The Case for Prescribing Extended-Release Buprenorphine for Youth

This is an exclusive BHB+ story

Extended-release medications to treat opioid use disorders (XR-MOUD) are highly effective. Still, the medications are consistently underutilized, despite being proven to help with treatment adherence. 

Providers and researchers see significant potential for XR-MOUD treatment among adolescent patients. While daily sublingual tablets of the MOUD, buprenorphine, are approved for use in patients as young as 16, a lack of data, efficacy and clinician hesitancy have largely prevented the adoption of extended-release versions to treat adolescents. Meanwhile, youth OUD diagnoses are rising.

As of now, extended-release buprenorphine is only approved for adults 18 and older. But promising data from a study led by researchers at the Children’s National Hospital Addictions Program and Howard University Hospital might be the first stepping stones to change that.

For patients between 12 and 19, a group that is constantly inundated with the busyness of school, socialization and other activities, prescriptions for extended-release MOUDs could be beneficial, relieving them from having to remember one more thing: to take a daily dose.

Pushing through the pushback

Between 2019 and 2021, drug overdose deaths increased by 109% among adolescents, according to data from the Centers for Disease Control and Prevention. Nearly all of those deaths – 90% – involved an opioid, with 73% attributed to illicitly manufactured fentanyl.

That’s exactly what Dr. Sivabalaji Kaliamurthy, attending physician and director of the addictions program at Children’s National Hospital in Washington, D.C., saw too: an abundance of children with a fentanyl addiction.

“These are kids and families who are motivated to do whatever it takes to enter recovery and stay in recovery, but just like adults, kids often have challenges,” Kaliamurthy told Behavioral Health Business. “We started thinking, what is one way to help them stay in recovery? That’s when XR-buprenorphine then becomes reasonable.”

The hospital has one of the only pediatric addiction programs in the country. It’s an outpatient clinic that meets the level one treatment standards of the American Society of Addiction Medicine Criteria. With that backing, Kaliamurthy moved forward to pilot a small-scale study of just six patients between 15 and 17 years old who had OUDs. The first opiate these children reported trying was fentanyl and their preferred method was smoking it.

Throughout treatment, each of the adolescents received monthly injections of extended-release buprenorphine.

“When we initially were sitting down trying to get it approved through Medicaid or commercial insurance, the challenge was often met with ‘Hey, what is this? There’s no safety data on this. There’s no efficacy data on this,’” Kaliamurthy said. “For this population of kids, it took a lot of pushback from our side because we knew the alternative is that these kids continue to use fentanyl – and of course, there’s no safety there either.”

Typically, use of extended-release MOUDs is reserved for patients after several other interventions have failed, but the medications lead to higher rates of opioid abstinence compared to standard care, he explained.

At three months into the small-scale study, there was a 60% retention rate in medication adherence. By the end of the 13-month research period, five of the six patients achieved opioid abstinence for longer than two months.

“One intervention is significantly better than no intervention and there’s no reason we shouldn’t be offering it to kids,” Kaliamurthy said. “What are the long-term consequences of children being on injections? One thing is, they’re alive. But we also don’t know what the neurological consequences are. Ideally, I would love it if I could get them to recovery without using an opioid agonist, per se, but again, in the real-world setting, that idealism does not really translate.”

Payer resistance has gone down, he said, even though some prior authorization issues still remain an issue.

Another barrier to lowering access to extended-release MOUD for youth treatment is that most pediatric systems are not even set up to meet the requirements set forth by the DEA to prescribe or store these controlled medications.

“Whatever policymakers can do to make it easier to access it in a timely manner, that’s the key here,” Kaliamurthy said. “Because those windows of opportunity where we have kids who are willing to accept injection as an intervention, which is very difficult for them, is narrow. If we miss that – it may take a while for that window to open up again. We are trying to keep them safe, trying to reduce any harms associated with their drug use. It’s challenging. So anything that can be done to reduce that barrier in a safe manner would be helpful, absolutely.”

New models of OUD intervention for youth and young adults

Not too far away from Children’s National Hospital, in Maryland two physicians at the Maryland Treatment Centers have been exploring new, assertive models of treatment for youth and young adults between 18 and 28.

Dr. Marc Fishman, the center’s medical director, and Dr. Kevin Wenzel, a clinical psychologist and the center’s director of research, developed the Youth Opioid Recovery Support (YORS) intervention. It’s a novel approach that combines MOUD – often extended-release forms – assertive outreach and intensive family involvement in the patient’s recovery.

Their recent study involved 53 patients – 35 of whom received their unique YORS intervention and 17 who received treatment as usual – over six months.

Medication adherence to extended-release MOUDs was higher for youth in the novel intervention group than for those receiving traditional treatment. Significantly, 94% of youth in the YORS intervention group had family members in their case who participated in family sessions throughout the six months.

All of these factors showed “a large and significant effect on XR-MOUD adherence, with [young adults] in the intervention receiving significantly more doses than [treatment as usual],” according to the conclusion.

“What’s the problem with treatment as usual? Why do we need to develop new models of care and new interventions for young people with OUDs? Unfortunately, treatment as usual fails many people,” Wenzel said during a presentation at the ASAM Conference in April. “It’s very difficult to retain youth in treatment for OUD. So even if they’re one of the lucky ones that start medications, it doesn’t necessarily mean that they’ll come back – and their trajectories may be chaotic. Unfortunately, relapses and overdose deaths do happen.”

Involving family members or caregivers in care is not the norm or standard of care for OUD treatment, but it yields better results, he explained. Giving a family member a role in treatment planning and strategies for effective communication with the patient can be a helpful influence. This is particularly true for an age cohort in which mental health issues sometimes begin to emerge simultaneously with substance use disorders.

“It’s hard to navigate the treatment system. There are different levels of care. There are all of these different medicines. What’s IOP? How many times do I have to go? It’s not intuitive. Episodic care is the norm,” Wenzel said. “All of this points us in the direction of maybe we do need new, innovative models that take into account all these types of barriers.”

The Maryland Treatment Centers are next pursuing a randomized trial to see outcomes from their YORS model with the use of extended-release buprenorphine in adolescents under 18, contributing more data to the body of work Kaliamurthy and Children’s National Hospital have started. The more data revealing outcomes and efficacy, the more the field may be able to move toward uptake of extended-release MOUDs for treating youth and saving lives, Fishman explained.

“Safety is an important thing to think about. Is this safe for young people?” Fishman said. “We just don’t have the data that we would like about longer-term outcomes for extended-release buprenorphine treatment. But it is especially exciting to think about the possibility of utilizing extended-release buprenorphine as a tool with the very, very compelling evidence that exists for its use in older adults with superior efficacy.”