A team of researchers, led by Lisa Marsch, PhD, at Dartmouth’s Geisel School of Medicine, has received a four-year $13-million grant from the National Institute on Drug Abuse (NIDA) to conduct the first-ever multisite clinical trial evaluating long-acting medication in the treatment of opioid use disorder among adolescents.
“We’ve seen a big spike in recent years in the number of youth and teens who are overdosing from opioids, and it has, increasingly, involved fentanyl, which is more potent than heroin,” says Marsch, the Andrew G. Wallace Professor at Geisel, and a professor of psychiatry and of biomedical data science, who directs the Center for Technology and Behavioral Health at Geisel.
“And while we’ve known for some time that buprenorphine is a safe and effective treatment for opioid use disorder, we don’t yet have the data to understand what our best practices are for treating the disorder in this really young and emerging cohort, and in this era of fentanyl,” she explains. Along with Marsch, other lead investigators on the project include Marc Fishman, MD, from Maryland Treatment Centers and the Johns Hopkins University School of Medicine, and Edward Nunes, MD, from the New York Node of NIDA’s Clinical Trials Network.
To help them establish guidelines for clinical care for teens, the researchers will conduct a randomized controlled trial evaluating the effectiveness of the long-acting version of buprenorphine compared to the daily version of the medication—during the 24-week treatment period.
For the study, the team will recruit 200 adolescents (age 14-21 years) with moderate-to-severe opioid use disorder from five sites across the U.S. (to be selected in the new year) within NIDA’s national Clinical Trials Network.
“One of the benefits of the extended-release version of buprenorphine is it’s given once a month, instead of every day, so it generally can keep people stabilized for about a month,” says Marsch. “We’re optimistic that this formulation of the medication might help people stay engaged in treatment longer.”
In addition to doing structured clinical assessments, the study will also use what’s known as ecological momentary assessment (EMA)—brief queries delivered via a secure smartphone app (in five bursts over 12 months)—to assess in-the-moment predictors of opioid use, including stress, self-regulation, sleep, craving or withdrawal symptoms, mood, and substance use risk.
“This will allow us to get a really rich picture of what the daily lives of this group of teens are like,” says Marsch, “to help us better understand how we can assist them in building resilience and change the self-defeating patterns of drug taking.”
The research team is hopeful that if the data shows that their approach is safe and effective, in engaging youth and stabilizing them as part of treating opioid disorder, it can be scaled up as a best-practice model for providers to use across the country. They also hope to work with the U.S. FDA to get a pediatric indication on the label of the medication, to go as low as age 14 for providing this type of medication for youth.
“We’re delighted about NIDA’s support in doing this work,” says Marsch. “I think it’s important to point out that we’re focused, not just on taking models that have worked for adults and doing them with youth, but making it youth centric. It’s about how we can provide a supportive environment that’s widely accessible but not burdensome, stigmatizing, or punitive. We want to meet the teens where they are, so they feel like this model is crafted for them and personalized in a way for their experiences.”
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Method of Research
Randomized controlled/clinical trial
Subject of Research
People