The Office of the Clinical Director (OCD), Intramural Research Program (IRP), National Institute on Drug Abuse (NIDA), NIH provides research support to two clinical research branches at the IRP. The scope of the research program is broad and is strongly represented in neuroimaging, while also incorporating both behavioral and pharmacological treatments for substance abuse disorders. The Office of the Clinical Director has a staff of an Administrative Assistant who provides primary support to the Director and Deputy 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. Four full time RNs provide the staffing for running the protocols. Additional Clinical staff supporting the NDA/IRP programs include 5 full time Research Associates. These positions are part of the clinical services provided through the Johns Hopkins Bayview Medical Contract with NIDA/IRP. This contract also provides essential infrastructure and services including professional physician consultations, laboratory medicine and staff support as well as overnights for subjects at Behavioral Pharmacological Research Unit (BPRU) located on the Bayview campus. The NIDA IRB office is under the direction of the OCD and is staffed by an IRB Administrator (Federal). The office handles approximately 400 IRB related actions a year, from 40 active protocols. This year the IRB office has joined with the NIAAA forming the Addictions IRB which continues to answer to the OHRP. The OCD oversees a fully funded contract with MMG, an outside organization. MMG represents NIDA/IRP, recruiting research participants in the Baltimore Washington area. At this time MMG employs 13 screening specialists, 2 patient counselors and a 3 member management team. There is a yearly budget of $225,000 for print, web, radio and television advertising and $50,000 for community outreach. The Medical Records Department at NIDA/IRP is designed to maintain department compliance of Policy and Procedures while safekeeping the Privacy of over 6300 electronic (HuRIS System) medical records annually. Both microfilm and/or DVD as well as hardcopy versions of the medical records are accessed for both in-house and outside sources. 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 IRP Pharmacy employs three full time pharmacists. The IRP pharmacy currently supports about 20 clinical studies including 5 Archway studies and 70 researchers/labs for nonclinical studies. One pharmacist devotes about 80% of her time supporting the Archway studies, including IND support. The other two pharmacist spends about 60 % effort on clinical and 40 % 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. Recently the OCD established the Office of Regulatory Affairs. The Regulatory Affairs Officer oversees the compliance of all research for local, federal and NIH guidelines. That full time Federal employee works with the IRB, DSMB (Data Safety and Monitoring Board)and outside contractors to fulfill monitoring needs.
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