Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00350532
Status:
COMPLETED
Last Update Posted:
2018-09-10
First Post:
2006-07-05
Brief Title:
Clonidine-induced Spinal Acetylcholine Release Normal Volunteers vs Neuropathic Pain
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
Clonidine-induced Spinal Acetylcholine Release Normal Volunteers vs Neuropathic Pain
Status:
COMPLETED
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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will be trained to accurately estimate pain by way of thermal heat testing Next a small amount of spinal fluid will be withdrawn from each participant to measure the amounts of naturally-made chemicals in the participants cerebrospinal fluid Participants then will receive an injection of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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P01NS041386 | NIH | None | httpsreporternihgovquickSearchP01NS041386 |