History of traumatic brain injury linked to higher rates of prescription opioid use and misuse
Evidence bolsters 'Perfect Storm' of opioid risks after TBI, reports special issue of JHTR
Peer-Reviewed PublicationSeptember 7, 2021 – Adults with a history of traumatic brain injury (TBI), even years previously, are at increased risk of use and misuse of prescription opioid medications, reports a study in the September/October special issue of the Journal of Head Trauma Rehabilitation (JHTR). The official journal of the Brain Injury Association of America, JHTR is published in the Lippincott portfolio by Wolters Kluwer.
After adjustment for other factors, "[P]ersons with TBI compared to those without had over 52 percent increased risk for using prescription opioids in the past year, and over 65 percent increased risk for prescription opioid misuse," according to the report by Rachel Sayko Adams, PhD, MPH, of Brandeis University, Waltham, Mass. The JHTR special issue presents eight invited research papers providing evidence for the hypothesis linking a history of TBI to a unique pattern of increased vulnerability to pain and other interrelated risks for opioid use and its potential consequences, including overdose.
New data support 'Perfect Storm' hypothesis of opioid risks after TBI
The study included data on nearly 3,500 participants from a 2018 study of health risks among adults in Ohio. Overall 22.8 percent of participants said they had at least one TBI sometime in their lives. Of these individuals, more than two-thirds had had a TBI with loss of consciousness, most before age 20.
One-fourth of participants (25.5 percent) reported using a prescription opioid in the past year. About three percent met criteria for prescription opioid misuse – defined as using opioids more frequently or in higher doses than prescribed and/or using a prescription opioid not prescribed to the respondent. (The study did not address use of illicit opioids, such as heroin, following TBI – a gap in knowledge requiring further research.)
Participants with a history of TBI were more likely to report prescription opioid use in the past year: 30.9 percent, compared to 23.9 percent of those without a TBI history. After controlling for demographic factors (sex, age, race/ethnicity, and marital status), history of TBI was associated with a 52 percent increase in the odds of prescription opioid use and a 65 percent increase in the odds of prescription opioid misuse.
The findings support the hypothesis – outlined by Dr. Adams and other TBI researchers, in a paper published last year – that persons with a history of TBI face a three-phase "Perfect Storm" of increased opioid risks:
- Phase I: Greater exposure to opioids related to pain and other factors following TBI
- Phase II: Greater likelihood of progression to long-term opioid treatment, opioid misuse, or diagnosed opioid use disorder (OUD)
- Phase III: Greater barriers to successful treatment for patients with TBI who develop OUD.
These "cascading vulnerabilities" may combine to lead to potential consequences of opioid misuse and OUD, including increased risk for overdose and suicide.
The special issue papers add to the growing body of evidence that persons with a history of TBI are more likely to be treated with prescription opioids (Phase I), in both civilian and military settings. Some papers provide new evidence that a history of TBI is associated with increased odds of opioid misuse (Phase II), in adolescents as well as adults. So far, there have been few studies investigating if TBI leads to increased obstacles to OUD treatment (Phase III).
Persons with TBI are at increased risk for pain, which is thought to be an important driver of their increased opioid risks. One of the new studies finds that opioids are more likely to be prescribed for patients with comorbid pain and/or psychological health conditions after TBI. Previous research has found that alcohol or drug use is a risk factor for TBI, and persons with TBI are at elevated risk for substance use after injury. The new studies in the special issue suggest that prescription opioid use follows a similar cyclical pattern with TBI as alcohol or other drugs.
"Empirical investigation into each element of the 'perfect storm' is needed to identify treatment targets and prevention opportunities," Dr. Adams writes in an introduction to the special issue. She and her colleagues believe that substance use treatment providers need to be trained to screen for and address problems related to a history of TBI, while rehabilitation professionals treating TBI patients should perform screening for at-risk substance use.
DOI: 10.1097/HTR.0000000000000729
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About The Journal of Head Trauma Rehabilitation
The Journal of Head Trauma Rehabilitation is a leading, peer-reviewed resource that provides up-to-date information on the clinical management and rehabilitation of persons with traumatic brain injuries. Six issues each year aspire to the vision of “knowledge informing care” and include a wide range of articles, topical issues, commentaries and special features. It is the official journal of the Brain Injury Association of America.
About the Brain Injury Association of America
The Brain Injury Association of America is the country’s oldest and largest nationwide brain injury advocacy organization. Our mission is to advance awareness, research, treatment and education and to improve the quality of life for all individuals impacted by brain injury. Through advocacy, we bring help, hope and healing to millions of individuals living with brain injury, their families and the professionals who serve them.
About Wolters Kluwer
Wolters Kluwer (WKL) is a global leader in professional information, software solutions, and services for the clinicians, nurses, accountants, lawyers, and tax, finance, audit, risk, compliance, and regulatory sectors. We help our customers make critical decisions every day by providing expert solutions that combine deep domain knowledge with advanced technology and services.
Wolters Kluwer reported 2020 annual revenues of €4.6 billion. The group serves customers in over 180 countries, maintains operations in over 40 countries, and employs approximately 19,200 people worldwide. The company is headquartered in Alphen aan den Rijn, the Netherlands.
Wolters Kluwer provides trusted clinical technology and evidence-based solutions that engage clinicians, patients, researchers and students in effective decision-making and outcomes across healthcare. We support clinical effectiveness, learning and research, clinical surveillance and compliance, as well as data solutions. For more information about our solutions, visit https://www.wolterskluwer.com/en/health and follow us on LinkedIn and Twitter @WKHealth.
For more information, visit www.wolterskluwer.com, follow us on Twitter, Facebook, LinkedIn, and YouTube.
JOURNAL
Journal of Head Trauma Rehabilitation
DOI
First-in-human clinical trial for a vaccine to treat opioid use disorders enrolls first patients
The vaccine has been developed by researchers at the University of Minnesota Medical School
Business AnnouncementMINNEAPOLIS/ST. PAUL (09/07/2021) — The first patients have been enrolled in a phase 1 randomized placebo-controlled clinical trial to study a therapeutic vaccine for opioid use disorder developed by researchers at the University of Minnesota Medical School.
Funded by a grant from the National Institutes of Health, the trial will test the safety and potential efficacy of a vaccine that is designed to selectively prevent the euphoric and toxic effects of oxycodone.
Volunteers for the trial are being enrolled at Columbia University in New York City and Clinilabs Drug Development Corporation, based in Eatontown, New Jersey.
Marco Pravetoni, PhD, a leading expert of biologics for the treatment of substance use disorders and developer of the vaccine candidate, is an associate professor of pharmacology and medicine at the University of Minnesota Medical School. His laboratory led the development of a series of vaccines and monoclonal antibodies effective in counteracting respiratory depression (depressed breathing) and bradycardia (depressed heart rate) induced by oxycodone, fentanyl and heroin in preclinical studies, as published in the Journal of Pharmacology and Experimental Therapeutics and the Journal of Medicinal Chemistry.
The vaccine currently being tested stimulates the body’s immune system to produce antibodies to oxycodone. If someone who has been vaccinated takes oxycodone, those antibodies would bind to the drug molecule, stopping it from entering the brain and, ultimately, preventing the “high” produced by the drug. Because of its selectivity for oxycodone, the vaccine will not interfere with FDA-approved medications, including methadone, buprenorphine, naltrexone and naloxone, potentially offering a long-lasting, safe and cost-effective alternative that is complementary to standard medical intervention for opioid use disorders.
“In this study, my laboratory will conduct pharmacokinetic and immunological monitoring in blood samples from immunized volunteers to ensure that they are making antibodies to oxycodone and determine whether or not the antibodies are preventing the drug from reaching the brain,” said Pravetoni, who is also a member of the U of M Medical School’s Medical Discovery Team on Addiction.
Sandra Comer, PhD, director of the Opioid Laboratory in the Division on Substance Use Disorders in the Department of Psychiatry at Columbia University Vagelos College of Physicians and Surgeons, is the principal investigator of the study. Comer will oversee a team of physicians and nurses led by Jeanne Manubay, MD, the study’s medical director, who is monitoring the patients’ response to the vaccine, including their subsequent drug use and behaviors. She has nearly three decades of experience in developing medications for treating opioid and other substance use disorders and provides overall scientific and regulatory oversight of the clinical trial.
“This medication approach is unique in that it can be used alone or in combination with other treatment medications and, importantly, may offer patients long-lasting protection against overdose if they relapse to opioid use,” Comer said. “The long-term goal of this program is to develop a series of opioid vaccines that target other commonly used opioids, such as heroin and fentanyl. We are very excited about this research and hope to eventually provide a safe, new treatment option for patients with opioid use disorder.”
The study seeks volunteers who:
Are between the ages of 18-59;
Are currently using opioids and not seeking treatment for drug use; and,
Have prior experience with intranasal opioid use.
The study plans to enroll up to 45 volunteers. Volunteers will be closely monitored for several weeks on inpatient units at Columbia University Irving Medical Center and at Clinilabs to look for adverse events and determine their response to oxycodone after vaccination, before studying their drug behavior on an outpatient basis.
“Clinilabs is privileged to be working with the University of Minnesota Medical School and Columbia University on this groundbreaking trial. Exploring a preventative vaccine to treat opioid use disorder has the potential to be life-altering for patients and their families who are battling opioid abuse,” said Gary Zammit, Clinilabs’ President and CEO.
To learn more about the study or to review the volunteer qualifications, call 646-774-6243 or visit https://recruit.cumc.columbia.edu/clinical_trial/2168.
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Research reported in this press release was supported by The National Institute on Drug Abuse of the National Institutes of Health under award number UG3DA047711. The total project cost is financed with federal dollars. The content of this press release is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
About the University of Minnesota Medical School
The University of Minnesota Medical School is at the forefront of learning and discovery, transforming medical care and educating the next generation of physicians. Our graduates and faculty produce high-impact biomedical research and advance the practice of medicine. We acknowledge that the U of M Medical School, both the Twin Cities campus and Duluth campus, is located on traditional, ancestral and contemporary lands of the Dakota and the Ojibwe, and scores of other Indigenous people, and we affirm our commitment to tribal communities and their sovereignty as we seek to improve and strengthen our relations with tribal nations. For more information about the U of M Medical School, please visit med.umn.edu.
Photos and videos from the Pravetoni Lab are available for media use. Credit should be given to Lisa Anderson, University of Minnesota Medical School.
METHOD OF RESEARCH
Randomized controlled/clinical trial
SUBJECT OF RESEARCH
People
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