Buprenorphine News Feed

Safety of Buprenorphine Transdermal System in the Management of Pain in Older Adults.

December 9, 2016 - 7:05am

Safety of Buprenorphine Transdermal System in the Management of Pain in Older Adults.

Postgrad Med. 2016 Dec 08;

Authors: Pergolizzi JV, Raffa RB, Marcum Z, Colucci S, Ripa SR

Abstract
OBJECTIVES: To evaluate whether buprenorphine transdermal system (BTDS; Butrans®) is an option for the treatment of chronic pain in older adults.
METHODS: This retrospective analysis of 16 placebo- and active-controlled and uncontrolled studies (N=6566) evaluated the safety and tolerability profile in patients exposed to BTDS and compared the safety profiles associated with BTDS treatment in older patients ≥ 65 years of age (65 to 98 years) and younger patients < 65 years of age (18 to 64 years). Safety analyses included adverse events (AEs), laboratory values, and electrocardiograms.
RESULTS: Overall, the incidence of AEs was similar in the ≥ 65 year patient cohort (N = 1715) and the < 65 year patient cohort (N = 4843) (63.8% and 61.0%, respectively). The older patient cohort experienced more constipation, peripheral edema, and urinary tract infection, but fewer application-site AEs (eg, erythema, irritation, pruritus, rash) and headaches. A statistically significant treatment-by-age interaction was observed for fall, arthralgia, and localized and non-application site-related rash, suggesting a differential increase in the risk of these events among older patients treated with BTDS that cannot be explained by age or treatment alone. A similar trend was observed for accidents and injuries, and for falls, in patients treated with both BTDS and active controls (oxycodone/acetaminophen [OXY/APAP] and hydrocodone/acetaminophen [HCD/APAP]), suggesting an opioid class effect. However, due to small sample sizes of the active control groups, a statistical test of treatment-by-age interaction could not be conducted for the active controls. The incidences of serious AEs and of clinically significant increases in liver enzymes, such as AST, ALT and bilirubin were small, regardless of age.
CONCLUSION: BTDS appears to be a viable option for the management of pain in older adults, but the benefits need to be tempered by potential risks among older adults.

PMID: 27929709 [PubMed - as supplied by publisher]

Effects of Buprenorphine on QT Intervals in Healthy Subjects: Results of 2 Randomized Positive- and Placebo-Controlled Trials.

December 9, 2016 - 7:05am
Related Articles

Effects of Buprenorphine on QT Intervals in Healthy Subjects: Results of 2 Randomized Positive- and Placebo-Controlled Trials.

Postgrad Med. 2016 Dec 07;

Authors: Harris SC, Morganroth J, Ripa SR, Thorn MD, Colucci S

Abstract
OBJECTIVES: To study the effect of transdermal buprenorphine on QTc prolongation at dose levels of 10, 40, and 80 mcg/h, (BTDS 10, BTDS 40, BTDS 80).
METHODS: Two randomized, placebo- and positive-controlled, parallel-group, dose-escalating clinical studies evaluated healthy adult subjects randomized to BTDS, placebo, or moxifloxacin in the first study; and to BTDS only, BTDS plus naltrexone, naltrexone alone at the same dose, placebo, or moxifloxacin in the second study. QT intervals were corrected for heart rate using data from each individual subject (QTcI).
RESULTS: In the first study (n=44), the maximum upper bounds of the 90% confidence interval (CI) for mean placebo-corrected change from baseline in QTcI across 13 time points over 24 hours were: 10.0 msec for BTDS 10 (Day 6) and 13.3 msec for BTDS 40 (Day 13); and 17.0 msec (Day 6) and 15.5 msec (Day 13) for moxifloxacin, respectively. Similarly, in the second study (n=66), the upper bound of the 90% CI for mean placebo-corrected change from baseline for QTcI was under 10 msec at all time points for BTDS 10 (maximum upper bound, 5.63 msec), over 10 msec at 5 time points for BTDS 40 (maximum 11.81 msec) and over 10 msec at all 13 time points for BTDS 80 (maximum, 14.14 msec). Naltrexone administered with BTDS eliminated the QTcI prolongation seen with supratherapeutic BTDS doses (BTDS 40, BTDS 80) administered without naltrexone.
CONCLUSIONS: At the therapeutic dose of 10 mcg/h, BTDS has no clinically significant effect on QTc. At supratherapeutic doses of 40 and 80 mcg/h, BTDS treatment produces prolongation of QTcI similar in magnitude to that produced by a 400 mg dose of moxifloxacin. Despite the modest, dose-dependent increase in QTcI noted in these studies, transdermal buprenorphine has not been associated with proarrhythmic effects.

PMID: 27927048 [PubMed - as supplied by publisher]

Efficacy and Tolerability of Co-Administering Full µ-Opioid Receptor Agonists with Buprenorphine and Mixed Opioid Agonists.

December 8, 2016 - 6:01am

Efficacy and Tolerability of Co-Administering Full µ-Opioid Receptor Agonists with Buprenorphine and Mixed Opioid Agonists.

Drug Res (Stuttg). 2016 Dec 07;

Authors: Ruan X, Luo J, Kaye A

PMID: 27926949 [PubMed - as supplied by publisher]

Overlapping buprenorphine, opioid, and benzodiazepine prescriptions among Veterans dually enrolled in VA and Medicare Part D.

December 8, 2016 - 6:01am

Overlapping buprenorphine, opioid, and benzodiazepine prescriptions among Veterans dually enrolled in VA and Medicare Part D.

Subst Abus. 2016 Dec 07;:0

Authors: Gellad WF, Zhao X, Thorpe CT, Thorpe JM, Sileanu FE, Cashy JP, Mor M, Hale JA, Radomski T, Hausmann LR, Fine MJ, Good CB

Abstract
BACKGROUND: Buprenorphine is a key tool in the management of opioid use disorder, but there are growing concerns about abuse, diversion and safety. These concerns are amplified for the Department of Veterans Affairs (VA), whose patients may receive care concurrently from multiple prescribers within and outside VA. To illustrate the extent of this challenge, we examined overlapping prescriptions for buprenorphine, opioids, and benzodiazepines among Veterans dually enrolled in VA and Medicare Part D.
METHODS: We constructed a cohort of all Veterans dually enrolled in VA and Part D who filled an opioid prescription in 2012. We identified patients who received tablet or film buprenorphine products from either source. We calculated the proportion of buprenorphine recipients with any overlapping prescription (based on days supply) for a non-buprenorphine opioid or benzodiazepine, focusing on Veterans who received overlapping prescriptions from a different system than their buprenorphine prescription (Part D buprenorphine recipients receiving overlapping opioids or benzodiazepines from VA and vice versa).
RESULTS: We identified 1,790 dually enrolled Veterans with buprenorphine prescriptions, including 760 (43%) from VA and 1,091 (61%) from Part D (61 Veterans with buprenorphine from both systems were included in each group). Among VA buprenorphine recipients, 199 (26%) received an overlapping opioid prescription and 11 (1%) received an overlapping benzodiazepine prescription from Part D. Among Part D buprenorphine recipients, 208 (19%) received an overlapping opioid prescription and 178 (16%) received an overlapping benzodiazepine prescription from VA. Among VA and Part D buprenorphine recipients with cross-system opioid overlap, 25% (49/199) and 35% (72/208), respectively, had >90 days of overlap.
CONCLUSIONS: Many buprenorphine recipients receive overlapping prescriptions for opioids and benzodiazepines from a different health care system than the one in which their buprenorphine was filled. These findings highlight a previously undocumented safety risk for Veterans dually enrolled in VA and Medicare.

PMID: 27925868 [PubMed - as supplied by publisher]

Intravenous Use of Intranasal Naloxone: A Case of Overdose Reversal.

December 8, 2016 - 6:01am

Intravenous Use of Intranasal Naloxone: A Case of Overdose Reversal.

Subst Abus. 2016 Dec 07;:0

Authors: Das S, Shah N, Ghadiali M

Abstract
BACKGROUND: Opioid overdose is a growing concern in the United States and internationally. Prehospital or pre-medical-personnel (lay person) administration of naloxone, an opioid antagonist, to reverse overdose, is an expanding mode of harm reduction. Recently, community clinics, methadone clinics, needle exchanges, some pharmacies and other health care facilities have made naloxone available to the community.
CASE: This case describes heroin overdose reversal of a 28-year-old male who had been using about a gram of heroin intravenously for 3 years, but recently reduced frequency of use in an attempt to stop. He was seen initially 1 week prior to a buprenorphine induction in our clinic. After the initial intake he used intravenous heroin, a larger amount than over the past several weeks in anticipation of abstinence, lost consciousness and was difficult to arouse. A friend with him noted the patient's respirations to become shallow and administered naloxone nasal spray that the patient had obtained from a needle exchange, but did so intravenously by attaching an unused drug needle to the syringe barrel in place of the nasal atomizer. The patient's overdose was reversed and he recovered.
DISCUSSION: This is the first known published case of a community-distributed naloxone nasal spray being used intravenously by a lay person (bystander). The case emphasizes the efficacy of naloxone in overdose reversal, and also the need for education or instructions on naloxone use by others (not just the user). Finally it highlights the risk of overdose in those entering treatment, seeking intoxication one last time.

PMID: 27925864 [PubMed - as supplied by publisher]

Inhibition of Glucuronidation and Oxidative Metabolism of Buprenorphine Using GRAS Compounds or Dietary Constituents/Supplements: In Vitro Proof of Concept.

December 8, 2016 - 6:01am

Inhibition of Glucuronidation and Oxidative Metabolism of Buprenorphine Using GRAS Compounds or Dietary Constituents/Supplements: In Vitro Proof of Concept.

Biopharm Drug Dispos. 2016 Dec 07;:

Authors: Maharao NV, Joshi AA, Gerk PM

Abstract
The present study investigated the potential of generally recognized as safe compounds or dietary substances to inhibit the presystemic metabolism of buprenorphine and increase its oral bioavailability. Using IVIVE, the buprenorphine extraction ratios in intestine and liver were predicted as 96% and 71%, respectively. In addition, the relative fraction of buprenorphine metabolized by oxidation and glucuronidation in these two organs was estimated using pooled human intestinal and liver microsomes. In both organs, oxidation appeared to be the major metabolic pathway with a six and four fold higher intrinsic clearance than glucuronidation in intestine and liver, respectively. The oral bioavailability of buprenorphine was predicted to be 1.16%. Inhibition of 75% and 50% of intestinal and hepatic presystemic metabolism would result in Foral of 49%, which is comparable to the bioavailability of sublingual buprenorphine. In human liver microsomes, chrysin, curcumin, ginger extract, hesperitin, magnolol, quercetin and silybin inhibited ≥50% glucuronidation whereas chrysin, curcumin, ginger extract, 6-gingerol, pterostilbene, resveratrol and silybin exhibited ≥30% inhibition of oxidation. In human intestinal microsomes, curcumin, ginger extract, α-mangostin, quercetin and silybin inhibited ≥50% glucuronidation while chrysin, ginger extract, α-mangostin, pterostilbene and resveratrol exhibited ≥30% inhibition of oxidation. These results demonstrate the feasibility of our proposed approach of using generally recognized as safe or dietary compounds to inhibit the presystemic metabolism of BUP and thus improve its oral bioavailability. An oral buprenorphine formulation containing these inhibitors or their combinations has promising potential to replace sublingual buprenorphine.

PMID: 27925249 [PubMed - as supplied by publisher]

Comparison of Abuse, Suspected Suicidal Intent, and Fatalities related to the 7-day Buprenorphine Transdermal Patch versus other Opioid Analgesics in the National Poison Data System.

December 7, 2016 - 6:54am

Comparison of Abuse, Suspected Suicidal Intent, and Fatalities related to the 7-day Buprenorphine Transdermal Patch versus other Opioid Analgesics in the National Poison Data System.

Postgrad Med. 2016 Dec 06;

Authors: Coplan PM, Sessler NE, Harikrishnan V, Singh R, Perkel C

Abstract
OBJECTIVE: Prescription opioid related abuse, suicide and death are significant public health problems. This study compares rates of poison center calls categorized as intentional abuse, suspected suicidal intent or fatality for the 7-day buprenorphine transdermal system/patch (BTDS) with other extended-release and long-acting (ER/LA) opioids indicated for chronic pain.
DESIGN: Retrospective 24-month cohort study using National Poison Data System data from July 2012 through June 2014. BTDS was introduced in the United States in January 2011.
METHODS: Numbers and rates of calls of intentional abuse, suspected suicidal intent and fatalities were evaluated for BTDS, ER morphine, ER oxycodone, fentanyl patch, ER oxymorphone and methadone tablets/capsules, using prescription adjustment to account for community availability. Rate ratios (RR) and 95% confidence intervals (CI) were calculated.
RESULTS: Absolute numbers and prescription-adjusted rates of intentional abuse and suspected suicidal intent with BTDS were significantly lower (p<.0001) than for all other ER/LA opioid analgesics examined. No fatalities associated with BTDS exposure were reported.
CONCLUSION: This post-marketing evaluation of BTDS indicates infrequent poison center calls for intentional abuse and suspected suicidal intent events, suggesting lower rates of these risks with BTDS compared to other ER/LA opioids.

PMID: 27922764 [PubMed - as supplied by publisher]

Primary Care-Based Models for the Treatment of Opioid Use Disorder: A Scoping Review.

December 6, 2016 - 7:50am

Primary Care-Based Models for the Treatment of Opioid Use Disorder: A Scoping Review.

Ann Intern Med. 2016 Dec 06;:

Authors: Korthuis PT, McCarty D, Weimer M, Bougatsos C, Blazina I, Zakher B, Grusing S, Devine B, Chou R

Abstract
Greater integration of medication-assisted treatment (MAT) for opioid use disorder (OUD) in U.S. primary care settings would expand access to treatment for this condition. Models for integrating MAT into primary care vary in structure. This article summarizes findings of a technical report for the Agency for Healthcare Research and Quality describing MAT models of care for OUD, based on a literature review and interviews with key informants in the field. The report describes 12 representative models of care for integrating MAT into primary care settings that could be considered for adaptation across diverse health care settings. Common components of existing care models include pharmacotherapy with buprenorphine or naltrexone, provider and community education, coordination and integration of OUD treatment with other medical and psychological needs, and psychosocial services and interventions. Models vary in how each component is implemented. Decisions about adopting MAT models of care should be individualized to address the unique milieu of each implementation setting.

PMID: 27919103 [PubMed - as supplied by publisher]

Osteotomy models - the current status on pain scoring and management in small rodents.

December 2, 2016 - 2:33pm
Related Articles

Osteotomy models - the current status on pain scoring and management in small rodents.

Lab Anim. 2016 Dec;50(6):433-441

Authors: Lang A, Schulz A, Ellinghaus A, Schmidt-Bleek K

Abstract
Fracture healing is a complex regeneration process which produces new bone tissue without scar formation. However, fracture healing disorders occur in approximately 10% of human patients and cause severe pain and reduced quality of life. Recently, the development of more standardized, sophisticated and commercially available osteosynthesis techniques reflecting clinical approaches has increased the use of small rodents such as rats and mice in bone healing research dramatically. Nevertheless, there is no standard for pain assessment, especially in these species, and consequently limited information regarding the welfare aspects of osteotomy models. Moreover, the selection of analgesics is restricted for osteotomy models since non-steroidal anti-inflammatory drugs (NSAIDs) are known to affect the initial, inflammatory phase of bone healing. Therefore, opioids such as buprenorphine and tramadol are often used. However, dosage data in the literature are varied. Within this review, we clarify the background of osteotomy models, explain the current status and challenges of animal welfare assessment, and provide an example score sheet including model specific parameters. Furthermore, we summarize current refinement options and present a brief outlook on further 3R research.

PMID: 27909193 [PubMed - in process]

Analgesia in clinically relevant rodent models of sepsis.

December 2, 2016 - 2:33pm
Related Articles

Analgesia in clinically relevant rodent models of sepsis.

Lab Anim. 2016 Dec;50(6):418-426

Authors: Jeger V, Hauffe T, Nicholls-Vuille F, Bettex D, Rudiger A

Abstract
Postoperative analgesia in rodent sepsis models has been considerably neglected in the past. However, intentions to model clinical practice, increasing awareness of animal ethics, efforts to apply the 3Rs (replacement, reduction, refinement), and stricter legislation argue for a change in this respect. In this review, we describe different concepts of analgesia in rodent models of sepsis focusing on opioid agonists as well as non-opioid analgesics. Advantages and pitfalls in study design and side-effects are discussed. Score sheets should be used to adapt analgesia or to terminate experiments using humane endpoints. Further research is needed to differentiate behavioral changes caused by sepsis and pain or as a consequence of analgesia. Information on the efficacy of analgesia in sepsis models is scarce. Hence, studies are needed to identify the best ways to reduce suffering of research animals and thereby optimize the clinically relevant rodent models of sepsis.

PMID: 27909191 [PubMed - in process]

Effect of Nerolidol and/or Levulinic Acid on the Thermotropic Behavior of Lipid Lamellar Structures in the Stratum Corneum.

December 2, 2016 - 2:33pm
Related Articles

Effect of Nerolidol and/or Levulinic Acid on the Thermotropic Behavior of Lipid Lamellar Structures in the Stratum Corneum.

Chem Pharm Bull (Tokyo). 2016;64(12):1692-1697

Authors: Utsumi S, Nakamura T, Obata Y, Ohta N, Takayama K

Abstract
Permeation enhancers are required to deliver drugs through the skin efficiently and maintain effective blood concentrations. Studies of the barrier function of the stratum corneum using l-menthol, a monocyclic monoterpene widely used in medicines and foods, have revealed an interaction between characteristic intercellular lipid structures in the stratum corneum and permeation enhancers. The variety of permeation enhancers that can be used to contribute to transdermal delivery systems beyond l-menthol is increasing. In this study, we focused on nerolidol and levulinic acid and investigated their influence on stratum corneum lipid structures. Nerolidol, a sesquiterpene, has been reported to enhance the permeation of various drugs. Levulinic acid is reported to enhance the permeability of buprenorphine and is used as a component of the buprenorphine(®) patch. Synchrotron X-ray diffraction and attenuated total reflectance Fourier transform IR spectroscopy measurements revealed that nerolidol disturbs the rigidly arranged lipid structure and increases lipid fluidity. Levulinic acid had a smaller effect on stratum corneum lipid structures, but did increase lipid fluidity when co-administered with nerolidol or heat. We found that nerolidol has an effect on stratum corneum lipids similar to that of l-menthol, and levulinic acid had an effect similar to that of oleic acid.

PMID: 27904078 [PubMed - in process]

Prescription drug abuse - A timely update.

December 2, 2016 - 2:33pm
Related Articles

Prescription drug abuse - A timely update.

Aust Fam Physician. 2016 Dec;45(12):862-866

Authors: Monheit B, Pietrzak D, Hocking S

Abstract
BACKGROUND: Prescription drug abuse is a rising problem in Australia and pharmaceutical drugs have been the most frequent contributors to overdose deaths in Victoria in recent years.
OBJECTIVE: The objectives of this article are to examine the main prescription drugs contributing to overdose deaths and to consider how doctors may help in reducing this problem.
DISCUSSION: Data from the Coroners Court of Victoria list the main drugs that contributed to drug-related deaths in 2009-15. Analysis of the data reveals that pharmaceutical drugs contributed to 80% of overdose deaths; benzodiazepines and opioids were the main drug groups involved. Strategies for reducing and managing prescription drug abuse in primary care settings are outlined in this article, including references to published evidence-based clinical guidelines from The Royal Australian College of General Practitioners (RACGP). The safety profile of buprenorphine/ naloxone over methadone is noted and raised as a consideration for clinicians when assessing a patient for opioid replacement therapy.

PMID: 27903034 [PubMed - in process]

Buprenorphine Transdermal System Utilization.

December 2, 2016 - 2:33pm
Related Articles

Buprenorphine Transdermal System Utilization.

Postgrad Med. 2016 Nov 30;

Authors: Wallace L, Kadakia A

Abstract
OBJECTIVES: To evaluate utilization patterns in patients initiating buprenorphine transdermal system (BTDS), CIII, and estimate the proportion decreasing their total opioid dose over time.
METHODS: This retrospective cohort study used data from the Truven Health Analytics MarketScan® Commercial Claims and Encounters Database from January 1, 2011 through December 31, 2015. Eligible individuals were adults aged 18-64 years newly dispensed BTDS (index prescription) who had at least six months of insurance coverage prior to (baseline period) and following (study period) the index prescription.
RESULTS: Back and neck pain was the most common pain condition in the study population (n=31,533) and 88% were dispensed opioids in the baseline period. Nearly half (48%) received BTDS in a strength of 10 mcg/hour as their index prescription. Most (80%) patients prescribed BTDS had concomitant prescriptions for other opioids, chiefly immediate-release (IR) opioids (77%). During the baseline period, median opioid dose among patients prescribed opioids was 50 morphine-equivalent doses (MED), with 33% of patients using nonsteroidal anti-inflammatory drugs and 44% adjuvant analgesics. During the study period, BTDS use lasted a median 30 days and mean 100 days. Median dose of BTDS remained largely constant, and median dose of all opioids during continuous use of BTDS was 65.6 units MED. However, 24% of patients reduced total units MED from the baseline period (median mean dose, 74.5 units MED) until the end of the study period (42.8).
CONCLUSIONS: Most patients initiating treatment with BTDS had a history of treatment with IR opioids. Though the average change in total opioid daily dose after patients were prescribed BTDS was modest, an important subpopulation of approximately one-quarter of patients were able to markedly reduce their total units MED compared with prior opioid therapy. BTDS should be investigated as an option to help patients step down from higher opioid doses.

PMID: 27901359 [PubMed - as supplied by publisher]

Distinctive Trajectories of Opioid Use Over an Extended Follow-up of Patients in a Multisite Trial on Buprenorphine + Naloxone and Methadone.

November 30, 2016 - 6:19am

Distinctive Trajectories of Opioid Use Over an Extended Follow-up of Patients in a Multisite Trial on Buprenorphine + Naloxone and Methadone.

J Addict Med. 2016 Nov 24;

Authors: Hser YI, Huang D, Saxon AJ, Woody G, Moskowitz AL, Matthews AG, Ling W

Abstract
OBJECTIVES: Uncovering heterogeneities in longitudinal patterns (trajectories) of opioid use among individuals with opioid use disorder can increase our understanding of disease progression and treatment responses to improve care. The present study aims to identify distinctive opioid use trajectories and factors associated with these patterns among participants randomized to treatment with methadone (MET) or buprenorphine + naloxone (BUP).
METHODS: Growth mixture modeling was applied to identify distinctive opioid use trajectories among 795 opioid users after their enrollment in a multisite trial during 2006 to 2009, with follow-up interviews conducted during 2011 to 2014.
RESULTS: Four distinctive trajectories were identified based on opioid use over the follow-up period: low use (42.0%), high use (22.3%), increasing use (17.1%), and decreasing use (18.6%). Greater odds of being in the high use group (relative to low use) was associated with Hispanics (relative to African American, odds ratio [OR] 3.21), injection drug use (OR 2.12), higher mental health functioning at baseline (OR 1.23), location on the West Coast (vs East Coast, OR 2.15), and randomization to BUP (relative to MET, OR 1.53). High use and increasing use groups had greater severity in problems related to drug, employment, legal, and social/family relationships, and worsened mental health functioning at follow-up. Participation in treatment significantly accounted for both within and between-group differences in opioid use.
CONCLUSIONS: Continued treatment is necessary to reduce risk for opioid use and related adverse consequences, particularly among individuals (eg, injecting drug) at risk for consistently high level of opioid use.

PMID: 27898496 [PubMed - as supplied by publisher]

Buprenorphine Shared Medical Appointments for the Treatment of Opioid Dependence in a Homeless Clinic.

November 30, 2016 - 6:19am

Buprenorphine Shared Medical Appointments for the Treatment of Opioid Dependence in a Homeless Clinic.

Subst Abus. 2016 Nov 29;:0

Authors: Doorley SL, Ho CJ, Echeverria E, Preston C, Ngo H, Kamal A, Cunningham CO

Abstract
BACKGROUND: Opioid misuse and dependence are prevalent and rising problems in the United States. Treatment with buprenorphine is a successful treatment option for individuals with opioid dependence. We describe and preliminarily evaluate a unique delivery system that provides buprenorphine treatment via a shared medical appointment.
METHODS: We conducted a retrospective medical record review on all 77 opioid-dependent patients referred for a buprenorphine shared medical appointment in a homeless clinic from 2010-2012. We examined retention in treatment at 12 and 24 weeks.
RESULTS: Most patients were currently homeless (61%), unemployed (92%), had an Axis I psychiatric diagnosis (81%), and had recent polysubstance use (53%). Of the 77 patients, 95% attended at least one shared medical appointment. Treatment retention at 12 and 24 weeks was 86% and 70%, respectively.
CONCLUSIONS: In a patient population with complex social and mental health histories, buprenorphine treatment via a shared medical appointment had high retention rates. Findings can help guide the development of unique delivery systems to serve real-world complex patients with opioid dependence.

PMID: 27897918 [PubMed - as supplied by publisher]

Opioid receptor agonists may favorably affect bone mechanical properties in rats with estrogen deficiency-induced osteoporosis.

November 30, 2016 - 6:19am

Opioid receptor agonists may favorably affect bone mechanical properties in rats with estrogen deficiency-induced osteoporosis.

Naunyn Schmiedebergs Arch Pharmacol. 2016 Nov 28;

Authors: Janas A, Folwarczna J

Abstract
The results of epidemiological, clinical, and in vivo and in vitro experimental studies on the effect of opioid analgesics on bone are inconsistent. The aim of the present study was to investigate the effect of morphine (an agonist of opioid receptors), buprenorphine (a partial μ opioid receptor agonist and κ opioid receptor antagonist), and naloxone (an antagonist of opioid receptors) on the skeletal system of female rats in vivo. The experiments were carried out on 3-month-old Wistar rats, divided into two groups: nonovariectomized (intact; NOVX) rats and ovariectomized (OVX) rats. The bilateral ovariectomy was performed 7 days before the start of drug administration. Morphine hydrochloride (20 mg/kg/day s.c.), buprenorphine (0.05 mg/kg/day s.c.), or naloxone hydrochloride dihydrate (2 mg/kg/day s.c.) were administered for 4 weeks to NOVX and OVX rats. In OVX rats, the use of morphine and buprenorphine counteracted the development of osteoporotic changes in the skeletal system induced by estrogen deficiency. Morphine and buprenorphine beneficially affected also the skeletal system of NOVX rats, but the effects were much weaker than those in OVX rats. Naloxone generally did not affect the rat skeletal system. The results confirmed the role of opioid receptors in the regulation of bone remodeling processes and demonstrated, in experimental conditions, that the use of opioid analgesics at moderate doses may exert beneficial effects on the skeletal system, especially in estrogen deficiency.

PMID: 27896372 [PubMed - as supplied by publisher]

Naloxone and Metabolites Quantification in Cord Blood of Prenatally Exposed Newborns and Correlations with Maternal Concentrations.

November 30, 2016 - 6:19am

Naloxone and Metabolites Quantification in Cord Blood of Prenatally Exposed Newborns and Correlations with Maternal Concentrations.

AJP Rep. 2016 Oct;6(4):e385-e390

Authors: Wiegand SL, Swortwood MJ, Huestis MA, Thorp J, Jones HE, Vora NL

Abstract
Objective To quantify naloxone and metabolite concentrations in newborns prenatally exposed to sublingual buprenorphine/naloxone and to correlate neonatal and maternal metabolite concentrations. Methods This is a prospective observational cohort study. Eleven pregnant women treated for opioid use disorder with sublingual buprenorphine/naloxone were enrolled. Maternal and newborn blood was collected and analyzed for naloxone, buprenorphine, and metabolites via liquid chromatography tandem mass spectrometry. Descriptive statistics and correlation coefficients were utilized to analyze data. Results Maternal daily naloxone and buprenorphine doses were 1 to 5 mg and 4 to 20 mg, respectively; the mean (standard deviation) time from medication until delivery was 9.9 (4.3) hours. Naloxone was below the limits of quantification (LOQ) in five infants and six mothers with a range of less than LOQ to 0.3 μg/L. There was a strong positive correlation between maternal and newborn naloxone concentrations: Spearman's ρ = 0.89 (p < 0.01). There were strong positive correlations between maternal and neonatal assays for the buprenorphine analyte concentrations: buprenorphine ρ = 0.88 (p < 0.01), norbuprenorphine ρ = 0.71 (p = 0.01), and norbuprenorphine-glucuronide ρ = 0.98 (p < 0.01), but not for buprenorphine-glucuronide, ρ = 0.53 (p = 0.10). Conclusion Naloxone and buprenorphine are transferred to the fetus during prenatal exposure to maternal sublingual buprenorphine/naloxone. The quantity of naloxone transferred from maternal circulation is minimal and highly correlated with maternal concentrations.

PMID: 27896019 [PubMed - in process]

The relationship between gestational age and the severity of neonatal abstinence syndrome.

November 26, 2016 - 6:50am

The relationship between gestational age and the severity of neonatal abstinence syndrome.

Addiction. 2016 Nov 25;:

Authors: Gibson KS, Stark MS, Kumar D, Bailit JL

Abstract
BACKGROUND AND AIMS: The relationship between gestational age at delivery and the severity of neonatal abstinence syndrome (NAS) is poorly understood. Our objective was to compare the length of pharmacotherapy and hospital stay among opioid exposed infants born during the late preterm, early term, full term, and late term periods.
DESIGN: Retrospective cohort study of infants affected by NAS SETTING: MetroHealth Medical Center in Cleveland, Ohio, USA: an urban tertiary care hospital serving as the referral center for opioid dependency in pregnancy with a level III neonatal intensive care unit PARTICIPANTS: All deliveries complicated by maternal opioid exposure from January 2000 to October 2014; 403 were eligible to be included (n = 102 Late Preterm, 34-36weeks (LP), n = 158 Early Term, 37-38weeks (ET), n = 122 Full Term, 39-40weeks (FT), n = 21 Late Term, ≥41 weeks (LT)).
MEASUREMENTS: NAS requiring pharmacotherapy with opioids and hospital stay duration were compared between gestational age cohorts. Interaction by type of maternal medication was evaluated.
FINDINGS: The necessity for pharmacotherapy for NAS was similar in all gestational age groups (LP n = 45 (44%), ET 69 (44%), FT 58 (48%), LT 9 (43%); P = 0.92). However median duration of pharmacotherapy for NAS was significantly different between the groups (LP =16.0 median [interquartile range 10.0-24.0] days, ET = 22.5 [15.0-40.0], FT = 23.0 [16.0-38.0], LT 22.0 [16.0-28.0]; P = 0.02). Neonatal intensive care unit admission for NAS (P = 0.07) and total length of stay (P = 0.27), which includes observation for NAS not requiring medication, were not different. There was no significant interaction between gestational age cohorts and maternal medication assisted treatment therapy on the need for or duration of NAS treatment. The results were unchanged when evaluated for potential confounding variables.
CONCLUSIONS: Gestational age (pre-term, term or late term) at birth appears to be unrelated to the need for pharmacotherapy to treat neonatal abstinence syndrome (NAS) in late preterm and term infants. If treatment is needed it may tend to be given for longer in term than pre-term or late term infants.

PMID: 27886650 [PubMed - as supplied by publisher]

Successful control of a large outbreak of HIV infection associated with injection of cathinone derivatives in Tel Aviv, Israel.

November 24, 2016 - 6:39am

Successful control of a large outbreak of HIV infection associated with injection of cathinone derivatives in Tel Aviv, Israel.

Clin Microbiol Infect. 2016 Nov 19;:

Authors: Katchman E, Ben-Ami R, Savyon M, Chemtob D, Avidor B, Wasserman A, Zeldis I, Girshengorn S, Amitai Z, Sheffer R, Turner D

Abstract
OBJECTIVES: Outbreaks of HIV infection have been linked to injectable drug abuse, but specific triggers often remain obscure. We report on an outbreak of primary HIV infection among people who inject drugs (PWID) in Tel Aviv, associated with a local shift in drug-use practices.
METHODS: A cluster of primary HIV infection cases in PWID was detected in May 2012. Retrospective and prospective multi-hospital case finding was initiated. PWID were interviewed and risk factors for primary HIV infection were identified. Starting in December 2012, a multifaceted intervention was implemented, including educational activities, increasing syringe exchange supplies, active screening, early initiation of antiretroviral therapy, and referral to drug withdrawal programs.
RESULTS: Forty-two PWID with primary HIV infection were detected between May 2012 and April 2013. Compared with the corresponding pre-outbreak period, the annual incidence of primary HIV infection in PWID increased from 0 to 20 cases/1000 population (P <0.0001). Sixty-nine percent were hospitalised due to concomitant bacterial infections and sepsis. Phylogenetic analysis of HIV isolates from case patients showed tight clustering suggesting a single common source of infection. The outbreak was temporally related to a widespread shift from heroin to injectable cathinone-derivatives and buprenorphine, which entailed high-risk injection practices. Targeted intervention resulted in a dramatic and sustained reduction in HIV infection in the PWID population.
CONCLUSIONS: Injectable amphetamines are gaining momentum among PWID worldwide. Tracing of this outbreak to cathinone use and implementing a targeted intervention program effectively terminated the outbreak.

PMID: 27876594 [PubMed - as supplied by publisher]

Psychoactive medications and disengagement from office based opioid treatment (obot) with buprenorphine.

November 20, 2016 - 8:22am

Psychoactive medications and disengagement from office based opioid treatment (obot) with buprenorphine.

Drug Alcohol Depend. 2016 Nov 5;170:9-16

Authors: Weinstein ZM, Cheng DM, Quinn E, Hui D, Kim H, Gryczynski G, Samet JH

Abstract
BACKGROUND: The prevalence of psychoactive medications (PAMs) use in patients enrolled in Office Based Opioid Treatment (OBOT) and its association with engagement in this care is largely unknown.
OBJECTIVE: To describe the use of PAMs, including those medications with emerging evidence of misuse ("emerging PAMs" - gabapentin, clonidine and promethazine) among patients on buprenorphine, and its association with disengagement from OBOT.
METHODS: This is a retrospective cohort study of adults on buprenorphine from January 2002 to February 2014. The association between use of PAMs and 6-month disengagement from OBOT was examined using multivariable logistic regression models. A secondary analysis exploring time-to-disengagement was conducted using Cox regression models.
RESULTS: At OBOT entry, 43% of patients (562/1308) were prescribed any PAM; including 17% (223/1308) on an emerging PAM. In separate adjusted analyses, neither the presence of any PAM (adjusted odds ratio [AOR] 1.07, 95% CI [0.78, 1.46]) nor an emerging PAM (AOR 1.28 [0.95, 1.74]) was significantly associated with 6-month disengagement. The results were similar for the Cox model (any PAM (adjusted hazard ratio [AHR] 1.16, 95% CI [1.00, 1.36]), emerging PAM (AHR 1.18 [0.98, 1.41])). Exploratory analyses suggested gabapentin (AHR 1.30 [1.05-1.62]) and clonidine (AHR 1.33 [1.01-1.73]) specifically, may be associated with an overall shorter time to disengagement.
CONCLUSIONS: Psychoactive medication use is common among patients in buprenorphine treatment. No significant association was found between the presence of any psychoactive medications, including medications with emerging evidence of misuse, and 6-month disengagement from buprenorphine treatment.

PMID: 27865152 [PubMed - as supplied by publisher]

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