Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00333242
Status:
UNKNOWN
Last Update Posted:
2017-01-11
First Post:
2006-06-01
Brief Title:
Hyperalgesia in Methadone Patients Can it be Treated
Sponsor:
National Institute on Drug Abuse NIDA
Organization:
National Institute on Drug Abuse NIDA
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2008-08
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In the proposed study we will build upon our previous studies validating and characterizing hyperalgesia in MM samples to explore its underlying mechanism from a pharmacological perspective Utilizing a double-blind placebo-controlled designs the proposed work will evaluate the ability of dextromethorphan an N-methyl-D-aspartate NMDA-antagonists to diminish or reverse the opioid-induced hyperalgesia complicating the pain states suffered by MM patients Specifically in a sample of MM patients dextromethorphan theorized to interfere with the development of opioid-induced hyperalgesia will be evaluated for its ability to ameliorate or diminish the opioid-induced hyperalgesia in these patients as reflected by changes on pain threshold and tolerance to both cold-pressor and electrical pain at peak and trough methadone blood levels The results of this work will not only provide pharmacologic insight into the mechanisms underlying poor pain tolerance in this at-risk population but also direction for the medical management of pain complicated by opioid-induced hyperalgesia
Detailed Description:
Addressing the undertreatment of clinical pain has become a national priority with a central goal being to identify effective interventions for those subgroups of patients most at risk for suffering unrelieved pain NIH Program Announcement PA-01-115 In fact the undertreatment of pain was recently ruled a form of patient abuse with a California court awarding one million dollars in damages to the family of such a patient Novel data accumulated by our investigative group has shown that patients maintained on the mu-opioid agonist methadone for the treatment of addiction are significantly hyperalgesic to cold-pressor experimental pain as compared to normal controls This diminished pain tolerance in addition to the contextual prohibitions associated with providing known opioid addicts with opioid analgesics makes them a population uniquely vulnerable to the undertreatment of pain Unfortunately little is known about how to best manage the pain suffered by the over 120000 methadone-maintained MM patients in this country in part because the hyperalgesia they suffer appears to be akin to neuropathic pain and opioid-induced
In the proposed series of studies the Principal Investigator a first-time R01 applicant will build upon her previous studies validating and characterizing hyperalgesia in MM samples to explore its underlying mechanism from a pharmacological perspective Utilizing slightly different double-blind placebo-controlled designs the proposed work will evaluate the ability of three classes of medication N-methyl-D-aspartate NMDA-antagonists adjuvant anticonvulsant analgesics and novel opioid analgesics to diminish or reverse the opioid-induced hyperalgesia complicating the pain states suffered by MM patients Specifically in a sample of MM patients 1 dextromethorphan which interferes with the development of opioid-induced hyperalgesia 2 gabapentin which has proven efficacy in treating neuropathic pain and 3 oxycodone which has novel opioid activity will each be evaluated for its ability to ameliorate or diminish the opioid-induced hyperalgesia in these patients as reflected by changes on pain threshold and tolerance to both cold-pressor and electrical pain at peak and trough methadone blood levels The results of this work will not only provide pharmacologic insight into the mechanisms underlying poor pain tolerance in this at-risk population but also direction for the medical management of pain complicated by opioid-induced hyperalgesia
In the proposed series of studies the Principal Investigator a first-time R01 applicant will build upon her previous studies validating and characterizing hyperalgesia in MM samples to explore its underlying mechanism from a pharmacological perspective Utilizing slightly different double-blind placebo-controlled designs the proposed work will evaluate the ability of three classes of medication N-methyl-D-aspartate NMDA-antagonists adjuvant anticonvulsant analgesics and novel opioid analgesics to diminish or reverse the opioid-induced hyperalgesia complicating the pain states suffered by MM patients Specifically in a sample of MM patients 1 dextromethorphan which interferes with the development of opioid-induced hyperalgesia 2 gabapentin which has proven efficacy in treating neuropathic pain and 3 oxycodone which has novel opioid activity will each be evaluated for its ability to ameliorate or diminish the opioid-induced hyperalgesia in these patients as reflected by changes on pain threshold and tolerance to both cold-pressor and electrical pain at peak and trough methadone blood levels The results of this work will not only provide pharmacologic insight into the mechanisms underlying poor pain tolerance in this at-risk population but also direction for the medical management of pain complicated by opioid-induced hyperalgesia
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None