Clonidine-induced Spinal Acetylcholine Release: Normal Volunteers vs. Neuropathic Pain - Full Text View

Purpose

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
Pain	Drug: clonidine	Phase 2

Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Clonidine-induced Spinal Acetylcholine Release: Normal Volunteers vs. Neuropathic Pain

Resource links provided by NLM:

MedlinePlus related topics: Chronic Pain

Drug Information available for: Acetylcholine chloride Clonidine Clonidine hydrochloride

U.S. FDA Resources

Further study details as provided by Wake Forest University:

Primary Outcome Measures:

Acetylcholine Concentration in Cerebrospinal Fluid [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]
Acetylcholine levels in CSF after administration of intrathecal clonidine measured by High-performance liquid chromatography (HPLC).

Enrollment:	43
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
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 Next a small amount of spinal fluid will be withdrawn from each participant to measure the amounts of naturally-made chemicals in the participants' cerebrospinal fluid.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.	Drug: clonidine 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 Next a small amount of spinal fluid will be withdrawn from each participant to measure the amounts of naturally-made chemicals in the participants' cerebrospinal fluid.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.	Drug: clonidine Patients will receive intrathecal clonidine (or clonidine injected into cerebrospinal fluid)

Arms

Assigned Interventions

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.

Drug: clonidine

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.

Drug: clonidine

Patients will receive intrathecal clonidine (or clonidine injected into 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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00350532

Locations

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

Sponsors and Collaborators

Wake Forest University

National Institute of Neurological Disorders and Stroke (NINDS)

Investigators

Principal Investigator:	James C. Eisenach, M.D.	Wake Forest University
Principal Investigator:	Richard Rauck, M.D.	The Center for Clinical Research

More Information

No publications provided

Responsible Party:	James C. Eisenach, M.D., Professor, Wake Forest University
ClinicalTrials.gov Identifier:	NCT00350532 History of Changes
Other Study ID Numbers:	P01NS041386_TRIAL2
Study First Received:	July 5, 2006
Results First Received:	March 23, 2009
Last Updated:	February 14, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Wake Forest University:

pain, chronic pain
acetylcholine
clonidine
a2-adrenergic agonists
alpha2-adrenergic agonists

Additional relevant MeSH terms:

Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Acetylcholine
Clonidine
Adrenergic Agonists
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Cholinergic Agonists

Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic Agents
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Analgesics
Sensory System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on June 18, 2013