Clonidine Versus Adenosine to Treat Neuropathic Pain

NCT ID: NCT00349921

Last Updated: 2018-09-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-08-31
• Study Completion Date: 2008-01-31

Brief Summary

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

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.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

clonidine first, then adenosine

clonidine given in first injection adenosine given in second injection

Group Type: ACTIVE_COMPARATOR

clonidine

Intervention Type: DRUG

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 first, then clonidine

adenosine given in first injection clonidine given in second injection

Group Type: ACTIVE_COMPARATOR

adenosine

Intervention Type: DRUG

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.

clonidine given first, then placebo

placebo

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

inactive substance

adenosine given first, then placebo

placebo

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

inactive substance

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

placebo

inactive substance

Intervention Type: DRUG

placebo

inactive substance

Intervention Type: DRUG

Other Intervention Names

duraclon; dummy; dummy

Eligibility 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)

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

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_TRIAL1

Identifier Type: -

Identifier Source: org_study_id