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Clinicians in the Department of Psychiatry and Behavioral Health at St. Luke's and Roosevelt Hospitals are actively engaged in a variety of clinical research projects targeting mental health, substance abuse, and other behavioral health problems. Many of these research studies are funded by the National Institutes of Health (NIH), other federal agencies, or pharmaceutical companies and thus are able to offer patients free or limited-fee care for specific problems in exchange for their research participation. Because research projects are time-limited, available studies will vary depending on when a patient wants to participate. Also, as each study has specific rules about who can or cannot participate, even patients who want to enroll may not be able to participate. Therefore, it is important for patients to check the website to determine if any studies they are interested in and likely would qualify for are either active or soon will begin. Examples of the kind of studies our clinicians are conducting include those for depression, anxiety, post-traumatic stress disorder (PTSD), attention-deficit hyperactivity disorder (ADHD), alcoholism, "Crystal Meth", heroin abuse in teens, and drug abuse in medical patients with chronic pain or who require an organ transplant.

Treatment
As most of our research studies are "clinical" studies, treatment is often available to patients who choose to enroll. This includes new or state-of-the-art interventions that are still being tested as well as established treatments that are being tried in new populations. Before a patient enrolls in a research project, a staff member will review the study's goals, the pros and cons of participating, and the burden associated with being a participant (such as time commitment). All participants must sign an "informed consent form" prior to beginning the study. It is important to recognize that participation in a research study is strictly voluntary and failure to participate will not affect a patient's routine medical care; however, some treatments may not be available other than through the research study.

Because the treatments are being delivered within the context of research projects, patients may be "randomly assigned" to various treatment options. This means they may or may not get the treatment of their choice. In addition, participants in clinical trials often are required to provide information to the researchers on a regular basis by completing questionnaires or giving blood or urine samples. Patients may or may not be compensated for the time they spend completing research measures and providing samples.

The Research Team
Depending on the study selected, the research team will vary. However, all research projects have a Principal Investigator (PI) who is responsible for the project and many also have a research coordinator, research assistant, study physician, study nurse, and/or study therapists. Treatment personnel are licensed medical and mental health professionals who have special training in the research treatments and advanced trainees who are working alongside and are supervised by the research faculty.

Program Location and Hours of Operation
While the various research projects are located throughout St. Luke's and Roosevelt Hospitals as well as in the community, the administrative offices of the Division of Clinical Research are located at St. Luke's Hospital in the Behavioral Science Research Unit (BSRU). A Research Administrative Assistant is available to take calls, answer questions, and direct patients to studies from 9 am to 5 pm, Monday to Friday. Please contact us at (212) 523-5232.

Current Research Projects as of 1/17/08

TITLE FUNDING SOURCE PI
CTN0028 "Randomized Clinical Trial of Osmotic-Release Methylphenidate for ADHD in Adolescents with Substance Use Disorders" (CTN 0028; Fresh Focus) National Institute of Drug Abuse, Clinical Trials Network/RFMH (subcontract) Michelle Acosta, PhD
CTN030: "A two-phase randomized controlled clinical trial of buprenorphine/ naloxone treatment plus standard medical management or enhanced medical management for opioid analgesic dependence" (CTN 0030; POATS) National Institute of Drug Abuse, Clinical Trials Network/RFMH (subcontract) Deborah Haller, PhD
Drug Treatment for Liver Transplant Candidates (TAP) National Institute of Drug Abuse Deborah Haller, PhD
MRI of Infants Exposed Prenatally to Drugs of Abuse (Babies Study) National Institute of Drug Abuse Deborah Haller, PhD
Crystal Clear Evaluation Project New York City Department of Health Deborah Haller, PhD
Combined Treatment of Alcohol Dependent Women with PTSD (SAFE STEPS) National Institute on Alcoholism and Alcohol Abuse/Columbia University School of Social Work (subcontract) Denise Hien, PhD
Science-Based Treatment for Opioid-Dependent Adolescents National Institute on Drug Abuse Lisa Marsch, PhD
Computer-Assisted HIV Prevention for Young Drug Users National Institute of Drug Abuse Lisa Marsch, PhD
The Use of Acamprosate in Alcohol Dependent Individuals with Co-morbid Anxiety and Depressive Disorders Forest Research Institute Richard N. Rosenthal, MD
Adolescent Screening, Assessment, and Treatment (ASAT) Center for Substance Abuse Treatment (CSAT)/Substance Abuse and Mental Health Services Administration (SAMHSA)

Philip Clemmey, MD

PRO-808: An Open-Label, Multi-Center Study Of Probuphine® In Patients With Opioid Dependence Titan Pharmaceuticals, Inc
Richard N. Rosenthal, MD
Brief Motivational Intervention during Hospital Admission to Promote Attendance to Smoking Cessation Programs after Cardiac or Pulmonary Care (NIDA 2P50 DA09236-12 entitled “Novel Medication Approaches For Substance Abuse” PI: Herbert D. Kleber, M.D.). NIDA
Deborah L. Haller, Ph.D.

Site PI: Angela R. Bethea, Ph.D.
Client Centered Intervention To Increase Treatment Adherence In Patients With Mental Illness   Susan Tross PhD, Robin Kerner PhD

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