- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00350532
Clonidine-induced Spinal Acetylcholine Release: Normal Volunteers vs. Neuropathic Pain
Study Overview
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).
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 Next a small amount of spinal fluid will be withdrawn from each participant to measure the amounts of naturally-made chemicals in the participants' cerebrospinal fluid.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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
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North Carolina
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Winston-Salem, North Carolina, United States, 27103
- The Center for Clinical Research, 145 Kimel Park Drive
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Winston-Salem, North Carolina, United States, 27157-1009
- Wake Forest University School of Medicine, Medical Center Boulevard
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy adult volunteers
- Patients with neuropathic pain
Exclusion Criteria:
- Pregnancy
- Allergy to clonidine
- Currently taking clonidine or other direct a2-adrenergic agonists
- Taking cholinesterase inhibitors
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Neuropathic Pain Subjects
Chronic Pain 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.
|
Patients will receive intrathecal clonidine (or clonidine injected into cerebrospinal fluid)
|
Active Comparator: Healthy Subjects
Healthy 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.
|
Patients will receive intrathecal clonidine (or clonidine injected into cerebrospinal fluid)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acetylcholine Concentration in Cerebrospinal Fluid
Time Frame: 60 minutes
|
Acetylcholine levels in CSF after administration of intrathecal clonidine measured by High-performance liquid chromatography (HPLC).
|
60 minutes
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Nervous System Diseases
- Pain
- Neurologic Manifestations
- Neuromuscular Diseases
- Peripheral Nervous System Diseases
- Neuralgia
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Autonomic Agents
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Sympatholytics
- Clonidine
Other Study ID Numbers
- P01NS041386_TRIAL2
- P01NS041386 (NIH)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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