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Sponsors and Collaborators: |
Wake Forest University National Institute of Neurological Disorders and Stroke (NINDS) |
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Information provided by: | National Institute of Neurological Disorders and Stroke (NINDS) |
ClinicalTrials.gov Identifier: | NCT00350532 |
The purpose of this study is to compare the amount of acetylcholine release after a single injection of clonidine in normal volunteers and individuals with neuropathic pain.
Condition | Intervention | Phase |
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Pain |
Drug: clonidine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Placebo Control, Single Group Assignment, Efficacy Study |
Official Title: | Clonidine-Induced Spinal Acetylcholine Release: Normal Volunteers vs. Neuropathic Pain |
Estimated Enrollment: | 48 |
Study Start Date: | September 2004 |
Study Completion Date: | March 2008 |
Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Participants will be trained to accurately estimate pain by way of thermal heat testing. Next a small amount of spinal fluid will be withdrawn from each participant to measure the amounts of naturally-made chemicals in the participants' cerebrospinal fluid. Participants then will receive an injection of clonidine. After the injection, additional samples of spinal fluid will be taken to measure chemical changes in the fluid.
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Drug: clonidine
Patients will receive intrathecal clonidine (or clonidine injected into cerebrospinal fluid)
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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).
The way that nerve fibers carry pain information to the brain is thought to change after surgery and in cases of chronic pain. For this reason, some medicines work better to relieve pain in healthy people who have a sudden painful injury when compared to people after surgery or to people with chronic pain. Currently available pain medications may not relieve all types of pain or may relieve pain only at doses that produce side effects and potential complications.
The aim of this study is to understand the mechanisms by which intrathecal clonidine (or clonidine injected into cerebrospinal fluid) increases in potency and efficacy by examining the cerebrospinal fluid of healthy individuals, before and after clonidine administration, as well as looking at the spinal fluid of people with chronic neuropathic nerve pain. More specifically, in this study, researchers will compare acetylcholine release (a protein-like substance found in cerebrospinal fluid) in normal volunteers and patients with neuropathic pain after a single injection of clonidine.
After baseline measurements, including blood pressure and heart rate, participants will be trained to accurately estimate pain by way of thermal heat testing. Next a small amount of spinal fluid will be withdrawn from each participant to measure the amounts of naturally-made chemicals in the participants' cerebrospinal fluid. Participants then will receive an injection of clonidine. After the injection, additional samples of spinal fluid will be taken to measure chemical changes in the fluid.
Duration of the study for participants is 1 day, and includes 1 visit to the research center, lasting approximately 3 hours.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, North Carolina | |
Wake Forest University School of Medicine, Medical Center Boulevard | |
Winston-Salem, North Carolina, United States, 27157-1009 | |
The Center for Clinical Research, 145 Kimel Park Drive | |
Winston-Salem, North Carolina, United States, 27103 |
Principal Investigator: | James C. Eisenach, M.D. | Wake Forest University |
Principal Investigator: | Richard Rauck, M.D. | The Center for Clinical Research |
Responsible Party: | Wake Forest University School of Medicine ( James C. Eisenach, MD, Professor of Anesthesiology ) |
Study ID Numbers: | P01NS041386_TRIAL2 |
Study First Received: | July 5, 2006 |
Last Updated: | July 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00350532 |
Health Authority: | United States: Food and Drug Administration |
pain, chronic pain acetylcholine clonidine a2-adrenergic agonists alpha2-adrenergic agonists |
Clonidine Acetylcholine Pain |
Sympatholytics Neurotransmitter Agents Vasodilator Agents Adrenergic alpha-Agonists Molecular Mechanisms of Pharmacological Action Adrenergic Agents Physiological Effects of Drugs Cardiovascular Agents Antihypertensive Agents |
Cholinergic Agents Pharmacologic Actions Adrenergic Agonists Autonomic Agents Sensory System Agents Therapeutic Uses Peripheral Nervous System Agents Analgesics Central Nervous System Agents |