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Pharmacodynamic Modelling of Placebo and Buprenorphine Effects on Event-Related Potentials in Experimental Pain.

Buprenorphine Research (PubMed) - Fri, 08/29/2014 - 7:00am

Pharmacodynamic Modelling of Placebo and Buprenorphine Effects on Event-Related Potentials in Experimental Pain.

Basic Clin Pharmacol Toxicol. 2014 Feb 23;

Authors: Juul RV, Foster DJ, Upton RN, Andresen T, Graversen C, Drewes AM, Christrup LL, Kreilgaard M

Abstract
The purpose of the study was to investigate placebo and buprenorphine effects on event-related potentials (ERPs) in experimental pain and the potential benefit of population pharmacodynamic modelling in data analysis. Nineteen healthy volunteers received transdermal placebo and buprenorphine in a cross-over study. Drug plasma concentrations and ERPs after electrical stimulation at the median nerve with intensity adjusted to pain detection threshold were recorded until 144 hrs after administration. Placebo and concentration-effect models were fitted to data using non-linear mixed-effects modelling implemented in NONMEM (V7.2.0.). Pharmacodynamic models were developed to adequately describe both placebo and buprenorphine ERP data. Models predicted significant placebo effects, but did not predict significant effects related to buprenorphine concentration. Models revealed that ERPs varied both between subjects and between study occasions. ERPs were found to be reproducible within subjects and occasions as population variance was found to be eight times higher than the unexplained variances. Between-subject variance accounted for more than 75% of the population variance. In conclusion, pharmacodynamic modelling was successfully implemented to allow for placebo and variability correction in ERP of experimental pain. Improved outcome of ERP studies can be expected if variation between subjects and study occasions can be identified and described.

PMID: 25163749 [PubMed - as supplied by publisher]

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Buprenorphine for Cancer Pain: Is It Ready for Prime Time?

Buprenorphine Research (PubMed) - Fri, 08/29/2014 - 7:00am

Buprenorphine for Cancer Pain: Is It Ready for Prime Time?

Am J Hosp Palliat Care. 2014 Aug 27;

Authors: Prommer E

Abstract
Buprenorphine (BUP) is a semisynthetic derivative of the opium alkaloid thebaine found in the poppy Papaver somniferum. Its chemical structure contains the morphine structure but differs by having a cyclopropylmethyl group. Buprenorphine is a potent µ opioid agonist. Buprenorphine undergoes extensive first-pass metabolism in the liver and gut. The development of a transdermal BUP formulation in 2001 led to its evaluation in cancer pain. This article provides the practitioner with an update on the current role of BUP in cancer care. It highlights data suggesting effectiveness in various types of cancer pain. The article reviews pharmacology, routes of administration, adverse effects, drug interactions, and cost considerations.

PMID: 25163678 [PubMed - as supplied by publisher]

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Where do we stand in the field of anti-abuse drug discovery?

Buprenorphine Research (PubMed) - Thu, 08/28/2014 - 8:00am

Where do we stand in the field of anti-abuse drug discovery?

Expert Opin Drug Discov. 2014 Aug 27;:1-4

Authors: Tzschentke TM

Abstract
Drug abuse and addiction to licit and illicit drugs constitute an almost worldwide health and socioeconomic problem. This problem can be addressed in a number of ways. As far as pharmaceutical development and drug therapy is concerned, abuse-deterrent formulations (ADF), substitution therapies, antagonist therapies, aversion therapies, and diverse novel approaches can be considered. ADF (or tamper-resistant formulations) are an important step towards preventing the abuse of medically used drugs, such as strong opioid analgesics, and some drug treatments are well established, such as substitution therapy in opioid dependence with methadone and buprenorphine. Nevertheless, a large medical need remains, and drugs that effectively curb opioid or psychostimulant addiction by promoting abstinence and preventing relapse have yet to be developed. Many different targets and mechanisms are currently being considered in preclinical research, but apart from repurposing or reformulating already known drugs, very little clinical development is currently ongoing. It is hoped that at least a few of the investigated approaches (e.g., various glutamate and GABA receptor modulators, nociceptin/orphanin FQ peptide receptor agonists, or histamine H3 receptor antagonists) reach the stage of clinical development and eventually reach regulatory approval.

PMID: 25162980 [PubMed - as supplied by publisher]

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Buprenorphine in the workers' compensation setting.

Buprenorphine Research (PubMed) - Thu, 08/28/2014 - 8:00am

Buprenorphine in the workers' compensation setting.

J Opioid Manag. 2014 July-August;10(4):277-283

Authors: Colameco S, Pohl M

Abstract
Buprenorphine is approved by the Food and Drug Administration for the treatment of chronic pain in low-dose transdermal patch formulations and for the treatment of addiction in high-dose sublingual tablets and films. Clinicians often prescribe these high-dose preparations "off label" for pain management. In the workers' compensation setting, it is particularly important to consider factors such as a) if the injured person has, and is being treated for co-occurring addiction as well as pain; b) if alternative therapies, including opioid withdrawal, were considered prior to initiating buprenorphine treatment; and c) the anticipated duration of treatment. This article reviews buprenorphine's approved indications, formulations, pharmacology, clinical efficacy, and special considerations in the workers' compensation setting.

PMID: 25162607 [PubMed - as supplied by publisher]

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Buprenorphine-naloxone buccal soluble film for the treatment of opioid dependence: current update.

Buprenorphine Research (PubMed) - Wed, 08/27/2014 - 8:30am
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Buprenorphine-naloxone buccal soluble film for the treatment of opioid dependence: current update.

Expert Opin Drug Deliv. 2014 Aug 25;:1-9

Authors: Soyka M

Abstract
Introduction: Opioid dependence is a severe medical disorder with a high psychiatric and somatic comorbidity and mortality rate. The opioid agonist methadone, mixed agonist-antagonist buprenorphine and the combination of buprenorphine with the opioid antagonist naloxone are the first-line maintenance treatments for opioid dependence. Risk of diversion and accidental intoxications, especially in children, are of great concern. To lower these risks, a novel buprenorphine-naloxone film has been developed and introduced in the USA and Australia. Areas covered: This review evaluates the available preclinical and clinical data on the novel buprenorphine-naloxone film for treatment of opioid dependence. Literature was identified through a comprehensive PubMed search. Data sources also included official FDA information and material made public by the manufacturer. Expert opinion: Few preclinical and clinical data on safety and efficacy have been published. The pharmacological differences between the novel film and the conventional buprenorphine/naloxone are small. In an experimental study, the new formulation suppressed symptoms of opioid withdrawal. The spectrum of adverse events seems to be similar to that of the conventional sublingual tablet. Recent data show that patients prefer the novel film over the conventional sublingual tablet. Emerging surveillance data indicate a lower risk of accidental poisoning in children compared with the conventional formulation. Further clinical and preclinical data are needed to explore additional possible advantages of the new formulation.

PMID: 25156759 [PubMed - as supplied by publisher]

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Meloxicam and Buprenorphine Treatment after Ovarian Transplantation Does Not Affect Estrous Cyclicity and Follicular Integrity in Aged CBA/J Mice.

Buprenorphine Research (PubMed) - Tue, 08/26/2014 - 6:30am

Meloxicam and Buprenorphine Treatment after Ovarian Transplantation Does Not Affect Estrous Cyclicity and Follicular Integrity in Aged CBA/J Mice.

PLoS One. 2014;9(8):e106013

Authors: Le AH, Bonachea LA, Cargill SL

Abstract
Angiogenesis, the formation of new blood vessels, is important for the survival of ovarian transplants and the restoration of ovarian functions. Without angiogenesis, transplanted ovarian tissue becomes more susceptible to tissue damage and necrosis. Administration of analgesics for pain management has been shown to decrease angiogenesis, which can influence transplant success especially in aged animals. Aging and the effects of hypoxia after transplantation decrease reproductive viability of the ovarian transplant; therefore, it is important to understand the additional effects of analgesics on aged animal models. The present study investigated the effects of two analgesics, buprenorphine, an opiate, and meloxicam, a non-steroidal anti-inflammatory drug (NSAID), on the reproductive indicators related to estrous cyclicity and follicular integrity after ovarian transplantation of young ovaries into aged CBA/J mice. These aged females did not show any different reproductive responses when treated with either buprenorphine or meloxicam. No significant differences were observed in estrous cycle length, the onset of estrous cycling, the regularity of estrous cycles, and the proportion of viable follicles and total number of follicles per ovarian sample across treatment groups.

PMID: 25153315 [PubMed - as supplied by publisher]

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Prenatal Buprenorphine Versus Methadone Exposure and Neonatal Outcomes: Systematic Review and Meta-Analysis.

Buprenorphine Research (PubMed) - Tue, 08/26/2014 - 6:30am
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Prenatal Buprenorphine Versus Methadone Exposure and Neonatal Outcomes: Systematic Review and Meta-Analysis.

Am J Epidemiol. 2014 Aug 22;

Authors: Brogly SB, Saia KA, Walley AY, Du HM, Sebastiani P

Abstract
Increasing rates of maternal opioid use during pregnancy and neonatal withdrawal, termed neonatal abstinence syndrome (NAS), are public health concerns. Prenatal buprenorphine maintenance treatment (BMT) versus methadone maintenance treatment (MMT) may improve neonatal outcomes, but associations vary. To summarize evidence, we used a random-effects meta-analysis model and estimated summary measures of BMT versus MMT on several outcomes. Sensitivity analyses evaluated confounding, publication bias, and heterogeneity. Subjects were 515 neonates whose mothers received BMT and 855 neonates whose mothers received MMT and who were born from 1996 to 2012 and who were included in 12 studies. The unadjusted NAS treatment risk was lower (risk ratio = 0.90, 95% confidence interval (CI): 0.81, 0.98) and mean length of hospital stay shorter (-7.23 days, 95% CI: -10.64, -3.83) in BMT-exposed versus MMT-exposed neonates. In treated neonates, NAS treatment duration was shorter (-8.46 days, 95% CI: -14.48, -2.44) and morphine dose lower (-3.60 mg, 95% CI: -7.26, 0.07) in those exposed to BMT. BMT-exposed neonates had higher mean gestational age and greater weight, length, and head circumference at birth. Fewer women treated with BMT used illicit opioids near delivery (risk ratio = 0.44, 95% CI: 0.28, 0.70). Simulations suggested that confounding by indication could account for some of the observed differences. Prenatal BMT versus MMT may improve neonatal outcomes, but bias may contribute to this protective association. Further evidence is needed to guide treatment choices.

PMID: 25150272 [PubMed - as supplied by publisher]

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The role of nurses in comprehensive care management of pregnant women with drug addiction.

Buprenorphine Research (PubMed) - Tue, 08/26/2014 - 6:30am
Related Articles

The role of nurses in comprehensive care management of pregnant women with drug addiction.

Nurs Womens Health. 2014 Aug;18(4):284-93

Authors: McKeever AE, Spaeth-Brayton S, Sheerin S

Abstract
Drug addiction during pregnancy is a complex health and social issue that requires an interdisciplinary health care team providing nonjudgmental, comprehensive care. Critical challenges include onset of and attendance at prenatal care, potential obstetric complications, transition to extrauterine life and potential neonatal abstinence syndrome for the neonate, newborn feeding issues, postpartum depression and risk of relapse for women.

PMID: 25145717 [PubMed - in process]

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The Opioid System and Brain Development: Effects of Methadone on the Oligodendrocyte Lineage and the Early Stages of Myelination.

Buprenorphine Research (PubMed) - Thu, 08/21/2014 - 9:00am
Related Articles

The Opioid System and Brain Development: Effects of Methadone on the Oligodendrocyte Lineage and the Early Stages of Myelination.

Dev Neurosci. 2014 Aug 19;

Authors: Vestal-Laborde AA, Eschenroeder AC, Bigbee JW, Robinson SE, Sato-Bigbee C

Abstract
Oligodendrocytes express opioid receptors throughout development, but the role of the opioid system in myelination remains poorly understood. This is a significant problem as opioid use and abuse continue to increase in two particular populations: pregnant addicts (in whom drug effects could target early myelination in the fetus and newborn) and adolescents and young adults (in whom late myelination of 'higher-order' regions takes place). Maintenance treatments for opioid addicts include the long-lasting opioids methadone and buprenorphine. Similar to our previous findings on the effects of buprenorphine, we have now found that early myelination in the developing rat brain is also altered by perinatal exposure to therapeutic doses of methadone. Pups exposed to this drug exhibited elevated brain levels of the 4 major splicing variants of myelin basic protein, myelin proteolipid protein, and myelin-oligodendrocyte glycoprotein. Consistent with the enrichment and function of these proteins in mature myelin, analysis of the corpus callosum in these young animals also indicated an elevated number of axons with already highly compacted myelin sheaths. Moreover, studies in cultured cells showed that methadone exerts direct effects at specific stages of the oligodendrocyte lineage, stimulating the proliferation of progenitor cells while on the other hand accelerating the maturation of the more differentiated but still immature preoligodendrocytes. While the long-term effects of these observations remain unknown, accelerated or increased oligodendrocyte maturation and myelination could both disrupt the complex sequence of synchronized events leading to normal connectivity in the developing brain. Together with our previous observations on the effects of buprenorphine, the present findings further underscore a crucial function of the endogenous opioid system in the control of oligodendrocyte development and the timing of myelination. Interference with these regulatory systems by opioid use or maintenance treatments could disrupt the normal process of brain maturation at critical stages of myelin formation. © 2014 S. Karger AG, Basel.

PMID: 25138998 [PubMed - as supplied by publisher]

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Parenting and Concerns of Pregnant Women in Buprenorphine Treatment.

Buprenorphine Research (PubMed) - Wed, 08/20/2014 - 9:00am

Parenting and Concerns of Pregnant Women in Buprenorphine Treatment.

MCN Am J Matern Child Nurs. 2014 September/October;39(5):319-324

Authors: Rizzo RA, Neumann AM, King SO, Hoey RF, Finnell DS, Blondell RD

Abstract
PURPOSE:: Opioid-dependent pregnant women are characterized by drug use during pregnancy and deficits in knowledge of newborn care and feeding, and of child development. We assessed parenting skills and concerns among pregnant women in buprenorphine treatment for prescription opioid dependence.
STUDY DESIGN AND METHODS:: We interviewed 32 pregnant women who received buprenorphine treatment for prescription opioid dependence in a primary care setting and administered questionnaires, including the Adult-Adolescent Parenting Inventory version 2 (AAPI-2) and Childhood Experience of Care and Abuse Questionnaire.
RESULTS:: AAPI-2 scores revealed medium risk of abuse for all five scales: inappropriate expectations of the child, low level of empathy, strong belief in corporal punishment, reversal of parent-child roles, and oppression of children's power and independence. Primary concerns of participants were neonatal abstinence syndrome (NAS) and their child's health. Pregnant women who received buprenorphine for treatment of prescription opioid dependence showed a lack of appropriate parenting skills, but did not express concern about their ability to parent.
CLINICAL IMPLICATIONS:: Our findings suggest a need for nurses to assist prescription opioid-dependent pregnant women in acquiring additional parenting skills, to refer for educational parenting intervention, and to educate patients about NAS.

PMID: 25137081 [PubMed - as supplied by publisher]

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Addiction Disorders.

Buprenorphine Research (PubMed) - Wed, 08/20/2014 - 9:00am

Addiction Disorders.

Med Clin North Am. 2014 Sep;98(5):1097-1122

Authors: Merrill JO, Duncan MH

Abstract
Substance use disorders are common in primary care settings, but detection, assessment, and management are seldom undertaken. Substantial evidence supports alcohol screening and brief intervention for risky drinking, and pharmacotherapy is effective for alcohol use disorders. Substance use disorders can complicate the management of chronic noncancer pain, making routine monitoring and assessment for substance use disorders an important aspect of long-term opioid prescribing. Patients with opioid use disorders can be effectively treated with methadone in opioid treatment programs or with buprenorphine in the primary care setting.

PMID: 25134875 [PubMed - as supplied by publisher]

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