Author Interviews, CDC, JAMA, Opiods, Pharmacology / 16.10.2015

MedicalResearch.com Interview with: Beth Han, MD, PhD, MPH Substance Abuse and Mental Health Services Administration U.S. Department of Health and Human Services Rockville, Maryland Medical Research: What is the background for this study? What are the main findings? Dr. Han: Since 1999, the United States has experienced increases in negative consequences and deaths associated with nonmedical use of prescription opioids. During this period, emergency department visits and drug overdose deaths involving these drugs have increased rapidly. To fully understand the current status of this public health crisis and who is currently most affected, we conducted this study based on nationally representative U.S. surveillance data. Our main study findings include:
  • Among adults age 18 through 64 years, the prevalence of nonmedical use of prescription opioids decreased from 5.4 percent in 2003 to 4.9 percent in 2013, but the prevalence of prescription opioid use disorders increased from 0.6 percent in 2003 to 0.9 percent in 2013. The 12-month prevalence of high-frequency use (200 days or more) also increased from 0.3 percent in 2003 to 0.4 percent in 2013.
  • Mortality assessed by drug overdose death rates involving prescription opioids increased from 4.5 per 100,000 in 2003 to 7.8 per 100,000 in 2013. The average number of days of nonmedical use of prescription opioids increased from 2.1 in 2003 to 2.6 in 2013. The prevalence of having prescription opioid use disorders among nonmedical users increased to 15.7 percent in 2010, 16.1 percent in 2011, 17 percent in 2012, and 16.9 percent in 2013, from 12.7 percent in 2003.
(more…)
Author Interviews, Opiods, Pediatrics, Pharmacology / 29.09.2015

Shannon M. Monnat, PhD Assistant Professor of Rural Sociology, Demography, and Sociology Department of Agricultural Economics, Sociology, and Education The Pennsylvania State University University Park, PA 16802MedicalResearch.com Interview with: Shannon M. Monnat, PhD Assistant Professor of Rural Sociology, Demography, and Sociology Department of Agricultural Economics, Sociology, and Education The Pennsylvania State University University Park, PA 16802  Medical Research: What is the background for this study? What are the main findings? Dr. Monnat: Given concurrent rapid increases in opioid prescribing and adolescent prescription opioid misuse since the 1990s and historical problems with opioid abuse in rural areas, we were interested in whether adolescents in rural areas were more likely to abuse prescription opioids than their peers in urban areas. Adolescence is a really crucial time to study substance abuse disorders because most abuse begins during adolescence, and individuals who begin use before age 18 are more likely to develop a long-term disorder as an adult compared to those who first try a substance later in life. The active ingredient in prescription opioids and heroin is the same. Prescription opioids are highly addictive and can be dangerous if utilized incorrectly. Prescription opioid abuse is currently responsible for over 16,000 deaths in the US annually and has an estimated annual cost of nearly $56 billion dollars. Therefore, it is correctly viewed as a major public health problem. We found that teens living in rural areas are more likely to abuse prescription opioids compared to teens living in large urban areas. Several important factors increased rural teens’ risk of abusing prescription opioids, including that they are more likely to rely on emergency department treatment than their urban peers, they have less risky attitudes and perceptions about substance abuse than their urban peers, and they are less likely to be exposed to drug/alcohol prevention messages outside of the school environment than their urban peers. Rural teens are also buffered by several factors that help to reduce opioid abuse, including stronger religious beliefs, less depression, less peer substance abuse, and less access to illicit drugs. If not for these protective factors, the current epidemic we see in rural areas could be even worse. We also found that both rural and urban adolescents were most likely to report obtaining the prescriptions they abused from friends or family. However, rural adolescents were less likely than urban adolescents to obtain the pills this way. Rural adolescents were more likely than urban adolescents to report getting the pills they abuse directly from physicians.  (more…)
Author Interviews, Opiods, Pain Research / 10.09.2015

Lynn Webster, M.D. Vice President of Scientific Affairs PRA Health Sciences (lead study investigator, and former President of the American Academy of Pain Medicine) photo: WikipediaMedicalResearch.com Interview with: Lynn Webster, M.D. Vice President of Scientific Affairs PRA Health Sciences (lead study investigator, and former President of the American Academy of Pain Medicine) Medical Research: What is the background for this study? What are the main advantages of the buccal film? Dr. Webster: Because of its partial agonist activity and high affinity for mu-opioid receptors, buprenorphine has the potential to precipitate withdrawal in patients who are already on mu-opioid full agonists.  As a result, the current practice is to taper patients who are on around-the-clock (ATC) opioid therapy to a morphine sulfate equivalent (MSE) dose before switching to buprenorphine.  But tapering can result in a loss of pain control for patients.  For this study, we wanted to determine if patients on around-the-clock opioid full agonist therapy could be safely transitioned to buprenorphine HCl buccal film – an opioid partial agonist administered through the buccal mucosa – without the need for an opioid taper, and without inducing opioid withdrawal or sacrificing pain control.  Buprenorphine HCl buccal film is the first pain product in development to combine the efficacy of buprenorphine with this unique delivery system, which allows for efficient and convenient delivery of buprenorphine into the bloodstream. (more…)
Author Interviews, JAMA, Opiods, Pharmacology / 21.08.2015

Lainie Rutkow, JD, PhD, MPH Associate Professor Department of Health Policy and Management Johns Hopkins Bloomberg School of Public HealMedicalResearch.com Interview with: Lainie Rutkow, JD, PhD, MPH Associate Professor Department of Health Policy and Management Johns Hopkins Bloomberg School of Public Health  Medical Research: What is the background for this study? What are the main findings? Dr. Rutkow: Rates of prescription drug diversion and misuse, as well as overdose deaths, have increased throughout the United States. CDC estimates that each day, 44 people die from a prescription drug overdose. In the mid-2000s, Florida was viewed as the epicenter of this epidemic, with prescription drug overdose deaths increasing more than 80% from 2003 to 2009. In response, Florida enacted several laws to mitigate prescription drug abuse and diversion. Its pill mill law required pain management clinics to register with the state and prohibited physician dispensing of certain drugs. Florida’s Prescription Drug Monitoring Program (PDMP) collects data about dispensing of prescription drugs and can be accessed by physicians and pharmacists. Little is known about how these laws have affected prescribing of opioids. We applied comparative interrupted time series analyses to pharmacy claims data to examine four outcomes related to opioid prescribing in Florida, with Georgia as a comparison state. We found that in the first year of implementation, Florida’s Prescription Drug Monitoring Program and pill mill law were associated with modest reductions in prescription opioid volume, prescriptions written, and the dose per prescription. These declines were statistically significant among the highest volume prescribers and patients at baseline. (more…)
Author Interviews, Emergency Care, FDA, Opiods, Pharmacology / 15.07.2015

MedicalResearch.com Interview with: Christopher M. Jones, Pharm D., M.P.H Senior advisor, Office of Public Health Strategy and Analysis Office of the Commissioner, Food and Drug Administration Medical Research: What is the background for this study? Dr. Jones: Opioid analgesics and benzodiazepines are the two most common drug classes involved in prescription drug overdose deaths. In 2010, 75% of prescription drug overdose deaths involved opioid analgesics and 29% involved benzodiazepines. Opioid analgesics and benzodiazepines are also the most common drugs associated with emergency department visits due to nonmedical use of prescription drugs. Combined opioid and benzodiazepine use has been suggested as a risk factor for overdose death. Opioids and benzodiazepines have complex drug interactions and in combination can result in synergistic respiratory depression, but the exact mechanisms by which benzodiazepines worsen opioid-related respiratory depression are not fully understood. Widespread co-use of benzodiazepines and opioids has been documented in both chronic pain and addiction treatment settings. Studies suggest that among patients who receive long-term opioids for chronic non-cancer pain, 40% or more also use benzodiazepines. Among patients who abuse opioids, benzodiazepine abuse also is prevalent, and co-users report using benzodiazepines to enhance opioid intoxication. This study builds on the prior literature by analyzing trends on how the combined use of opioids and benzodiazepines in the U.S. contributes to the serious adverse outcomes of nonmedical use–related ED visits and drug overdose deaths. A better understanding of the consequences of co-use of these medications will help identify at-risk populations, inform prevention efforts, and improve the risk–benefit balance of these medications. Medical Research: What are the main findings? Dr. Jones: From 2004 to 2011, the rate of nonmedical use–related Emergency Department visits involving both opioid analgesics and benzodiazepines increased from 11.0 to 34.2 per 100,000 population. During the same period, drug overdose deaths involving both drugs increased from 0.6 to 1.7 per 100,000. Statistically significant increases in Emergency Department visits occurred among males and females, non-Hispanic whites, non-Hispanic blacks, and Hispanics, and all age groups except 12–17-year-olds. For overdose deaths, statistically significant increases were seen in males and female, all three race/ethnicity groups, and all age groups except 12–17-year-olds. Benzodiazepine involvement in opioid analgesic overdose deaths increased each year, increasing from 18% of opioid analgesic overdose deaths in 2004 to 31% in 2011. (more…)
Author Interviews, Mayo Clinic, Opiods, Tobacco Research / 10.07.2015

W. Michael Hooten, M.D Professor of Anesthesiology Mayo ClinicMedicalResearch.com Interview with: W. Michael Hooten, M.D Professor of Anesthesiology Mayo Clinic Medical Research: What is the background for this study? Dr. Hooten: The purpose of the study was to investigate a gap in knowledge related to the progression of short-term opioid use to longer-term use. Medical Research: What are the main findings? Dr. Hooten: The main findings are that a history of substance abuse or tobacco use is associated with the progression from short-term to a longer-term pattern of opioid prescribing. (more…)
Author Interviews, Neurological Disorders, NYU, Opiods, Pain Research, Pharmacology / 25.06.2015

Dr. Mia T. Minen, MD, MPH Director, Headache Services at NYU Langone Medical Center Assistant professor, Department of Neurology MedicalResearch.com Interview with: Dr. Mia T. Minen, MD, MPH Director, Headache Services NYU Langone Medical Center Assistant professor, Department of Neurology   Medical Research: What is the background for this study? What are the main findings? Dr. Minen: We conducted a survey on opioid and barbiturate use among patients visiting a headache center to find out which medications they were receiving for treatment. There’s limited evidence that long-term use of these medications can help treat headaches or migraines, and even short-term use in small quantities can cause medication overuse headache. It is important to determine which providers start these medications so that educational interventions can be tailored to these physician specialties to try to prevent situations such as incorrect prescribing practices and medication overuse. In this sample of patients from a specialty headache center, approximately 20 percent of patients -- or 1 in 5 -- were using opioids or barbiturates, and about half had been prescribed these medications at some point in the past for their headaches. These findings show that opioids and barbiturates are commonly prescribed to patients with headaches. While two-thirds of patients found opioids or barbiturates helpful, many did not like them, were limited by side effects or did not find them to be helpful. Emergency department physicians were reported to be the most frequent first prescribers of opioids and general neurologists were the most frequent prescribers of barbiturate-containing medications. Primary care physicians were also identified as frequent first prescribers of these medications. (more…)
Author Interviews, Opiods, Orthopedics, Pain Research, Surgical Research / 02.06.2015

MedicalResearch.com Interview with: Winfried Meissner, M.D. Dep. of Anesthesiology and Intensive Care Jena University Hospital University Hospital Jena, Germany Medical Research: What is the background for this study? Dr. Meissner: Post-operative pain is managed inadequately worldwide. There are probably many reasons for this, one of which may be lack of evidence about outcomes of treatment in the clinical routine. PAIN OUT was established  as a  multi-national research network and quality improvement project offering healthcare providers  validated tools to collect data about pain-related patient reported outcomes and management after surgery. Patients fill in a questionnaire asking for pain intensity, pain interference and side effects of pain management. The questionnaire has now been translated into 20 languages. Data are collected electronically and clinicians are provided with feedback about management of their own patients, compared to similar patients in other hospitals.  Furthermore, the findings are used for outcomes and comparative effectiveness research. PAIN OUT is unique in that  outcomes of postoperative pain management can be examined internationally. PAIN OUT was created in 2009 with funds from the European Commission, within the FP7 framework and  has now been implemented in hospitals in Europe, USA, Africa and SE Asia. The findings allow us to gain insights as to how pain in managed in different settings and countries. For this particular study, we compared management of pain in the US to other countries. We assessed a large group of patients who underwent different types of orthopedic surgery and compared their patient reported outcomes and management regimens. We included 1011 patients from 4 hospitals in the USA  and 28,510 patients from  45  hospitals in 14 countries (“INTERNATIONAL”). Medical Research: What are the main findings? Dr. Meissner: Postoperative pain intensity of US patients was higher than in INTERNATIONAL patients; they felt more often negatively affected by pain-associated anxiety and helplessness, and more US patients stated they wished to have received more pain treatment. However, other patient-reported outcomes like time in severe pain or the level of pain relief did not differ. We found that treatment regiments of American patients differed compared to INTERNATIONAL patients. More US patients received opioids, and their opioid doses were higher compared to INTERNATIONAL patients. In contrast, INTERNATIONAL countries use more nonopioid medications intraoperatively and postoperatively. Thus, under-supply with opioids cannot explain our findings. Mean BMI of US patients was 30.3 while for INTERNATIONAL it was 27.4. However, insufficient evidence exists that this finding might account for differences in pain intensity. Routine pain assessment was performed in almost all US patients, in contrast to about 75% in the INTERNATIONAL group. Obviously, routine pain assessment, as practiced in the United States, fails to result in lower postoperative pain. Perhaps it has the opposite effect by directing patients’ attention to the pain. (more…)
Author Interviews, Opiods, Orthopedics, Pain Research, Pharmacology / 08.05.2015

Hassan R. Mir, MD, MBA Associate professor of Orthopaedics and Rehabilitation Vanderbilt Orthopaedic InstituteMedicalResearch.com Interview with: Hassan R. Mir, MD, MBA Associate professor of Orthopaedics and Rehabilitation Vanderbilt Orthopaedic Institute and and Brent J. Morris, M.D. Shoulder and Elbow Surgery Fellowship Texas Orthopaedic Hospital in affiliation with the University of Texas Houston Health Science Center, Houston, TexasDr. Brent J. Morris, M.D. Shoulder and Elbow Surgery Fellowship Texas Orthopaedic Hospital University of Texas Houston Health Science Center, Houston, Texas Medical Research: What is the background for this study? What are the main findings? Dr. Mir: The past few decades have seen an alarming rise in opioid use in the United States, and the negative consequences are dramatically increasing. The US represents less than 5% of the world's population, yet consumes 80% of the global opioid supply. Management of pain is an important part of patient care, however, the increased usage of opioids for the treatment of pain has led to several unanticipated aftereffects for individual patients and for society at large. Orthopaedic surgeons are the third highest prescribers of opioid prescriptions among physicians in the United States. Orthopaedic patients can experience a tremendous amount of pain with acute injuries and chronic conditions, and the treatment plan may involve opioid prescriptions for relief of discomfort. A significant number of orthopaedic patients and their families are at risk for repercussions from opioid use. We must work together to decrease the use of opioids for musculoskeletal pain. Clinicians should aim to control pain and improve patient satisfaction while avoiding overprescribing opioids. A comprehensive strategy of risk assessment is needed to identify patients who may be at risk for opioid abuse. Objective measures including patient history, recognition of aberrant behavior, urine drug testing, state prescription drug–monitoring programs, and opioid risk-assessment screening tools may be necessary in select cases. (more…)
Author Interviews, Columbia, Opiods / 30.04.2015

Silvia S. Martins, MD, PHDAssociate Professor of Epidemiology Department of Epidemiology Mailman School Of Public Health Columbia University New York, NY 10032MedicalResearch.com Interview with Silvia S. Martins, MD, PHD Associate Professor of Epidemiology Department of Epidemiology Mailman School Of Public Health Columbia University New York, NY 10032 MedicalResearch: What is the background for this study? What are the main findings? Dr. Martins: The background for this study is former studies showing links between nonmedical use of prescription opioids and transition to heroin and other illegal substances, prescription opioid-related and heroin-related fatal overdoses . In addition, a particular public health concern is that the transition to heroin and further injecting heroin may increase the risk of bloodborne infections. We used data from the National Survey on Drug Use and Health, a large nationally representative household sample of 67,500 people, and self-reported heroin use within the last 12 months, the researchers examined the change in patterns of past-year non-prescription drug and heroin use between 2002-2005 and 2008-2011 across racial and ethnic groups. The most significant rise in heroin use was among Hispanics and non-Hispanic whites, where the rate of heroin use for the latter group increased by 75 percent in 2008-2011 compared to earlier years. Regarding frequency of use, for Hispanics, increases were significant only among those using opioids about 1-29 days in the past year. Among blacks and whites, significant increases in the rate of heroin use were observed among those using prescription opioids more frequently (100-365 days) in the past year. (more…)
Author Interviews, Dermatology, Opiods / 24.03.2015

Madhulika A. Gupta MD University of Western OntarioMedicalResearch.com Interview with: Madhulika A. Gupta MD  University of Western Ontario Medical Research: What is the background for this study? What are the main findings? Dr. Gupta: Opioid (narcotic) analgesics (OA) are FDA-approved primarily for the symptomatic relief of pain in acute and chronic conditions. The prescription rates of Opioid analgesics in the US have increased significantly since 1989, and their possible inappropriate use has been declared a public health concern. We have recently reported (GuptaMA et al. J Dermatol Treat, 2014) that the use of Opioid analgesics in primarily skin disorders (with no reported non-dermatologic comorbidities) has increased from 1995-2010. Skin disorders are associated with psychiatric pathology in up to 30% of cases. Psychiatric disorders have been associated with an increased use of Opioid analgesics and other potentially addictive drugs. We examined psychiatric disorders, comorbidities and psychotropic drugs in patient visits with skin disorders and Opioid analgesics use (‘Skin Disorders+OA’). We examined nationally representative cross-sectional data collected between 1995-2010 by the NAMCS and NHAMCS. Up to 3 ICD9-CM diagnoses are coded for each patient visit; the following codes were used to create the ‘Skin Disorders’ variable: ICD9-CM codes 680-709 ‘Diseases of the Skin and Subcutaneous Tissue’ and ICD9-CM codes 172, 173, 216 and 232 for cutaneous malignancies. Ambulatory Care Drug Database System drug codes were used for creation of variables for Opioid analgesics and other psychotropics. (more…)
Author Interviews, JAMA, Opiods, Pharmacology / 13.03.2015

Theodore J. Cicero, PhD Professor, Vice Chairman for Research Department of Psychiatry, Washington University St Louis, MissouriMedicalResearch.com Interview with: Theodore J. Cicero, PhD Professor, Vice Chairman for Research Department of Psychiatry, Washington University St Louis, Missouri MedicalResearch: What is the background for this study? What are the main findings? Dr. Cicero: Prescription opiate abuse (eg Vicodin, Percocet, OxyContin) has reached epidemic proportions in this country over the past decade. Although most people swallow the drugs whole, a relatively large number either chew the drugs to produce an immediate delivery of large quantities of drugs or they crush them and/or dissolve them in some solvent which makes them useful for intranasal (eg snorting) or intravenous administration. Non-oral routes, particularly injection, represent the most serious public health risk due to a high incidence of infection, including Hepatitis C and HIV, and the much greater severity of abuse. In an effort to reduce these practices, drug companies are introducing so-called abuse deterrent formulations (ADF) which are resistant to crushing or dissolving in an aqueous solution. In one such important effort, the company responsible for distributing one of the most widely abused prescription opiates, OxyContin, introduced an ADF in 2010. Although the abuse deterrent formulations was highly successful in reducing abuse of OxyContin by either chewing, crushing, or dissolving in water, there was none-the-less a clear limit to how effective it was. For example, some people simply switched to the oral route of administration or never did snort or inject the drug, whereas a small number found ways to defeat the abuse deterrent formulations and persisted in harmful patterns of abuse. Unfortunately, there was also an unintended result. ADF-OxyContin caused many individuals to abandon the use of OxyContin - a good thing - in favor of other opiates (a bad thing). Most serious, however, was that 70% of those who switched drugs moved from OxyContin to heroin abuse. Although by no means the only factor, the abuse deterrent formulations has contributed to the wide-spread reports of heroin abuse in suburban and rural Caucasian male and females, a group here-to-fore not the typical heroin users (i.e. poor minorities, living in large urban centers). (more…)
Author Interviews, CDC, Opiods, Pharmacology / 21.02.2015

Dr. Zhou Yang Office of the Associate Director for Policy Centers for Disease Control and Prevention, Atlanta, GAMedicalResearch.com Interview with: Dr. Zhou Yang Office of the Associate Director for Policy Centers for Disease Control and Prevention, Atlanta, GA Medical Research: What is the background for this study? Response: Prescription drug misuse and abuse, largely those involving opioid painkillers, have been characterized as an epidemic. According to a CDC report, drug-related overdose has surpassed traffic crashes to become the leading cause of injury death in the U.S. in 2009. Medicaid programs in most states implement Patient Review and Restriction (PRR) programs, also called ‘lock-in’ program. The PRR programs use a set of behavioral indicators to identify patients at higher risk of opioid drug misuse and abuse, and ‘locks’ them in to a designated provider, pharmacy, or both. Pharmacy shopping is one of the key indicators employed by the PRR program. However, definition of pharmacy shopper varies widely across states. In addition, the PRR programs have not paid attention to the indicators of prescribing overlapped drugs, which we see as a missed opportunity to help the PRR program to better target users at high risk of overdose. Medical Research: What are the main findings? Response: Among a number of currently used definitions of pharmacy shopping, we found that the definition of ‘four or more pharmacies visited within any 90-day period’ is the most effective one. We also found that having overlapping opioid prescriptions is associated with an elevated risk of overdose. In fact, patients who exhibited both pharmacy shopping and having overlapping prescription had more than twice the risk of overdose than those who only exhibited pharmacy shopping. (more…)
Author Interviews, NEJM, Opiods, Pharmacology / 29.01.2015

Richard C. Dart, M.D., Ph.D Denver Health & Hospital Authority Professor, University of Colorado School of MedicineMedicalResearch.com Interview with: Richard C. Dart, M.D., Ph.D Denver Health & Hospital Authority Professor, University of Colorado School of Medicine   Medical Research: What is the background for this study? What are the main findings? Dr. Dart: For the past two decades, prescription opioid medication abuse has increased significantly in the US. An estimated 25 million people initiated nonmedical use of pain relievers between 2002 and 2011.  In 2010 the number of death attributed to prescription opioid medications reached 16,651. The  RADARS® System (Researched Abuse, Diversion and Addiction Related Surveillance) has been monitoring prescription drug abuse and diversion for over 13 years. We use a “mosaic” approach, measuring abuse and diversion from multiple perspectives, to describe this hidden phenomenon as comprehensively as possible. For the current publication we used 5 separate RADARS® System programs to collect data and the study period was from January 2002 through December 2013. We noticed a substantial increase  of prescription drug abuse from 2002 through 2010, followed by a flattening or decrease in 2010 and, lastly, a decline in 2011 through 2013. We also noticed a similar pattern in opioid-related deaths. Nonmedical use did not change significantly among college students. (more…)
Author Interviews, CDC, OBGYNE, Opiods / 25.01.2015

Dr. Jennifer Lind PharmD, MPH Division of Birth Defects and Developmental Disabilities, National Center on Birth Defects and Developmental Disabilities, CDCMedicalResearch.com Interview with: Dr. Jennifer Lind PharmD, MPH Division of Birth Defects and Developmental Disabilities, National Center on Birth Defects and Developmental Disabilities, CDC Medical Research: What is the background for this study? Dr. Lind:  CDC researchers published a new study estimating the proportion of women aged 15-44 years who filled a prescription for opioid pain medications.  Opioids are prescribed by healthcare providers to treat moderate to severe pain. They are also found in some prescription cough medications. Opioids include medications like codeine, oxycodone, hydrocodone, or morphine. For this study, researchers used data from two large insurance claims datasets—one on Medicaid and one on private insurance—and looked at data from 2008-2012. Medical Research: What are the main findings? Dr. Lind: Opioid medications are widely used among women of reproductive age in the United States, regardless of insurance type. On average, more than a third (39 percent) of women aged 15-44 years enrolled in Medicaid, and more than one fourth (28 percent) of those with private insurance filled a prescription for an opioid pain medication each year during 2008-2012. Taking these medications early in pregnancy, often before women know they are pregnant, can increase the risk for some birth defects (such as spina bifida) and other poor pregnancy outcomes (such as preterm birth or low birth weight). (more…)
Opiods / 21.12.2014

Erik Gunderson, M.D., FASAM Assistant Professor Department of Psychiatry and Neurobehavioral Sciences and Department of Medicine University of Virginia Principal Investigator of the studyMedicalResearch.com Interview with: Erik Gunderson, M.D., FASAM Assistant Professor Department of Psychiatry and Neurobehavioral Sciences and Department of Medicine University of Virginia Principal Investigator of the study Medical Research: What is the background for this study? What are the main findings? Response: The ISTART/006 study was a randomized, multicenter, non-inferiority Phase 3 clinical trial designed to evaluate the efficacy of ZUBSOLV® (buprenorphine and naloxone) sublingual tablet (CIII) compared with generic buprenorphine tablets during induction and with Suboxone® film during stabilization of patients with opioid dependence. The co-primary endpoint was retention in treatment at day 3 (when patients began maintenance therapy with either ZUBSOLV or Suboxone film) and retention in treatment at day 15. Secondary endpoints included assessment of treatment effects on opioid withdrawal symptoms for ZUBSOLV versus Suboxone film via both the Clinical Opiate Withdrawal Scale (COWS) score and Subjective Opiate Withdrawal Scale (SOWS), and opioid cravings via the visual analogue scale (VAS). 758 patients participated in a two-day blinded induction phase randomized to ZUBSOLV or generic buprenorphine tablets, and on day 3 those taking the generic tablets were switched to Suboxone film for a 20-day open-label stabilization and early maintenance phase. At day 15, ZUBSOLV patients switched to Suboxone film and those taking Suboxone film switched to ZUBSOLV. Please note ZUBSOLV currently is not indicated for induction treatment. In October 2014, Orexo submitted a sNDA to the FDA for that indication. We found ZUBSOLV demonstrated comparable patient retention in treatment at days 3 and 15 versus generic buprenorphine and Suboxone film respectively, as well as no increased rate of withdrawal symptoms or opioid cravings versus Suboxone film. The safety profile of ZUBSOLV was similar to that of Suboxone film. (more…)
Author Interviews, Opiods, Pharmacology, University Texas / 11.12.2014

Barbara J Turner MD, MSEd, MA, MACP James D and Ona I Dye Professor of Medicine Director, Center for Research to Advance Community Health (ReACH) University of Texas Health Science Center San AntonioMedicalResearch.com Interview with: Barbara J Turner MD, MSEd, MA, MACP James D and Ona I Dye Professor of Medicine Director, Center for Research to Advance Community Health (ReACH) University of Texas Health Science Center San Antonio Medical Research: What is the background for this study? What are the main findings? Dr. Turner: Daily dose of opioid analgesics has been widely used to assess the risk of overdose death and this risk has been reported to be greatest for a morphine equivalent dose at least 100 to 120 mg per day. However, the total dose of filled opioid prescriptions over a period of time may offer a complementary measure of the risk to that provided by the daily dose. In fact, the total dose is not necessarily a simple linear transformation of the daily dose because not all patients use opioids every day, instead it reflects the total amount of opioids available to a patient. Among 206,869 national HMO patients aged 18-64 with non-cancer pain filling at least 2 schedule II or III opioid analgesic prescriptions, the rate of overdose was 471 per 100,000 person-years. Over the study period of 3.5 years, risk of drug overdose was two to three times greater for patients with a daily dose >100 mg regardless of the total dose filled or a daily dose of 50-99 mg with a high total dose (>1830 mg) filled a six month interval (versus no opioids). The overdose risk was increased slightly for 50-99 mg per day with a lower total dose and not increased at all for daily doses under 20 mg regardless of the total dose. (more…)
Author Interviews, Opiods / 02.12.2014

Silvia S. Martins, MD, PHD Associate Professor of Epidemiology Department of Epidemiology Mailman School Of Public Health Columbia University New York, NY 10032MedicalResearch.com Interview with: Silvia S. Martins, MD, PHD Associate Professor of Epidemiology Department of Epidemiology Mailman School Of Public Health Columbia University New York, NY 10032 MedicalResearch: What is the background for this study? What are the main findings? Dr. Martins: While a large proportion of young adults, ages 18 to 22, are prescribed opiates, non-medical use of opioids is second only to marijuana as the most prevalent form of illegal drug use among young adults. Until this study, little was known about nonmedical use of prescription drugs among non-college-attending young adults in the United States. Approximately 70 percent of all U.S. young adults enroll in some form of college education, but around 30% do not. We analyzed public data for 36,781 young adults between the ages of 18 and 22 over a 12-month period in 2008 through 2010 from the National Survey on Drug Use and Health, an annual cross-sectional survey of the Substance Abuse and Mental Health Administration. Using the Kessler 6 screening instrument, we also measured past-year serious psychological distress as self-reported by the respondents. Among non-college-attending young adults with at least a high school degree, 13.1 percent reported using prescription opioids for non-medical reasons. The figure rose slightly to 13.2 percent for those who did not graduate from high school, and declined to 11.3 percent among college attendees. (more…)
Author Interviews, JAMA, Opiods, Yale / 21.10.2014

David A. Fiellin, M.D. Professor of Medicine, Investigative Medicine and Public Health Yale University School of MedicineMedicalResearch.com Interview with David A. Fiellin, M.D. Professor of Medicine, Investigative Medicine and Public Health Yale University School of Medicine   Medical Research: What are the main findings of the study? Dr. Fiellin: The main finding of our randomized clinical trial, conducted in primary care, was that among prescription opioid dependent patients, ongoing buprenorphine therapy resulted in better treatment retention and reduced illicit opioid use when compared to buprenorphine taper (detoxification). (more…)
Addiction, Author Interviews, Opiods, Pharmacology / 10.07.2014

Tara Gomes St Michael's Hospital Toronto, ON, CanadaMedicalResearch.com Interview with: Tara Gomes St Michael's Hospital Toronto, ON, Canada Medical Research: What are the main findings of the study? Tara Gomes: We found that rates of opioid overdose in Ontario have increased more than 3-fold over the past 2 decades. Furthermore, these deaths are clustered among younger Ontarians; in 2010, 1 in 8 deaths among those aged 25 to 34 years were related to opioids. This has led to considerable burden due to loss of life. (more…)
Author Interviews, Opiods, Pharmacology / 19.06.2014

Nicholas B. King, PhD, Biomedical Ethics Unit McGill University Montreal QC CanadaMedicalResearch.com Interview with: Nicholas B. King, PhD, Biomedical Ethics Unit McGill University Montreal QC Canada MedicalResearch: What are the main findings of the study? Dr. King: Unintentional overdoses from prescription opioid painkillers have been rising sharply in the US and Canada during the past two decades, killing thousands of people every year. A lot has been written about the subject in both popular media and scholarly literature, but we still don't have a very good idea of why this has happened. So we tried to objectively and systematically assess evidence for what has contributed to increasing mortality. We found the following: (1) The evidence base for why mortality has increased is very thin, and more research is urgently required. (2) We found evidence for at least 17 different causes of increased mortality. We found the most evidence for the following factors: dramatically increased prescription and sales of opioids; increased use of strong, long-acting opioids like oxycodone and methadone; combined use of opioids and other (licit and illicit) drugs and alcohol; and social and demographic characteristics. We found little evidence that internet sales of pharmaceuticals and errors by doctors and patients--factors commonly cited in the media--have played a significant role. (more…)
Addiction, Opiods, Orthopedics, Pharmacology, Surgical Research / 11.03.2014

Brent J. Morris, M.D. Shoulder and Elbow Surgery Fellowship Texas Orthopaedic Hospital in affiliation with the University of Texas Houston Health Science Center, Houston, TexasMedicalResearch.com Interview with: Brent J. Morris, M.D. Shoulder and Elbow Surgery Fellowship Texas Orthopaedic Hospital in affiliation with the University of Texas Houston Health Science Center, Houston, Texas MedicalResearch.com: What are the main findings of the study?

 Dr. Morris: There are concerns that an increasing percentage of patients are receiving narcotics by “doctor shopping” or seeking narcotics from multiple providers. One in five of our postoperative orthopedic trauma patients received narcotics from one or more additional providers other than the treating surgeon. Patients that doctor-shopped postoperatively had a significant increase in narcotic prescriptions, duration of narcotics, and morphine equivalent dose per day. (more…)
Author Interviews, JAMA, Opiods, Pharmacology, Weight Research / 02.10.2013

Marsha A. Raebel, PharmD, BCPS, FCCP Investigator in Pharmacotherapy Institute for Health Research 10065 E. Harvard Ave Suite 300 Denver, CO 80231.MedicalResearch.com Interview with: Marsha A. Raebel, PharmD, BCPS, FCCP Investigator in Pharmacotherapy Institute for Health Research 10065 E. Harvard Ave Suite 300 Denver, CO 80231. MedicalResearch.com: What are the main findings of the study? Answer: We found that in a group of patients who took chronic opioids for non-cancer pain and who underwent bariatric surgery there was greater chronic use of opioids after surgery compared with before surgery, findings that suggest the need for proactive management of chronic pain in these patients after surgery. (more…)