Clonidine Versus Adenosine to Treat Neuropathic Pain
Information source: National Institute of Neurological Disorders and Stroke (NINDS)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain
Intervention: clonidine (Drug); adenosine (Drug); placebo (Other)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: Wake Forest University Official(s) and/or principal investigator(s):
James C. Eisenach, M.D., Principal Investigator, Affiliation: Wake Forest University
Richard Rauck, M.D., Principal Investigator, Affiliation: The Center for Clinical Research
Summary
The purpose of this study is to determine the effects of clonidine and adenosine on nerve
pain.
Clinical Details
Official title: Clonidine Versus Adenosine to Treat Neuropathic Pain
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment
Primary outcome: Percent change in pain report
Detailed description:
This study is part of a pain center grant that focuses on how pain, especially chronic
neuropathic pain, alters the response to traditional and non-traditional analgesics (pain
medications).
Clonidine—a drug commonly used to treat high blood pressure—has been shown to effectively
treat neuropathic pain, is FDA-approved for administration via epidural (an injection given
in the lower back), and is the third most commonly prescribed drug for chronic intrathecal
(an injection into the cerebrospinal fluid) use in people with chronic pain.
Adenosine—a drug commonly administered intravenously (into a vein) to treat certain types of
abnormal heart rhythms—has been found to reduce areas of allodynia (pain caused by a stimulus
that does not normally cause pain) after intrathecal, but not intravenous administration in
people with neuropathic pain.
Intrathecal clonidine relieves pain by actions on a2-adrenoceptors in the spinal cord,
whereas adenosine relieves pain by actions on A1 adenosine receptors. Researchers believe
that intrathecal adenosine and clonidine may prove to be excellent painkillers for nerve
pain. Therefore, the goal of this study is to determine the effects of clonidine and
adenosine on nerve pain.
After initial screening, baseline measurements, and training to learn to estimate pain
accurately using thermal heat testing, a sample of spinal fluid will be taken from each
participant. Participants then will be randomly chosen to receive either clonidine,
adenosine, or placebo. After receiving the study medication, participants will be monitored,
with their vital signs checked at 30, 60, 120, 180, and 240 minutes.
Duration of the study for participants is 2 weeks, and includes two visits to the research
center, each lasting approximately 6 hours.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients with complex regional pain syndrome (CRPS), type I involving a lower
extremity
Exclusion Criteria:
- Pregnancy
- Allergy to clonidine
- Currently taking clonidine or other direct a2-adrenergic agonists, or taking
cholinesterase inhibitors
- Patients with any serious or unstable medical problems (heart, lung, liver, kidney, or
nervous system disease)
Locations and Contacts
The Center for Clinical Research, 145 Kimel Park Drive, Winston-Salem, North Carolina 27103, United States
Wake Forest University School of Medicine, Medical Center Boulevard, Winston-Salem, North Carolina 27157-1009, United States
Additional Information
Starting date: August 2004
Ending date: January 2008
Last updated: December 10, 2007
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