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Characteristics and quality of life of opioid-dependent pregnant women in Austria.

Buprenorphine Research (PubMed) - Wed, 07/16/2014 - 8:30am
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Characteristics and quality of life of opioid-dependent pregnant women in Austria.

Arch Womens Ment Health. 2014 Jul 15;

Authors: Metz VE, Comer SD, Wuerzl J, Pribasnig A, Fischer G

Abstract
This study investigated pregnant opioid-dependent women undergoing maintenance therapy, applying a multidisciplinary, case-management approach at the Addiction Clinic of the Medical University of Vienna, Austria. It aimed at characterizing the patients' basic demographic and clinical parameters and evaluating their overall quality of life (QoL) prepartum and postpartum. Three hundred ninety women were treated between 1994 and 2009 with buprenorphine (n = 77), methadone (n = 184), or slow-release oral morphine (SROM) (n = 129) on an outpatient basis throughout their pregnancy and postpartum period. All patients were subject to standardized prepartum and postpartum medical and psychiatric assessments, including QoL assessments using a German adaptation of the Lancashire QoL Profile (Berliner Lebensqualitaetsprofil), and regular supervised urine toxicologies. No medication group differences were revealed regarding basic demographic or clinical data. Mean maintenance doses (SD) at time of delivery were as follows: 64 mg (36 mg) methadone, 10 mg (6 mg) buprenorphine, 455 mg (207 mg) SROM. However, buprenorphine-medicated women showed significantly less concomitant benzodiazepine consumption than methadone- or SROM-maintained women (p = 0.005), and significantly less concomitant opioid consumption than methadone-maintained women (p = 0.033) during the last trimester. Overall QoL was good prepartum and postpartum in all measured domains except "finances" and "prospect of staying in the same housing situation," and no differences were observed in QoL among the three medication groups (p = 0.177). QoL improved significantly after delivery in most of the domains (p < 0.001). Although opioid-dependent pregnant women face high-risk pregnancies and show variability in addiction severity, they report good QoL independent of the medication administered. These results show that individually tailored treatment interventions are effective for this patient population and suggest a QoL improvement after delivery.

PMID: 25023716 [PubMed - as supplied by publisher]

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[Sécurité de la plus récente classe d'antagonistes des opioïdes durant la grossesse.]

Buprenorphine Research (PubMed) - Wed, 07/16/2014 - 8:30am
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[Sécurité de la plus récente classe d'antagonistes des opioïdes durant la grossesse.]

Can Fam Physician. 2014 Jul;60(7):e348-e349

Authors: Poon S, Pupco A, Koren G, Bozzo P

Abstract
QUESTION: J'ai une patiente dont 6 semaines de grossesse viennent d'être confirmées. Depuis 6 mois, elle suit une thérapie pour une dépendance aux opioïdes à l'aide d'une combinaison de buprénorphine et de naloxone. Devrais-je m'inquiéter qu'elle ait été exposée à cette combinaison de médicaments jusqu'à ce stade de sa grossesse? Faudrait-il que je change sa médication pour de la méthadone maintenant qu'elle est enceinte? RÉPONSE: Les données limitées sur l'exposition à la buprénorphine durant la grossesse ne révèlent pas d'augmentation du risque de résultats indésirables chez le nouveau-né. Il y a peu de données sur la naloxone durant la grossesse; par ailleurs, on ne s'attendrait pas à ce que l'administration par voie orale soit associée avec un risque accru de résultats de grossesse défavorables. On conseille aux médecins qui traitent des femmes enceintes ou qui deviennent enceintes et dont l'état est stable en prenant une thérapie à la buprénorphine et naloxone de continuer ce traitement mais d'envisager une transition à une monothérapie à la buprénorphine.

PMID: 25022652 [PubMed - as supplied by publisher]

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Safety of the newer class of opioid antagonists in pregnancy.

Buprenorphine Research (PubMed) - Wed, 07/16/2014 - 8:30am
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Safety of the newer class of opioid antagonists in pregnancy.

Can Fam Physician. 2014 Jul;60(7):631-2

Authors: Poon S, Pupco A, Koren G, Bozzo P

Abstract
QUESTION: I have a patient recently confirmed to be 6 weeks pregnant. For the past 6 months she has been treated for an opioid addiction with buprenorphine-naloxone combination. Should I be concerned about her exposure to this drug combination up to this point of the pregnancy? Should I switch her medication to methadone now that she is pregnant?
ANSWER: The limited data on buprenorphine exposure during pregnancy show no increased risk of adverse outcomes in the newborn. There are limited data on naloxone exposure during pregnancy; however, oral use is not expected to be associated with an increased risk of adverse pregnancy outcomes. Physicians treating pregnant women or women who become pregnant while they are stable taking buprenorphine-naloxone treatment are advised to continue this treatment but to consider transition to buprenorphine monotherapy.

PMID: 25022635 [PubMed - in process]

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PC.84 Withdrawal from "therapeutic" opiate during the neonatal period: an increasing problem?

Buprenorphine Research (PubMed) - Wed, 07/16/2014 - 8:30am
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PC.84 Withdrawal from "therapeutic" opiate during the neonatal period: an increasing problem?

Arch Dis Child Fetal Neonatal Ed. 2014 Jun;99 Suppl 1:A65

Authors: Johnson K, Balain M

Abstract
BACKGROUND: There are well developed services for pregnant substance users maintained on opiate replacement therapies (ORT) both nationally and locally. Recently the problem of addiction to prescription drugs has been highlighted by the Home Affairs Select Committee report(1) and has received national media attention. Locally an increase in pregnant women addicted to such prescription drugs, particularly opiates, has been observed. Whilst ORT are prescription medications, they are distinct in some ways from opiates prescribed for non replacement therapy. Such opiates are referred to in this report as "therapeutic" opiates.
METHODS: Cases of infants born to mothers using "therapeutic" opiates over the last 2 years were reviewed. A literature review was performed looking specifically at the common substances used during pregnancy in such situations.
RESULTS: 22 women delivered 23 infants over the 2 year period. The most commonly prescribed substances were codeine, oxycodone and buprenorphine patches, prescribed mainly for chronic pain. All infants were admitted to the neonatal service for observation/treatment of Neonatal Abstinence Syndrome Very few women had accessed the local multi disciplinary antenatal clinic for drug using women and antenatal communication and planning was poor.
CONCLUSIONS: The use of "therapeutic" opiates during pregnancy is not uncommon Women using "therapeutic" opiates are not accessing specialist local services, probably as they do not see themselves/are not seen as "addicts" in the classic sense of the word. There is clearly a need for improved services for this group of pregnant women.
REFERENCE: House of Commons Home Affairs Committee. Drugs: new psychoactive substances and prescription drugs. Twelfth Report of Session 2013-14. 17/12/2013.

PMID: 25021313 [PubMed - in process]

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[Opioid substitution treatment and risk reduction].

Buprenorphine Research (PubMed) - Wed, 07/16/2014 - 8:30am
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[Opioid substitution treatment and risk reduction].

Rev Prat. 2014 Mar;64(3):395-6

Authors: Karila L, Zarmdini R, Cottencin O, Lejoyeux M

PMID: 24851376 [PubMed - indexed for MEDLINE]

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A latent class analysis of self-reported clinical indicators of psychosocial stability and adherence among opioid substitution therapy patients: Do stable patients receive more unsupervised doses?

Buprenorphine Research (PubMed) - Sun, 07/13/2014 - 7:00am

A latent class analysis of self-reported clinical indicators of psychosocial stability and adherence among opioid substitution therapy patients: Do stable patients receive more unsupervised doses?

Drug Alcohol Depend. 2014 Jun 2;

Authors: Larance B, Carragher N, Mattick RP, Lintzeris N, Ali R, Degenhardt L

Abstract
AIMS: To develop a stability typology among opioid substitution therapy patients using a range of adherence indicators derived from clinical guidelines, and determine whether stable patients receive more unsupervised doses.
METHODS: An interviewer-administered cross-sectional survey was used in opioid substitution therapy programmes in three Australian jurisdictions, totalling 768 patients in their current treatment episode for ≥4 weeks. A structured questionnaire collated data from patients about their demographics, treatment characteristics, past 6-month drug use and medication adherence, psychosocial stability, comorbidity, child welfare concerns and levels of supervised dosing. Latent class analysis (LCA) was used to derive a stability typology. Linear regression models examined predictors of unsupervised dosing in the past month.
RESULTS: LCA identified two classes: (i) a higher-adherence group (67%) who had low-moderate probabilities of endorsing the opioid substitution therapy stability indicators and (ii) a lower-adherence group (33%) who had moderate-high probabilities of endorsing the stability indicators. There was no association between adherence profile and the number of unsupervised doses. Significant predictors of receiving larger numbers of unsupervised doses included being older, living in New South Wales or South Australia (vs. Victoria), receiving methadone (vs. mono-buprenorphine), being prescribed in private clinic or general practice (vs. public clinic), reporting a longer current treatment episode, not receiving a urine drug screen in the past month, being currently employed and not having a prison history.
CONCLUSIONS: This study suggested that system-level factors and observable indicators of social functioning were more strongly associated with the receipt of less supervised treatment. Future research should examine this issue using prospectively collected data.

PMID: 25015687 [PubMed - as supplied by publisher]

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A Population Pharmacokinetic and Pharmacodynamic Modelling Approach to Support the Clinical Development of RBP-6000, a New, Subcutaneously Injectable, Long-Acting, Sustained-Release Formulation of Buprenorphine, for the Treatment of Opioid Dependence.

Buprenorphine Research (PubMed) - Sun, 07/13/2014 - 7:00am

A Population Pharmacokinetic and Pharmacodynamic Modelling Approach to Support the Clinical Development of RBP-6000, a New, Subcutaneously Injectable, Long-Acting, Sustained-Release Formulation of Buprenorphine, for the Treatment of Opioid Dependence.

Clin Pharmacokinet. 2014 Jul 12;

Authors: Nasser AF, Heidbreder C, Gomeni R, Fudala PJ, Zheng B, Greenwald MK

Abstract
BACKGROUND AND OBJECTIVES: This study implemented pharmacokinetic/pharmacodynamic modelling to support the clinical development of RBP-6000, a new, long-acting, sustained-release formulation of buprenorphine for the treatment of opioid dependence. Such a formulation could offer advantages over existing buprenorphine pharmacotherapy by improving patient compliance and reducing the diversion of the product.
METHODS: A population pharmacokinetic model was developed using 36 opioid-dependent subjects who received single subcutaneous doses of RBP-6000. Another pharmacokinetic/pharmacodynamic model was developed using μ-opioid receptor occupancy (µORO) data to predict efficacy of RBP-6000 after repeated doses. It was also assessed how buprenorphine plasma concentrations were correlated with opioid withdrawal symptoms and hydromorphone agonist blockade data from 15 heroin-dependent subjects.
RESULTS: The resulting pharmacokinetic model accurately described buprenorphine and norbuprenorphine plasma concentrations. A saturable maximum effect (E max) model with 0.67 ng/mL effective concentration at 50 % of maximum (EC50) and 91 % E max best described µORO versus buprenorphine plasma concentrations. Linear relationships were found among µORO, withdrawal symptoms and blockade of agonist effects.
CONCLUSION: Previously published findings have demonstrated µORO ≥70 % is needed to achieve withdrawal suppression and blockade of opioid agonist subjective effects. Model simulations indicated that a 200 mg RBP-6000 dose should achieve 2-3 ng/mL buprenorphine average concentrations and desired efficacy.

PMID: 25015174 [PubMed - as supplied by publisher]

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Hepatotoxicity in a 52-week randomized trial of short-term versus long-term treatment with buprenorphine/naloxone in HIV-negative injection opioid users in China and Thailand.

Buprenorphine Research (PubMed) - Tue, 07/08/2014 - 8:00am

Hepatotoxicity in a 52-week randomized trial of short-term versus long-term treatment with buprenorphine/naloxone in HIV-negative injection opioid users in China and Thailand.

Drug Alcohol Depend. 2014 Jun 19;

Authors: Lucas GM, Young A, Donnell D, Richardson P, Aramrattana A, Shao Y, Ruan Y, Liu W, Fu L, Ma J, Celentano DD, Metzger D, Jackson JB, Burns D

Abstract
BACKGROUND: Buprenorphine/naloxone (BUP/NX), an effective treatment for opioid dependence, has been implicated in hepatic toxicity. However, as persons taking BUP/NX have multiple hepatic risk factors, comparative data are needed to quantify the risk of hepatoxicity with BUP/NX.
METHODS: We compared rates of alanine aminotransferase (ALT) elevation≥grade 3 (ALT≥5.1 times the upper limit of normal) and graded bilirubin elevations in HIV-negative opioid injectors randomized to long-term (52 weeks) or short-term (18 days) medication assisted treatment (LT-MAT and ST-MAT, respectively) with BUP/NX in a multisite trial conducted in China and Thailand. ALT and bilirubin were measured at baseline, 12, 26, 40 and 52 weeks, times temporally remote from BUP/NX exposure in the ST-MAT participants.
RESULTS: Among1036 subjects with at least one laboratory follow-up measurement, 76 (7%) participants experienced ALT elevation≥grade 3. In an intent-to-treat analysis, the risk of ALT events was similar in participants randomized to LT-MAT compared with ST-MAT (adjusted hazard ratio 1.25, 95% confidence interval 0.79 to 1.98). This finding was supported by an as-treated analysis, in which actual exposure to BUP/NX was considered. Hepatitis C seroconversion during follow-up was strongly associated with ALT events. Bilirubin elevations≥grade 2 occurred in 2% of subjects, with no significant difference between arms.
CONCLUSIONS: Over 52-week follow-up, the risk of hepatotoxicity was similar in opioid injectors receiving brief and prolonged treatment with BUP/NX. These data suggest that most hepatotoxic events observed during treatment with BUP/NX are due to other factors.

PMID: 24999060 [PubMed - as supplied by publisher]

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Comments on "Medical Outcomes Associated with Nonmedical Use of Methadone and Buprenorphine"

Buprenorphine Research (PubMed) - Tue, 07/08/2014 - 8:00am

Comments on "Medical Outcomes Associated with Nonmedical Use of Methadone and Buprenorphine"

J Emerg Med. 2014 Jul 3;

Authors: Connors NJ, Hoffman RS

PMID: 24998500 [PubMed - as supplied by publisher]

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Opioid substitution treatment in New Zealand: a 40 year perspective.

Buprenorphine Research (PubMed) - Mon, 07/07/2014 - 6:00am

Opioid substitution treatment in New Zealand: a 40 year perspective.

N Z Med J. 2014;127(1397):57-66

Authors: Deering D, Sellman JD, Adamson S

Abstract
We provide an overview of the history and philosophy of the treatment for opioid dependence, which has been dominated by methadone substitution treatment for the past 40 years in New Zealand. Although changes in approach have occurred over this time, influenced by various sociopolitical events and changing ideologies, opioid substitution treatment has still "not come of age". It remains undermined by stigma and risk concerns associated with methadone and has struggled to be accessible and attractive to illicit opioid drug users, comprehensive and integrated into mainstream health care. However, the introduction in 2012 of Pharmac-subsidised buprenorphine combined with naloxone (Suboxone) in the context of an emerging trend towards a broader recovery and well-being orientation could signal a new era in treatment. The availability of buprenorphine-naloxone may also facilitate a further shift in treatment from primarily siloed specialist addiction services to integrated primary care services. This shift will help reduce stigma, promote patient self-management and community integration and align opioid substitution treatment with treatment for other chronic health conditions such as diabetes and asthma.

PMID: 24997702 [PubMed - as supplied by publisher]

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Sublingual Buprenorphine as an Analgesic in Chronic Pain: A Systematic Review.

Buprenorphine Research (PubMed) - Sun, 07/06/2014 - 8:00am
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Sublingual Buprenorphine as an Analgesic in Chronic Pain: A Systematic Review.

Pain Med. 2014 Jul 4;

Authors: Cote J, Montgomery L

Abstract
OBJECTIVE: There is growing interest in the use of sublingual buprenorphine for the treatment of chronic pain due to the unique pharmacology of buprenorphine, widespread use of the transdermal buprenorphine patch for chronic pain, and recent availability of sublingual buprenorphine tablets for the treatment of opioid dependence. The aim of this systematic review was to evaluate the evidence from clinical trials that have assessed the effectiveness of sublingual buprenorphine for chronic pain analgesia.
METHODS: Electronic searches of MEDLINE, Embase, CINAHL, Web of Science, and the Cochrane Database of Systematic Reviews were used to identify clinical trials of sublingual buprenorphine for the treatment of chronic pain.
RESULTS: Ten trials involving 1,190 patients were included in the review. Due to heterogeneity of studies, pooling of the results and meta-analysis were not possible. All studies reported that sublingual buprenorphine demonstrated some effectiveness as a chronic pain analgesic. The majority of studies were observational and of low quality.
CONCLUSIONS: Preliminary trials suggest a plausible role; however, due to a paucity of high-quality trials, the current evidence is insufficient to determine the effectiveness of sublingual buprenorphine for the treatment of chronic pain. Rigorous further trials are warranted.

PMID: 24995716 [PubMed - as supplied by publisher]

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Clinical factors associated with sexual dysfunction among men in methadone maintenance treatment and buprenorphine maintenance treatment: a meta-analysis study.

Buprenorphine Research (PubMed) - Sun, 07/06/2014 - 8:00am
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Clinical factors associated with sexual dysfunction among men in methadone maintenance treatment and buprenorphine maintenance treatment: a meta-analysis study.

Int J Impot Res. 2014 Jul 3;

Authors: Yee A, Loh HS, Hisham Hashim HM, Ng CG

Abstract
Methadone maintenance treatment is proven to be effective treatment for opioid dependence. Of the many adverse events reported, sexual dysfunction is one of the most common side effects. However, there may be other clinical factors that are associated with sexual dysfunction among methadone users. We conducted a meta-analysis to examine the clinical factors associated with sexual dysfunction among male patients on methadone and buprenorphine treatments, of which eligible studies were selected using prior defined criteria. A total of 2619 participants from 16 eligible studies, published from inception till December 2012, were identified from the PubMed, OVID and EMBASE databases. The included studies provided prevalence estimates for sexual dysfunction among methadone users with a meta-analytical pooled prevalence of 52% (95% confidence interval (CI), 0.39-0.65). Only four studies compared sexual dysfunction between the two groups, with a significantly higher combined odds ratio in the methadone group (odds ratio=4.01, 95% CI, 1.52-10.55, P=0.0049). Our study shows that eight clinical factors are associated with sexual dysfunction among men receiving opioid substitution treatment, namely age, hormone assays, duration of treatment, methadone dose, medical status, psychiatric illness, other current substance use and familial status, and methadone versus buprenorphine treatment. Despite the methodological limitations, the findings of this meta-analysis study may offer better insights to clinicians in dealing with both sexual dysfunction and its related problems.International Journal of Impotence Research advance online publication, 3 July 2014; doi:10.1038/ijir.2014.18.

PMID: 24990199 [PubMed - as supplied by publisher]

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[Injectable extended-release naltrexone for the prevention of relapse to opioid dependence following opioid detoxification.]

Buprenorphine Research (PubMed) - Sun, 07/06/2014 - 8:00am
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[Injectable extended-release naltrexone for the prevention of relapse to opioid dependence following opioid detoxification.]

Zh Nevrol Psikhiatr Im S S Korsakova. 2014;114(5 Vypusk 2 Addiktivnye rasstroistva):64-72

Authors: Krupitskiĭ EM

Abstract
Opioid dependence is a growing, worldwide public health concern. In contrast to opioid ?-agonist (or 'substitution') maintenance treatments, injectable extendedrelease naltrexone (XR-NTX), approved in the USA and Russia, is an opioid antagonist, formulated to address nonadherence, which limits the utility of oral naltrexone for opioid dependence. This article reviews the clinical trial data underlying the approval of XR-NTX for opioid dependence and the agent's clinical use. XR-NTX met all primary and secondary end points in a multicenter, placebo-controlled trial (n=250) conducted in Russia, with two discontinuations in each group because of adverse events. Cost-effectiveness analysis of claims data found that 6-month total healthcare costs following XR-NTX (US$8582 per patient) were not significantly different from oral naltrexone (US$8903; p=0.867) or buprenorphine (US$10,049; p=0.414), and were 49% lower than with methadone (US$16,752; p<0.0001). Future research should address induction and duration of treatment with XR-NTX.

PMID: 24988978 [PubMed - as supplied by publisher]

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Perioperative management of a patient undergoing Clagett window closure stabilized on Suboxone(®) for chronic pain: a case report.

Buprenorphine Research (PubMed) - Sun, 07/06/2014 - 8:00am
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Perioperative management of a patient undergoing Clagett window closure stabilized on Suboxone(®) for chronic pain: a case report.

Can J Anaesth. 2014 Jul 2;

Authors: Huang A, Katznelson R, de Perrot M, Clarke H

Abstract
PURPOSE: Buprenorphine is a semisynthetic opioid with both agonist and antagonist activity at the opioid receptor. Currently, buprenorphine is commonly available in sublingual preparations combined with naloxone (e.g., Suboxone(®), Subutex(®)). There has been increased use of buprenorphine derivatives in the areas of substance addiction and chronic pain. Nevertheless, there is limited and conflicting information in the literature pertaining to the optimal management of buprenorphine-stabilized patients presenting for surgery. We present our experience with a chronic pain patient on buprenorphine presenting for thoracic surgery.
CLINICAL FEATURES: A 47-yr-old female with a history of a Clagett window procedure for pulmonary aspergillosis and subsequent chronic pain presented to our institute for a window closure procedure. Preoperatively, her pain regimen included Suboxone 16 mg bid, which was continued perioperatively. Postoperatively, her course was complicated by suboptimal pain at the surgical site requiring in excess of 70 mg/24 hr of intravenous hydromorphone. Liberal addition of long-acting oral opioids was ineffective in improving pain management. Eventually, concern was raised regarding opioid receptor blockade by her long-acting Suboxone, and the decision was made to taper her Suboxone. Following this, her pain control improved dramatically and her opioid requirements were markedly reduced. By discharge, her Suboxone was discontinued and she was managed on oral hydromorphone.
CONCLUSION: In a chronic pain patient continued on Suboxone perioperatively, significant improvement in control of postoperative pain was observed following tapered doses, and eventually her use of Suboxone was discontinued. This case highlights the potential for opioid receptor blockade by Suboxone, which can interfere with acute pain management.

PMID: 24985936 [PubMed - as supplied by publisher]

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Factors contributing to the rise of buprenorphine misuse: 2008-2013.

Buprenorphine Research (PubMed) - Sun, 07/06/2014 - 8:00am
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Factors contributing to the rise of buprenorphine misuse: 2008-2013.

Drug Alcohol Depend. 2014 Jun 18;

Authors: Cicero TJ, Ellis MS, Surratt HL, Kurtz SP

Abstract
OBJECTIVE: The purpose of the present study was to examine the motivations underlying the use of buprenorphine outside of therapeutic channels and the factors that might account for the reported rapid increase in buprenorphine misuse in recent years.
METHODS: This study used: (1) a mixed methods approach consisting of a structured, self-administered survey (N=10,568) and reflexive, qualitative interviews (N=208) among patients entering substance abuse treatment programs for opioid dependence across the country, centered on opioid misuse patterns and related behaviors; and (2) interviews with 30 law enforcement agencies nationwide about primary diverted drugs in their jurisdictions.
RESULTS: Our results demonstrate that the misuse of buprenorphine has increased substantially in the last 5 years, particularly amongst past month heroin users. Our quantitative and qualitative data suggest that the recent increases in buprenorphine misuse are due primarily to the fact that it serves a variety of functions for the opioid-abusing population: to get high, manage withdrawal sickness, as a substitute for more preferred drugs, to treat pain, manage psychiatric issues and as a self-directed effort to wean themselves off opioids.
CONCLUSION: The non-therapeutic use of buprenorphinehas risen dramatically in the past five years, particularly in those who also use heroin. However, it appears that buprenorphine is rarely preferred for its inherent euphorigenic properties, but rather serves as a substitute for other drugs, particularly heroin, or as a drug used, preferable to methadone, to self-medicate withdrawal sickness or wean off opioids.

PMID: 24984689 [PubMed - as supplied by publisher]

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