Papers by Annemarie Unger
Klinische Padiatrie, Jul 25, 2014
Due to the steady increase of substance-dependent pregnant women the neonatal abstinence syndrome... more Due to the steady increase of substance-dependent pregnant women the neonatal abstinence syndrome has become an increasingly important issue in neonatology. The present study investigates site-specific differences of detailed symptoms and treatment of neonatal abstinence syndrome within the context of an international multicenter clinical trial. Site specific neonatal data analyses from a prospective randomized, double-blind, double-dummy clinical trial (MOTHER study) was performed. A standardized NAS rating and treatment protocol was applied, while non-pharmacological care of NAS symptoms differed across the sites. Urban US neonates exhibited most neurological symptoms (p<0.001) while in Europe autonomous, respiratory and gastrointestinal symptoms were found significantly more often compared to urban and/or rural US (p<0.05). Methadone produced significantly greater scores than buprenorphine in neurological, behavioural and respiratory symptoms regardless of the sites (ps<0.05). NAS treatment rates in all site clusters were similar for methadone-exposed neonates, while in Europe significantly more buprenorphine-exposed neonates were treated (p=0.001) than in US site clusters. Urban US neonates had significantly higher NAS scores (p<0.01) compared to rural US and European neonates, and needed significantly higher morphine doses (p<0.05) with longer treatment duration. Birth weight, length and head circumference did not differ significantly among the site clusters, but APGAR scores were significantly higher in European (p<0.01) neonates. In addition to intrauterine medication exposure other aspects such as different addiction severity of the mothers, different treatment modalities including rooming-in as well as the frequency of NAS ratings may be influencing the course of NAS.
European Psychiatry, Mar 1, 2015
European Neuropsychopharmacology, Oct 1, 2013
European Addiction Research, Aug 29, 2015
Aims: The aim of this exploratory analysis of European Quality Audit of Opioid Treatment data was... more Aims: The aim of this exploratory analysis of European Quality Audit of Opioid Treatment data was to identify areas of improvement for current opioid maintenance treatment (OMT) approaches. Methods: Factors facilitating treatment entry, retention and refusal were compared between 8 European countries and between OMT patient (OMT-P) and active opioid user (AOU) sample groups. Both groups were divided into those who had never had OMT before (un-experienced OMT-P (n = 573) and AOU (n = 360)) and those who had been maintained at least once prior to this investigation (experienced OMT-P (n = 746) and AOU (n = 377)). Results: The European comparison showed that motives for starting OMT vary distinctly between countries (p ≤ 0.001). Transnationally, experienced AOU reported concerns about their ability to follow treatment rules and negative treatment experiences as decisive reasons for staying out of OMT. Greater flexibility, less pressure to reduce their treatment dose and greater treatment structure were ranked significantly higher by experienced compared to un-experienced OMT-P as factors that might facilitate treatment retention (p ≤ 0.05). Conclusion: Increasing awareness of potential shortcomings of OMT delivery systems is crucial to optimally match treatment approaches to patient needs and also to reduce the considerable economic burden of addiction to society.
Alcohol and Alcoholism, Sep 1, 2014
Suchttherapie, May 14, 2013
ABSTRACT Objective: Patients receiving office-based buprenorphine/naloxone maintenance treatment ... more ABSTRACT Objective: Patients receiving office-based buprenorphine/naloxone maintenance treatment for opiate dependence were examined over a time span of 12 months in order to determine treatment efficacy, acceptance, tolerance and retention rates. Methods: An open-label, prospective multicenter trial (25 centres) was conducted including 307 patients with a DSM-IV diagnosis of opiate dependence with or without prior treatment. Study dropouts were analysed for predictors of treatment discontinuation. Results: The overall retention rate after 12 months was 45.6%. Patients with prior buprenorphine experience showed the highest retention rate. 3 significant predictors for premature study dropout were detected: a shorter duration of heroin dependence at study entrance (p=0.038), younger age at initial drug exposure (p=0.028) and a higher initial dose of maintenance medication (p=0.017). Two thirds of patients reported to be satisfied with treatment. However, self-assessment was not congruent with assessments provided by doctors. Conclusions: The study shows that there is a considerable need for further training concerning buprenorphine/naloxone treatment. Results on patient satisfaction and retention are comparable to other chronic conditions.
Gerontology, 2012
Research has shown that substance use, abuse and addiction are not limited to a specific age grou... more Research has shown that substance use, abuse and addiction are not limited to a specific age group. Problems related to substance addiction are an important cause of morbidity in the population aged 65 years and above, especially the abuse of prescription drugs and legal substances. A lack of evidence-based studies and tailored treatment options for the aging population is evident. Appropriate and effective health care is an important goal to improve the health-related quality of life of elderly people. Research in the increasingly aging population needs to include an age- and gender-sensitive approach.
Journal of Addictive Diseases, Apr 16, 2010
Obstetrics and Gynecology International, 2012
Pregnancy in opioid-dependent women is a major public health issue. Women who are afflicted by op... more Pregnancy in opioid-dependent women is a major public health issue. Women who are afflicted by opioid addiction are a highly vulnerable group of patients frequently becoming pregnant unplanned and at risk of adverse pregnancy outcomes and peri-natal complications. Opioid agonist maintenance treatment is the best option for the majority of women. Ideally, early and closely monitored treatment in an interdisciplinary team approach including social workers, nurses, psychologists, psychiatrists, gynecologists, anesthesiologists, and pediatricians should be provided. The treatment of comorbid psychiatric conditions, the resolution of financial, legal, and housing issues, and the psychosocial support provided have a significant effect on optimizing pregnancy outcomes. This paper aims to update health professionals in the field of gynecology and obstetrics on the latest optimal treatment approaches for mothers suffering from opioid dependence and their neonates.
Journal of Addictive Diseases, 2010
Gender, a biological determinant of mental health and illness, plays a critical role in determini... more Gender, a biological determinant of mental health and illness, plays a critical role in determining patients' susceptibility, exposure to mental health risks, and related outcomes. Regarding sex differences in the epidemiology of opioid dependence, one third of the patients are women of childbearing age. Women have an earlier age of initiation of substance use and a more rapid progression to drug involvement and dependence than men. Generally few studies exist which focus on the special needs of women in opioid maintenance therapy. The aim of this paper is to provide an overview of treatment options for opioid-dependent women, with a special focus on buprenorphine, and to look at recent findings related to other factors that should be taken into consideration in optimizing the treatment of opioid-dependent women. Issues addressed include the role of gender in the choice of medication assisted treatment, sex differences in pharmacodynamics and pharmacokinetics of buprenorphine drug interactions, cardiac interactions, induction of buprenorphine in pregnant patients, the neonatal abstinence syndrome and breastfeeding. This paper aims to heighten the awareness for the need to take gender into consideration when making treatment decisions in an effort to optimize services and enhance the quality of life of women suffering from substance abuse.
Human Psychopharmacology: Clinical and Experimental, 2012
Objectives Lessons learned in research and treatment of opioid dependence demonstrate the need to... more Objectives Lessons learned in research and treatment of opioid dependence demonstrate the need to include pregnant women in clinical trials. Methods Two double-blind, double-dummy, randomized controlled trials (Pilot study, European sample † of MOTHER-trial) comparing buprenorphine and methadone in opioid-dependent pregnant women were conducted. In both studies, participants received voucher-based incentives for attendance and completion of study assessments. In the MOTHER trial, participants additionally received escalating voucher incentives for drug-free urine samples. Neonatal abstinence syndrome was treated with oral morphine solution based on standardized modified Finnegan scores. Results After a mean treatment period of 13.79 weeks in the Pilot study (PS, n = 18) and 20.78 weeks in the MOTHER-trial (MT, n = 41), respectively (p < 0.001), PS patients delivered at mean doses of 14.00 mg buprenorphine/52.50 mg methadone and MT participants at 13.44 mg buprenorphine/63.68 mg methadone. Nonsignificant differences regarding dropout rates were found (22% in PS versus 10% in MT), but dropout was significantly earlier in the MT (p = 0.013). Significantly higher rates of concomitant consumption of opioids and benzodiazepines occurred in the PS compared with the MT (p < 0.001), however, with no significant differences in neonatal data between both settings. Conclusions Early treatment enrolment combined with contingency management contributes to reduced illicit drug use throughout pregnancy, surprisingly without influencing neonatal outcome parameters.
European Addiction Research, 2012
Background: Multi-center trials enable the recruitment of larger study samples, although results ... more Background: Multi-center trials enable the recruitment of larger study samples, although results might be influenced by site-specific factors. Methods: 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. Results: 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 diffe...
Addiction, 2011
Background-Chronic medical conditions such as opioid dependence require evidence-based treatment ... more Background-Chronic medical conditions such as opioid dependence require evidence-based treatment recommendations. However, pregnant women are underrepresented in clinical trials. We describe the first within-subject comparison of maternal and neonatal outcomes for methadone vs. buprenorphine exposed pregnancies. Though methadone is the established treatment of pregnant opioid dependent women, recent investigations have shown a trend for a milder neonatal abstinence syndrome (NAS) under buprenorphine. However, it is not only the choice of maintenance medication that determines the occurrence of NAS, other factors such as maternal metabolism, illicit substance abuse and nicotine consumption also influence its severity and duration and represent confounding factors in the assessment of randomized clinical trials. Case series description-Three women who were part of the European cohort of a randomized, double-blind multicenter trial with a contingency management tool [the Maternal Opioid Treatment: Human Experimental Research (MOTHER) study], each had two consecutive pregnancies and were maintained on either methadone or buprenorphine for their first and then the respective opposite, still-blinded medication for their second pregnancy. Birth measurements, the total neonatal abstinence score, the total amounts of medication used to treat NAS and the days of NAS treatment duration were assessed. Results-Both medications were effective and safe in reducing illicit opioid relapse and avoiding preterm labour. Methadone maintenance yielded to a significantly higher neonatal birth weight. Data patterns suggest that buprenorphine-exposure was associated with lower neonatal
Angehörige von Schizophrenie-Kranken leiden unter zahlreichen Belastungen. Ziel der vorliegenden ... more Angehörige von Schizophrenie-Kranken leiden unter zahlreichen Belastungen. Ziel der vorliegenden Studie war es zu erfassen, wie häufig Angehörige welche Hilfen benötigen. Methode: In die vorliegende Untersuchung wurden 135 Angehörige von Schizophrenie-Kranken eingeschlossen, jeweils ein Drittel der Patienten aus ambulanter, tagesklinischer bzw. stationärer psychiatrischer Behandlung. Der Bedarf wurde mittels des "Carers' Needs Assessment for Schizophrenia" (CNA-S) erfasst. Ergebnisse: Zu den häufigsten Problemen der Angehörigen gehörte "Trauer bzw. Enttäuschung über den Verlauf der Krankheit und Sorgen bezüglich der
Neuropsychiatrie, 2008
Angehörige von Schizophrenie-Kranken leiden unter zahlreichen Belastungen. Ziel der vorliegenden ... more Angehörige von Schizophrenie-Kranken leiden unter zahlreichen Belastungen. Ziel der vorliegenden Studie war es zu erfassen, wie häufig Angehörige welche Hilfen benötigen. Methode: In die vorliegende Untersuchung wurden 135 Angehörige von Schizophrenie-Kranken eingeschlossen, jeweils ein Drittel der Patienten aus ambulanter, tagesklinischer bzw. stationärer psychiatrischer Behandlung. Der Bedarf wurde mittels des "Carers' Needs Assessment for Schizophrenia" (CNA-S) erfasst. Ergebnisse: Zu den häufigsten Problemen der Angehörigen gehörte "Trauer bzw. Enttäuschung über den Verlauf der Krankheit und Sorgen bezüglich der
psychopraxis. neuropraxis, 2018
European Journal of Pain, 2012
Increased pain sensitivity and the development of opioid tolerance complicate the treatment of pa... more Increased pain sensitivity and the development of opioid tolerance complicate the treatment of pain experienced by opioid maintained pregnant women during delivery and the perinatal period. The aim of the present study was to investigate differences in pain management of opioid maintained compared to non-dependent pregnant women during delivery and the postpartum period. 40 deliveries of 37 opioid dependent women enrolled in a double-blind, double-dummy randomized controlled trial (RCT) examining the safety and efficacy of methadone (mean dose at the time of delivery = 63.89 mg) and buprenorphine (mean dose at the time of delivery = 14.05 mg) during pregnancy were analyzed and participants were matched to a non-dependent comparison group of 80 pregnant women. Differences in pain management (opioid and non-opioid analgesic medication) during delivery and perinatal period were analyzed. Following cesarean delivery opioid maintained women received significantly less opioid analgesics (day of delivery p = 0.038; day 1: p = 0.02), NSAIDs were administered more frequently to opioid dependent patients than to the comparison group during cesarean section and on the third day postpartum. Significantly higher nicotine consumption in the group of opioid dependent women had a strong influence on the retrieved results, and might be considered as an independent factor of altered pain experience. Differences in pain treatment became evident when comparing opioid maintained women to healthy controls. These differences might be based on psychosocial consequences of opioid addiction along with the lack of an interdisciplinary consensus on pain treatment protocols for opioid dependent patients.
Gender Medicine, 2011
Objective-Prior studies have shown an increased vulnerability among males, to adverse outcomes du... more Objective-Prior studies have shown an increased vulnerability among males, to adverse outcomes during the postnatal period. The majority of children exposed to opioids and other medication in utero develop a neonatal abstinence syndrome (NAS), yet individual predisposition for NAS is poorly understood. This investigation examines the role of neonatal sex in the postnatal period, for neonates exposed to standardized opioid maintenance treatment in utero with a focus on the neonatal abstinence syndrome (NAS) regarding severity, medication requirements and duration. Patients and Methods-This is a secondary analysis of data collected in a prospective randomized, double-blind, double-dummy multi-center trial examining the comparative safety and efficacy of methadone and buprenorphine during pregnancy (Maternal Opioid Treatment: Human Experimental research MOTHER-study). 131 neonates born to opioid-dependent women randomized at six US sites (n=74) and one European site (n=37) were analyzed. Sex-based differences in birth weight, length, head circumference, NAS duration, NAS severity, and treatment parameters of full-term neonates were assessed. Results-Males had a significantly higher birth weight (p=0.027) and head circumference (p=0.017) than females, with no significant sex difference in rates of preterm delivery. No significant sex-related differences were found for NAS development, severity, duration, or medication administered with non significant differences in concomitant drug consumption during pregnancy (p =0.959).
European Addiction Research, 2012
At the Viennese site a comparable mean duration of neonatal treatment with no significant differe... more At the Viennese site a comparable mean duration of neonatal treatment with no significant differences between the two opioid medications was noted. No significant differences pertaining to the amount of mean total morphine medication administered to neonates were found. However, at the European site, a significantly lower mean total morphine dose for NAS treatment compared to urban US sites became evident. In particular, the mean total morphine dose for methadone-exposed children was considerably higher including a high standard deviation, suggesting a heterogeneous newborn sample with regard to NAS. Non-pharmacological aspects which should be considered in multi-site research planning, study implementation and interpretation of results like screening procedures as well as sociodemographic, therapeutic and clinical variables may have also played a substantial role in site differences [4, 5]. However, these aspects were not investigated on a standardized basis.
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Papers by Annemarie Unger