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Clinical Trials

Chronic Pain Studies in the Department of Pain Medicine and Palliative Care at Beth Israel
List of Open Trials
ClinicalTrials.gov
Centerwatch: Clinical Trials Listing Service
American Pain Foundation Clinical Trials Resource Center


Chronic Pain Studies in the Department of Pain Medicine and Palliative Care at Beth Israel

Pain is one of the most common reasons for visiting a physician. Although there are a wide range of treatments now available, new approaches are being investigated. At Beth Israel Medical Center's Department of Pain Medicine and Palliative Care, studies are currently recruiting patients with some types of chronic pain, neuropathic pain, pain due to cancer, and low back pain.

Neuropathic pain includes many conditions caused by injury to nerves. The discomfort experienced by patients with this type of pain can be severe, long-lasting, and not easily treated by current analgesics.

Clinical trials are also currently underway to study breakthrough pain, cancer pain, chronic pain, methadone, and novel pain treatments.

For more information write or call

Ella Dvorkin, CCRP
Senior Research Manager
Department of Pain Medicine and Palliative Care
Beth Israel Medical Center
16th Street and First Avenue
NY, NY 10003
Phone: (212) 844-8536
Email: stoppain@chpnet.org

List of Open Trials

Compassionate Use Study of the Non-Invasive Transcranial Stimulation (tDCS) for Relief of Neuropathic Pain

IRB# 073-07 Compassionate Use Study of the Non-Invasive Transcranial Stimulation (tDCS) for Relief of Neuropathic Pain

Principal Investigator: Helena Knotkova, PhD
Contact: Helena Knotkova, PhD, 212-844-8539
Status: Open for Enrollment

Design:This is an open-label compassionate use study on non-invasive tDCS stimulation to relieve neuropathic pain.

Eligible participants are adult male and female patients who previously completed one of the following studies:

  • A double-blind study “Pilot Study on Safety and Efficacy of the Non-invasive Transcranial Stimulation (tDCS) to Relieve Neuropathic Pain in Patients with Complex Regional Pain Syndrome” or,
  • A double-blind study “Pilot Study on Safety and Efficacy of The Non-Invasive Transcranial Stimulation (tDCS) to Relieve Neuropathic Pain in Cancer Patients” and meet Inclusion/Exclusion criteria.

This study is funded by the Department of Pain Medicine and Palliative Care, Institute for Non-invasive Brain Stimulation of New York (INBSNY).

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IRB# 206-10
A Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study of Sativex Oromucosal Spray (Sativex; Nabiximols) as Adjunctive Therapy in Relieving Uncontrolled Persistent Chronic Pain in Patients with Advanced Cancer, Who Experience Inadequate Analgesia During Optimized Chronic Opioid Therapy. GWCA0958

Principal Investigator: Russell Portenoy, MD
Contact: Jeffin Mathew, 212-844-8533
Status: Soon to Open for Enrollment

Design: This is a Phase 3 study to evaluate the efficacy of Sativex, when used as an adjunctive (not breakthrough) medication, compared with placebo in relieving uncontrolled persistent chronic pain in patients with advanced cancer, who experience inadequate analgesia during optimized chronic opioid therapy.

Eligible participants must have chronic cancer-related pain, be currently taking opiate treatments, such as morphine or oxycodone, but still having trouble managing your pain.

This study is being funded by GW Pharma.

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IRB #073-10
Randomized Double Blind Comparison of Peri-Operative Standard Analgesia with Peri-Operative Lidocane, Ketamine, or Lidocane and Ketamine Combination, Infusion for Patients Undergoing Spine Surgery

Principal Investigator: Ronald Kaplan, MD
Contact: Ronald Kaplan, MD, 212-844-8844
Status: Open for Enrollment

Design: This is a randomized controlled clinical trial to determine whether an intravenous infusion of lidocaine, ketamine or the combination of lidocaine and ketamine during and immediately after surgery improves pain control or other outcomes in subjects undergoing spinal surgery.

A secondary goal of the study is to determine if this pain treatment is compatible with standard neurophysiological (electrical) techniques used to monitor the spine during surgery.

Eligible participants include individuals undergoing first-time fusion surgery, surgery to revise a prior fusion, or surgery to repair a spinal deformity.

This study is supported by the Department of Pain Medicine and Palliative Care.

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Transcranial Direct Current Stimulation (tDCS) for the Treatment of Neuropathic Facial Pain


IRB #148-10 Transcranial Direct Current Stimulation (tDCS) for the Treatment of Neuropathic Facial Pain

Principal Investigator: Ricardo Cruciani, MD
Contact: Joy Hao, MD, 212-844-8844
Status: Open to Enrollment

Design: This is a pilot study evaluating the pain-relieving effects of a non-invasive treatment, transcranial direct current stimulation (tDCS), on pain, functional status, and quality of life in patients diagnosed with neuropathic facial pain.

Eligible participants must be age >21 with facial neuropathic pain.

The findings from this study may help to improve pain and well-being in patients with persistent facial pain. Treatment is free to those who qualify.

This study is being funded by Empire Clinical Research Investigators Program.

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Assessment of Body Image-Related Cognitions among Women with Persistent Pain


IRB #149-11 Assessment of Body Image-Related Cognitions among Women with Persistent Pain

Principal Investigator: Lara Dhingra, PhD
Contact: Mallorie Gordon, 212-844-6179
Status: Open for Enrollment

Design: This is an observational study to evaluate the thoughts and feelings that women with persistent non-cancer pain have about their bodies.

Eligible women who are between the ages of 18 and 65 and have been diagnosed with a pain condition may qualify.

The findings from this study may help to improve the management of psychological distress in women with negative body-image concerns and persistent pain.

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Multi-Site Clinical Assessment of Chronic Fatigue Syndrome


IRB #283-11 Multi-Site Clinical Assessment of Chronic Fatigue Syndrome

Principal Investigator: Benjamin Natelson, MD
Contact: Diana Vu, 212-844-6747
Status: Open for Enrollment

Design: The Center for Disease Control (CDC), our national agency for the study of disease, has been the action site where doctors like Dr. Natelson have met to come up with diagnostic criteria for Chronic Fatigue Syndrome (CFS). Recently the CDC announced a competition among researchers to develop a team to use the “splitter’s approach” to see if subgroups of patients have different characteristics from others. Dr. Natelson has been using this approach successfully over the past ten years and so his application was successful. Now he and his research team will collect patient-related data from 75 CFS patients over the next year. Since this study seeks to determine how well the current formula for diagnosing CFS works across our nation, patients can participate without changing their current treatment. If you are interested in participating in this study, please go to the following link: http://painandfatigue.com to get the Health Screen Form, complete it and send it in. Please use DARK INK so that it is legible.

Eligible participants must have a diagnosis of CFS, must be 18 – 70 years old and must have been diagnosed with CFS before age 62.

This study is funded by the CDC.

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IRB #050-12
Utilizing Transcranial Direct Current Stimulation (TDCS) to treat Chemotherapy-Related Cognitive Difficulties (“CHEMO-FOG”) in Cancer Survivors

Principal Investigator: Helena Knotkova, PhD, 212-844-8541
Contact: Helena Knotkova, PhD, 212-844-8541
Status: Open for Enrollment

Design: This is a Phase II open-label pilot feasibility study to evaluate safety, tolerability, acceptability, patients’ satisfaction and clinical outcomes of a one-week protocol using tDCS to improve Chemotherapy-Related Cognitive Impairment (CRCI) in cancer survivors.

If you are eligible and you decide to participate you will receive five tDCS treatments, once every day from Monday to Friday, each session consisting of 20 min of tDCS. Two weeks after the last tDCS session, you will come for the Follow up/Completion Visit.

Eligible participants must be >21 years old, have undergone chemotherapy and are experiencing “chemo-fog”.

This study is funded by the Department of Pain Medicine and Palliative Care, Institute for Non-invasive Brain Stimulation of New York (INBSNY).

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Effect of Milnacipran or Placebo on Ventricular Lactate and FM-Induced “Brain Fog”


IRB #212-09 Effect of Milnacipran or Placebo on Ventricular Lactate and FM-Induced “Brain Fog”

Principal Investigator: Benjamin H. Natelson, MD
Contact: Diana Vu, 212-844-6747
Status: Open for Enrollment

Design: The primary objective of this study is to determine if patients with Fibromyalgia have elevated levels of ventricular lactate, which has been identified as a possible biomarker in some patients with Chronic Fatigue Syndrome and to determine if Minalcipran, a drug that alters brain chemistry to reduce pain, reduces ventricular lactate levels in these patients. The secondary objective of this study is to determine whether Milnacipran improves attention and concentration difficulty, which is a major complaint among FM patients.

Eligible study participants include individuals who experience pain all over their body with no apparent cause or patients who have received the diagnosis of Fibromyalgia.

This study is being funded by Forest Labs, the manufacturer of Milnacipran.




Web-Based CBT for Opioid-treated, Chronic Pain Patients with Aberrant Behavior

IRB# 121-10 Web-Based CBT for Opioid-treated, Chronic Pain Patients with Aberrant Behavior

Principal Investigator: Russell K. Portenoy, MD
Contact: Sarah Moore, PhD, 1-800-305-9506
Status: Open for Enrollment

Design: This study is being conducted by the National Development and Research Institutes (NDRI) in collaboration with DPMPC. The purpose of this project is to develop, implement, and evaluate an innovative CBT intervention for the treatment of chronic pain tailored to the specific needs of patients who are being prescribed opioids and who present with aberrant behaviors. The project will include: focus groups, feedback sessions, and randomized, controlled trial.

This study is being funded by the National Institute on Drug Abuse (NIDA).




Cancer Pain

IRB #013-10 A Double Blind, Randomized, Placebo-Controlled, Parallel Group study of Sativex Oromucosal Spray (Sativex®; Nabiximols) as Adjunctive Therapy in Relieving Uncontrolled Persistent Chronic Pain in Patients with Advanced Cancer, Who Experience Inadequate Analgesia during Optimized Chronic Opioid Therapy, GWCA0962.

Principal Investigator: Russell K. Portenoy, MD
Contact: Jeffin Mathew, 212-844-8533
Status: Open for Enrollment

Rational for the study: This is a Phase III Study. Recent studies have shown that Sativex® is an effective treatment for cancer-related pain in subjects who were diagnosed with advanced incurable malignancy, and exhibited severe levels of pain despite ongoing treatment with strong opioid analgesics. After two weeks of treatment, a response to Sativex® reached a statistically significant treatment difference from placebo was obtained. Primary objectives: To evaluate the efficacy of Sativex compared with placebo in relieving pain in patients with advanced cancer, who experience inadequate analgesia during optimized chronic opioid therapy.

This study is being funded by GW Pharma.




IRB# 014-10 A Multicenter, Non-comparative, Open-label Extension Study to Assess the Long Term Safety of Sativex Oromucosal Spray (Sativex®; Nabiximols) as Adjunctive Therapy in Patients with Uncontrolled Persistent Chronic cancer related Pain. GWCA0999.

Principal Investigator: Russell K. Portenoy, MD
Contact: Jeffin Mathew, 212-844-8533
Status: Soon to Open for Enrollment

Design: Primary objective: To evaluate the safety of long-term Sativex therapy in patients with advanced cancer. Secondary objectives: To evaluate the maintenance of effect through long-term usage of Sativex for the relief of cancer related pain; to evaluate the impact of long-term Sativex therapy on the quality of life of patients with advanced cancer.

This study is being funded by GW Pharma.




IRB# 083-09 Quality Improvement for Symptom Control in Underserved Chinese American Patients

Principal Investigator: Lara Dhingra, PhD
Contact: Jack Chen, 212-844-6780
Status: Open for Enrollment

Design: The main goal of this study is to develop and test a quality improvement intervention for pain and symptom management in underserved Chinese American cancer patients. The effectiveness of the intervention will be determined by longitudinal data collection in separate cohorts of 50 patients in two community-based oncology practices every four to six months after implementation begins. Approximately 1,000 patients will be enrolled in this study from Drs. Kin Lam’s and William Cheung’s practices in Chinatown.

This study is being funded by the American Cancer Society, Research Scholar Grant.





For more information on these studies, or to see if your patients qualify for participation, please write or call:

Ella Dvorkin, CCRP
Senior Research Manager
Department of Pain Medicine and Palliative Care
Beth Israel Medical Center
16th Street and First Avenue
NY, NY 10003
Telephone: (212) 844-8536
Email: stoppain@chpnet.org

   
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