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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
James C. Eisenach, M.D., Wake Forest School of Medicine
ClinicalTrials.gov Identifier:
NCT00350532
First received: July 5, 2006
Last updated: March 5, 2014
Last verified: March 2014
  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: Allocation: Randomized
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:


Further study details as provided by Wake Forest School of Medicine:

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 Next a small amount of spinal fluid will be withdrawn from each participant to measure the amounts of naturally-made chemicals in the participants' cerebrospinal fluid.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 Next a small amount of spinal fluid will be withdrawn from each participant to measure the amounts of naturally-made chemicals in the participants' cerebrospinal fluid.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)

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 School of Medicine
Investigators
Principal Investigator: James C. Eisenach, M.D. Wake Forest School of Medicine
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 School of Medicine
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: March 5, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Wake Forest School of Medicine:
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
Clonidine
Adrenergic Agonists
Acetylcholine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antihypertensive Agents
Cardiovascular Agents
Sympatholytics
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Cholinergic Agonists
Cholinergic Agents

ClinicalTrials.gov processed this record on September 30, 2014