The United States faces a major opioid epidemic. Thousands of people die each year from an opioid overdose. Historically, the only treatments for opioid use disorder (OUD) were abstinence, which has a 90 percent failure rate, or methadone, which must be provided in a specialty addiction clinic. In 2000, legislation was passed that allowed trained primary care providers to treat OUD and addiction in their own practices with buprenorphine. Medication-assisted treatment (MAT) with buprenorphine, a long-term treatment, is increasingly available in primary care offices. MAT includes three major phases: induction, stabilization, and maintenance. For induction, a person with OUD must stop using opioids and be in active withdrawal for buprenorphine to be effective. If the person is not in withdrawal, serious side effects, such as nausea, vomiting, tremor, and dysphoria, can occur. The recommended MAT induction has been at the primary care office, where withdrawal can be confirmed and patients can be monitored and benefit from connections with nurses, physicians, peer counselors, and other staff.
However, timing withdrawal to coincide with office hours can be difficult, and office induction requires considerable practice resources. More recently, patients have been offered induction at home, where they determine when they are in adequate withdrawal and start buprenorphine on their own schedule. However, many people suffering from OUD may not have a comfortable home or the social connections often necessary for successful MAT. Although both home and office induction can be safe and effective, there is an evidence gap around which induction method is better—and for which patients. Our community advisory councils (CACs), practices, and stakeholders have asked, “Which MAT induction method is better: home or office? Do certain patients do better with one method or the other?” These are important questions, because successful induction provides the foundation for transition to stabilization, long-term maintenance, and improved quality of life. Without a successful induction, patients may not have the resources and motivation to continue through the disruptive stabilization phase and reach long-term maintenance. Guided by our CACs, patients, and providers, we will conduct a comparative effectiveness research study to compare short- and long-term patient-centered outcomes of home versus office-based induction.
This randomized trial in primary care practice–based research networks will offer a pragmatic approach to answering these important questions in a real-world setting. Results will provide valuable evidence for patients and providers to consider as they determine their treatment options. Our active CACs will help develop patient recruitment materials, finalize our social determinant and quality-of-life measurement tools, and interpret and disseminate findings. These community groups have been involved in all aspects of our current MAT for OUD work and are eager to continue asking and answering questions that will help their communities suffering from this opioid epidemic. MAT induction is a disruptive activity for patients and practices; this study aims to better equip primary care practices to offer MAT for their patients.
Other Clinical Interventions
Other Health Services Interventions
Training and Education Interventions
*All proposed projects, including requested budgets and project periods, are approved subject to a programmatic and budget review by PCORI staff and the negotiation of a formal award contract.