Opioid Agonist Therapy for OUD in Primary Care vs Specialty Care

Is delivery of opioid agonist therapy for opioid use disorder (OUD) as safe and effective in primary care settings as it is in specialty care settings?

Opioid agonist therapy for OUD delivered in primary care vs specialty care may result in increased rates of abstinence from nonprescribed opioids; however, it does not result in a difference in treatment retention, quality of life, or adverse events.¹ (Strength of Recommendation: B, inconsistent or limited-quality patient-oriented evidence.)

In 2024, there were 4.8 million people living with OUD and more than 50,000 opioid-related overdose deaths in the United States.^2,3 Despite this substantial burden, only 17% of individuals with OUD received medications to manage the disorder, even though these medications reduce all-cause mortality by more than one-half.^2,4 To bridge this care gap, the provision of opioid agonist therapy in primary care could improve timely access to care in a less socially stigmatizing setting. This Cochrane review assessed the effectiveness and safety of opioid agonist therapy for OUD delivered in primary care settings compared with specialty care settings.¹

The review included seven randomized controlled trials with 1,952 adults (average age 38 years) with OUD (defined by trial-specific criteria) from the United States (five trials), France, and Ukraine.¹ Trials that included only patients who were pregnant or incarcerated were excluded. Mean follow-up was 50 weeks (range 12–104 weeks). Opioid agonist therapy was a buprenorphine-based product or methadone.

Definition of primary care and specialty care varied across studies.¹ Primary care was typically clinic-based, with medications dispensed by community pharmacies and care provided by primary care physicians, whereas specialty care included methadone maintenance treatment programs or centers specializing in drug and alcohol dependence.

Primary outcomes included treatment retention, abstinence from nonprescribed opioids, and major adverse events (eg, all-cause mortality, opioid-related mortality, all-cause hospitalizations or emergency department visits, all-cause incarceration).¹ Secondary outcomes were quality of life, patient satisfaction, and minor adverse events (eg, opioid withdrawal symptoms, fatigue, insomnia, constipation).

Low-certainty evidence showed that delivery in the primary care setting may improve abstinence from nonprescribed opioids compared with delivery in a specialty care setting (risk ratio = 1.59; 95% CI, 1.03–2.46; n = 428; five trials; number needed to treat = 5; 95% CI, 4.1–6.2).¹ Very low-certainty evidence showed no apparent differences in treatment retention (seven studies; n = 1,952) or major adverse events (one study; n = 93). Although only three studies reported patient satisfaction and the data could not be combined, the available evidence suggests that patients treated in primary care may have higher satisfaction than those treated in specialty care settings. This Cochrane review showed no difference in quality of life, all-cause mortality, or minor adverse events.

The review excluded high-risk patients such as those who were pregnant or those with comorbid alcohol or sedative use disorder, psychiatric illness, or housing insecurity, which limited generalizability.¹ In addition, included primary care practices were often not representative of typical primary care settings because they were closely connected to specialized OUD clinics or had robust integrated behavioral health services with designated care managers. Finally, differences in study design, measured outcomes, and service models produced heterogeneity across trials. Small sample sizes in some studies further reduced the precision of the estimates, thereby lowering overall certainty.