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Through the use of health surveys, the STOP intervention hopes to identify and treat opioid use disorder early. Credit: Getty Images.

An individual treated for pain might start taking a prescribed opioid more frequently than instructed, later take a leftover opioid painkiller for an unrelated ache — or even share it with a friend. These are all examples of opioid misuse, and they may seem harmless at first. But for some people, misuse progresses to continued drug use that be can’t stopped, despite harmful consequences.

About 20% of people who misuse opioids take this route and develop moderate to severe opioid use disorder, according to Jennifer McNeely, M.D., a primary care physician and addiction medicine specialist at New York University.

Treatment guidelines are clear for these individuals: Research shows that use of medications for opioid use disorder (like buprenorphine or methadone) work well to help people with moderate to severe cases. But that’s not so for people who misuse opioids but haven’t yet developed addiction, presenting a clear unmet medical need.

“The other 80% we know very little about,” she said. “What drives their opioid use? What makes things get better or worse? What is their risk of overdose?”

Researchers want to know more about that 80% — individuals who misuse opioids and aren’t yet addicted but are at high risk for progressing to a more severe opioid use disorder. McNeely and her colleague Jane Liebschutz, M.D., M.P.H., of the University of Pittsburgh are co-leading a study to test whether an experimental intervention can stop this group from progressing from misuse to moderate to severe opioid use disorder.

Their research is part of the Helping to End Addiction Long-term® Initiative, or NIH HEAL Initiative®, and its effort to find new strategies to prevent and treat opioid addiction.

The STOP Intervention

The researchers are conducting a study called the Subthreshold Opioid Use Disorder Prevention (STOP), which will take place in primary care clinics in New Hampshire, Pennsylvania, Maryland, Ohio, and Utah. It is a novel, much-needed approach to integrate primary care with diagnosis and treatment of opioid misuse, toward preventing progression to moderate or severe opioid use disorder.

The intent is to help people make changes in health behaviors focused on drug use. “We’re trying to do this before the brain chemistry has changed drastically — to intervene before a substance use disorder appears,” McNeely explains.

The STOP intervention consists of three parts. First, primary care providers talk to patients about their opioid use. After the medical visit, patients watch a short “video doctor” giving the same advice. Second, a telephone behavioral health coach conducts two to six sessions with each patient, discussing personal motivations and strategies for making changes related to their opioid use. Finally, a nurse care manager at the primary care clinic is available to the primary care provider and to the patient to work on individual health care needs (including opioid use) for a year.

During that time, participants will respond to monthly surveys about their health behaviors, as well as quarterly assessments, to see whether people receiving the STOP intervention use opioids less frequently.

Through the STOP intervention, scientists will learn whether helping people to recognize opioid misuse, understand its risks, and receive support for making changes, may help them to reduce their use and limit the progression to a more severe opioid use disorder.

According to McNeely, perhaps the biggest challenge of this study is finding people who misuse opioids but do not have moderate to severe opioid use disorder. Many may not realize their misuse is a problem, or they may be embarrassed or scared to bring it up. Most patients do not volunteer this kind of information to their doctors.

But many people will disclose opioid misuse if they are directly asked about it — particularly if they are asked via a self-completed questionnaire. The STOP intervention screens patients through a set of computer surveys that ask about lifestyle and habits, including misuse of opioids. Those who report misuse of opioids and who don’t have symptoms of moderate-severe opioid use disorder will be invited to join the study.

The researchers hope to recruit about 60 primary care providers and 480 of their patients to participate in the study. The primary care providers will be randomly assigned to either offer the STOP intervention to participants or a control “intervention:” a video and pamphlet with general health information, along with information about drug overdose.

Power of Collaborative Care

The STOP intervention is based on collaborative care: a health care model already in use to support people with mental health and other conditions. Another NIH HEAL Initiative project is studying the use of collaborative care for people who have both mental illness and opioid use disorder.

Telephone health coaches and nurse care managers can help people with many different health issues, not just opioid misuse — in fact, the researchers suspect that helping participants with other issues could also make them less interested in opioids. Some participants, for instance, may misuse opioids to help with pain. A nurse care manager can work such patients to help identify non-opioid approaches that may work to manage their pain.

“We did a pilot study to test some of the parts of the STOP intervention, and patients loved the coaching,” Liebschutz says, adding that several wanted a coach’s help with stress and depression — problems that can drive opioid misuse and potentially increase the risk of developing opioid use disorder.

This research is being conducted as part of the National Drug Abuse Treatment Clinical Trials Network, established and funded by the National Institute on Drug Abuse. This research network brings together researchers, medical and treatment providers, patients, and NIH staff to develop, test, and implement new addiction treatments. Over the last two decades, the CTN’s research has contributed to broad-reaching changes in medical practice, including the development of buprenorphine.

Funding from the NIH HEAL Initiative made it possible to expand the CTN network, which is conducting several new clinical trials. Studies include comparing two ways of taking buprenorphine for pregnant women with opioid use disorder, looking for ways to support people taking medication-based treatment, and treating opioid use disorder in Native communities.

Prevention is an important component of the NIH HEAL Initiative’s multipronged strategy to end the opioid epidemic long-term. While understanding opioid misuse is important on its own, learning how to manage it in routine healthcare encounters fills a crucial gap — so the 10 million Americans who misuse opioids never escalate to moderate/severe opioid use disorder.

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