The Office of the Clinical Director (OCD), Intramural Research Program (IRP), National Institute on Drug Abuse (NIDA), NIH provides clinical research support to two clinical research branches, the Clinical Pharmacology and Therapeutics Research Branch (CPTRB) and the Neuroimaging Research Branch (NRB). The scope of the research program is broad and is strongly represented in the behavioral and pharmacological treatments for opioid use disorder and other substance use disorders as well as non-invasive brain stimulation and neuroimaging. The Office of the Clinical Director has a staff of an Administrative Assistant who provides primary support to the Clinical Director and Deputy Clinical Director. This Administrative Assistant also coordinates with the IRP Pharmacy, Matthews Media Group, Inc. (MMG), Medical Records Department, the Mid-Level Providers and Nursing. The three full time Mid-Level Providers (Federal) medically screen potential participants as well as assist in the day to day running of various protocols. Of note, one of these providers retired in Jan 2018 and has not been replaced. Three full time nurses also staff and run protocols and ensure patient safety and quality clinical care. Additional clinical staff supporting the NIDA/IRP clinical program includes 4 full time Research Associates. These positions are part of the clinical services provided through the Kelly Services Contract with NIDA/IRP. Due to a reorganization of the clinical program in Jan 2018, 2 additional RAs and 3 additional nurses were brought under the OCD from the CPTRB as well as one counselor and one clinic manager. Of note, one of the 6 total nurses also retired in FY2018 and was not replaced. Essential infrastructure and services including professional physician consultations, laboratory medicine and staff support as well as overnights for subjects at Clinical Research Unit (CRU) located on the Bayview campus are provided through a clinical services contract with the Johns Hopkins Bayview Medical Campus (JHBMC). The Addictions IRB, while under the direction of the NIH Office of Human Subjects Research Protections (OHSRP) is supported by the OCD. Staffing includes an IRB Administrator (Federal) with assistance from two other staff members (1 Federal and 1 contractor). The office handles approximately 400 IRB related actions a year, from about 50 active protocols (21 from NIDA). The Addictions IRB serves both NIDA and NIAAA. The OCD also supports the Data Safety and Monitoring Board (DSMB) which is comprised of a statistician, a secretary, and 4-6 outside experts in pharmacology, clinical research, neurobiology, and psychiatry. The DSMB meets quarterly to review protocols and ensure patient safety and compliance with protocol monitoring and safety procedures. The OCD oversees a contract with MMG which provides advertising, recruiting and, research participant screening for all NIDA IRP protocols in the Baltimore Washington area. At this time MMG employs 6 screening specialists, 2 participant counselors, 1 medical assistant and an on-site manager. The Medical Records Department at NIDA/IRP is designed to maintain department compliance of Policy and Procedures while safekeeping the Privacy of over 6600 electronic (HuRIS System) medical records annually. Hardcopy documents of the medical records currently include signed consents and outside medical records; otherwise everything is electronic. Some older charts are available on microfilm. We continue to broaden our use of electronic consent and quiz procedures in our studies which further enhances our digital profile. This is done according to the National Institute of Health, Federal and State Rules and Regulations (Including the Privacy Act of 1974 and HIPPA). The NIDA IRP Pharmacy employs two full time pharmacists and one pharmacy technician. The NIDA IRP pharmacy currently supports about 21 clinical studies including opioid and other drug addiction treatment studies and 40 researchers/labs for nonclinical studies. One pharmacist devotes about 80% of her time supporting the clinical studies and 20 % nonclinical studies. The other pharmacist spends about 50% effort on clinical and 50% effort on nonclinical studies. Clinical research support includes reviewing, preparing, compounding, and dispensing the study medications. Nonclinical support includes ordering, compounding, dispensing, and laboratory auditing. In addition, the pharmacy monitors drug inventories, and meets all DEA and FDA regulatory requirements including licensing and IND reporting.
| Preston, Kenzie L; Kowalczyk, William J; Phillips, Karran A et al. (2017) Context and craving during stressful events in the daily lives of drug-dependent patients. Psychopharmacology (Berl) 234:2631-2642 |
| Weiner, Elaine; Buchholz, Alison; Coffay, Agnes et al. (2011) Varenicline for smoking cessation in people with schizophrenia: a double blind randomized pilot study. Schizophr Res 129:94-5 |
