Showing posts with label Substance Abuse. Show all posts
Showing posts with label Substance Abuse. Show all posts

November 6, 2014

Maintenance Opioid Agonists Protect Against HCV in Injection Drug Users

Judith I. Tsui, MD, MPH1,2; Jennifer L. Evans, MS3; Paula J. Lum, MD, MPH4; Judith A. Hahn, PhD3,4; Kimberly Page, PhD, MPH5

[+-] Author Affiliations

1Clinical Addiction Research and Education Unit, Section of General Internal Medicine, Department of Medicine, Boston University School of Medicine, Boston, Massachusetts
2Department of Medicine, Boston Medical Center, Boston, Massachusetts
3Department of Epidemiology and Biostatistics, University of California, San Francisco
4Department of Medicine, University of California, San Francisco
5Division of Epidemiology, Biostatistics and Preventive Medicine, Department of Internal Medicine, University of New Mexico Health Sciences Center, Albuquerque

JAMA Intern Med. Published online October 27, 2014. doi:10.1001/jamainternmed.2014.5416

Abstract

Importance Injection drug use is the primary mode of transmission for hepatitis C virus (HCV) infection. Prior studies suggest opioid agonist therapy may reduce the incidence of HCV infection among injection drug users; however, little is known about the effects of this therapy in younger users.

Objective To evaluate whether opioid agonist therapy was associated with a lower incidence of HCV infection in a cohort of young adult injection drug users.

Design, Setting, and Participants Observational cohort study conducted from January 3, 2000, through August 21, 2013, with quarterly interviews and blood sampling. We recruited young adult (younger than 30 years) injection drug users who were negative for anti-HCV antibody and/or HCV RNA.

Exposures Substance use treatment within the past 3 months, including non–opioid agonist forms of treatment, opioid agonist (methadone hydrochloride or buprenorphine hydrochloride) detoxification or maintenance therapy, or no treatment.

Main Outcomes and Measures Incident HCV infection documented with a new positive result for HCV RNA and/or HCV antibodies. Cumulative incidence rates (95% CI) of HCV infection were calculated assuming a Poisson distribution. Cox proportional hazards regression models were fit adjusting for age, sex, race, years of injection drug use, homelessness, and incarceration.

Results Baseline characteristics of the sample (n = 552) included median age of 23 (interquartile range, 20-26) years; 31.9% female; 73.1% white; 39.7% who did not graduate from high school; and 69.2% who were homeless. During the observation period of 680 person-years, 171 incident cases of HCV infection occurred (incidence rate, 25.1 [95% CI, 21.6-29.2] per 100 person-years). The rate ratio was significantly lower for participants who reported recent maintenance opioid agonist therapy (0.31 [95% CI, 0.14-0.65]; P = .001) but not for those who reported recent non–opioid agonist forms of treatment (0.63 [95% CI, 0.37-1.08]; P = .09) or opioid agonist detoxification (1.45 [95% CI, 0.80-2.69]; P = .23). After adjustment for other covariates, maintenance opioid agonist therapy was associated with lower relative hazards for acquiring HCV infection over time (adjusted hazard ratio, 0.39 [95% CI, 0.18-0.87]; P = .02).

Conclusions and Relevance In this cohort of young adult injection drug users, recent maintenance opioid agonist therapy was associated with a lower incidence of HCV infection. Maintenance treatment with methadone or buprenorphine for opioid use disorders may be an important strategy to prevent the spread of HCV infection among young injection drug users.

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December 18, 2013

Characteristics and Impact of Methamphetamine Use in Patients With Chronic Hepatitis C

J Addict Med. 2013 Dec 13. [Epub ahead of print]

Riley DE, Liu L, Cohen B, Robinson S, Groessl EJ, Ho SB.

Abstract

OBJECTIVES:: Methamphetamine (MA) use has increased in the United States in the last 20 years and is a risk factor for hepatitis C virus(HCV) infection. The purpose of this study was to determine the characteristics and HCV infection outcomes of patients with a history of MA use.

METHODS:: Subjects consisted of newly entered patients in the Veterans Affairs (VA) HCV registry at a single VA medical center from January 1, 2004, to June 30, 2004, and from January 1, 2007, to June 30, 2007. Univariate and multivariate analyses related to HCV infection antiviral treatment outcomes through 2010 was performed.

RESULTS:: A total of 198 consecutive eligible HCV registry patients were analyzed, and 40% had a history of MA use. Of patients with MA use history, 46% (36/79) had active use (within 6 months) at initial contact. Active MA users were significantly younger (mean age, 45.5 years), with more concomitant drug use (86%), compared with patients without MA use (mean age, 53.5 years; 42% minority; 29% other drug use). Overall, 71% of the 198 patients reported a history of problematic alcohol use, and 47% of those reported active abuse. Logistic regression analyses indicated that MA use did not significantly adversely affect antiviral treatment initiation, completion, or sustained virological response rates compared with that in patients without MA use. Active alcohol users had lower treatment initiation than patients without alcohol use.

CONCLUSIONS:: MA use is common in recent US veterans with HCV infection and occurs in younger patients with polysubstance use. Prior history or active MA use does not seem to adversely affect HCV infection clinic treatment compared with that in HCV-infected patients without MA use.

PMID: 24343127 [PubMed - as supplied by publisher]

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November 22, 2013

Hepatitis C, mental health and equity of access to antiviral therapy: a systematic narrative review

International Journal for Equity in Health 2013, 12:92  doi:10.1186/1475-9276-12-92

Research

Julie Hepworth, Tanya Bain and Mieke van Driel

Author Affiliations

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Published: 18 November 2013

Abstract (provisional)

Introduction

Access to hepatitis C (hereafter HCV) antiviral therapy has commonly excluded populations with mental health and substance use disorders because they were considered as having contraindications to treatment, particularly due to the neuropsychiatric effects of interferon that can occur in some patients. In this review we examined access to HCV interferon antiviral therapy by populations with mental health and substance use problems to identify the evidence and reasons for exclusion.

Methods

We searched the following major electronic databases for relevant articles: PsycINFO, Medline, CINAHL, Scopus, Google Scholar. The inclusion criteria comprised studies of adults aged 18 years and older, peer-reviewed articles, date range of (2002--2012) to include articles since the introduction of pegylated interferon with ribarvirin, and English language. The exclusion criteria included articles about HCV populations with medical co-morbidities, such as hepatitis B (hereafter HBV) and human immunodeficiency virus (hereafter HIV), because the clinical treatment, pathways and psychosocial morbidity differ from populations with only HCV. We identified 182 articles, and of these 13 met the eligibility criteria. Using an approach of systematic narrative review we identified major themes in the literature.

Results

Three main themes were identified including: (1) pre-treatment and preparation for antiviral therapy, (2) adherence and treatment completion, and (3) clinical outcomes. Each of these themes was critically discussed in terms of access by patients with mental health and substance use co-morbidities demonstrating that current research evidence clearly demonstrates that people with HCV, mental health and substance use co-morbidities have similar clinical outcomes to those without these co-morbidities.

Conclusions

While research evidence is largely supportive of increased access to interferon by people with HCV, mental health and substance use co-morbidities, there is substantial further work required to translate evidence into clinical practice. Further to this, we conclude that a reconsideration of the appropriateness of the tertiary health service model of care for interferon management is required and exploration of the potential for increased HCV care in primary health care settings.

The complete article is available as a provisional PDF. The fully formatted PDF and HTML versions are in production.

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November 19, 2013

The Media Needs to Stop Stigmatizing Our Best Weapon Against Heroin Addiction

NOVEMBER 19, 2013

BY ALEC MACGILLIS @AlecMacGillis

Earlier this year, I followed Senator Joe Manchin to town hall meetings with constituents in southern West Virginia to see how voters were reacting to his role in pushing for expanded background checks for gun purchases. What I found, on the whole, was that voters weren’t that exercised about guns. What they wanted to talk about most of all was painkiller drug abuse, which has been wreaking havoc in Appalachia and many other parts of the country (prescription drug abuse is up 36 percent since 2002, according to the federal government, afflicting some 2.5 million Americans) and leading to a rise in heroin usage (doubling over the decade to more than 450,000 users) as authorities try to restrict access to prescription pills. One of the primary concerns the constituents raised with Manchin was the lack of options for opiate addicts seeking treatment. For one thing, they said, local residents had to drive a long ways to get access to buprenorphine.

Haven’t heard of buprenorphine? That means you’re happily sheltered from the hellscape of opiate addiction. But the drug, which goes by the commercial name Suboxone, has emerged over the past decade as the biggest development on the drug treatment front. Made by the British consumer goods company Reckitt Benckiser and approved by the FDA in 2002, the drug has proven remarkably effective as a “maintenance therapy” for opiate addicts. It allays cravings for painkillers or heroin while, crucially, being harder to get a high off of than methadone. That means it can be prescribed for use at home, with no need for traveling daily to a clinic, as addicts must do to legally obtain methadone.

Buprenorphine—bupe for short—has proven so successful at allowing opiate addicts to feel normal and go about their lives that advocates hail it as something of a wonder drug. And the benefits multiply—less painkiller and heroin abuse means less HIV transmission, less hepatitis C, and, yes, fewer fatal overdoses. Check out the recent trends in buprenorphine use and heroin overdoses in Baltimore, which has embraced bupe as a weapon against its deeply entrenched heroin problem. No, correlation does not equal causation—for one thing, Baltimore was over the same period also expanding the use of naloxone, medication used by drug users and EMTs to reverse overdoses as they’re occurring. Still, it’s hard not to draw certain conclusions from these lines displayed in a recent article in the American Journal of Public Health, which echo the plunge in overdoses in France, an early adopter of buprenorphine.

overdose-chart

So what’s not to like? Why are we not shipping us much buprenorphine as possible into small towns in Maine and eastern Oregon and eastern Kentucky and all the other places reporting surges in abuse of painkillers and now, increasingly, heroin? Well, partly because bupe has gotten stuck with its own stigma—not as strong as methadone's, but damaging nonetheless. My old newspaper, the Baltimore Sun, ran a very critical series on the drug shortly after I left the paper. My current employer, theNew Republic, chimed in not long ago with a piece about the troubles that the country of Georgia has had with a more powerful form of the drug called Subutex. And now, in by far the biggest p.r. blow of all, comes a massive two-day series in the New York Times that casts bupe in a deeply ambivalent light.

The reporter, Deborah Sontag, is to be commended for deep reporting on a realm of American life that is far too easily overlooked. She takes pains to present the complex picture that has emerged since the drug’s debut, with many accounts of opiate addicts who—using their real names, in a sign of remarkable candor—credit bupe with saving their lives, alongside accounts of the complications that have arisen with the spread of the drug, including Reckitt Benckiser’s questionable efforts to keep the market all for itself. But for all of the granular reporting, the overall tone and framing of the pieces is bluntly ominous: “Addiction Treatment With a Dark Side: In Demand in Clinics and on the Street, ‘Bupe’ Can Be a Savior or a Menace” was the headline of the first article; “At Clinics, Troubled Lives and Turbulent Care” was the headline of the second one.

The dark cast of the series, running in the nation’s paper of record, is surely going to make it even harder for buprenorphine to gain acceptance from doctors, regulators and the friends and families of addicts. “If you’re somebody that doesn’t like it already, it’s not going to make you like it. And if you do like it, you may have doubts now,” said Dr. Sharon Stancliff, medical director of the Harm Reduction Coalition in New York and a strong advocate of buprenorphine treatment. “Policy makers will say we need more restrictions, when the science says we need fewer restrictions.”

And that could well only exacerbate the complications described by the article, because so many of those problems grow out of the restrictions on addicts’ access to the drug. When the drug was approved, it came with strict limits—doctors needed to attend lengthy training sessions, they could prescribe to no more than 30 patients at a time, and they needed to provide counseling. The 30-person threshold was later raised to 100, but advocates say that it is still far too hard for many addicts to find prescriptions, not least because the regulations forbid prescriptions by physicians' assistants and nurse practitioners, who are the primary health care providers in many rural areas.

With so many physicians not wanting to go through the hassles of being approved to prescribe the drug—and the attendant hyper-scrutiny from the Drug Enforcement Agency—addicts have increasingly had to turn to the doctors who are less shy about milking the drug for its commercial potential. And not surprisingly, the lack of ready access to buprenorphine has resulted in some addicts buying and selling it on the street, a fact that both the Sun and Times series dwell on considerably.

But this street-selling is not necessarily as foreboding as it’s made to sound. Of course addicts are looking to get their hands on bupe by whatever means they can—it staves off the horror of opiate withdrawal and makes them feel normal. Yes, some addicts go to great lengths to abuse the drug to try to get a high off of it despite its pharmacological limitations, by injecting it or mixing it with other drugs. But this needs to be kept in perspective, too. The Times cites data showing 402 fatal overdoses linked to buprenorphine in the United States reported to the F.D.A. from spring 2003 through September. As the article notes, this pales in comparison with the 2,826 attributed to methadone over roughly the same period and the more than 19,000 fatal overdoses from opioids overall in 2010 alone.

The fact is, there is no silver bullet for the country’s growing opiate addiction problem. And any approach is going to seem tainted, to bourgeois eyes, by the inherently chaotic and desperate nature of the milieu in which opiate addiction is rooted (though not confined to—painkiller abuse has been on the rise in tony suburbs, too). It would be deeply unfortunate if fraught portrayals in the media with decidedly oversimplified, alarmist headlines had the side effect of dulling one of the best tools we have in this fight.

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September 2, 2013

Third International Symposium on Hepatitis Care in Substance Users, Munich, Germany

[Event Date: 2013-09-05]
[Expiry Date: 2013-09-05]

The Third International Symposium on Hepatitis Care in Substance Users (INHSU) will be held from 5 to 6 September 2013 in Munich, Germany.

Hepatitis C is caused by the virus (HCV) which is most prevalent among injecting drug users. This high-risk group acts as a virus reservoir and threatens to be responsible for the future burden of HCV-induced disease.

This event will bring together experts from various disciplines in health and social care. It will promote novel intervention strategies for hepatitis in substance users by taking a cross-sectional approach to pathogenic, diagnostic and therapeutic research.

For further information, please visit:
http://www.inhsu.com/about-inhsu.html

Category: Events
Data Source Provider: Arud Centres for Addiction Medicine
Document Reference: Based on an event announcement
Subject Index: Healthcare delivery/services; Medicine, Health

RCN: 35995

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June 22, 2013

Meds to Treat Addiction Often Hard to Get

By David Pittman, Washington Correspondent, MedPage Today

Published: June 20, 2013

WASHINGTON -- Medicaid programs and health insurance companies are hindering access to FDA-approved drugs that treat opioid addiction, according to a report released Thursday by the American Society of Addiction Medicine (ASAM).

The 216-page report -- called the "most comprehensive" on addiction medications to date -- showed wide variation in state coverage of opioid addiction medications, with many Medicaid programs requiring other treatments to fail before covering addiction drugs.

Furthermore, private insurance companies use techniques like prior authorization to restrict access to drugs like buprenorphine (Probuphine), methadone, and naltrexone (Vivitrol), the Chevy Chase, Md. group said.

The restrictions come at a time when the CDC has declared prescription opioid abuse and addiction an epidemic, with nearly 4 million Americans addicted to prescription opioids.

"We have effective ways of treating these devastating illnesses," Tom McLellan, PhD, chief executive and founder of the Treatment Research Institute -- the organization that conducted the study -- said at a press conference here. "Let's start using them."

A little more than half of state Medicaid programs (28) cover all three drugs, the report found. "However, it is important to note that the extent of coverage varies greatly among the states, and access requirements attached to any or all of these medications differ from one state to another," the authors wrote.

For example, prior authorization is required by Medicaid in 42 states for buprenorphine. Coverage limits for lifetime benefits and daily doses are also common.

The study of private insurance carriers found similar barriers in their health plans, with spotty coverage of products such as buprenorphine/naloxone (Suboxone) and injectable naltrexone.

The report shows that "we could be saving lives and effectively treating the disease of addiction if state governments and insurance companies remove roadblocks to the use of these medications," ASAM president Stuart Gitlow said at the press conference.

Removing those roadblocks, however, may be difficult for states and health plans.

Congressional limits exist on the number of patients physicians can prescribe to at once. "I have 100, and I have a waiting list of 270," Gitlow said. "I'm not coming anywhere near meeting the need, and those patients have nowhere else to go because the only other docs prescribing are full."

Also, prescribers also need a special Drug Enforcement Administration waiver created by the Drug Addiction Treatment Act of 2000 to prescribe certain opioid addiction drugs.

The FDA subjects buprenorphine-containing products to a rigorous risk evaluation and mitigation strategy (REMS) with several elements to assure safe use, including patient monitoring and prescriber certification programs. The agency has deemed the risk-benefit profile of such products unfavorable enough to try to restrict their access.

The report also examined studies that evaluated buprenorphine, methadone, injectable naltrexone, and oral naltrexone and concluded a benefit in patient outcomes as well as costs.

"I can say with no hint of opinion here, it's simple fact, they are all effective," McLellan said. "They're effective not just in reducing opioid use, they're effective in so many other ways that are important to societies and families."

He called these medications "underutilized," saying about 30% of treatment programs use such drugs and about half of the patients in those programs receive such medication.

Gitlow and McLellan called on growing a coalition of interested parties, including the various addiction medicine groups, to raise awareness on the issue and educate the public and policymakers about their needs.

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May 26, 2013

A novel program for treating patients with trimorbidity: hepatitis C, serious mental illness, and active substance use

Sockalingam S,et al. Show all

Sockalingam S, Blank D, Banga CA, Mason K, Dodd Z, Powis J.

Journal

Eur J Gastroenterol Hepatol. 2013 May 15. [Epub ahead of print]

Affiliation

aMedical Psychiatry Program, University Health Network, Toronto General Hospital Departments of bPsychiatry cPsychology dMedicine, University of Toronto eSouth Riverdale Community Health Centre fToronto East General Hospital, Toronto, Ontario, Canada.

Abstract

BACKGROUND: Advances in hepatitis C virus (HCV) treatment have yielded improved virological response rates, and yet, many individuals with psychiatric illness still fail to receive HCV therapy. Concerns about safety, adherence, and efficacy of HCV treatment are compounded and treatment is further deferred when substance use is also present. This is especially problematic given the disproportionately high rates of both mental health issues and substance use among individuals living with HCV.

OBJECTIVE: This study sought to examine HCV treatment outcomes in clients with serious mental illness (SMI) and with high rates of active substance use who were participating in a community-based HCV treatment program.

PATIENTS AND METHODS: A retrospective chart review of 129 clients was carried out. Patients were classified as having an SMI if they had a history of bipolar disorder, psychotic disorder, past suicide attempt or mental health related hospitalization.

RESULTS: Fifty-one patients were defined as having an SMI. Among the 46 patients with SMI and a detectable HCV viral load, HCV antiviral therapy was initiated in nine (19.6%). A relapse or an increase in substance use was common (77.8% or n=7), as was the requirement for adjustment or initiation of psychotropic medications (66.7% or n=6) during HCV antiviral therapy. Despite these barriers, rates of adherence to antiviral therapy were high and overall sustained virological response rates were comparable with published trials.

CONCLUSION: This study is the first to report HCV treatment outcomes in a population in which SMI and active polysubstance use was prevalent and suggests that with appropriate models of care, clients with trimorbidity can be treated safely and effectively.

PMID
23680911 [PubMed - as supplied by publisher]

Full text: Lippincott Williams & Wilkins

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January 9, 2013

FDA issues draft guidance on abuse-deterrent opioids

FDA NEWS RELEASE

For Immediate Release: Jan. 9, 2013
Media Inquiries: Morgan Liscinsky, 301-796-0397; morgan.liscinsky@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

The U.S. Food and Drug Administration today issued a draft guidance document to assist industry in developing new formulations of opioid drugs with abuse-deterrent properties.

The document “Guidance for Industry: Abuse-Deterrent Opioids – Evaluation and Labeling,” explains the FDA’s current thinking about the studies that should be conducted to demonstrate that a given formulation has abuse-deterrent properties, how those studies will be evaluated by the agency, and what labeling claims may be approved based on the results of those studies.

“The FDA is extremely concerned about the inappropriate use of prescription opioids, which is a major public health challenge for our nation,” said FDA Commissioner Margaret A. Hamburg, M.D. “This draft guidance is an important part of a larger effort by FDA aimed at preventing prescription drug abuse and misuse.”

Opioids can be abused in a number of ways. Abuse-deterrent formulations target the known or expected routes of abuse, such as crushing in order to snort or dissolving in order to inject, for the specific opioid drug substance in that formulation. The science of abuse deterrence is relatively new, and both the formulation technologies and the analytical, clinical, and statistical methods for evaluating those technologies are rapidly evolving. In working with industry, the FDA will take a flexible, adaptive approach to the evaluation and labeling of potentially abuse-deterrent products.

“While prescription opioids are an important component of pain management, abuse and misuse of these products have resulted in too many injuries and deaths across the United States,” said Douglas Throckmorton, M.D., deputy director for regulatory programs in the FDA’s Center for Drug Evaluation and Research. “An important step towards the goal of creating safer opioids is the development of products that are specifically formulated to deter abuse.”

The FDA continues to encourage the development of abuse-deterrent formulations of opioids and believes that these products have promise to help reduce prescription drug abuse. At the same time, the FDA remains committed to ensuring that patients with pain have appropriate access to opioid analgesics.

This draft guidance fulfills mandates under the Food and Drug Administration Safety and Innovation Act (FDASIA) and the Office of National Drug Control Policy’s (ONDCP) Prescription Drug Abuse Prevention Plan.

“Our nation is in the midst of a prescription drug abuse epidemic,” said Gil Kerlikowske, director of National Drug Control Policy. “While there are no silver bullet solutions to this public health and safety challenge, abuse-deterrent formulations of powerful prescription opioids can make a difference in addressing this epidemic. This guidance is a vitalcomponent of the Administration’s comprehensive effort to reduce prescription drug abuse in America, and we commend the FDA for its commitment to this challenge.”

FDA is seeking public comment on the draft guidance for 60 days and encourages additional scientific and clinical research that will advance the development and assessment of abuse-deterrent technologies. Instructions on how to submit comments will be announced in an upcoming Federal Register notice. The FDA will also hold a public meeting to discuss and receive feedback on the draft guidance. In finalizing the guidance document, the agency will consider the information received from the public.

For more information:

FDA: Draft Guidance for Industry: Abuse-Deterrent Opioids – Evaluation and Labeling1

ONDCP: Prescription Drug Abuse2

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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