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, CSW
Department of Pain Medicine and Palliative Care
Institute for Education and Research
Beth Israel Medical Center
16th Street and First Avenue
NY, NY 10003
Phone: (212) 844-8536
Email: stoppain@chpnet.org
Breakthrough Pain in Patients with Cancer
IRB #213-05 A Double-Blind, Randomized, Placebo-Controlled,
Multicenter Study to Evaluate the Efficacy and Safety of EN3267 for the
Treatment of Breakthrough Pain in Opioid Tolerant Cancer Patients Followed
by an up to 12-Month Non-Randomized, Open-Label Extension to Assess Long-Term
Safety - Protocol EN3267-005
Principal Investigator: Russell K. Portenoy,
MD
Contact: Ella Dvorkin, CSW, 212-844-8536
Status: Open for Enrollment
Design: Endo Pharmaceuticals Inc. is conducting
a research study of an experimental drug called EN3267 as a therapy
in the management of breakthrough pain (intermittent or irregular flares
of pain that can occur suddenly). The study drug, EN3267, is the drug
fentanyl citrate. Subjects will be instructed to place the study medication
under the tongue and allow it to dissolve. The medication should dissolve
completely in approximately 1 minute. This dosing method of fentanyl
is a new investigational preparation.
The purpose of this study is to compare the effectiveness (the power
to produce an effect) of EN3267 with that of placebo (inactive substance
or “sugar pill”) in treating breakthrough pain episodes
in subjects with cancer.
The first part of the study begins with a titration of EN3267 (methods
of increasing the study drug that a study participant will take until
a dose is reached that best works for his/her breakthrough pain). Every
participant will receive EN3267 during this study period. Once a dose
has been identified as an adequate treatment for their breakthrough
pain, subjects will enter the double-blind part of the study. In the
double-blind part, they will be assigned by chance, to get either EN3267
or placebo (a look-alike with no active ingredients, sometimes called
a sugar pill) during the treatment period of the study.
The second part of the study is an open-label, long-term extension
period. Subjects who complete the double-blind period may continue to
use EN3267 to treat breakthrough pain episodes over a 12-month period.
Participation will involve approximately 13 months with up to 18 separate
visits at the site.
Breakthrough Pain in Patients with Cancer
IRB #214-05 A Multiple-Dose, Non-Randomized,
Open-Label, Multicenter Study to Evaluate the Long-Term Safety and Effectiveness
of EN3267 in the Treatment of Breakthrough Pain in Cancer Patients - Protocol
EN3267-007 Principal Investigator: Russell
K. Portenoy, MD
Contact: Ella Dvorkin, CSW, 212-844-8536
Status: Open for Enrollment
Design: EN3267, a rapidly dissolving tablet
formulation of fentanyl citrate, is currently under development for
the treatment of breakthrough cancer pain in patients already receiving
an opioid (narcotic) medication for pain. This formulation of fentanyl
is designed specifically to be placed under the tongue and allowed to
dissolve. The medication should dissolve completely in approximately
1 minute. This dosing method of fentanyl is a new investigational preparation.
Eligible study participants will begin a titration of EN3267 (methods
of increasing EN3267 that study participants will take until a dose
is reached that best works for their breakthrough pain). Every participant
will receive EN3267 during this study period.
Once a dose has been identified as an adequate treatment for their
breakthrough pain, subjects will be able to receive EN3267 for up to
12 months to treat breakthrough pain episodes. Patients will return
to the study site each month.
Safety and effectiveness of EN3267 will be assessed throughout the
12 months.
Breakthrough Pain in Patients with Cancer
IRB #214-06 An Open-Label Study Investigating
Long-Term Safety and Tolerability of Nasalfent (Fentanyl Citrate Nasal
Spray) in the Treatment of Breakthrough Cancer Pain (BTCP) in Subjects
Taking Regular Opioid Therapy
Principal Investigator: Russell K. Portenoy,
MD
Contact: Jolanta Dmochowska, 212-844-8535
Status: Open for Enrollment
Design: This is an open-label study conducted
at approximately 100 centers in the United States, Canada and Europe.
The objectives of the study are to investigate the long-term safety,
tolerability, and acceptability of Nasalfent in the treatment of breakthrough
cancer pain.
The study drug, NASALFANET, is a nasal formulation of fentanyl. The
nasal route has the potential to deliver the drug rapidly, and is safe
and convenient for most subjects. Fentanyl is a well-established and
characterized drug, with many years of clinical use. Its side-effect
profile is well documented, and is qualitatively similar to that of
other opioid analgesics.
The study will enroll subjects ages 18 and older with a clinical diagnosis
of cancer related pain. Subjects who are taking regular, 24-hour medication
(60 mg oral morphine or equivalent opioid) for his or her underlying
persistent cancer pain and who typically have 1 to 4 episodes of breakthrough
cancer pain per day are eligible for participation.
Study participation will last for approximately 16 to 18 weeks. Following
this Main Study, subjects will have the opportunity to enter a long-term
Extension Phase where they will be allowed to use Nasalfent for as long
as necessary, up until the time that Nasalfent becomes commercially
available in this country. Read
more (.pdf)...
This study has been funded by Archimedes Development Limited.
Cancer Pain
IRB #001-08 Identifying the Epidemiology
of Cancer Pain among First Generation Ethnic Chinese Cancer Patients
Treated in a Multi-Culturally Diverse Community Cancer Setting
Principal Investigator: Lara Dhingra,
PhD
Contact: Lara Dhingra, PhD, 212-844-1429
Status: Open for Enrollment
Design: The main goal of this epidemiological
survey is to identify the prevalence, characteristics, treatment and
psychosocial impact of pain in a sample of first generation ethnic Chinese
cancer patients. To date, cancer pain has not been systematically evaluated
in the Chinese American population.
This study will provide information that will guide clinicians and
researchers in developing culturally relevant pain interventions for
the ethnic Chinese population.
Eligible participants include ethnic Chinese adults with a history
of cancer diagnosis whose primary language is English, Mandarin or Cantonese,
and the presence of frequent or persistent cancer-related pain for the
past three months. Read
more (.pdf)...
This study has been funded by the United States Cancer Pain Relief
Committee.
Cancer Pain
IRB# 123-07 A Double Blind, Randomized,
Placebo Controlled, Parallel Group Dose-Range Exploration Study Of Sativex®
In Relieving Pain In Patients With Advanced Cancer, Who Experience Inadequate
Analgesia During Optimized Chronic Opioid Therapy - Study Code GWCA0701
Principal Investigator: Russell K. Portenoy,
MD
Contact: Jolanta Dmochowska, 212-844-8535
Status: Soon to Open for Enrollment
Design: There is evidence that cannabinoids
may have some promise in relieving cancer-related pain.
Sativex® is a medicine formulated from chemical varieties of Cannabis
sativa L that contains THC and CBD in an approximate 1:1 ratio. Sativex®
has been well tolerated in previous studies and no evidence of misuse
has emerged from the 1100 patients in the current clinical program.
The side effects of Sativex® are usually mild or moderate in severity
and resolve without treatment. Taken in coordination with an opioid
regimen, Sativex® may provide a new opportunity for pain relief
in patients with advanced cancer.
This is a 9-week study. The study will include a 5-week double blind
treatment period incorporating one week of titration after which subjects
will remain on a stable dose of treatment where possible.
The study drug will be presented as a pump action oral mucosal spray.
This study has been funded by GW Pharma LTD.
Chronic Pain
IRB #150-07 Sublingual Buprenorphine for Chronic Pain in Patients at Risk for Drug Abuse
Principal Investigator: Russell K. Portenoy,
MD
Contact: Ella Dvorkin, CSW, 212-844-8536
Status: Open for Enrollment
Design: The primary objective of this
study is to create a set of guidelines for the use of sublingual buprenorphine
in the treatment of chronic pain in populations with substance use disorders.
These guidelines will be developed by an expert panel comprising leaders
in pain medicine, addiction medicine and buprenorphine pharmacology.
Subjects will include 40 patients with chronic pain and substance abuse
histories or current aberrant drug-related behavior. All patients will
be recruited at Beth Israel Medical Center.
This study is being conducted by the National Development and Research
Institutes (NDRI) and the Beth Israel Medical Center (BIMC) and is funded
by the National Institute on Drug Abuse.
Chronic Pain in Patients with Fibromyalgia
Syndrome (FMS)
IRB #031-07 Randomized Evaluation of a
Low-frequency Investigational Device Employing Neuromodulation Therapy
in Patients with Fibromyalgia - A Double-Blind, Placebo-Controlled Trial
(RELIEF)
Principal Investigator: Ricardo Cruciani,
MD, PhD
Contact: Jolanta Dmochowska, 212-844-8533
Status: Closed
Design: Fralex Therapeutics and PharmaNet
are conducting a research study of an experimental device called the
PRIMA device as a possible treatment for pain secondary to fibromyalgia.
The study device is an investigational neuromodulation device that has
not yet been approved by the U.S. Food and Drug Administration (FDA).
It is being studied as a therapy in the management of chronic pain associated
with fibromyalgia.
The PRIMA device consists of a specialized headset and a transmission
unit that is about the size of a cell phone. The headset is placed on
the head so that the pads are centered above the ears. The transmission
unit generates a weak, extremely low frequency, pulsed magnetic field
which is delivered through the attached headset into the brain. In this
study, the device will be used twice daily, at least 4 hours apart.
Each session will last for 40 minutes.
Included in the study will be adult subjects over the age of 18 who
have had a diagnosis of fibromyalgia for at least 3 months. For participation
in the study, subjects will be asked to stop all medication for pain,
sleep, and depression, with the exception of Tylenol and cardiac aspirin.
The study consists of a 4-week Screening Period during which subjects
will be asked to keep a daily diary recording their levels of pain,
a 12-week Treatment Period in which the subjects will receive and utilize
the investigational device, and a 4-week Follow-up Period. During the
Treatment Period, 50% of the subjects will receive an active therapeutic
device, while the other 50% will receive a sham device that delivers
no active therapy. There will be a total of 8 clinic visits and 6 telephone
visits over the course of approximately 20 weeks.
Eligible subjects will be compensated for their time and travel expense
required to participate in the study.
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: Ella Dvorkin, CSW, 212-844-8536
Status: Soon to 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.
Genetic Profiles and Opioid Side Effects
IRB #070-07 Pharmacogenomics of Opioid Analgesia and Side Effects
Principal Investigator: Russell K. Portenoy,
MD
Contact: Ella Dvorkin MSW, CSW, 212-844-8536
Status: Open for Enrollment
Design: In this study, the effects of oxycodone,
one of the most widely used opioids for chronic pain and a standard
treatment for pain after surgery will be studied. This research is being
done to better understand the good and bad effects that standard treatments
for pain may have on individual patients following surgery. The reason
for this study is to see if a person’s DNA (the body’s genetic
material) can explain how they respond to certain pain medications.
Information from this research may guide health care providers to choose
the best pain medications most suitable for each individual.
Consenting subjects who are undergoing joint replacement at Beth Israel
Medical Center will be asked to provide a blood sample and respond to
questionnaires on the second day after surgery.
This study has been funded by the Department of Pain Medicine and Palliative
Care at Beth Israel Medical Center.
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. Read
more (.pdf) ...
This study has been funded by the Beth Israel Head and Neck and Thyroid
Cancer Institute.
Neuropathic Pain
IRB #147-08 Improving Pain and Function
in Hip Fracture
Principal Investigator: Knox Todd, MD
Contact: Saima Siddiqui, MPH, 212-420-2851
Status: Enrollment Anticipated to Begin
in November 2008
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.
Painful Conditions of the Wrist
IRB #092-05 A Study of the Effectiveness and
Safety of the Carpal-Ease Unit for the Treatment of Wrist Pain
Principal Investigator: Peter Homel, PhD
Contact: Peter Homel, PhD, (212) 844-8547
Status: Open for Enrollment
Design: This is a research study of an experimental
device called Carpal-Ease as a therapy in the management of painful conditions
of the wrist. The Carpal-Ease unit is investigational, which means that it
has not received marketing approval from the U.S. Food and Drug Administration
(FDA).
This research study is being done to see if the Carpal-Ease unit is an effective
treatment for wrist pain due to carpal tunnel syndrome, wrist arthritis or
wrist repetitive stress syndrome. The study will compare the active treatment,
when the Carpal-Ease unit is turned on, to a placebo (when the unit is turned
off).
The Carpal-Ease unit is a newly designed system that uses a low voltage electrical
energy to encourage the flow of excess fluid (swelling) inside the carpal
tunnel to flow outward. The result relieves pressure on the median nerve,
which in turn leads to reduction in pain and greater ease of movement.
The study will take place over four weeks.
Sickle Cell Disease
IRB #157-07 Pilot Study of Human Recombinant
Hyaluronidase Enhanced Subcutaneous Hydration and Opioid Administration
of Sickle Cell Disease Acute Pain Episodes (SCDAPE)
Principal Investigator: Knox Todd, MD
Contact: Saima Siddiqui, MPH, 212-420-2851
Status: Open for Enrollment
Design: This is an open-label, pilot study
of ten patients with Sickle Cell Disease Acute Pain Episodes. The primary
aim is to determine the feasibility of a four-hour recombinant hyaluronidase
enhanced subcutaneous hydration and opioid protocol for adults presenting
to the Emergency Department with SCDAPE.
The study will enroll subjects ages 18-60 with a clinical diagnosis
of sickle cell hemoglobinopathy or a diagnosis of uncomplicated acute
pain episode.
This study has been funded by Baxter International Inc.
tDCS Research Study
IRB #038-08 Pilot Study on Safety and Efficacy
of the Non-Invasive Transcranial Stimulation (tDCS) to Relieve Neuropathic
Pain in Patients with Head and Neck Cancer
Principal Investigator: Ricardo Cruciani, MD,
PhD
Contact: Maria Nieto, MD, 212-844-8531
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
tDCS Research Study
IRB #096-07 Relations Between Excitability
of the Somatosensory Cortex and Pain Relief Induced by the Transcranial
Stimulation (tDCS) in Patients with Complex Regional Pain Syndrome
Principal Investigator: Helena Knotkova, PhD
Contact: Helena Knotkova, PhD, 212-844-8541
Status: Open for Enrollment
Participants: Subjects with CRPS-related pain localized in an upper limb, and 10 tDCS naïve healthy volunteers
Design: This is a pilot, prospective,
controlled, open-label trial, with the goal to determine relations between
excitability of the somatosensory cortex and pain-relief induced by
the tDCS in patients with CRPS-related pain. The study will enroll 10
tDCS naïve patients with CRPS-related pain localized in an upper
limb, and 10 tDCS naïve healthy volunteers.
All participants (patients and healthy volunteers) will undergo a
screening procedure, including physical examination and clinical laboratory
tests. One week later (allowing the study personnel to obtain and evaluate
lab results), individuals who qualify for the study and meet Inclusion/Exclusion
criteria will undergo SSEP recordings and will receive the first tDCS
stimulation. The second and the third tDCS stimulation will be done
on two following consecutive days. SSEPs will be recorded again at the
end of the third tDCS session, and participants will undergo physical
examination and clinical laboratory tests.
The study will last up to 2 weeks and will consist
of four study visits (the screening visit and three
tDCS sessions with SSEPs recordings before the first- and after the
last tDCS stimulation). About
tDCS (.pdf)...
Institute for Noninvasive Brain Stimulation of New York (INBSNY),
212-844-8539
tDCS Research Study
IRB #098-06 Pilot Study on Safety and Efficacy
of the Non-invasive Transcranial Stimulation (t-DCS) to Relieve Neuropathic
Pain in Patients with Complex Regional Pain Syndrome
Principal Investigator: Ricardo Cruciani, MD,
PhD
Contact: Helena Knotkova, PhD, 212-844-8541
Status: Open for Enrollment
Participants: Patients with CRPS/RSD with
affected an upper or lower limb and a unilaterally localized CRPS-related
pain
Design: This pilot study is proposed as
a two-arm randomized sham-controlled trial to determine the effect tDCS
stimulation at current intensity of 2 mA performed on five consecutive
days, on pain, somatosensory abnormalities and motor function in patients
with CRPS-related neuropathic pain.
Patients will be randomized into two arms of the study to receive either
the real tDCS treatment (group A) or sham (group B). When randomized,
participants will undergo initial (baseline) evaluation of pain, somatosensory
abnormalities, and motor function of the affected vs. unaffected limb.
Then, patients will undergo 5 sessions of 20 min of 2 mA stimulation
(group A) or sham (group B) on 5 consecutive days. Two weeks after the
last tDCS treatment/sham, patients will come for the follow-up visit.
Patients who will not experience pain relief in the sham-controlled
part of the study will continue in the open-label part of the study
and will receive the real tDCS treatment in 5 sessions of 20 min of
2 mA stimulation on 5 consecutive days, Mon-Fri. To participate in the
study, patients do not have to change their medication regimen.
The duration of the study is up to 6 weeks. About
tDCS (.pdf)...
Institute for Noninvasive Brain Stimulation of New York (INBSNY),
212-844-8539
For more information on these studies, or to see if your patients qualify
for participation, please write or call:
Ella Dvorkin, CSW
Department of Pain Medicine and Palliative Care
Institute for Education and Research
Beth Israel Medical Center
16th Street and First Avenue
NY, NY 10003
Telephone: (212) 844-8536
Email: stoppain@chpnet.org
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