VA Cooperative Studies Program (CSP)

CSP Coordinating Center - Perry Point, MD

The CSP Coordinating Center at Perry Point VA Medical Center was established in 1972 after a reorganization of the Central Neuropsychiatric Research Laboratory, the coordinating center for psychiatric cooperative studies. Dating back to the 1940s, key historical studies conducted by the coordinating center include a multi-hospital evaluation of prefrontal lobotomy of schizophrenic patients, a series of evaluations on the safety and efficacy of standard antipsychotic drugs, investigations of some of the earliest anti-depressive drugs, and the first large-scale evaluation of lithium carbonate for affective disorders. Several other major studies have been done to help patients with substance abuse problems. More recently, the Perry Point CSP Coordinating Center completed studies on a range of areas including:

• Lens implants in cataract patients
• Treatments for alcoholic cirrhosis of the liver (colchicine) and alcoholism (naltrexone)
• The efficacy and toxicity of carbamazepine to divalproex sodium for partial seizures
• Pharmacological treatments for epilepsy (phenobarbital, phenytoin, primidone, and carbamazepine)
• Alpha blockade and androgen suppression for the treatment of benign prostatic hyperplasia
• Clinical and economic impact of olanzapine in the treatment of schizophrenia
• Antibiotic treatment of Gulf War Syndrome
• Digitalis and heart failure
• Symptomatic and asymptomatic carotid stenosis
• Total parenteral nutrition in malnourished surgical patients
• Medical and surgical therapies for gastroesophageal reflux disease
• Antithrombotic therapies in patients with congestive heart failure
• Heart bypass graft surgery
• Prostate cancer
• Risk factors for asymptomatic large colonic adenomas
• Survey of long-term health outcomes of women veterans service in Vietnam

Through an interagency agreement between the VA and the National Institute on Drug Abuse (NIDA), Perry Point CSPCC provides clinical trials and statistical guidance, data management and administrative oversight for NIDA sponsored multi-center clinical trials on potential medications for addiction to controlled substances or alcoholism. The goal of these efforts is to support the development and subsequent marketing of new pharmaceutical entities to treat addictive disorders and certain mental illnesses. Some of these studies have examined:

• Treatments for cocaine dependence (baclofen; selegiline transdermal system)
• Treatments for opiate dependence (buprenorphine/naloxone; buprenorphine; levo-alpha acetylmethadol)
• Treatment for opiate withdrawal (lofexidine)
• Treatment for methamphetamine dependence

Facilities, Staff, and Equipment

The CSP Coordinating Center is housed in Research Bldg. 4 (3 floors) and two modular buildings (13,400 square feet) on the grounds of Perry Point VA Medical Center located about 40 miles north of Baltimore, MD. Personnel include biostatisticians, statistical and database programmers, project managers, computer assistants and administrative staff. SAS serves as the primary statistical programming package and staff have a range of specialty software packages available to support center efforts. Perry Point CSP Coordinating Center is certified in ISO 9001:2008 (International Organization of Standardization).

Perry Point CSPCC also has some unique capabilities based on efforts that it has developed. One capability utilizes a centralized, automated telephone system that can randomize subjects into clinical trials. Randomizations can be done 24 hours a day, 7 days a week, making it convenient for use in trials that span multiple time zones. Another capability of the center is a secure web-based data collection application called the Centralized On-line Research Data Exchange System (CORDES). This SAS-based application utilizes relational databases that contain metadata about questions, forms, and protocol properties for a clinical trial. Its interactive graphical interface is flexible, user-friendly, and offers a reusable/repeatable method for creating, storing, and managing data collected via the web.

Perry Point CSPCC also serves as a central printing resource facility to the other centers.

Academic Affiliations

University of Maryland (UMD) School of Medicine

Department of Epidemiology and Preventive Medicine

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