Protocol NIDA-CTN-0099: Emergency Department-Initiated Buprenorphine and Validation Network Trial (ED-INNOVATION)

Multi-site study, CTN0099 ED-INNOVATION, sponsored by the National Institute of Drug Abuse Treatment Clinical Trials Network (CTN). Study site principal investigator (PI) will be responsible for oversight of all local scientific and administrative processes and procedures required for implementation of ED-initiated buprenorphine in their ED, including use of both SL and XR BUP formulations, and conducting the randomized clinical trial (RCT). They will develop ED protocols, including site-specific standard operating procedures (SOPs) for study and if needed, will establish referral sites including developing partnerships with community opioid treatment providers and programs. They will engage their IT colleagues to ensure that the necessary reports will be available on time. They will hire the research associates (RAs) and assist with their training and supervision. In addition, they will assist in training the ED providers, physicians, advanced practice practitioners (APPs) and nurses on how to administer and prescribe both formulations of buprenorphine. They will work with the pharmacy to be sure that both formulations are in the ED pyxis or easily accessible to the ED providers. They will ensure that all study forms are completed accurately during the baseline index visit, as well as at the 7- and 30-day assessments. They will be responsible for all the local CQI and monitoring of the research protocol and ensuring quality, and for securing initial and ongoing Institutional Review Board (IRB) approval utilizing the single IRB. Activities for which the site will invoice under the sub contract include all research protocol associated activities performed by study personnel. Routine research activities include recruitment and enrollment of study subjects, conducting follow up and patient compensation, prescription and medical management of study medication, as well as collection and testing of study specimens. Other activities include faculty and staff travel to initial and ongoing study related trainings and meetings.