HyperalgesiaNCT00218374
Dextromethorphan, Gabapentin, and Oxycodone to Treat Opioid-Induced Hyperalgesia
A study testing Gabapentin in people with Hyperalgesia and Opioid-Related Disorders, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Hyperalgesia, Opioid-Related Disorders
- What is being tested?
- Gabapentin
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Jun 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Be between the ages of 18 and 55 years of age.
- Meets DSM-IV diagnostic criteria for opioid dependence
- Taking a stable dose of methadone for 6 weeks prior to study entry and is compliant in methadone maintenance treatment
- Is in good physical health or under a physician's care if a medical condition requires ongoing treatment
Who cannot join
- Known sensitivity to dextromethorphan, gabapentin, or oxycodone
- Currently dependent on alcohol, benzodiazepine, or any drug (other than nicotine)
- Currently in an acutely psychotic, severely depressed state and in need of inpatient treatment
- Immediate suicide risk
- Neurological or psychiatric illness (e.g., peripheral neuropathy, schizophrenia, neuropathic pain, Raynaud's disease, or urticaria)
- Acute medical condition that would make study participation medically dangerous (e.g., acute hepatitis, unstable cardiovascular disease, liver disease, or kidney disease)
Show all 11Show fewer
- Liver enzyme values five times greater than normal
- Currently taking analgesic medication for a painful condition on a regular basis
- Current or past history of high blood pressure, heart disease, or stroke
- Currently using a pacemaker
- Pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Los Angeles
Los Angeles, California, 90024
About this study
Official title: Hyperalgesia in Methadone Patients: Can it be Treated?
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.
Read the 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 individual's 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 individual's 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.
- Conditions
- Hyperalgesia, Opioid-Related Disorders
- Being tested
- Gabapentin
- Keywords
- Opiate Addiction, Opiate Dependence
- Medical subject headings
- Hyperalgesia, Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GabapentinDrug
Gabapentin initiated up to a daily dose of 2400mg PO x 5 weeks
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain response (measured after each pain testing session on Days 1, 4, 36, and 39)
Measured: 6 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startOct 2006
- Primary completionJun 2007
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperalgesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Investigators
- Margaret Compton, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00218374
- Sponsor's protocol ID
- NIDA-15463-1
- Other IDs
- R01-15463-1, DPMC
- Status last verified
- Aug 2008
- First submitted
- 16 Sep 2005
- Last updated
- 12 Jan 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperalgesia in Methadone Patients: Can it be Treated?
- ClinicalTrials.gov ID
- NCT00218374
- Acronym / sponsor ID
- NIDA-15463-1
- Conditions
- Hyperalgesia, Opioid-Related Disorders
- Keywords
- Opiate Addiction, Opiate Dependence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- Oct 2006
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 individual's 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 individual's 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Be between the ages of 18 and 55 years of age.
- Meets DSM-IV diagnostic criteria for opioid dependence
- Taking a stable dose of methadone for 6 weeks prior to study entry and is compliant in methadone maintenance treatment
- Is in good physical health or under a physician's care if a medical condition requires ongoing treatment
Key exclusion criteria (11 listed)
- Known sensitivity to dextromethorphan, gabapentin, or oxycodone
- Currently dependent on alcohol, benzodiazepine, or any drug (other than nicotine)
- Currently in an acutely psychotic, severely depressed state and in need of inpatient treatment
- Immediate suicide risk
- Neurological or psychiatric illness (e.g., peripheral neuropathy, schizophrenia, neuropathic pain, Raynaud's disease, or urticaria)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GabapentinGabapentin initiated up to a daily dose of 2400mg PO x 5 weeks | Drug | – |
Primary outcome
Pain response (measured after each pain testing session on Days 1, 4, 36, and 39)
Time frame: 6 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margaret Compton, PhD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gabapentin in people with Hyperalgesia and Opioid-Related Disorders, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain response (measured after each pain testing session on Days 1, 4, 36, and 39) (time frame: 6 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2017; AzTrials last refreshed its copy on 6 Nov 2026.