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

Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Pain
Intervention:	Drug: clonidine

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were recruited from 9/1/2004-6/2/2006. Subjects were recruited from a pain clinic and the control group were healthy subjects.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No significant events or abnormal approaches noted.

Reporting Groups

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 Next a small amount of spinal fluid will be withdrawn from each participant to measure the amounts of naturally-made chemicals in the participants' cerebrospinal fluid.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 Next a small amount of spinal fluid will be withdrawn from each participant to measure the amounts of naturally-made chemicals in the participants' cerebrospinal fluid.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

Description

Neuropathic Pain Subjects

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 Next a small amount of spinal fluid will be withdrawn from each participant to measure the amounts of naturally-made chemicals in the participants' cerebrospinal fluid.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

Healthy Subjects

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 Next a small amount of spinal fluid will be withdrawn from each participant to measure the amounts of naturally-made chemicals in the participants' cerebrospinal fluid.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

Participant Flow: Overall Study

	Neuropathic Pain Subjects	Healthy Subjects
STARTED	24	19
COMPLETED	24	19
NOT COMPLETED	0	0

Baseline Characteristics

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Reporting Groups

	Description
Neuropathic Pain Subjects	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.
Healthy Subjects	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.

Description

Neuropathic Pain Subjects

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.

Healthy Subjects

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.

Baseline Measures

	Neuropathic Pain Subjects	Healthy Subjects	Total
Number of Participants [units: participants]	24	19	43
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	24	19	43
>=65 years	0	0	0
Age [units: years] Mean ± Standard Deviation	47.875 ± 11.48	32 ± 8.51	40.86 ± 12.91
Gender [units: participants]
Female	18	13	31
Male	6	6	12

Outcome Measures

1. Primary:

Acetylcholine Concentration in Cerebrospinal Fluid [ Time Frame: 60 minutes ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Dr. James Eisenach
Organization: Wake Forest University School of Medicine
phone: 336-716-4498
e-mail: jimeisenach@gmail.com

No publications provided

Responsible Party:	James C. Eisenach, MD, Professor of Anesthesiology, Wake Forest University 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:	July 21, 2010
Health Authority:	United States: Food and Drug Administration