Office of the Clinical Director

Overview

Clinical Director: Dr. Markus Heilig
Deputy Clinical Director: Suzy Coffay, M.D.

The Office of the Clinical Director (OCD) coordinates, supports, and supervises the development, implementation and conduct of intramural clinical research activities. The OCD provides the infrastructure needed to promote top quality clinical research and to ensure research participant safety and confidentiality. This infrastructure includes research participant recruitment and screening center, a 45-slot methadone outpatient research clinic and multiple specialized study rooms (including smoking chambers, mock MRI scanner, physiological monitoring). In addition, a digital medical record system on a secure network has been developed and allows for all research related data to be accessible from within the IRP.

The OCD provides clinical support personnel to complement research personnel in specific laboratory groups. The personnel include clinical research nurses, research associates, mid-level providers, research pharmacists, protocol specialists, IRB administrators, and a quality assurance medical officer.

The clinical research portfolio at the NIDA IRP include a wide variety of collaborative investigation that focus on:

• Development of a nicotine dependence laboratory model with conditioned smoking cues and nicotine reinforcement measures to study potential pharmacotherapies for nicotine dependence
  
• Cognitive and attentional processes influenced by nicotine withdrawal and nicotine administration
  
• Mechanisms of action of cannabinoid agonists and antagonists
  
• Neurobiology and pharmacokinetics of MDMA (Ecstasy)
  
• Efficacy and safety of new treatments for drug abuse
  
• Factors that impact drug taking and relapse
  
• Application of MRI-based structural and functional imaging to elucidate acute and chronic drug effects and their consequences on cognitive processes
  
• Specific individual genetic polymorphisms and the group variance imaging endophenotypes to understand trait related predisposition and treatment outcome.
  
• Molecular genetic bases of individual differences in vulnerability to develop dependence on an addictive substance
  
• Recruitment and characterization of subjects for genome wide association studies
  
• Development of advanced functional and structural magnetic resonance imaging/spectroscopy techniques
  
• Structural MRI techniques to assess tissue integrity related to brain dysfunction

The independent clinical investigators include:

• Stephen Heishman, Ph.D. (Section Chief, Nicotine Psychopharmacology)
• Marilyn Huestis, Ph.D. (Section Chief, Chemical & Drug Metabolism)
• Kenzie Preston, Ph.D. (Branch Chief, Clinical Pharmacology & Therapeutics)
• Elliot Stein, Ph.D. (Branch Chief, Neuroimaging Research)
• George Uhl, M.D., Ph.D. (Branch Chief, Molecular Neurobiology)
• Yihong Yang, Ph.D. (Section Chief, fMRI Neuroimaging)

Research Participant Recruitment and Screening

An integral component of Clinical Research for the NIDA IRP is participant recruiting and screening. Core services include advertising and media outreach for clinical research populations targeting healthy control participants, individuals’ with nicotine addiction and other substance abusers, including those seeking and not seeking therapeutic intervention. Participant recruitment is active at 2 sites - one in East Baltimore at the BRC and the other in West Baltimore in conjunction with the Maryland Psychiatric Research Center (MPRC).

FAQ about Clinical Studies Participation

Administrative Management of the Clinical Research Program

The OCD is involved in:

• monitoring reviews (scientific, resource, medical safety, IRB) for all clinical research protocols
• overseeing protocol implementation and execution by assuring availability of support personnel, space, equipment, and supplies; assessing data safety and monitoring plans and quality assurance reviews of clinical records
• overseeing and training of clinical personnel developing clinical policies and standard operating procedures in collaboration with the clinical investigators, the medically accountable investigators, and the clinical support staff
• hosting the NIDA IRP Clinical Rounds
  

Institutional Review Board

All NIDA clinical research protocols are reviewed by the NIDA Addictions Institutional Review Board.