Rationale, design and methods of VA-BRAVE: a randomized comparative effectiveness trial of two formulations of buprenorphine for treatment of opioid use disorder in veterans.

BACKGROUND: To address the US opioid epidemic, there is an urgent clinical need to provide persons with opioid use disorder (OUD) with effective medication treatments for OUD (MOUD). Formulations of sublingual buprenorphine/naloxone (SL-BUP/NLX) are considered the standard of care for OUD including within the Veterans Healthcare Administration (VHA). However, poor retention on MOUD undermines its effectiveness. Long-acting injectable monthly buprenorphine (INJ-BUP) (e.g., Sublocade®) has the potential to improve retention and therefore reduce opioid use and overdose. Designing and conducting studies for OUD pose unique challenges. The strategies and solutions to some of these considerations in designing Cooperative Studies Program (CSP) 2014, Buprenorphine for Treating Opioid Use Disorder in Veterans (VA-BRAVE), a randomized, 20-site, clinical effectiveness trial comparing INJ-BUP to SL-BUP/NLX conducted within the VHA may provide valuable guidance for others confronted with similar investigation challenges. METHODS: This 52-week, parallel group, open-label, randomized controlled trial (RCT) evaluates the comparative effectiveness of two current FDA-approved formulations of buprenorphine: (1) daily SL-BUP/NLX vs. (2) monthly (28-day) INJ-BUP for Veterans with moderate to severe OUD (n = 952). The primary outcomes are (1) retention in MOUD and (2) opioid abstinence. Secondary outcomes include measures of other drug use, psychiatric symptoms, medical outcomes including prevalence rates of HIV, hepatitis B and C as well as social outcomes (housing instability, criminal justice involvement), service utilization and cost-effectiveness. Special considerations in conducting a comparative effectiveness trial with this population and during COVID-19 pandemic were also included. DISCUSSION: The evaluation of the extended-release formulation of buprenorphine compared to the standard sublingual formulation in real-world VHA settings is of paramount importance in addressing the opioid epidemic. The extent to which this new treatment facilitates retention, decreases opioid use, and prevents severe sequelae of OUD has not been studied in any long-term trial to date. Positive findings in this trial could lead to widespread adoption of MOUD, and, if proven superior INJ-BUP, by clinicians throughout the VHA and beyond. This treatment has the potential to reduce opioid use among Veterans, improve medical, psychological, and social outcomes, and save lives at justifiable cost. Trial registration Registered at Clinicaltrials.gov NCT04375033.

Association of Symptoms of Attention Deficit and Hyperactivity with Problematic Internet Use among University Students in Wuhan, China During the COVID-19 Pandemic.

BACKGROUND: COVID-19 is still spreading worldwide and posing a threat to individuals' physical and mental health including problematic internet use (PIU). A potentially high-risk group for PIU are those with symptoms of attention deficit and hyperactivity (ADHD symptoms), because of restrictions in their physical activity levels and engagement in computer diversions requiring only short attention spans. METHODS: We used convenience sampling in a cross-sectional survey of university students from 30 universities in Wuhan, Hubei Province, China. We assessed PIU using the Internet Addiction Test and ADHD symptoms using the WHO Adult ADHD Self-Report Screening Scale. Using logistic regression and linear regression analyses we adjusted for demographic, epidemic-related and psychological covariates in models of the association between ADHD symptoms and PIU. RESULTS: Among 11,254 participants, we found a 28.4% (95% CI, 27.5%-29.2%) prevalence of PIU, relatively higher than before the pandemic. In our final logistic regression model, participants with ADHD symptoms had approximately two times the risk for PIU (OR: 2.31, 95% CI: 1.89-2.83). Similarly, individuals with depression, anxiety, insomnia, PTSD symptoms and feeling stress during the pandemic had a higher risk of PIU, while those exercising regularly during the pandemic had a lower risk. LIMITATIONS: The cross-sectional design and reliance on internet based self-reports for ADHD symptoms and PIU assessments, without direct structured interviews for validation, are limitations. CONCLUSIONS: The prevalence of PIU was high during COVID-19, and those people with ADHD symptoms and other mental illness symptoms appear to be at higher risk of PIU. Regular exercise may reduce that PIU risk and hence should be recommended during the COVID-19 pandemic.