Effect of Ketamine on Opioid-Induced Hyperalgesia
This study is ongoing, but not recruiting participants.
Sponsor:
Massachusetts General Hospital
Information provided by (Responsible Party):
Jianren Mao, MD, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00833755
First received: January 29, 2009
Last updated: January 8, 2013
Last verified: January 2013
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Purpose
The purpose of this study is to compare pain threshold, pain tolerance, and wind up, as measured by QST, before and after a single dose of ketamine infusion under two clinical conditions: chronic pain patients on opioid therapy and chronic pain patients without opioid therapy.
| Condition | Intervention |
|---|---|
|
Pain Chronic Pain Hyperalgesia |
Drug: Ketamine |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Health Services Research |
| Official Title: | Effect of Ketamine on Opioid-Induced Hyperalgesia |
Resource links provided by NLM:
Further study details as provided by Massachusetts General Hospital:
Primary Outcome Measures:
- Intravenous ketamine, an NMDA receptor antagonist, could be used to differentiate between opioid-induced hyperalgesia and opioid tolerance. [ Time Frame: After completion of study. ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 136 |
| Study Start Date: | September 2008 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Group 1: 90 subjects who have chronic pain conditions treated with an opioid regimen. Subjects will be randomized to receive either a ketamine (45 subjects) or a placebo (45 subjects) treatment during the study.
|
Drug: Ketamine
To compare pain threshold, pain tolerance, and wind up, as measured by QST, before and after a single dose of ketamine infusion under two clinical conditions: chronic pain patients on opioid therapy and chronic pain patients without opioid therapy.
|
|
Active Comparator: 2
Group2: This group will include 46 subjects who have chronic pain conditions similar to those in Group 1 but not on an opioid regimen over the last 3 months. Subjects in this group also will be randomized to receive either ketamine (23 subjects) or a placebo (23 subjects) treatment.
|
Drug: Ketamine
To compare pain threshold, pain tolerance, and wind up, as measured by QST, before and after a single dose of ketamine infusion under two clinical conditions: chronic pain patients on opioid therapy and chronic pain patients without opioid therapy.
|
Detailed Description:
We hypothesize that:
- Chronic pain patients on chronic opioids would have a lower pain threshold and lower pain tolerance when compared to opioid naïve patients (patients with chronic pain with non-opioids treatment)., as measured by QST in a non-affected neutral limb;
- Chronic pain patients on chronic opioids would have an increased response to painful stimulation, so called "windup" as demonstrated by QST;
- Both "wind-up" and altered pain threshold and tolerance would be indicative of the presence of opioid-induced hyperalgesia;
- Intravenous ketamine, an NMDA receptor antagonist, could be used to differentiate between opioid-induced hyperalgesia and opioid tolerance.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria for Group 1
- Subject will be between ages 18 to 65 years.
- Subject has a chronic pain condition for at least three months. This requirement is set in order to avoid the clinical uncertainty of an unstable pain condition and to minimize the study variation. Subjects should have a VAS pain score at 4 or above at the time of study.
- Subject is on a chronic opioid treatment regimen (e.g., morphine, fentanyl, oxycodone, methadone, hydromorphone, hydrocodone) for at least three months. There should have been no changes in the type and amount of opioid dose for at least one month. Only patients with a minimal daily dose of at least 60 mg morphine equianalgesic dose will be included.
Inclusion Criteria for Group 2
- Subject who meets the criteria #1 & #2 as listed for Group 1.
- Subject has not been on an opioid regimen for the last three or more months.
Exclusion Criteria for all groups:
- Subject has an altered sensation at the skin site of QST (one of upper extremities).
- Subject has scar tissue or acute injury at the skin site of QST.
- Subject has neurological disease or a condition causing upper extremities or generalized polyneuropathy, such as diabetic neuropathy, alcoholic neuropathy, AIDS neuropathy, multiple sclerosis, amyotrophic lateral sclerosis, and post-stroke residual neurological deficits.
- Subject has a diagnosis of renal or liver failure.
- Subject has a diagnosis of unstable angina, congestive heart failure, cardiac arrythmias or myocardial infarction within 1 year.
- Subject is allergic to ketamine.
- Subject had recent therapy that may influence QST results, e.g., neuroablative procedure involving upper extremities within six-months or peripheral neurolytic block involving upper extremities within two-months.
- Subject has a confirmed diagnosis of and is under the care of a psychiatrist for major depression disorder, eating disorder; alcohol or drug dependence; or attention deficit hyperactivity disorder. Subject has any history of a confirmed diagnosis of bipolar disorder, schizophrenia, anxiety disorder or a psychotic disorder
- Subject is tested positive on drug urine screening test.
Subject is pregnant or breast-feeding.
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Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00833755
Locations
| United States, Massachusetts | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
| Principal Investigator: | Jianren Mao, M.D., Ph.D. | Massachusetts General Hospital |
More Information
Additional Information:
No publications provided
| Responsible Party: | Jianren Mao, MD, PhD, Principal Investigator, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT00833755 History of Changes |
| Other Study ID Numbers: | 2008P 000879 |
| Study First Received: | January 29, 2009 |
| Last Updated: | January 8, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Massachusetts General Hospital:
|
Pain Chronic pain Opioid induced hyperalgesia Opioid therapy |
Additional relevant MeSH terms:
|
Hyperalgesia Somatosensory Disorders Sensation Disorders Neurologic Manifestations Nervous System Diseases Signs and Symptoms Ketamine Analgesics, Opioid Anesthetics, Dissociative Anesthetics, Intravenous Anesthetics, General Anesthetics |
Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Analgesics Sensory System Agents Peripheral Nervous System Agents |
ClinicalTrials.gov processed this record on May 19, 2013