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IMPORTANCE: Few primary care (PC) practices treat patients with medications for opioid use disorder (OUD) despite availability of effective treatments. OBJECTIVE: To assess whether implementation of the Massachusetts model of nurse care management for OUD in PC increases OUD treatment with buprenorphine or extended-release injectable naltrexone and secondarily decreases acute care utilization. DESIGN, SETTING, AND PARTICIPANTS: The Primary Care Opioid Use Disorders Treatment (PROUD) trial was a mixed-methods, implementation-effectiveness cluster randomized clinical trial conducted in 6 diverse health systems across 5 US states (New York, Florida, Michigan, Texas, and Washington). Two PC clinics in each system were randomized to intervention or usual care (UC) stratified by system (5 systems were notified on February 28, 2018, and 1 system with delayed data use agreement on August 31, 2018). Data were obtained from electronic health records and insurance claims. An implementation monitoring team collected qualitative data. Primary care patients were included if they were 16 to 90 years old and visited a participating clinic from up to 3 years before a system’s randomization date through 2 years after. INTERVENTION: The PROUD intervention included 3 components: (1) salary for a full-time OUD nurse care manager; (2) training and technical assistance for nurse care managers; and (3) 3 or more PC clinicians agreeing to prescribe buprenorphine. MAIN OUTCOMES AND MEASURES: The primary outcome was a clinic-level measure of patient-years of OUD treatment (buprenorphine or extended-release injectable naltrexone) per 10 000 PC patients during the 2 years postrandomization (follow-up). The secondary outcome, among patients with OUD prerandomization, was a patient-level measure of the number of days of acute care utilization during follow-up. RESULTS: During the baseline period, a total of 130 623 patients were seen in intervention clinics (mean [SD] age, 48.6 [17.7] years; 59.7% female), and 159 459 patients were seen in UC clinics (mean [SD] age, 47.2 [17.5] years; 63.0% female). Intervention clinics provided 8.2 (95% CI, 5.4-∞) more patient-years of OUD treatment per 10 000 PC patients compared with UC clinics (P = .002). Most of the benefit accrued in 2 health systems and in patients new to clinics (5.8 [95% CI, 1.3-∞] more patient-years) or newly treated for OUD postrandomization (8.3 [95% CI, 4.3-∞] more patient-years). Qualitative data indicated that keys to successful implementation included broad commitment to treat OUD in PC from system leaders and PC teams, full financial coverage for OUD treatment, and straightforward pathways for patients to access nurse care managers. Acute care utilization did not differ between intervention and UC clinics (relative rate, 1.16; 95% CI, 0.47-2.92; P = .70). CONCLUSIONS AND RELEVANCE: The PROUD cluster randomized clinical trial intervention meaningfully increased PC OUD treatment, albeit unevenly across health systems; however, it did not decrease acute care utilization among patients with OUD. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03407638

Neonatal ICU (NICU) hospitalizations provide opportunities to engage individuals/families who smoke with evidence-based cessation treatments to protect infants from tobacco smoke exposure. The aim of this pilot study was to establish the feasibility and potential efficacy of providing motivational advice and NRT (MA + NRT) to families of NICU infants. RCT methodology equally allocated participants who reported ≥1 household smoker (N = 32) from a large NICU to MA + NRT or referral to a Quitline. The primary outcome was accepting NRT patches (MA + NRT) and use of NRT. Bayesian analyses modeled NRT use as a function of treatment group. Most MA + NRT participants (81.3%; n = 13) accepted the patches. No Quitline participants called the Quitline. NRT use differed across groups, indicating a 0.907 posterior probability that a positive effect for MA + NRT exists (RR = 2.32, 95% CI = [0.68–11.34]). This study demonstrated feasibility and acceptability for offering NRT and motivational advice to NICU parents and supports further intervention refinement with NICU families.

Methamphetamine (MA) use is marked by high rates of comorbid tobacco smoking, which is associated with more severe drug use and worse clinical outcomes compared to single use of either drug. Research has shown the combination of naltrexone plus oral bupropion (NTX-BUP) improves smoking cessation outcomes in non-MA-using populations. In the Accelerated Development of Additive Pharmacotherapy Treatment (ADAPT-2) study, NTX-BUP successfully reduced MA use. Our aim in this secondary data analysis was to examine changes in cigarette smoking among the subgroup of participants reporting comorbid tobacco use in the ADAPT-2 trial.

•Positive treatment effects have been found for ACT and DBT with substance abusers.•Significant emphasis is placed on understanding treatment mechanisms for ACT and DBT.•Additional research with larger samples and active control groups is needed.