, week of delivery, birth weight, length, umbilical pH or neurodevelopmental progress. Future prospective studies with larger study populations are warranted.

Aims: To assess the maternal and fetal acceptability of buprenorphine and neonatal abstinence syndrome (NAS) in children born to buprenorphine-maintained mothers. Design and setting: Open-label, flexible dosing, inpatient induction with outpatient maintenance, conducted at the University of Vienna within the existing pregnancy and drug addiction program. Participants: Fifteen opioid-dependent pregnant women. Intervention. Sublingual buprenorphine tablets (1-10 mg/day). Measurements: Mothers: withdrawal symptoms (Wang Scale), nicotine dependence (Fagerstrom Scale: FTQ) and urinalysis. Neonates: birth outcome and NAS (Finnegan Scale). Findings: All subjects were opioid-, nicotine- and cannabis-dependent. Buprenorphine was well tolerated during induction (Wang Score \< = 4) and illicit opioid use was negligible (91% opioid-negative). All maternal, fetal and neonatal safety laboratory measures were within normal limits or not of clinical significance. Mean birth outcome measures including gestational age at delivery (39.6 ± 1.5 weeks), Apgar scores (1 min = 8.9; 5 min = 9.9; and 10 min = 10), birth weight (3049 ± 346 g), length (49.8 ± 1.9 cm) and head circumference (34.1 ± 1.8 cm) were within normal limits. The NAS was absent, mild (without treatment) and moderate (with treatment) in eight, four and three neonates, respectively. The mean duration of NAS was 1.1 days. Conclusions: Buprenorphine appears to be well accepted by mother and fetus, and associated with a low incidence of NAS. Further investigation of buprenorphine as a maintenance agent for opioid-dependent pregnant women is needed.

Cerebrospinal fluid (CSF) space enlargement has been demonstrated in substance-related disorders like alcohol and cocaine dependence. Experimental animal studies showed a reduction in shape and size of mesolimbic dopaminergic neurons after chronic morphine administration. Other studies indicated a change of neurofilament and glial fibrillary acid proteins after chronic opiate administration. Furthermore, frequent overdosing and toxicological effects of 'street'-heroin may lead to CSF space enlargement in opioid dependence. In our study the pericortical and ventricular CSF space of 21 male opioid-dependent patients was compared with an age- and sex-matched normal control group. Considering serious problems with ratio and proportion measures, we used a battery of linear (cella media index, Huckman number, frontal horn index), planimetric (cortical atrophy score) and stereological volumetric measures in order to detect differences in cranial computerized tomography scans. We found a significant ventricular and cortical volume loss of the brain in opioid-dependent patients. A higher degree of frontal lobe volume loss seemed to be associated with a shorter period of abstinence before relapse. However, the etiology of volume loss of the brain in opioid-dependent patients is still unclear, but experimental animal studies provide some evidence that long-term, chronic opiate exposure is associated with visible changes of specific structures in the brain.

Opioid maintenance agents such as methadone and slow-release morphine have provided beneficial effects in pregnant opioid-dependent women in both themselves and their child. However, one of the major drawbacks involved with these agents is that they cause an increase in the severity of neonatal abstinence syndrome (NAS) when compared to mothers using heroin. Consequently, a trial was performed to investigate the effects of buprenorphine use during pregnancy. A total of nine pregnant opioid-dependent women were transferred from either a mean daily dose of 39.7 mg methadone or 400 mg slow-release morphine to a mean daily dose of 8.1 mg buprenorphine. The buprenorphine-maintained patients were integrated into an already established outpatient maintenance treatment programme covering all aspects of prenatal and perinatal care. Results demonstrated that buprenorphine administration in opioid-dependent pregnant patients is efficacious and well tolerated. Babies born to buprenorphine-maintained patients had birthweight and Apgar scores within the normal range (2,500–4,500 g and 9–10, respectively) and no evidence of opioid-related NAS was observed. The results from this preliminary study indicate the potential for buprenorphine maintenance therapy in pregnant addicts, although further research is required to confirm this hypothesis.

As a maintenance agent for opioid dependency, buprenorphine offers advantages such as a lower level of dependence and minimal withdrawal symptoms, due to its partial agonist properties at the µ-opioid receptor. Previous studies have shown 8 mg sublingual buprenorphine to be equivalent to 60 mg oral methadone in terms of retention rate and opioid-negative urine levels. In a 24-week, ongoing European study, 34 opioid-dependent subjects were assessed; 16 receiving buprenorphine and 18 methadone. A free dosing schedule was used with no upper limit for methadone dosing but with a maximum buprenorphine dose of 8 mg. Screening prior to the study excluded subjects with polysubstance dependence, somatic disease and/or HIV infection. Primary outcome measures were abstinence from other drugs, for which subjects provided weekly urine samples for analysis of opioids, cocaine and benzodiazepines, and retention in treatment. Patients in the buprenorphine group provided a greater proportion of negative urine samples, in particular cocaine-negative samples, compared with the methadone group, although this was not statistically significant. Retention in the buprenorphine group was significantly lower than in the methadone group, suggesting that the 8 mg buprenorphine limit may have biased the results in favour of methadone, and that this dose may have been too low for those subjects with high levels of dependence. However, buprenorphine is clearly effective in the more motivated subjects and further investigation in this subgroup is recommended.

Aims. To evaluate the effectiveness of buprenorphine compared with methadone maintenance therapy in opiate addicts over a treatment period of 24 weeks. Design. Subjects were randomized to receive either buprenorphine or methadone in an open, comparative study. Setting. Subjects were recruited and treated at the drug addiction outpatient clinic at the University of Vienna. Participants. Sixty subjects (19 females and 41 males) who met DSM-IV criteria for opioid dependence and were seeking treatment. Intervention. Subjects received either sublingual buprenorphine (2-mg or 8-mg tablets; maximum daily dose 8 mg) or oral methadone (racemic D2 /1 L-methadone; maximum daily dose 80 mg). A stable dose was maintained following the 6-day induction phase. Measurement. Assessment of treatment retention and illicit substance use (opiates, cocaine and benzodiazepines) was made by urinalysis. Findings. The retention rate was signi® cantly better in the methadone maintained group (p, 0.05) but subjects completing the study in the buprenorphine group had signi® cantly lower rates of illicit opiate consumption (p5 0.04). Conclusion. The results support the superiority of methadone with respect to retention rate. However, they also con® rm previous reports of buprenorphine use as an alternative in maintenance therapy for opiate addiction, suggesting that a speci® c subgroup may be bene® ting from buprenorphine. This is the ® rst comparative trial to use sublingual buprenorphine tablets: previously published comparison studies refer to 30% solutions of buprenorphine in alcohol.