Clonidine Versus Adenosine to Treat Neuropathic Pain

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ClinicalTrials.gov Identifier: NCT00349921

Recruitment Status : Completed

First Posted : July 10, 2006

Results First Posted : February 26, 2014

Last Update Posted : September 10, 2018

View this study on Beta.ClinicalTrials.gov

Sponsor:

Collaborator:

National Institute of Neurological Disorders and Stroke (NINDS)

Information provided by (Responsible Party):

Wake Forest University Health Sciences

Study Description

Brief Summary:

The purpose of this study is to determine the effects of clonidine and adenosine on nerve pain.

Condition or disease	Intervention/treatment	Phase
Pain	Drug: clonidine Drug: adenosine Drug: placebo	Phase 2

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).

Clonidine-a drug commonly used to treat high blood pressure-has been shown to effectively treat neuropathic pain, is FDA-approved for administration via epidural (an injection given in the lower back), and is the third most commonly prescribed drug for chronic intrathecal (an injection into the cerebrospinal fluid) use in people with chronic pain.

Adenosine-a drug commonly administered intravenously (into a vein) to treat certain types of abnormal heart rhythms-has been found to reduce areas of allodynia (pain caused by a stimulus that does not normally cause pain) after intrathecal, but not intravenous administration in people with neuropathic pain.

Intrathecal clonidine relieves pain by actions on a2-adrenoceptors in the spinal cord, whereas adenosine relieves pain by actions on A1 adenosine receptors. Researchers believe that intrathecal adenosine and clonidine may prove to be excellent painkillers for nerve pain. Therefore, the goal of this study is to determine the effects of clonidine and adenosine on nerve pain.

After initial screening, baseline measurements, and training to learn to estimate pain accurately using thermal heat testing, a sample of spinal fluid will be taken from each participant. Participants then will be randomly chosen to receive either clonidine, adenosine, or placebo. After receiving the study medication, participants will be monitored, with their vital signs checked at 30, 60, 120, 180, and 240 minutes.

Duration of the study for participants is 2 weeks, and includes two visits to the research center, each lasting approximately 6 hours.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	24 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Clonidine Versus Adenosine to Treat Neuropathic Pain
Study Start Date :	August 2004
Actual Primary Completion Date :	January 2008
Actual Study Completion Date :	January 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Adenosine Clonidine Clonidine hydrochloride

Genetic and Rare Diseases Information Center resources: Complex Regional Pain Syndrome Chronic Graft Versus Host Disease

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: clonidine first, then adenosine clonidine given in first injection adenosine given in second injection	Drug: clonidine Clonidine-a drug commonly used to treat high blood pressure-has been shown to effectively treat neuropathic pain, is FDA-approved for administration via epidural (an injection given in the lower back), and is the third most commonly prescribed drug for chronic intrathecal (an injection into the cerebrospinal fluid) use in people with chronic pain. Other Name: duraclon
Active Comparator: adenosine first, then clonidine adenosine given in first injection clonidine given in second injection	Drug: adenosine Adenosine-a drug commonly administered intravenously (into a vein) to treat certain types of abnormal heart rhythms-has been found to reduce areas of allodynia (pain caused by a stimulus that does not normally cause pain) after intrathecal, but not intravenous administration in people with neuropathic pain.
Placebo Comparator: clonidine given first, then placebo placebo	Drug: placebo inactive substance Other Name: dummy
Placebo Comparator: adenosine given first, then placebo placebo	Drug: placebo inactive substance Other Name: dummy

Outcome Measures

Primary Outcome Measures :

Number Meeting Success Criterion [ Time Frame: baseline and 2 hours ]
Verbal pain report 2 hours post injection compared to baseline verbal pain scores prior to injection

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	Child, Adult, Older Adult
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with complex regional pain syndrome (CRPS), type I involving a lower extremity

Exclusion Criteria:

Pregnancy
Allergy to clonidine
Currently taking clonidine or other direct a2-adrenergic agonists, or taking cholinesterase inhibitors
Patients with any serious or unstable medical problems (heart, lung, liver, kidney, or nervous system disease)

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00349921

Locations

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United States, North Carolina
The Center for Clinical Research, 145 Kimel Park Drive
Winston-Salem, North Carolina, United States, 27103
Wake Forest University School of Medicine, Medical Center Boulevard
Winston-Salem, North Carolina, United States, 27157-1009

Sponsors and Collaborators

Wake Forest University Health Sciences

National Institute of Neurological Disorders and Stroke (NINDS)

Investigators

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Principal Investigator:	James C. Eisenach, M.D.	Wake Forest University Health Sciences
Principal Investigator:	Richard Rauck, M.D.	The Center for Clinical Research

More Information

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Responsible Party:	Wake Forest University Health Sciences
ClinicalTrials.gov Identifier:	NCT00349921
Other Study ID Numbers:	P01NS041386_TRIAL1 P01NS041386 ( U.S. NIH Grant/Contract )
First Posted:	July 10, 2006 Key Record Dates
Results First Posted:	February 26, 2014
Last Update Posted:	September 10, 2018
Last Verified:	August 2018

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Studies a U.S. FDA-regulated Drug Product:	Yes
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Wake Forest University Health Sciences:


pain chronic pain clonidine adenosine	complex regional pain syndrome CRPS a2-adrenergic agonists alpha2-adrenergic agonists

Additional relevant MeSH terms:

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Neuralgia Peripheral Nervous System Diseases Neuromuscular Diseases Nervous System Diseases Pain Neurologic Manifestations Adenosine Clonidine Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Antihypertensive Agents	Sympatholytics Autonomic Agents Adrenergic alpha-2 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Anti-Arrhythmia Agents Vasodilator Agents Purinergic P1 Receptor Agonists Purinergic Agonists Purinergic Agents

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