Clonidine-induced Spinal Acetylcholine Release: Normal Volunteers vs. Neuropathic Pain
Information source: Wake Forest School of Medicine
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain
Intervention: clonidine (Drug); clonidine (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Wake Forest School of Medicine Official(s) and/or principal investigator(s):
James C. Eisenach, M.D., Principal Investigator, Affiliation: Wake Forest School of Medicine
Richard Rauck, M.D., Principal Investigator, Affiliation: The Center for Clinical Research
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.
Clinical Details
Official title: Clonidine-induced Spinal Acetylcholine Release: Normal Volunteers vs. Neuropathic Pain
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Acetylcholine Concentration in Cerebrospinal Fluid
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
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: September 2004
Last updated: March 5, 2014
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