| 2009 |
| IRB # | Code | Study Title/PI |
| 09-002 |
ED |
Advanced Clinician Program. PI: Michelle Goldbach, BSN, MHA. Sponsor: SDHIPM |
| 2008 |
| IRB # | Code | Study Title/PI |
| 08-002 |
PS |
Support by Telephone for Caregivers in Hospice (Support Tech). PI: Kristin, Kilbourn, PhD, MPH. Sponsor: University of Colorado |
| 2007 |
| IRB # | Code | Study Title |
| 07-001 |
ED |
Goals of Care For The Younger Breast Patient – A Joint Project Between San Diego Hospice & Palliative Care and the UCSD Moores Comprehensive Cancer Center. PI: Wayne Bardwell, PhD. Sponsor: UCSD |
| 07-002 |
PS |
Prevalence of Depression and Delirium and the Impact of Screening on Their Recognition in a Large-Scale Hospice and Palliative Care Setting. PI: Scott Irwin, MD. Sponsor: SDHIPM |
| 07-004 |
MR |
Clinical Experience with Human Recombinant Hyaluronidase (Hylenex). PI: Charles von Gunten, MD. Sponsor: SDHIPM |
| 07-007 |
MI |
A Prospective Uncontrolled Study of Parenteral Lidocaines Ability to Acutely Relieve Opioid-Resistant Pain. PI: Jay Thomas, MD. Sponsor: SDHIPM |
| 07-008 |
MI |
A Prospective Pilot Study on the Prevalence of QTc Prolongation in Hospice/Palliative Medicine Patients on Methadone for Pain. PI: Anh Nguyen, MD. Sponsor: SDHIPM |
| 2006 |
| IRB # | Code | Study Title |
| 06-001 |
MI |
A Double-Blind, Placebo Controlled, Multicenter Phase IIB Extension Study to Evaluate the Safety and Efficacy of Multiple Alvimopan Dosage Regimens for the Treatment of Opioid-Induced Bowel Dysfunction in Cancer Pain Subjects. PI: Renee Smilde, MD. Sponsor: GlaxoSmithKline. |
| 06-002 |
MI |
Pain Assessment, Incidence, and Nature in Heart Failure. PI: Jay Thomas, MD. Sponsor: PC-HEART |
| 06-003 |
ED |
Correlation of Opioid Doses with Blood Concentrations: Morphine Sulfate. PI: Charles von Gunten, MD. Sponsor: SDHIPM |
| 06-006 |
MI |
A Double-Blind, Placebo Controlled Evaluation of the Efficacy, Safety, and Tolerability of BEMA ™ Fentanyl in the Treatment of Breakthrough Pain in Cancer Subjects: Jay Thomas, MD. Sponsor: BioDelivery Sciences International, Inc. |
| 06-008 |
MI |
An Open-Label, Long-Term Treatment Evaluation of the Safety of BEMA ™ Fentanyl Use for Breakthrough Pain in Cancer Subjects on Chronic Opioid Therapy. PI: Jay Thomas, MD. Sponsor: BioDelivery Sciences International, Inc. |
| 2005 |
| IRB # | Code | Study Title |
| 05-002 |
MI |
A Randomized, Placebo Controlled Phase II Study of Parenteral Lidocaine Ability to Acutely Relieve Opioid Refractory Pain. PI: Jay Thomas, MD. Sponsor: SDHIPM |
| 05-004 |
SD |
A Study to Validate the Content of the Functional “Assessment of Chronic Illness Therapy-Ascites Index (FACIT-AI) in Patients With Recurrent Symptomatic Malignant Ascites due to Ovarian Cancer. PI: Jay Thomas, MD. Sponsor: Fresenius Biotech |
| 05-005 |
SD |
Values Assessment: Hospice and Child Welfare Social Workers. PI: Andra Kariiti. Sponsor: Master’s Thesis-California State University, Long Beach |
| 05-008 |
MI |
A Randomized, Double-Blind, Placebo Controlled, Multicenter Phase IIB Study to Evaluate the Efficacy and Safety of Multiple Alvimopan Dosage Regimens for the Treatment of Opioid-Induced Bowel Dysfunction in Cancer Pain Subjects. PI: Renee Smilde. MD. Sponsor: GlaxoSmithKline. |
| 05-010 |
MI |
Patients and Technology in Hospice. PI: Jean S. Kutner, MD, MSPH. Sponsor: Population-Based Palliative Care Research Network. |
| 05-011 |
MR |
Investigation of The Currently Identified Prevalence of Depression in Patients Enrolled in Hospice Care at San Diego Hospice& Palliative Care (SDHPC) During 2005. PI: Scott Irwin, MD. Sponsor: SDHIPM |
| 05-015 |
MI |
Increased Flow Using Subcutaneously Enhanced Morphine (INFUSE-Morphine) Study: A Phase IIIB, Double-Blind, Randomized, Crossover Study Comparing the Pharmacokinetics, Safety, and Tolerability of Morphine Administered Subcutaneously With and Without Human Recombinant Hyaluronidase (HYENEX) and Intravenously. PI: Jay Thomas, MD. Sponsor: Halozyme Therapeutics, Inc. |
| 05-016 |
BR |
An Exploration of Culture in Memorial Making with the Bereaved. PI: Noreen Carrington, LMFT. Sponsor: SDHIPM |
| 05-018 |
ED |
Qualitative Evaluation of the Personal Project Component of the Evaluation Plan for the Existing Third-year Medical Student Curriculum. PI: Charles von Gunten, MD. Sponsor: SDHIPM |
| 05-019 |
SD |
Practical Depression and Delirium Screening for Inpatients (ICC) at San Diego Hospice & Palliative Care (SDHPC): A Pilot Study. PI: Scott Irwin, MD. Sponsor: SDHIPM |
| 05-021 |
ED |
Palliative Care Culture and The First Class of Nurses Interns. PI: Ann Sturley, DrPH. Sponsor: SDHIPM |
| 05-022 |
BR |
The Effect of Dream Interpretation Intervention on Grief in Bereaved Individuals. PI: Rochelle Perper, MA. Sponsor PhD Dissertation, Alliant International University |
| 2004 |
| IRB # | Code | Study Title |
| 04-001 |
PS |
Patient and Caregiver Well-Being. PI: Kathryn Herbst. Sponsor: PhD Dissertation |
| 04-007 |
MI |
Correlation Between Myoclonus and the 3-Glucuronide Meabolites in Patients on Morphone or Hydromorphone: A Pilot Study. PI: Shawn McCann, MD. Sponsor: SDHIPM |
| 04-009 |
SD |
Consensus Working Group for Nutritional Supplements Guidelines in Palliative Care: A Performance Improvement Project for SDHPC. PI: Sharon O-Mary, MSN. Sponsor: SDHIPM |
| 04-018 |
MI |
A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Tolerability of OraVescent Fentanyl Citrate in Opioid-Tolerant Patients with Cancer and Breakthrough Pain. PI: Laurel Herbst, MD. Sponsor: Cephalon, Inc. |
| 04-019 |
MI |
A Multicenter, Open-Label, Long-Term Study of OraVescent Fentanyl Citrate for the Treatment of Breakthrough Pain in Opioid-Tolerant Cancer Patients. PI: Laurel Herbst, MD. Sponsor: Cephalon, Inc. |
| 2003 |
| IRB # | Code | Study Title |
| 03-002 |
MR |
Retrospective Assessment of Selected NHPCO/CMMS Guidelines for Hospice Care. PI: Laurel Herbst, MD. Sponsor: SDHIPM |
| 03-003 |
MI |
A Three-month Open-Label Treatment Extension of Protocol MNTX 301 (MNTX 301 EXT). PI: Jay Thomas, MD. Sponsor: Progenics Pharmaceuticals, Inc |
| 03-004 |
ED |
Palliative Care Curriculum for 3rd Year Medical Students. PI: Charles von Gunten, MD. Sponsor: SDHIPM |
| 03-005 |
CM |
Reducing End-of-Life Symptoms with Touch (REST). PI: Jean Kutner, MD. Sponsor: Population-Based Palliative Care Research Network |
| 03-006 |
CM |
The Use of Music Therapy to Decrease Agitation in Dementia Patients Receiving Hospice Homecare Services. PI: Barbara Reuer. Sponsor: MusicWorx |
| 03-008 |
MI |
Analgesic Efficacy of Smoke Cannabis in Refractory Cancer Pain. PI: Mark Wallace, MD. Sponsor: UCSD |
| 03-010 |
ED |
Dyspnea: Effect of Auricular Acupressure in End Stage Lung Cancer Patients. PI: Roger Strong, NP. Sponsor: PhD Dissertation |
| 03-011 |
MI |
A Double Blind Phase 3, Two-week Placebo Controlled Study of Methylnaltrexone (MNTX) for the Relief of Constipation Due to Opioid Therapy in Advanced Medical Illness (MNTX 302). PI: Jay Thomas, MD. Sponsor: Progenics Pharmaceuticals, Inc. |
| 03-012 |
MI |
A Three-Month Open-Label Treatment Extension of Protocol MNTX 302. PI: Jay Thomas, MD. Sponsor: Progenics Pharmaceuticals, Inc. |
| 03-014 |
MR |
A Retrospective Evaluation of a Simplified Methadone Dosing Protocol. PI: Loren Friendman, MD. Sponsor: The Hospice of the National Capital Region. |
| 2002 |
| IRB # | Code | Study Title |
| 02-002 |
MI |
A Comparison of Four Pain Intensity Scales Using Hospice Patients with Cancer Pain. PI: Terri Gibbs, RN. Sponsor: SDHIPM |
| 02-004 |
MR |
The Effects of Social Support on Longevity and Quality of Life of Hospice Patients. PI: Kathryn Herbst. Sponsor: UCSD |
| 02-005 |
MI |
A Phase II Double-Blind, Randomized, Parallel Group, Dose Ranging Study of Subcutaneous Methylnaltrexone in Patients with Opioid-Induced Bowel Dysfunction (MNTX 251). PI: Jay Thomas, MD. Sponsor: Progenics Pharmaceuticals, Inc. |
| 02-007 |
MI |
Communication and Quality of Care for Terminal Cancer. PI: Wayne Beach, Ph.D. Sponsor: UCSD. |
| 02-010 |
SD |
A Description of Home Nursing Interventions Provided to People with HIV/AIDS. PI: Linda Robinson, PhD. Sponsor: USD Hahn School of Nursing. |
| 02-014 |
SD |
Monitoring Informed Consent for Hospice Enrollment. PI: David J. Casarett, ME. Sponsor: University of Pennsylvania |
| 02-015 |
MI |
A Compassionate Use Study of Methylnaltrexone inpatients with Opioid-Induced Side Effects (MNTX 901). PI: Jay Thomas, MD. Sponsor: Progenics Pharmaceuticals, Inc |
| 02-016 |
SD |
Phase III - National Hospice Outcomes Project. ISIS / National Hospice and Palliative Care Organization & Institute for Clinical Outcomes Research. PI: Deborah Dunne, MSN, MBA. Sponsor: SDHIPM |
| 02-017 |
ED |
Relaxation Training and the Improvement of Quality of Life of Hospice Patients. PI: Carrie Nelson-Vasquez, MD. Sponsor: UCSD |
| 02-018 |
SD |
Medication Prescribing Patterns by Hospice Medical Directors Study. PI: Jean S. Kutner, MD, MSPH. Sponsor: Population-Based Palliative Care Research Network |
| 02-019 |
MI |
A Double-Blind Placebo Controlled Study of Methylnaltrexone (MNTX) for the Relief of Symptomatic Constipation due to Chronic Opioid Therapy in Patients with Advanced Medical Illness (MNTX 301). PI: Jay Thomas, MD. Sponsor: Progenics Pharmaceuticals, Inc. |
| 2001 |
| IRB # | Code | Study Title |
| 01-001 |
MR |
Chart Review of Parenteral Lidocaine for the Management of Intractable Pain. PI: Charles von Gunten, MD & Gil Naco, MD. Sponsor: SDHIPM |
| 01-002 |
CM |
Feasibility Study of Acupuncture in Cancer Home Care. PI: Ana de Vedia, L.Ac. Sponsor: Pacific College of Oriental Medicine |
| 01-007 |
MI |
Helping Patients and Their Families Make Decisions About Hospice Enrollment. PI: Noreen Carrington. Sponsor: SDHIPM and University of Pennsylvania |
| 01-008 |
MI |
Values of Patients with CHF Enrolling in Palliative Care. PI: Paul E. Tatum, MD. Sponsor: University of Missouri Columbia. |
| 2000 |
| IRB # | | Study Title |
| 00-001 |
CM |
Assessment of Therapeutic Touch as a Method for Reduction of Nociceptive and Neuropathic Pain Due to Cancer Compared to Placebo and No Treatment in Terminal Phase Patients Enrolled in San Diego Hospice. PI: Irene H. Fu, MSIV, Independent Study Project. Sponsor: UCSD. |
| 00-002 |
ED |
The San Diego Hospice Experience - A Handbook for Children About What to Expect From Hospice. PI: Jeanette Galicinao, MSIV, Independent Study Project. Sponsor: UCSD. |
| 00-003 |
PS |
Psychosocial and Spiritual Symptoms among Hospice Patients. PI: Jean S. Kutner, MD, MSPH. Sponsor: Population-Based Palliative Care Research Network. |
| 00-004 |
MI |
A Randomized, Double-Blind, Two-Period Crossover Trial Comparing the Safety and Effectiveness of Numorphan CR (oxymorphone controlled-release tablets) and MS Contin (morphine sulfate controlled-release tablets) for the Relief of Moderate to Severe Pain in Patients with Cancer (#EN3202-018). PI: Laurel Herbst, MD. Sponsor: Endo Pharmaceuticals, Inc. |
| 00-005 |
MI |
An Open-Label Assessment of the Long-Term Safety and Utility of Numorphan CR for the Relief of Moderate to Severe Pain in Patients with Cancer (#EN3202-022). PI: Laurel Herbst, MD. Sponsor: Endo Pharmaceuticals, Inc. |
| 00-006 |
MR |
The Effects of Social Support on Longevity and Quality of Life of Hospice Patients. Kathryn Herbst, PhD. Sponsor: UCSD |
| 00-007 |
PS |
Hospice Discharge Follow-up Study. PI: Jean S. Kutner, MD, MSPH. Sponsor: Population-Based Palliative Care Research Network. |
| 00-008 |
MR |
Terminal Agitation: It's Prevalence, Causes, and the Effectiveness of Interventions in the Hospice Setting. PI: Tania Mieke, MSII. Sponsor: SDHIPM |
| 00-009 |
MI |
A Study to Assess the Safety, Dose Conversion and Titration of Duragesic (Fentanyl Transdermal System) in Pediatric Patients with Chronic Pain Requiring Opioid Therapy FEN-USA-87. PI: Alexander Rodarte. Sponsor: Janssen Research Foundation |
| 00-011 |
MI |
Proposal to Commence Clinical Trials to Test a New Palliative Drug - Hyperbaric Oxygen - Against Obligatory Enveloped Viruses: HIV, CMV, HSV, HCV. PI: Mark A. Baugh, PharmD |
| 1999 |
| IRB # | Code | Study Title |
| 99-001 |
MI |
The Effectiveness of Traditional Chinese Medicine on the Quality of Life of Terminally Ill Patients at San Diego Hospice. PI: Ana de Vedia, Chad Conner & Jill Blakeway. Sponsor: Pacific College of Oriental Medicine. |
| 99-002 |
PS |
Hospice in Nursing Homes: An Empirical Examination of its Scope and Quality Outcomes. PI: Susan C. Miller, PhD. Sponsor: Brown University |
| 1998 |
| IRB # | Code | Study Title |
| 98-001 |
MI |
Study of the Prevalence and Treatment of Breakthrough Pain in Patients Using Transdermally Delivered Fentanyl (Duragesic) for Management of Chronic Pain (C-98-034-00). PI: Laurel Herbst, MD. Sponsor: Alza Corporation |
| 98-002 |
MI |
Open-Label Dose-Titration Study of E-TRANS (fentanyl) for the Treatment of Breakthrough Pain in Patients with Chronic Pain (C-98-035-00). PI: Laurel Herbst, MD. Sponsor: Alza Corporation |
| 98-003 |
PS |
Effects of Communication About Terminal Illness on Marital Satisfaction and Quality of Life (Survey for patient and spouse). PI: Laura Holcomb, Clinical Psychology Ph.D. Candidate. Sponsor: University of Tennessee, Knoxville, TN |
| 1997 |
| IRB # | Code | Study Title |
| 97-001 |
MI |
An Open-label Trial to Assess the Efficacy of KADIAN (Morphine Sulfate Sustained Release) Using a 'Sprinkling' Method of Dose Administration in a Hospice Setting for Subjects with Chronic Moderate-to-Severe Pain. (3394US/0004) PI: Laurel Herbst, MD. Sponsor: Zeneca Pharmaceutical Company |
| 97-002 |
MI |
A pilot trial of once-daily oral RO93877 capsules vs. placebo in opioid-induced constipation in cancer patients. (RO93877-USA-8) PI: Laurel Herbst, MD. Sponsor: Janssen Research Foundation |
| 97-003 |
PS |
Sequenced versus Unsequenced Emotional Expression of the Conjugal Bereavement Experience. PI: Leslie Wilson, M.A. Sponsor: SDHIPM. |
| 1996 |
| IRB # | Code | Study Title |
| 96-001 |
MI |
Pilot Study of Three On-Demand Dose Levels of Fentanyl Delivered Intravenously by a PCA Device for the Management of Breakthrough Pain in Patients with Chronic Pain (C-95-023). Sponsor: Alza Pharmaceutical Co. |
| 96-002 |
MI |
A Randomized, Open-Label, Cross-Over Trial to Compare the Efficacy, Subject Preference, and Safety of Kadian (morphine sulfate sustained release) Capsules vs. MS Contin (Purdue Frederick) in the Management of Subjects with Chronic Moderate to Severe Cancer Pain (3394US/0002). Sponsor: Zeneca Pharmaceutical Co. |
| 96-003 |
PS |
Attitudes of Social Work Students and Social Workers Toward Euthanasia and Life Sustaining Treatment. PI: Ursula Leszczynska, MSW. Sponsor: Thesis |
| 96-004 |
MI |
An Open-Label Evaluation of the Safety and Local Tolerance of Continuous Subcutaneous Infusion of Dilaudid (20 and 50 mg/ml). PI: Laurel Herbst, MD. Sponsor: Knoll Pharmaceutical |
| 1995 |
| IRB # | Code | Study Title |
| 95-001 |
PS |
An Evaluation of Quality of Life and Treatment Satisfaction in Cancer Patients Receiving Duragesic, MS Contin or Oramorph. Sponsor: Technology Assessment Group (TAG) |
| 95-002 |
MI |
Randomized, Single Blind Crossover Comparison Between Nebulized and Subcutaneous Morphine in the Treatment of Dyspnea in Terminal Patients. Clint Pearson, MSIV Student, Independent Study Project. Sponsor: UCSD. |
| 95-003 |
MI |
Oral Transmucosal Fentanyl Citrate Titration and Effectiveness Study (Protocol AC 200/013) PI: Laurel Herbst, MD. Sponsor: Anesta Corp |
| 95-004 |
MI |
Oral Transmucosal Fentanyl Citrate Effectiveness Study (Extension Protocol - AC 200/014).PI: Laurel Herbst, MD. Sponsor: Anesta Corp |
| 95-005 |
PS |
Suicide Ideation Survey. PI: Deborah Lindholm. Sponsor: PhD Dissertation |
| 95-006 |
PS |
The transition of parents who survive the death of a child from a terminal illness: a cross-cultural perspective. PI: Sherlynn Owens. Sponsor: PhD Dissertation |
| 1993 |
| IRB # | Code | Study Title |
| 93-018 |
MI |
Open-Label Study of Senokot-S Tablets in the Treatment of Opioid-Induced Constipation in Cancer Patients: A Multicenter Study (SK91-1102). Sponsor: Purdue Frederick Company |
| 1992 |
| IRB # | Code | Study Title |
| 92-015 |
MI |
Protocol for a Randomized, Controlled, Phase IV Study Comparing the Cost-Effectiveness of Duragesic and Infusional Parental Morphine in Cancer Patients Under the Care of a Home Hospice (JRD4263/0102). Sponsor: Janssen Research Foundation |
| 92-016 |
MI |
A Three-Month Open-Label Extension of Protocol No. OC91-0402B: Controlled-Release Oxycodone Tablets (Q12H) in Patients with Chronic Cancer-Related Pain (OC91-0907B). Sponsor: Purdue Frederick Company |
| 92-017 |
PS |
Determinates of Hospice Patients Place of Death. PI: Donna McCarthy, PhD |
| 1991 |
| IRB # | Code | Study Title |
| 91-011 |
MI |
Open-Label Safety and Efficacy Study of Senokot-S in Treatment of Opioid-Induced Constipation (SK89-0804). Sponsor: Purdue Frederick Company |
| 91-012 |
MI |
Controlled Release Oxycodone Tablets (Q12H) vs. Immediate Release Oxycodone Tablets (QID): Comparative Efficacy Safety and Acceptability in Patients Previously Stabilized on Strong Opioid Analgesics for Chronic Cancer-Related Pain (C91-0402B). Sponsor: Purdue Frederick Company |
| 91-013 |
PS |
An Empirical Investigation of Death Dreams and the Psyche Among Cancer Patients. PI: Moruko Ralph-Wilkman, MA |
| 91-014 |
BR |
Family Factors Influencing Effective Pain Management for Cancer Patients in the Pediatric Population. PI: Betty Ferrell, PhD, FAAN & Liz Sumner |
| 1990 |
| IRB # | Code | Study Title |
| 90-002 |
BR |
Bereavement Study. PI: Kathleen Burns, PhD. Sponsor: SDHIPM. |
| 90-003 |
ED |
Needs Assessments Regarding Skills of Nurses. PI: Peggy Sereda, RN. Sponsor: SDHIPM. |
| 90-004 |
MI |
Accuracy of Cutaneous Oximetry in Assessing Dyspnea in a Population of Hospice Home Care Patients. PI: Laurel Herbst, MD. Sponsor: SDHIPM. |
| 90-005 |
MI |
Utilization of the Quality of Life Closure Scale in Patients Following Palliative Treatment of Recurrent Malignant Airway Obstruction. PI: Laurel Herbst, MD & Elaine Fox, LCSW. Sponsor: SDHIPM |
| 90-006 |
MI |
9A Cross-Sectional Study to Test the Reliability and Validity of a Severity Index Designed as an Indicator of Acuity. PI: Lawrence Piro, MD & Laurel Herbst, MD |
| 90-007 |
MI |
Alzheimer's Study. PI: Richard Katzman, MD |
| 90-008 |
PS |
The Role of Hardiness, Job Stressors and Co-dependency on Burnout Among a Population of Oncology Nurses. PI: Elaine Fox, LCSW, Pare Ware, LCSW, Mary Callaghan, RN, & Molly Drummond, LCSW |
| 90-009 |
PS |
Factors Affecting the Place of Death of Hospice Patients. PI: Donna McCarthy, PhD |
| 90-010 |
ED |
Nurse's Knowledge and Attitudes about Patient Controlled Analgesic (PCA). PI: Leslie Clark, RN, MSN. Sponsor: SDHIPM |
| 1989 |
| IRB # | Code | Study Title |
| 89-001 |
ED |
Interactive Compact Disc Simulation in Cancer Pain Management. PI: Richard Currier, MD. Sponsor: SDHIPM. |