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

NCT ID: NCT00350532

Last Updated: 2018-09-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-09-30
• Study Completion Date: 2008-03-31

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 Next a small amount of spinal fluid will be withdrawn from each participant to measure the amounts of naturally-made chemicals in the participants' cerebrospinal fluid.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

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

clonidine

Intervention Type: DRUG

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

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.

Group Type: ACTIVE_COMPARATOR

clonidine

Intervention Type: DRUG

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

Interventions

clonidine

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

Intervention Type: DRUG

clonidine

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

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James C. Eisenach, M.D.

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Richard Rauck, M.D.

Role: PRINCIPAL_INVESTIGATOR

The Center for Clinical Research

Locations

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, United States

Countries

United States

Other Identifiers

P01NS041386

Identifier Type: NIH

Identifier Source: secondary_id

View Link

P01NS041386_TRIAL2

Identifier Type: -

Identifier Source: org_study_id