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
Carol Straughn
Research Project Coordinator
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
Effect of Methadone on the QTc Interval
IRB #095-07 Effect of Oral Methadone on
the QTc Interval in Patients at Risk for QTc Prolongation
Principal Investigator: Ricardo Cruciani,
MD, PhD
Contact: Arun Sundaram, 212-844-8533
Status: Open for Enrollment
Design: The primary objective of this
study is to explore the association between methadone treatment in older
population and cardiac toxicity, and determine the sensitivity of a
single ECG compared to 24-hour monitoring in capturing cardiac events
indicative of this toxicity.
Given the expanding role of methadone in the treatment of pain, more research
is needed to determine its effect on the electrical properties of the
heart in the clinical setting. The present study has been designed as
a continued effort to clarify an association between methadone and QTc
prolongation.
This study has been funded by the U.S Cancer Pain Relief Committee.
Outcome Registry of Patients Implanted with Neuromodulation Devices
IRB# 011-10 Partnership for Advancement in Neuromodulation (PAIN): A Prospective Clinical Outcome Registry
Principal Investigator: Suelane Do Ouro,
MD
Contact: Karen Doblin, NP, 212-844-6262
Status: Open for Enrollment
Design: The primary objective of the registry
is to create a prospective, outcome registry of patients implanted with
neuromodulation devices and to evaluate application of NMD devices in
“real-world” practice to determine future corporate strategies.
This is a prospective non-interventional 24 month post implant registry.
Any patient that receives a St. Jude Medical FDA approved implantable
neuromodulation system is eligible for enrollment. A minimum of 600
patients will be enrolled from about 30 sites.
This study has been funded by Advanced Neuromodulation Systems, Inc.
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: Soon to 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).
Predicting Oxycodone Dose from Urine Drug Concentration
IRB# 249-09 Predicting Oxycodone Dose from Urine Drug Concentration
Principal Investigator: Russell K. Portenoy,
MD
Contact: Rodney Musoko, 212-844-8534; Arun
Sundaram, BA, 212-844-8533
Status: Open for Enrollment
Design: This cross-sectional pharmacokinetic
study of the relationship between the concentrations of oxycodone, its
metabolites in urine and the oxycodone dose would potentially represent
a major advance, facilitating monitoring and risk management over time.
The specific aim of this study is to develop a predictive model linking
single or multiple urine concentration measurements of oxycodone (or
oxycodone plus specific metabolites) to oral oxycodone dose during long-term
oxycodone therapy for chronic pain.
Subject Population: Male and female subjects >18 years of age with
any type of chronic pain, with duration of at least 6 months, and treatment
with oral opioid therapy including stable doses of Oxycodone in any
formulation. 480 patients will be enrolled in the study.
This study is being funded by Ameritox, Inc.
Cancer Pain
IRB #013-10 A Double Blind, Randomized,
Placebo-Controlled, Parallel Group Study of Sativex Oromucosal Spray
(Sativex; Nabiximols) in Relieving Pain in Patients with Advanced Cancer,
who Experience Inadequate Analgesia During Optimized Chronic Opioid
Therapy – Study Code GWCA0962
Principal Investigator: Russell K. Portenoy,
MD
Contact: Rodney Musoko, 212-844-8534
Status: Soon to 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-Comperative,
Follow-up Study to Assess the Long Term Safety of Sativex Oromucosal
Spray (Sativex; Nabiximols) Therapy in Patients with Cancer Related
Pain – Study Code GWCA0999
Principal Investigator: Russell K. Portenoy,
MD
Contact: Rodney Musoko, 212-844-8534
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.
Pain and Smoking After Successful Treatment
for Head and Neck Cancer
IRB #089-07 Establishing the Connection
between Pain and Smoking After Successful Treatment for Head and Neck
Cancer: A “Proof-of-Principle” Observational Pilot Study
Principal Investigator: Lara Dhingra,
PhD
Contact: Lara Dhingra, PhD, 212-844-1429
Status: Open for Enrollment
Design: This pilot study employs an innovative
data collection methodology, ecological momentary assessment (EMA),
in which a handheld computer is used to repeatedly measure pain and
smoking behavior during the day in a group of head and neck cancer survivors
who have pain and are current smokers.
This study will yield a novel contribution to the current literature on
smoking in head and neck cancer survivors and will inform the development
of new interventions for smoking cessation in this population.
Eligible participants include cancer survivors who have no evidence
of disease following successful treatment for head and neck cancer;
currently smoke 5 or more cigarettes per day, and have frequent or persistent
pain.
This study has been funded by the Beth Israel Head and Neck and Thyroid
Cancer Institute.
Pain and Function
in Hip Fracture
IRB #147-08 Improving Pain and Function
in Hip Fracture
Principal Investigator: Knox Todd, MD
Contact: Taja Ferguson, email: taja.ferguson@mssm.edu
Status: Open for Enrollment
Design: This project examines the efficacy
of two regional anesthesia techniques, femoral nerve blocks (FNB) and
fascia iliaca blocks (FIB), on the treatment of acute hip fracture pain.
Patients age 60 years and over presenting the emergency department with
hip fracture will be randomized to receive the intervention or usual
care. The intervention includes FNB in the ED followed by insertion
of a continuous FIB catheter within 24 hours plus non-opioid/opioid
analgesia as needed. Usual care patients will receive conventional therapy
with regularly scheduled and as needed intravenous or oral opioids.
We will examine the impact of the intervention on patients’ pain
intensity; systemic opioid requirements; post-operative function; incidence
of delirium, side effects; hospital length of stay and participation
in physical therapy.
This study has been funded by the National Institute of Aging/NIH and is conducted in collaboration with Mount Sinai School of Medicine.
tDCS Research Study
IRB #038-08 Pilot Study on Safety and Efficacy
of the Non-Invasive Transcranial Stimulation (tDCS) to Relieve Neuropathic
Pain in Cancer Patients
Principal Investigator: Ricardo Cruciani, MD,
PhD
Contact: Helena Knotkova, PhD, 212-844-8541
Status: Open for Enrollment
Participants: Subjects with a history of head and neck cancer and neuropathic pain
Design: The purpose of this study is to
determine if transcranial direct current stimulation (tDCS), the device
that regulates brain activity, can improve pain in people with a history
of head and neck cancer who have developed neuropathic pain as a result
of a surgical procedure, chemotherapy or radiation therapy.
This study has 2 parts; PHASE 1 and PHASE 2. If you qualify, your study
participation may last up to 7 weeks with up to 13 clinic visits expected.
These clinic visits will last about one hour. During the rest of the
study, you can remain at home.
In the double-blind, sham controlled Phase 1; participants will be randomized
2:1 into two arms to receive either the real tDCS treatment (group A,
16 participants) or sham (group B, 8 participants) in 5 sessions on
5 consecutive days. Patients whose pain will not improve at least by
3 of 10 points on the numerical pain rating scale at the end of the
double-blind Phase 1 will continue to the open-label Phase 2 of the
study and will receive the real tDCS treatment, i.e. 20 min of tDCS
at 2 mA, in 5 sessions on 5 consecutive days. About
tDCS (.pdf)...
Institute for Noninvasive Brain Stimulation of New York (INBSNY), 212-844-8539
For more information on these studies, please write or call:
Carol Straughn
Research Project Coordinator
Department of Pain Medicine and Palliative Care
Beth Israel Medical Center
16th Street and First Avenue
New York, NY 10003
Telephone: (212) 844-8536
Email: stoppain@chpnet.org
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