Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00218374
Status:
COMPLETED
Last Update Posted:
2017-01-12
First Post:
2005-09-16
Brief Title:
Dextromethorphan Gabapentin and Oxycodone to Treat Opioid-Induced Hyperalgesia
Sponsor:
National Institute on Drug Abuse NIDA
Organization:
National Institute on Drug Abuse NIDA
Study Overview
Official Title:
Hyperalgesia in Methadone Patients Can it be Treated
Status:
COMPLETED
Status Verified Date:
2008-08
Last Known Status:
None
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:
Individuals who reduce or stop use of opioid medications are at risk for developing hyperalgesia which is an increased sensitivity to pain This study will compare the effectiveness of dextromethorphan gabapentin and oxycodone at reducing hyperalgesia in individuals addicted to opioids who are concurrently receiving methadone treatment
Detailed Description:
Opioid medications are frequently used for the treatment of moderate to severe pain however individuals who use opioids have a high risk of becoming addicted Opioid users who abruptly stop using opioid drugs may experience withdrawal symptoms including drug craving sweating sleep disruption nausea irritability and pain Hyperalgesia a severe and excessive sensitivity to pain is a serious condition that may also occur when opioid use is reduced or discontinued Opioid medications affect both the pain inhibitory and facilitatory systems meaning that while they are effective at treating pain in many individuals they also have the ability to intensify pain and cause hyperalgesia in some opioid users Three medications dextromethorphan gabapentin and oxycodone may alleviate the symptoms of hyperalgesia and lessen an individuals sensitivity to pain Further research is needed to confirm the benefits of these medications for opioid addicts The purpose of this study is to compare the effectiveness of dextromethorphan gabapentin and oxycodone at reducing opioid-induced hyperalgesia in methadone-maintained opioid addicts
This study will involve three separate experiments Participants in Experiment 1 will be randomly assigned to receive either dextromethorphan or placebo in Experiment 2 participants will be randomly assigned to receive either gabapentin or placebo and in Experiment 3 participants will be randomly assigned to receive either oxycodone or placebo Each experiment will last 5 weeks All 3 experiments will begin with a screening session Potential participants will undergo a physical exam and an electrocardiogram Blood and urine will be collected for laboratory tests and drug screening Each individuals medical and drug history will be reviewed and psychological and opiate withdrawal symptoms will be assessed Individuals who complete the screening and meet all study requirements will be permitted to continue in the study
All participants will be maintained on methadone throughout the study Participants will also receive either the study medication dextromethorphan gabapentin or oxycodone or placebo four times per day beginning on Day 5 Study visits will take place once a week At each visit medications for the previous week will be accounted for and medications for the following week will be dispensed Questionnaires and self-reports will be completed to assess depression levels and drug use Urine tests will be used to screen for the presence of drugs and alcohol During the study participants will take part in four pain testing sessions to measure pain threshold and tolerance two sessions will take place during Week 1 and another two sessions will occur during Week 5 The pain testing sessions will include a cold pressor CP test and an electrical stimulation ES procedure The CP test will involve placing an arm in ice water for a short period of time the ES procedure will involve stimulating muscle nerve endings via electrodes placed on the skin Immediately after the CP and ES sessions blood will be drawn for laboratory testing Participants will again complete questionnaires and self-reports and urine samples will be collected Gift cards will be offered as an incentive for attending study visits and having negative drug tests
This study will involve three separate experiments Participants in Experiment 1 will be randomly assigned to receive either dextromethorphan or placebo in Experiment 2 participants will be randomly assigned to receive either gabapentin or placebo and in Experiment 3 participants will be randomly assigned to receive either oxycodone or placebo Each experiment will last 5 weeks All 3 experiments will begin with a screening session Potential participants will undergo a physical exam and an electrocardiogram Blood and urine will be collected for laboratory tests and drug screening Each individuals medical and drug history will be reviewed and psychological and opiate withdrawal symptoms will be assessed Individuals who complete the screening and meet all study requirements will be permitted to continue in the study
All participants will be maintained on methadone throughout the study Participants will also receive either the study medication dextromethorphan gabapentin or oxycodone or placebo four times per day beginning on Day 5 Study visits will take place once a week At each visit medications for the previous week will be accounted for and medications for the following week will be dispensed Questionnaires and self-reports will be completed to assess depression levels and drug use Urine tests will be used to screen for the presence of drugs and alcohol During the study participants will take part in four pain testing sessions to measure pain threshold and tolerance two sessions will take place during Week 1 and another two sessions will occur during Week 5 The pain testing sessions will include a cold pressor CP test and an electrical stimulation ES procedure The CP test will involve placing an arm in ice water for a short period of time the ES procedure will involve stimulating muscle nerve endings via electrodes placed on the skin Immediately after the CP and ES sessions blood will be drawn for laboratory testing Participants will again complete questionnaires and self-reports and urine samples will be collected Gift cards will be offered as an incentive for attending study visits and having negative drug tests
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01-15463-1 | None | None | None |
| DPMC | None | None | None |