Category: From Newswise – Substance Abuse

The Johns Hopkins Bloomberg School of Public Health is hosting an expert briefing for the media from 2:00 p.m. to 2:30 p.m. EDT, Thursday, June 15, on the recent Purdue Pharma ruling that shields the Sackler family from current and future civil lawsuits in exchange for contributing up to $6 billion to states and communities to fight the opioid epidemic.

Topics to be discussed include: the most effective ways states/localities can spend the settlement money; the implications of the Sackler family being shielded from future lawsuits; how potentially gaining access to Purdue documents could help in shaping future policies or preventative measures; and the current status of the opioid epidemic.

Johns Hopkins Bloomberg School of Public Health experts will include:

• Joshua M. Sharfstein, MD, vice dean for Public Health Practice and Community Engagement at the Johns Hopkins Bloomberg School of Public Health, director of the Bloomberg American Health Initiative, and professor of the practice in the Johns Hopkins Bloomberg School of Public Health’s Department of Health Policy and Management. Previously, he served as the secretary of the Maryland Department of Health and Mental Hygiene, and as the principal deputy commissioner of the U.S. Food and Drug Administration. 

• Susan G. Sherman, PhD, MPH, a Bloomberg Professor of American Health in the Johns Hopkins Bloomberg School of Public Health’s Department of Health, Behavior and Society who focuses on improving the health of marginalized populations, primarily people who use drugs and women who sell sex. In 2017 she founded the SPARC Women’s Center, which provides harm-reduction services, opioid maintenance therapy, health care, legal services, case management, and drop-in services. She also conducts research in support of evidence-based drug policy in Maryland and nationally.

• Sara Whaley, MPH, MSW, MA, a research associate in the Johns Hopkins Bloomberg School of Public Health’s Department of Health Policy and Management and program manager of the Bloomberg Overdose Prevention Initiative. She helped craft the Principles for The Use of Funds From The Opioid Litigation and is a member of the working group that coordinates efforts to advise state and local governments in the effective use of litigation funds.

Additional Resources

Increased alcohol use among pregnant and postpartum women during the COVID-19 pandemic was associated with autonomic nervous system dysregulation, known to negatively affect resilience to change and further exacerbate the risk of stress-related mental health disorders and substance use, a new study suggests. The findings, although preliminary, underline the potential for a new clinical biomarker and novel personalized mobile health apps in facilitating treatment interventions. Previous research linked the pandemic to increased stress levels and drinking, including in pregnant and postpartum women. Alcohol use, and stress-related conditions such as depression and anxiety, are associated with dysregulation in the feedback loop between the body and the brain. This process involves the peripheral autonomic nervous system, which regulates the heartbeat. Healthy, resilient people tend to have higher heart rate variability than people with stress and substance use disorders. Heart rate variability measures could inform interventions designed to reduce drinking, restore physiologic equilibrium, and improve goal-directed behavior. For the study in Alcohol: Clinical & Experimental Research, researchers assessed changes in substance use during the pandemic among pregnant and postpartum people and associations between their real-time substance use and autonomic nervous system imbalances, measured by changes in heart rate variability.Between 2020 and 2022, investigators worked with 49 pregnant and 22 postpartum women. The participants were interviewed about their pandemic experiences (physical and mental health, and more) and their use of alcohol, cannabis, and tobacco during the previous month, including whether this was higher or lower than usual. Over 14 days, the participants used a mobile app on their phones that nudged them three times daily to record their use of those substances; this generated 2,610 reports. Their heart rates were tracked in real-time via wearable electronic fitness devices. The researchers used statistical analysis to look for changes in the women’s substance use and associations between those and their heart rate variability. Using baseline surveys and real-time self-reports allowed the researchers to track individual and group changes.

Between 2020 and 2022, investigators worked with 49 pregnant and 22 postpartum women. The participants were interviewed about their pandemic experiences (physical and mental health, and more) and their use of alcohol, cannabis, and tobacco during the previous month, including whether this was higher or lower than usual. Over 14 days, the participants used a mobile app on their phones that nudged them three times daily to record their use of those substances; this generated 2,610 reports. Their heart rates were tracked in real-time via wearable electronic fitness devices. The researchers used statistical analysis to look for changes in the women’s substance use and associations between those and their heart rate variability. Using baseline surveys and real-time self-reports allowed the researchers to track individual and group changes.

Almost three in four participants reported that the pandemic had worsened their stress level or mental health. In the previous month and the 14-day study period, more than one in five reported drinking, 17% reported cannabis use, and 8.5% reported nicotine use. Alcohol was the substance most commonly consumed “more than usual.” In individuals who reported any alcohol use—primarily postpartum women—the heart rate data indicated substantial autonomic changes. This included decreased parasympathetic activity, which regulates the resting state; the effect persisted after accounting for maternal age and pregnancy status. Decreased parasympathetic activity has been linked to stress disorders, such as anxiety and PTSD, and substance use disorder. The study results also implicated alcohol use (not nicotine or cannabis) in increased sympathetic nervous system activity associated with stress and fight-or-flight responses.

The findings highlight the negative effect of the COVID-19 pandemic on the psychological health of pregnant and postpartum women. This was associated with higher substance use and, in turn, autonomic nervous system dysregulation, putting some women at risk of developing substance use disorder. The study identifies heart rate variability as a promising noninvasive measure of physical and psychological health and the feasibility of using mobile health technology with pregnant and postpartum women; both can contribute to developing just-in-time therapeutic interventions. Drinking during pregnancy and the postpartum period, and prenatal cannabis exposure, are linked to negative developmental consequences in offspring, underlining the necessity of universal screening for substance use in pregnant and postpartum women.

The Effect of the COVID-19 Pandemic on Substance Use Patterns and Physiological Dysregulation in Pregnant and Postpartum Women. S. Ruyak, M. Roberts, S. Chambers, X. Ma, J. DiDomenico, R. De Le Garza, L. Bakhireva. (pp xx)

ACER-22-5504.R1

Guidelines for managing surgical pain omit patients with a history of chronic pain, substance use disorder and/or opioid tolerance. To address this disparity, the American Society of Anesthesiologists (ASA) gathered 15 medical organizations representing more than 500,000 physicians to develop seven guiding principles to improve pain management before, during and after surgery for these challenging patients.

Millions of patients fall into this category. A recent U.S. survey found over 19 million adults had at least one substance use disorder. These new principles create a “North Star” for vulnerable patients and communities dealing with multiple public health crises; offer much-needed awareness, advocacy and education for safe and effective surgical care; and represent a step forward in understanding disparities and stigma. They provide recommendations for screening, treating and educating these patients as well as when and how to consult a pain medicine specialist. For example, the organizations recommend educating patients about avoiding alcohol and recognizing the signs of overdose along with using telehealth when needed to consult with pain management experts.

David Dickerson, M.D., chair of ASA’s Committee on Pain Medicine, is available to talk about the multiorganizational recommendations, including what patients and clinicians need to know. He can address:

• Why managing pain in patients with a history of chronic pain, substance use disorder and/or opioid tolerance can be challenging.
• What the seven principles address and what clinicians and patients need to know about these new recommendations.
• The rigorous process ASA and 14 other medical organizations used to develop and come to a consensus on the seven principles.

BYLINE: Janette Neuwahl Tannen

Newswise — Coming out to your parents can be a difficult and sensitive process for a person at any age. But for Hispanic teens, sharing that information can become even more challenging.  

Statistics from the U.S. Centers for Disease Control (CDC) indicate that Hispanic adolescents who identify as gay, lesbian, bisexual, or transgender—also known as sexual minorities—are struggling to share their authentic selves with their families. 

Figures from the CDC’s 2021 Youth Risk Behavior Survey show that Hispanic teens who consider themselves sexual minorities are more likely to experience symptoms of depression or attempt suicide than their Hispanic heterosexual peers. Hispanic sexual minorities are also more likely to use drugs or alcohol than Hispanic teens who identify as straight. 

Recognizing these troubling figures, in early 2019, professor of nursing and health studies Guillermo “Willy” Prado and public health graduate student, Alyssa Lozano, decided they wanted to explore the issue more. Lozano interviewed Hispanic youth who identified as sexual minorities to better understand the process of disclosing their sexual orientation and gender identity to their parents and families. She also wanted to unpack why they were using drugs and getting depressed. 

Prado was well suited to lead this effort, as much of his research has centered on Hispanic adolescents. With colleagues, he created an intervention more than 20 years ago called “Familias Unidas” to help improve family dynamics and communication among Hispanic parents and their adolescent children. The highly successful program now has been adapted to virtual platforms and is used in several states, as well as in countries like Chile and Ecuador. 

But Prado had never delved into crafting an intervention for sexual minority youth. 

“We tried to understand why these kids were using substances and getting depressed and a lot of it came down to the stigma they still experienced,” said Prado, who is also dean of the University of Miami Graduate School, the University’s vice provost for faculty affairs, and holds faculty appointments in nursing and health studies, public health sciences, and psychology. “We also saw that drug use and depression were higher among teens who reported that their disclosure process was not a positive one.” 

Armed with this information, Prado, Lozano, and their colleagues, set out to design a new intervention called “Familias con Orgullo,” or Families with Pride, which aimed to counteract the harmful implications of coming out on Hispanic youth who identify as sexual minorities. They asked Maria Tapia, a senior research associate, and Yannine Estrada, research assistant professor at the School of Nursing and Health Studies—who implemented Familias Unidas—to collaborate with them. And while Familias con Orgullo takes some cues from Familias Unidas, it is vastly different, Prado noted. Funded by the University, including funding from the Sylvester Comprehensive Cancer Center, a pilot study of Familias con Orgullo began in late 2019 with 30 local families in three cohorts. 

“This is a population where there is so much need,” said Prado. “We want to be able to prevent and reduce drug use, as well as to reduce rates of depression, and to improve family dynamics to help youth and parents navigate this coming out process.” 

After the pilot, many of the families involved reported improved communication overall, and most teen participants said their mental health had improved, according to Lozano. 

Then in May, the National Institute on Minority Health and Health Disparities gave Prado and his team more than $3 million to expand the program during the next five years, building upon the initial pilot study. Starting this fall, Prado and his team hope to recruit 306 Hispanic families from across South Florida with teens who recently have divulged their sexual orientation to one of their primary caregivers. 

“Long-term, assuming the results are positive, I would like to see this program—much like Familias Unidas—implemented and accepted across the United States as a standard of care for Hispanic sexual minority youth who have recently disclosed to their parents,” Prado said. “These parents are at different stages of acceptance, so a key goal is to increase that level of acceptance, regardless of where the parents are on that continuum.” 

Familias Con Orgullo is a 12-week program that includes parent-only group sessions, child-only group sessions, and individualized parent-child sessions. For some youth in the pilot, Lozano said, it was helpful for them to be among peers.

Lozano remains in touch with many of the youth participants from the pilot and marvels at how their lives changed afterward. One former participant, Javier Gomez, even spoke at the White House last spring when President Joseph Biden signed an executive order advancing equality for LGTBQ+ individuals. Lozano looks forward to working with more Hispanic families in the fall. 

“I was able to learn so much about the challenges these youth face and how resilient they are, which is so inspiring to me,” said Lozano, who graduates this summer and will join the School of Nursing and Health Studies as a research assistant professor in the fall. “I want to continue to focus on this population because these kids were so open and candid about what they went through—no literature review could give that level of detail. And it’s really important to be doing this work right now.” 

Newswise — The widely-available drug fentanyl, already the number one killer of Americans under 50, could be weaponized and used for terroristic mass poisoning, according to health experts at Rutgers and other institutions.

“Before fentanyl, the only viable mass poisons were rare and difficult-to-access agents such as cyanide or nerve agents,” said Lewis Nelson, chair of the Department of Emergency Medicine at Rutgers New Jersey Medical School and senior author of the new Frontiers in Public Health paper. “Fentanyl can be just as deadly if properly disseminated, and it’s ubiquitous. A motivated person could readily obtain enough to potentially poison hundreds of people — which, uncut, would fit easily onto a teaspoon.”

Unlike biological attacks, in which a weaponized disease could spread globally and kill millions, chemical attacks generally only harm the victim through direct exposure. Still, fentanyl’s high toxicity makes it a viable tool for unleashing a damaging, intentional event on an unsuspecting population.

Attackers with little technical knowledge could introduce the synthetic opioid in fatal doses into building ventilation systems or local food or water supplies. Nelson said it’s unlikely to be successful in a large-scale attack, so simply dumping a truckload in a reservoir would be unlikely to produce significant casualties.

History vividly demonstrates its potential as an aerosolized, inhaled poison. Russian authorities seem to have weaponized a fentanyl-like drug in 2002, after Chechen terrorists seized a crowded theater and threatened to execute hundreds of hostages unless Russia withdrew from Chechnya.

Conventional rescue operations against 40 well-armed and well-fortified captors appeared impossible, so security forces pumped a fentanyl analog into the theater’s ventilation system, incapacitating nearly everyone inside. They then stormed the building, shot the unconscious terrorists, and brought the hostages for medical care.

The operation left 130 hostages dead and demonstrated the scale of harm that is possible when fentanyl is used for non-peaceful purposes.

“We have no effective antidotes to many poisons, but we do have an antidote to fentanyl poisoning — naloxone, which also goes by the brand name Narcan — and the extreme frequency of unintentional fentanyl overdoses means we now stock this antidote in large quantities at health care facilities and pharmacies,” Nelson said.

The frequency of accidental overdose also means that many healthcare providers and non-medical personnel have learned to recognize the signs of fentanyl poisoning while there is still time to reverse it. The paper’s plan for minimizing vulnerability to fentanyl attacks calls for training more caregivers to spot victims quickly and administer naloxone early.

“Treating based on clinical findings rather than more definitive tests such as blood-test results is generally safe,” Nelson said. “If you suspect fentanyl poisoning, administer naloxone, and it turns out the poison was another agent, you generally haven’t hurt the patient.”

The panel’s response plan relies largely on such preparatory steps: training more people to recognize poisoning, creating channels to report unusual victims of fentanyl poisoning, finding commonalities among these victims, and eliminating the sources for obtaining fentanyl. It also involves devising ways to quickly transfer many doses of naloxone to where they are needed most.

“We have a lot of naloxone available in metropolitan and rural areas,” said Nelson. He noted that it’s safe to aid poisoning victims because fentanyl powder must be inhaled or ingested to hurt rescuers, and this is exceedingly unlikely to occur. There is essentially no risk of rapid absorption across the skin. “The key in a mass event will be quickly moving naloxone to the scene or to facilities that are suddenly overwhelmed with victims. Fentanyl generally kills more slowly than poisons like cyanide, but it still requires quick action to prevent harm.”

Newswise — With an urgent mission to address the alarming rise in drug overdose deaths, the University of Maryland  School of Medicine (UMSOM) has announced plans to open the new Kahlert Institute for Addiction Medicine. It will be funded with a $10 million gift from the Maryland-based Kahlert Foundation with an additional $10 million provided by the University of Maryland, Baltimore (UMB) and $5 million from UMSOM to renovate research facilities on campus. UMSOM has committed to raise an additional $5 million in philanthropic donations for the Kahlert Institute.

With a commitment of $30 million in funding, the new Kahlert Institute will bring together leading addiction experts in a shared research space to collaborate and create the synergy necessary for systemic change. UMSOM faculty will serve as an integral part of this Institute. They will include neuroscientists, studying the brain mechanisms underlying substance use and its lifelong consequences, and clinical researchers investigating potential interventions in patient trials. Institute members also will include substance use disorder specialists who understand the daily realities of caring for patients with complex disorders often involving psychiatric illness, trauma, and socioeconomic stressors.

Aiming for Radical Innovation

“We need revolutionary progress in the area of addiction treatment and recovery. The Kahlert Foundation recognizes that to achieve radical innovation, you need to bring together the leading experts across multiple disciplines,” said Greg Kahlert, President of the Kahlert Foundation. “Millions of people are affected by addiction in this country, including the child of one of our team members at the Kahlert Foundation. We are hopeful that the Kahlert Institute for Addiction Medicine will discover new treatments that will save countless lives in the future. ”

Maryland alone has experienced a more than doubling in its rate of drug overdose deaths from 2015 to 2020 – from 21 deaths to 44 deaths per 100,000 people. This increase is one of the highest in the nation with an overdose death rate that is 50 percent higher than the national average. In Baltimore City, 964 deaths were attributed to opioid overdose in 2020, nearly triple the number of deaths from homicide.

“There is not a person that I know who hasn’t been impacted by this opioid epidemic. It’s clear we need to do more,” said Kahlert Institute Associate Director Eric Weintraub, MD, Professor of Psychiatry and Director of the Division of Addiction Research and Treatment at UMSOM. “One critical goal is to establish a collaboration between basic scientists in the field of addiction and clinicians who are treating patients. We need to work closely, put our heads together, and develop strategies for research and treatment that will be effective in the long term.”

Education will serve as a foundational pillar of the Kahlert Institute with inter-professional training on addiction treatment provided within the University system, as well as to the greater Maryland community. Trainees will include community members and peer counselors as well as health professionals and UMB graduate students entering the medical field. The aim is to educate and increase the next generation of addiction counselors and health providers and to create a model that will serve as a national blueprint for community-academic partnerships.

“The University of Maryland, Baltimore is a research powerhouse dedicated to finding solutions to the most pressing problems of today, including addiction. Opioid use disorder and addiction have created a public health crisis in Baltimore, in Maryland, and across the country,” said Bruce Jarrell, MD, President of UMB. “UMB’s mission – to improve the human condition and serve the public good – means that we have a responsibility to do what we can to address this crisis, and I expect the research we will conduct at the Kahlert Institute will make a powerful difference.”

Hub for Multi-Disciplinary Research Collaboration

The Kahlert Institute will create a central hub allowing multidisciplinary investigators to bring together their knowledge and accelerate innovation by sharing the same physical space. It will be located on a currently shelled floor of the new Health Sciences Research Facility Ill on the UMSOM campus with state­ of-the-art labs to accelerate fundamental and translational science, alongside a fully integrated space for clinical care, clinical research, and education.

“Last year, 20 million Americans were diagnosed with substance use disorder, and only 10 percent received treatment. Overall, more than 100,000 people nationally died from a drug overdose,” said UMSOM Dean Mark T. Gladwin, MD, who is also Vice President for Medical Affairs, University of Maryland, Baltimore, and the John Z. and Akiko K. Bowers Distinguished Professor. “The Kahlert Institute seeks to build a bridge from the lab bench, where rapid advances in fundamental neuroscience will spur innovative therapies, to the clinic, where lifesaving medications like buprenorphine and methadone, require an optimized system to ensure access to any patient in need.”

Fundamental research will focus on developing and testing novel interventions, including behavioral therapies, drugs, and innovative technologies to reduce cravings, drug use, and the many complications of addiction. Faculty members also will conduct accelerated preclinical research to identify why certain individuals are more susceptible to addiction. Others will explore the cause of the high comorbidity between substance abuse disorders and neuropsychiatric diseases such as depression and schizophrenia. Fetal programming studies investigating how genes are expressed will aim to measure the impact of prenatal exposure to drugs and ways to reduce the long-term consequences.

“Our research techniques include behavioral, neurophysiological, genetic, molecular, and computational approaches. We investigate drugs as diverse as opioids, cocaine, amphetamines, cannabis, nicotine, and alcohol,” said Asaf Keller, PhD, the Donald E. Wilson, MD, MACP Distinguished Professor and Chair of Neurobiology, and Associate Director of the Kahlert Institute.  “This collaboration will help us expand our basic and translational research opportunities by more fully understanding the challenges in the field of addiction medicine to develop new strategies and research approaches.”

Supportive Therapies to Prevent Relapse

Clinical studies will include analyzing innovative treatment strategies to determine, for example, how supportive therapies delivered by peer counselors can prevent relapse. A foundational activity of the Kahlert Institute will be to establish a Community Advisory Board, which will include individuals with substance use disorder, community members affected by addiction, and harm reductionists.

“In order for the Kahlert lnstitute’s scientific, clinical, and educational work to have relevance and impact, it must be grounded in and shaped by the lived experience of individuals with addiction,” said Kahlert Institute Associate Director Sarah Kattakuzhy, MD, MPH, Associate Professor in the Division of Clinical Care & Research in the Institute of Human Virology (IHV) at UMSOM. “We want to reduce death and long-term complications of addiction especially in disproportionately affected communities. Black patients, for example, are far less likely to receive certain medications to treat opioid use disorder than white patients, and we need to find ways to eliminate this disparity.”  

Continuum of Care for Patients

Another major goal of the Kahlert Institute focuses on improving the continuum of care for individuals with addiction. Patients with addictions often face additional challenges in accessing traditional health care settings. Experts will focus on creating a more effective care model to address these patients ‘ primary health care needs and ensure they have continued access to medication like suboxone or methadone as well as psychiatric services for mental health issues. 

The Kahlert Institute also will closely collaborate with the Maryland Addiction Consultation Service (MACS), a UMSOM-run, state-sponsored program to expand treatment of opioid use disorder. Research programs with an established portfolio in addiction also will be part of the collaboration, including the new University of Maryland Institute for Health Computing; the IHV’s Research Initiative in Infectious Disease and Substance Use; UMSOM’s Institute for Substance Use in Pregnancy and Research Initiative in Infectious Disease in Substance Use; and The Center for Addiction Medicine (CAM) at the University of Maryland Medical Center Midtown Campus, a comprehensive clinical program offering medication-assisted treatment and outpatient counseling. The newly established University of Maryland-Medicine Institute for Neuroscience Discovery (UM-MIND) will have a strong connection to Kahlert Institute, with the two Institutes working together to further the science of addiction. UM-MIND Director Margaret McCarthy, MD, the James and Carolyn Frenkil Dean’s Professor and Chair of the Department of Pharmacology, will serve on the Executive Committee of Kahlert Institute.

About the University of Maryland School of Medicine

Now in its third century, the University of Maryland School of Medicine was chartered in 1807 as the first public medical school in the United States. It continues today as one of the fastest growing, top-tier biomedical research enterprises in the world — with 46 academic departments, centers, institutes, and programs, and a faculty of more than 3,000 physicians, scientists, and allied health professionals, including members of the National Academy of Medicine and the National Academy of Sciences, and a distinguished two-time winner of the Albert E. Lasker Award in Medical Research. With an operating budget of more than $1.2 billion, the School of Medicine works closely in partnership with the University of Maryland Medical Center and Medical System to provide research-intensive, academic, and clinically based care for nearly 2 million patients each year. The School of Medicine has more than $500 million in extramural funding, with most of its academic departments highly ranked among all medical schools in the nation in research funding. As one of the seven professional schools that make up the University of Maryland, Baltimore campus, the School of Medicine has a total population of nearly 9,000 faculty and staff, including 2,500 students, trainees, residents, and fellows. The School of Medicine, which ranks as the 8th highest among public medical schools in research productivity (according to the Association of American Medical Colleges profile) is an innovator in translational medicine, with 606 active patents and 52 start-up companies. In the latest U.S. News & World Report ranking of the Best Medical Schools, published in 2023, the UM School of Medicine is ranked #10 among the 92 public medical schools in the U.S., and in the top 16 percent (#32) of all 192 public and private U.S. medical schools. The School of Medicine works locally, nationally, and globally, with research and treatment facilities in 36 countries around the world. Visit medschool.umaryland.edu

About the Kahlert Foundation

For more than three decades, the Kahlert Foundation has devoted its primary efforts to improving the quality of life and well-being of people and communities in Maryland. The Foundation was established by William “Bill” E. Kahlert who was the co-founder of Evapco, Inc., an industry-leading manufacturing company with solutions for worldwide evaporative cooling and industrial refrigeration markets. Evapco’s corporate offices are in Taneytown, MD located in Carroll County.

Bill’s son, Greg Kahlert, has been the president of the Foundation since 2011. Greg has since devoted his time to furthering the impact of the organization around the state. In 2015, the Kahlert Foundation expanded its philanthropy mission to include the state of Utah where Greg’s daughter resides. In 2022, more than $17 million in grants were provided to charitable organizations in the areas of health care, education, youth programs, veteran organizations, and human services.

BYLINE: Eileen Scahill

Newswise — COLUMBUS, Ohio – Leveraging the HEALing Communities Study infrastructure, researchers are testing whether there is an association between fentanyl test strip use and overdose risk reduction behaviors among people who use drugs over a 28-day observation period. The study, known as the Stay Safe Study, is taking place in Kentucky, New York, and Ohio. Fentanyl test strips are legal to distribute or possess in all three states.

“We want to know if people who use fentanyl test strips compared to people who don’t, are more likely to engage in certain overdose risk reduction behaviors. Given the prevalence of fentanyl in our drug supply, this study is critical to identify how to best reduce risk of overdoses,” said Bridget Freisthler, PhD, professor at The Ohio State University College of Social Work who is now leading the Ohio HEALing Communities Study. “We want to learn about drug use, and what people use to stay safe from an overdose. Information gleaned from this study may help us provide better resources for people who use drugs in our communities.”

The Ohio arm of the Stay Safe Study, led by Janet Childerhose, PhD, and Soledad Fernandez, PhD at The Ohio State University Wexner Medical Center and College of Medicine, will also examine factors that encourage or prevent the use and distribution of fentanyl test strips at individual and organizational levels.

The Stay Safe Study is being conducted as part of the HEALing Communities Study, the largest implementation study ever conducted in addiction research. The HEALing Communities Study is investigating how to implement evidence-based practices to address opioid misuse, opioid use disorder (OUD), and opioid overdose at the local level.

The study is supported by the National Institute on Drug Abuse, part of the National Institutes of Health (NIH), through the Helping to End Addiction Long-term Initiative, or NIH HEAL Initiative, and the Substance Abuse and Mental Health Services Administration.

“People may not realize they are consuming fentanyl, especially if it has been mixed into or sold as other drugs such as heroin, cocaine, or counterfeit pills. Because it doesn’t take much for a dose of fentanyl to be lethal, using a drug that has been contaminated with or replaced by fentanyl can greatly increase your risk of overdose,” said Childerhose, assistant professor at Ohio State. She’s a medical anthropologist who investigates the ethics and implementation of harm reduction strategies to prevent fatal overdose in the United States and Canada. 

For the Ohio arm of the Stay Safe Study, researchers plan to recruit 250 study participants in Ohio to confidentially survey about their drug use and the practices they use to stay safe. After determining someone is eligible to participate in the study, researchers will survey them every week for 4 weeks. Study participants will be asked about:

Drugs they may have recently used, such as heroin, fentanyl, cocaine, methamphetamine, or medications that were not prescribed for them.

• Their behaviors that could reduce their risk for a drug overdose.
• Their behaviors that could put them at risk for a drug overdose.
• Their experiences using fentanyl test strips and with drug overdose.

Researchers will also interview 40 of the participants. All enrolled participants will be eligible to opt into a biomarker test. This consists of a short survey about the previous 48 hours of their drug use and an oral swab that the participants will use to swab their own mouth.

The team will send the swab to a contracted lab to produce a report. The purpose of the biomarker test is to learn what substances, including fentanyl, participants may have in their body and to understand whether participants are aware of what’s in their body.

Participants will be compensated for their time to participate in the research.  

“Over the past decade, we’ve seen a dramatic rise in drug overdose deaths in the United States caused by fentanyl. Our study is a step in the right direction to prevent these needless overdose deaths,” said Fernandez, professor, vice chair and director for Ohio State’s Center for Biostatistics.

Six Ohio partner organizations have joined the study, including:

• Brown County, Prevention Point
• Butler County, Regional Harm Reduction Collaborative
• Clermont County, The Exchange Project, Clermont Mercy Hospital
• Cuyahoga County, a harm reduction organization
• Franklin County, SafePoint
• Scioto County, SHRPS, Portsmouth City Public Health

The Stay Safe Study is supported by the National Institute on Drug Abuse through the NIH HEAL Initiative under award numbers UM1DA049394, UM1DA049406, UM1DA049412, UM1DA049415, and UM1DA049417. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

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The Helping to End Addiction Long-term® Initiative, or NIH HEAL Initiative®, is an NIH-wide effort to speed scientific solutions to stem the national opioid public health crisis. Launched in April 2018, the initiative is focused on improving prevention and treatment strategies for opioid misuse and addiction and enhancing pain management. For more information, visit: https://heal.nih.gov.

Newswise — In response to the opioid epidemic in the United States, interventions to prevent over-prescribing and misuse of opioids were enacted at institutional, state, and federal levels. To assess how changes in the prescribing landscape affected patients, a research team from the Yale COPPER Center examined the rates of both new and persistent opioid prescribing in patients with cancer as well as in patients without cancer, utilizing data from SEER-Medicare.

Yale Cancer Center member Henry Soo-Min Park, MD, MPH, an associate professor, vice chair for clinical research, and chief of the thoracic radiotherapy program for the Department of Therapeutic Radiology at Yale School of Medicine, will present research highlights on June 5, 2023, at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois.

In this study, researchers identified 238,470 patients with cancer with a mean age 76.3 years. New opioid use was higher in patients with cancer (46.4%) than in those without (6.9%). From 2012 to 2017, the predicted probability of new opioid use was more stable in the cancer group, the data showing relative declines of 2.4% for patients that had surgery and prescribed opioids, 0.4% for patients with surgery alone, and 8.8% for patients with metastatic cancer, compared to the non-cancer group that had an overall relative decline of 20%. The results showed that opioid prescribing declined over time at a slower rate in patients with cancer than in patients without cancer. The researchers say the study shows important but tempered effects of the changing opioid climate on patients with cancer.

“Our findings show that there has been a change in opioid prescribing across the board, including for patients with cancer, particularly in long-term cancer survivorship,” says lead researcher and Yale Cancer Center member Laura Baum, MD, MPH, assistant professor of medicine (medical oncology) at Yale School of Medicine. “At the same time, the results are reassuring that patients with cancer have maintained access to needed opioids, following cancer surgery or with metastatic disease.”

The ASCO presentation takes a closer look at the potential implications – and future directions for – improving the understanding of new and persistent opioid use, the impact of changing policies, and best practices for prescribing opioids for patients living with cancer.

“This work was only possible due to the strong collaborative spirit and support among Yale investigators, Mayo Clinic investigators, and the U.S. Food and Drug Administration (FDA),” says Dr. Park.

This research was supported by the FDA as part of a financial-assistance award from the U.S. Department of Health and Human Services.

• Programme of combined one-to-one and group support sessions was tested in landmark clinical trial 

   

• After one year, one in five people were able to stop taking opioids without their pain increasing  

   

• Experts say the new treatment is an alternative to opioid use and has potential to give patients better quality of life 

Newswise — Researchers at the University of Warwick and The James Cook University Hospital, Middlesbrough have led a clinical trial, funded by the National Institute for Health and Care Research (NIHR), on a new treatment which can help people stop needing to use opioid painkillers to manage chronic pain.

There are over 1 million people in the UK on prescription opioids*, over 50,000 of whom have been taking these for 6 months or more*, at an estimated cost of £500 million to the NHS annually.

Recent NHS initiatives have managed to reduce opioid prescribing by eight per cent, saving an estimated 350 lives.

New research has found evidence that could help many more people stop their opioid painkiller use.

Despite the evidence that taking opioids long term is harmful there are currently no alternative treatments available to safely help people who are coming off opioids and still dealing with chronic, non-cancer pain.

A team of researchers and clinicians have developed and successfully trialled an intervention programme designed to guide people in coming off prescription painkillers, taper their opioid intake and learn how to manage their pain using alternative techniques with a course which combines one-to-one and group support.

1 in 5 people came off opioids within one year

The study, titled I-WOTCH (Improving the Wellbeing of people with Opioid Treated Chronic Pain), found that the intervention programme helped 1 in 5 people come off their opioids within one year, without substituting medication and without making their pain worse.

Over 600 people took part in the randomised controlled study between 2017 and 2020 who at the beginning of the trial had been regularly taking strong opioids for at least three months. The participants were recruited from GP practices from the North East of England and the Midlands.

The study compared two treatments, dividing participants randomly into two groups.  One group had access to their existing GP care, plus a self-help booklet and relaxation CD; the second group had the same and also took part in an intervention programme specially developed by the study team.

The intervention programme included sessions on coping techniques, stress management, goal setting, mindfulness, posture and movement advice, how to manage any withdrawal symptoms and pain control after opioids.

Participants completed questionnaires about their everyday functioning and painkiller intake at intervals throughout the trial.

After one year, 29 per cent of people who took part in the intervention programme, were able to fully come off their opioids completely, compared to just 7 per cent who were treated with existing GP care, the self-help booklet and CD.

There was no difference between the two groups in terms of their pain, or how pain interfered with their lives.

Combined group and one-to-one support key to reduce opioid need

Harbinder Kaur Sandhu, Professor of Health Psychology at the University of Warwick, who led the clinical trial said: “Structured, group-based, psycho-educational self-management interventions help people to better manage their daily lives with a long-term condition, including persistent pain, but few of these have specifically targeted patients considering opioid withdrawal.

“The findings from the trial are extremely promising. Many people who have been taking prescription painkillers over a long period time suffer with harmful side effects but can feel reluctant to come off them because they think it could make their pain worse, or they do not know how to approach this with their clinician.

“Our trial has found a treatment that could help people to come off opioids, in a way that is safe, supportive and gradual. It’s a supported decision between the patient and the clinician, and not forced tapering. The programme helps people to learn alternative ways to manage their pain and help overcome challenges of withdrawal and has the potential to give people an overall better quality of life.”

Opioids have little long-term impact on chronic pain

Professor Sam Eldabe, clinical trial co-lead and consultant in pain medicine at The James Cook University Hospital, said: “Our trial is the culmination of six years of work during which we learned that the harms from long term opioids extend beyond the individual into their social circle. Patients taking opioids lose interest in social interaction with family and friends and gradually withdraw from society into an opioid-induced mental fog.

“Despite appreciating the social impact of the drugs, most patients utterly dread a worsening of their pain should they attempt to reduce their opioids.

“Our study shows clearly that opioids can be gradually reduced and stopped within no actual worsening of the pain. This confirms our suspicions that opioids have very little long-term impact on persistent pain.”

Colin’s story

Colin Tysall, 81 from Coventry, was prescribed painkillers, including opioids to treat chronic back pain, as a result of working as an aircraft radiologist for 30 years.

“I was an industrial radiologist and wore my back out x-raying aircraft parts and handling heavy castings for jet engines. The castings could weigh up to 200lbs and even though we would move some of the castings around in stillages, it was still a strain. We were having to move these castings around very carefully, with no lifting equipment.”

Colin started experiencing sciatic pain down both of his legs and found that he had three slipped discs in his back. He describes the devastating impact of painkiller dependency:

“The treatment at the time was bedrest and painkillers. The tablets got stronger and stronger until eventually I was prescribed opioids,” said Colin.

“I spent so much time in bed that I lost the use of my legs and fell into a deep depression, so I was prescribed antidepressants too. I couldn’t look after my family, and at one point I tried to take my own life.

“I didn’t like being on tablets. They addled my brain, they made it difficult to think straight, my brain wasn’t functioning as it should. I would have nightmares a lot. As soon as I could come off them, I did.”

After spending 10 years visiting hospital to treat his back and mental health, Colin turned to alternative treatments to treat his pain.

“I found that the best treatment for me was exercise. I got involved with mental health self-health groups, and I became friends with people experiencing similar problems. We would walk and talk together, which was the opposite of the guidelines at the time, but I found it helped keep my mind off the pain, and it made it easier to cope.”

After spending a couple of years tapering his medication to a lower level, Colin was eventually able to come off the tablets altogether. Recently he has found that he is no longer suffering with the pain.

Colin retrained as an associate mental health manager, and he continues to work at Coventry and Warwick universities helping to train psychiatric and nursing students.

Most recently, Colin got involved with the University of Warwick’s Clinical Trials Unit and has been helping support patients in the I-WOTCH clinical trial group support sessions as a trained I-WOTCH lay person.

The full intervention programme consisted of an 8-to-10-week course and included: 

• Group support sessions 

The group sessions consisted of three full day sessions per week. The group sessions included education about opioids and pain, case studies of people who have successfully tapered, learning self-management skills for pain and challenging beliefs. There was also the opportunity to practice techniques such as mindfulness and distraction. The group sessions were facilitated by a trained I-WOTCH nurse and a trained I-WOTCH lay person (someone who had personal experience of pain and opioid tapering).  

• Tailored one-to-one support and opioid tapering

In addition to the group sessions, people in the study were also given one-to-one sessions with the nurse to offer support and most importantly tailored advice for the opioid tapering which was delivered face-to-face and through telephone calls. A tapering app designed for the study was used to calculate a reduction on opioid intake based on current guidance at that time and actioned by the participants’ GPs. 

ENDS 

Notes to Editors

Further quotes:

Professor Roger Knaggs, President of the British Pain Society said: “Opioids are effective medicines for some types of pain including pain after an operation or in the last few days of life. However, it is now apparent that they are much less effective for many people who have been taking them for other types of long-term pain such as back and joint pain.

“The I-WOTCH study is one of the largest studies investigating how best to work collaboratively with people prescribed opioids who wish to reduce their dose. It has demonstrated that with support many people are able to stop taking opioids without affecting their pain intensity. The study demonstrates the importance of a holistic approach with group education sessions including people with lived experience and an individualised tapering plan to improve the outcomes and success of the intervention.

“With so many people prescribed opioids in the UK and throughout the world, the results of the i-WOTCH study have the potential to influence clinical practice in this field.” (Roger was not part of the study but sat on the trail’s steering committee which ensures the study adhere’s to protocol).

Harbinder K. Sandhu et al. Reducing Opioid Use for Chronic Pain With a Group-Based Intervention: A Randomized Clinical Trial. JAMA, 23^rd May 2023. DOI: 10.1001/jama.2023.6454

*Data cited from the following sources: There are 1 million people at risk from longer term continuous opioid prescriptions (NHS BSA, Dec 2022). We have 56,872 people who have been prescribed high-dose opioids for longer than 6 months (NHS BSA, April 2023)

There are approximately 15.5 million people who live with chronic long-term pain in England, which is defined as pain lasting for three months or more. Recent data shows that over 1 million people were prescribed an opioid in 2022 with over 800,000 people being prescribed moderate or high doses of opioids for six months or more. (Data cited from Versus Arthritis)

The I-WOTCH study was funded by the National Institute of Health Research (NIHR) Health Technology Assessment (project number 14/224/04).

About the National Institute for Health and Care Research

The mission of the National Institute for Health and Care Research (NIHR) is to improve the health and wealth of the nation through research. We do this by: 

• Funding high quality, timely research that benefits the NHS, public health and social care; 
• Investing in world-class expertise, facilities and a skilled delivery workforce to translate discoveries into improved treatments and services; 
• Partnering with patients, service users, carers and communities, improving the relevance, quality and impact of our research; 
• Attracting, training and supporting the best researchers to tackle complex health and social care challenges; 
• Collaborating with other funders, charities and industry to help shape a cohesive and globally competitive research system; 
• Funding applied global health research and training to meet the needs of the poorest people in low and middle income countries. 

NIHR is funded by the Department of Health and Social Care. Its work in low and middle income countries is principally funded through UK Aid from the UK government.  

https://www.nihr.ac.uk/

Newswise — Reforms to New Jersey’s Medicaid program successfully spurred ongoing increases in buprenorphine prescriptions for the treatment of opioid addiction, according to a Rutgers analysis.

Although medications such as buprenorphine effectively combat opioid addiction, less than 30 percent of potential users receive them nationwide. New Jersey sought to increase prescription numbers with three Medicaid reforms that took effect in 2019. The reforms:

• Removed prior authorization requirements for buprenorphine prescriptions
• Increased reimbursement rates for in-office opioid addiction treatment
• Established regional centers of excellence for addiction treatment

Medicaid records showed steady increases in buprenorphine prescriptions before 2019, but the rate of growth increased by 36 percent after the reforms took effect, and this increased rate of growth persisted until the end of the study period in December 2020.

A similar trend affected caregiver behavior. The percentage of caregivers prescribing buprenorphine had been rising before the reforms took effect, but it increased faster after their implementation.

New Jersey also experienced faster growth in buprenorphine prescriptions to Medicaid patients than did other states, the analysis reported, a strong indication that the boosts stemmed from the state’s reforms rather than some unrelated nationwide trend.

The only disappointment came from the study’s measurement of long-term usage. The percentage of buprenorphine prescriptions that remained active for more than 180 days didn’t rise during the study period.

“Usage remains far below the ideal where virtually everyone battling opioid addiction receives an effective medical treatment like buprenorphine,” said Peter Treitler, research project manager for the Rutgers Institute for Health, Health Care Policy and Aging Research and lead author of the analysis published in JAMA Network Open. “However, our analysis suggests these reforms may get us to that point years before we would have reached it under the previous policies.”

Buprenorphine — a once-daily prescription pill sold in the United States as Suboxone, Zubsolv and Sublocade — works in two ways. First, it binds to the same brain cells as drugs such as opium, heroin, morphine, oxycodone and fentanyl. Once it’s in place, those other drugs struggle to dislodge it, bind to the target cells and produce addictive highs. Second, it stimulates a milder effect that reduces cravings for those other drugs and prevents withdrawal symptoms.

Regulators once placed extra restrictions on buprenorphine prescriptions because they worried its mood-altering effects would create more addicts than it cured. These restrictions, which forced caregivers to justify each new buprenorphine prescription at length and investigated providers who prescribed the drug “too often,” led many to avoid prescribing the drug at all, said Treitler, who added Medicaid’s low reimbursement rates for office-based addiction treatment further reduced buprenorphine availability to poor patients.

Regulators have relaxed many restrictions on buprenorphine because opioid addiction has increased. Recent research has shown buprenorphine to be both safer and more effective than previously thought. The reforms to New Jersey’s Medicaid program further reduced barriers to medication usage among its patients.

“They looked at what obstacles were blocking the usage of a valuable drug in this particularly underserved patient population,” Treitler said. “They removed several of the biggest obstacles. And the results so far suggest they’re getting the desired results.”

Indeed, the positive numbers seen in initiatives such as the one undertaken by New Jersey’s Medicaid program may finally be affecting the most important number of all: overdose deaths. After several decades of speedy increases, overdoses nationwide rose by just 500 in 2022.

The trend was even better in New Jersey. Total overdose deaths fell by 232 from 2021 to 2022, and they were 93 lower in the first three months of 2023 than in the first three months of 2022.