Clonidine Versus Adenosine to Treat Neuropathic Pain

Pain Clinical Trial

Official title:

Clonidine Versus Adenosine to Treat Neuropathic Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00349921
• Other study ID #: P01NS041386_TRIAL1
• Secondary ID: P01NS041386
• Status: Completed
• Phase: Phase 2
• Start date: August 2004
• Est. completion date: January 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 determine the effects of clonidine and adenosine on nerve 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Neuralgia
• Pain

Intervention

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.
• 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
inactive substance
• placebo
inactive substance

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	Number Meeting Success Criterion	Verbal pain report 2 hours post injection compared to baseline verbal pain scores prior to injection	baseline and 2 hours