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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00350532
• Other study ID #: P01NS041386_TRIAL2
• Secondary ID: P01NS041386
• Status: Completed
• Phase: Phase 2
• Start date: September 2004
• Est. completion date: March 2008

Study information

• Verified date: August 2018
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 Next a small amount of spinal fluid will be withdrawn from each participant to measure the amounts of naturally-made chemicals in the participants' cerebrospinal fluid.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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neuralgia
• Pain

Intervention

Drug:
• clonidine
Patients will receive intrathecal clonidine (or clonidine injected into cerebrospinal fluid)
• clonidine
Patients will receive intrathecal clonidine (or clonidine injected into cerebrospinal fluid)

Locations

Country	Name	City	State
United States	The Center for Clinical Research, 145 Kimel Park Drive	Winston-Salem	North Carolina
United States	Wake Forest University School of Medicine, Medical Center Boulevard	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acetylcholine Concentration in Cerebrospinal Fluid	Acetylcholine levels in CSF after administration of intrathecal clonidine measured by High-performance liquid chromatography (HPLC).	60 minutes