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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


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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Page last updated: August 23, 2015

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