Gulf War IllnessPhase 2GWI TreatmentNCT02206490
Trial of Naltrexone and Dextromethorphan for Gulf War Illness
A Phase 2 study testing naltrexone and Dextromethorphan in people with Gulf War Illness, run by East Carolina University at 1 site in United States.
Trial summary
Veterans of the 1991 Gulf War who developed Gulf War Illness are being studied. Treatments with FDA approved generic drugs are being administered to see if they help with the symptoms of Gulf War Illness, such as chronic fatigue; difficulty with memory, concentration, and thinking; widespread chronic pain; and… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Gulf War Illness
- What is being tested?
- naltrexone and Dextromethorphan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Jan 2016
- Phase
- Phase 2
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Served in the Gulf War and developed the symptoms of Gulf War Illness as described by the modified Kansas Case Definition
Who cannot join
- Pregnant women, nursing mothers, individuals requiring medications that have drug interactions with dextromethorphan or naltrexone, cancer not in remission, chronic infectious disease, liver disease, lupus, multiple sclerosis, stroke, under current treatment for schizophrenia, bipolar disorder/manic depression, and depression.
- Those with a history of current illicit drug use will be excluded. Individuals who have had recent surgery will not be enrolled until they have completely recovered from the surgery.
- Subjects participating in other clinical trials will be excluded.
- Those enrolled recently in a clinical trial will be enrolled after a washout period of one month.
Trial locations and contacts
1 site in 1 country.
United States1 site
Brody School of Medicine a East Carolina Univesity
Greenville, North Carolina, 27834
About this study
Official title: Trial of Naltrexone and Dextromethorphan for Gulf War Veterans Illnesses
Veterans of the 1991 Gulf War who developed Gulf War Illness are being studied. Treatments with FDA approved generic drugs are being administered to see if they help with the symptoms of Gulf War Illness, such as chronic fatigue; difficulty with memory, concentration, and thinking; widespread chronic pain; and autonimic dysfunction. Drugs to be tested are dextromethorphan and naltrexone.
Read the detailed description
Gulf war veterans' illnesses comprise distinct clusters of symptom-defined illnesses for which there are neither diagnostic tests nor effective treatments. Gulf war veterans had variable exposures to a number of chemicals, including organophosphate insecticides, pyrethrum-related insecticides, DEET, Pyridostigmine bromide, smoke from oil well fires, and Sarin gas. Gulf war veterans' illnesses may reflect an inflammatory cycle involving the brain which may be a common mechanism of many neurological conditions, whether initiated by toxic exposures, infection, or trauma. In this theory, central nervous system inflammation initiated by toxic exposures and sometimes exacerbated by subsequent exposures is a component of illness hypothesized to explain the neurological manifestations. Substance P release at sensory nerve endings is an explanation for the peripheral pain manifestations of illness.
This theory suggests that novel anti-inflammatory drugs may be of benefit in symptom-defined illnesses related to a cycle of inflammation. Dr. J. S. Hong's laboratory at the National Institute of Environmental Health Sciences has demonstrated that Morphine-related analogs, including Naltrexone and Dextromethorphan, have great potency in anti-inflammation and neuroprotective effects. Naltrexone is a safe and readily available generic medication. Dextromethorphan is also a safe and readily available generic medication that is available without a prescription as a cough medication. Results from several clinical trials showed that Naltrexone is effective in several inflammation-related diseases, such as neurogenic pain, movement disorders, etc. In addition, there were no obvious side effects in patients taking this drug for six months. This project will conduct randomized double-blinded studies for treating ill Gulf war veterans with Naltrexone and Dextromethorphan. Laboratory tests for markers of inflammation including neurogenic inflammation will be performed pre- and post-treatment, to see if these markers are elevated and if so, to see if treatment modulates these markers.
Ill Gulf veterans will be recruited through the media, veterans groups, and individual veteran activists. A screening telephone interview will be performed to determine if the veterans meet a modified Kansas case definition for inclusion. Those veterans who meet study criteria will be invited to participate. Eligible veterans will be invited for an initial visit that will consist of obtaining written informed consent, a medical history, physical examination, and laboratory testing. Institutional review board approval of the study will be in place. The pharmacy staff at the institution will prepare the medications and placebo in identical capsules.
- Conditions
- Gulf War Illness
- Being tested
- naltrexone, Dextromethorphan
- Keywords
- Gulf War Illness, treatment, dextromethorphan, naltrexone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
naltrexoneDrug
Randomized controlled trial of naltrexone for Gulf War Illness.
DextromethorphanDrug
Randomized controlled trial of dextromethorphan for Gulf War Illness
| Study group | Role | What they receive |
|---|---|---|
| Naltrexone Study Drug | Active comparator | Subjects will take naltrexone 4.5 mg daily for three months. Receives: Drug: naltrexone |
| Naltrexone placebo | Placebo comparator | Subjects will take a 3 month course of a placebo pill identical in appearance to the naltrexone study drug. Receives: Drug: naltrexone |
| dextromethrophan study drug | Active comparator | subjects will take a sustained release dextromethorphan pill twice a day. Receives: Drug: Dextromethorphan |
| dextromethoprhan placebo | Placebo comparator | Subjects will take a 3 month course of a placebo pill identical in appearance to the dextromethorphan study drug. Receives: Drug: Dextromethorphan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptoms Scores
Symptoms of Gulf War Illness will be scored by participants using a ten center meter scale.
Scores will be collected at the end of 12 weeks/16 weeks/28weeks
Measured: 28 weeks approximately
Secondary outcomes (2)
SF-36
Subjects will complete a standard health assessment tool, the SF-36, at the end of each course of therapy.
Scores will be collected at 12 weeks/16 weeks/28 weeks
Measured: 28 weeks approximately
Connors Continuous Performance Test
Subjects will take the Connors Continuous Performance Test at the end of each course of study drug or placebo.
Scores will be collected at 12 weeks/16 weeks/28 weeks
Measured: 28 weeks approximately
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2014 (estimated)
- Study startJan 2012
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gulf War IllnessStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- East Carolina University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William J. Meggs, East Carolina University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02206490
- Sponsor's protocol ID
- 090562
- Acronym
- GWI Treatment
- Status last verified
- Mar 2016
- First submitted
- 24 Aug 2012
- Last updated
- 3 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of Naltrexone and Dextromethorphan for Gulf War Veterans Illnesses
- ClinicalTrials.gov ID
- NCT02206490
- Acronym / sponsor ID
- GWI Treatment / 090562
- Conditions
- Gulf War Illness
- Keywords
- Gulf War Illness, treatment, dextromethorphan, naltrexone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- East Carolina UniversityUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 1 Aug 2014 (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.
Veterans of the 1991 Gulf War who developed Gulf War Illness are being studied. Treatments with FDA approved generic drugs are being administered to see if they help with the symptoms of Gulf War Illness, such as chronic fatigue; difficulty with memory, concentration, and thinking; widespread chronic pain; and autonimic dysfunction. Drugs to be tested are dextromethorphan and naltrexone.
Detailed description
Gulf war veterans' illnesses comprise distinct clusters of symptom-defined illnesses for which there are neither diagnostic tests nor effective treatments. Gulf war veterans had variable exposures to a number of chemicals, including organophosphate insecticides, pyrethrum-related insecticides, DEET, Pyridostigmine bromide, smoke from oil well fires, and Sarin gas. Gulf war veterans' illnesses may reflect an inflammatory cycle involving the brain which may be a common mechanism of many neurological conditions, whether initiated by toxic exposures, infection, or trauma. In this theory, central nervous system inflammation initiated by toxic exposures and sometimes exacerbated by subsequent exposures is a component of illness hypothesized to explain the neurological manifestations. Substance P release at sensory nerve endings is an explanation for the peripheral pain manifestations of illness.
This theory suggests that novel anti-inflammatory drugs may be of benefit in symptom-defined illnesses related to a cycle of inflammation. Dr. J. S. Hong's laboratory at the National Institute of Environmental Health Sciences has demonstrated that Morphine-related analogs, including Naltrexone and Dextromethorphan, have great potency in anti-inflammation and neuroprotective effects. Naltrexone is a safe and readily available generic medication. Dextromethorphan is also a safe and readily available generic medication that is available without a prescription as a cough medication. Results from several clinical trials showed that Naltrexone is effective in several inflammation-related diseases, such as neurogenic pain, movement disorders, etc. In addition, there were no obvious side effects in patients taking this drug for six months. This project will conduct randomized double-blinded studies for treating ill Gulf war veterans with Naltrexone and Dextromethorphan. Laboratory tests for markers of inflammation including neurogenic inflammation will be performed pre- and post-treatment, to see if these markers are elevated and if so, to see if treatment modulates these markers.
Ill Gulf veterans will be recruited through the media, veterans groups, and individual veteran activists. A screening telephone interview will be performed to determine if the veterans meet a modified Kansas case definition for inclusion. Those veterans who meet study criteria will be invited to participate. Eligible veterans will be invited for an initial visit that will consist of obtaining written informed consent, a medical history, physical examination, and laboratory testing. Institutional review board approval of the study will be in place. The pharmacy staff at the institution will prepare the medications and placebo in identical capsules.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Naltrexone Study Drug | Active comparator | Drug: naltrexoneSubjects will take naltrexone 4.5 mg daily for three months. |
| Naltrexone placebo | Placebo comparator | Drug: naltrexoneSubjects will take a 3 month course of a placebo pill identical in appearance to the naltrexone study drug. |
| dextromethrophan study drug | Active comparator | Drug: Dextromethorphansubjects will take a sustained release dextromethorphan pill twice a day. |
| dextromethoprhan placebo | Placebo comparator | Drug: DextromethorphanSubjects will take a 3 month course of a placebo pill identical in appearance to the dextromethorphan study drug. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Served in the Gulf War and developed the symptoms of Gulf War Illness as described by the modified Kansas Case Definition
Key exclusion criteria (4 listed)
- Pregnant women, nursing mothers, individuals requiring medications that have drug interactions with dextromethorphan or naltrexone, cancer not in remission, chronic infectious disease, liver disease, lupus, multiple sclerosis, stroke, under current treatment for schizophrenia, bipolar disorder/manic depression, and depression.
- Those with a history of current illicit drug use will be excluded. Individuals who have had recent surgery will not be enrolled until they have completely recovered from the surgery.
- Subjects participating in other clinical trials will be excluded.
- Those enrolled recently in a clinical trial will be enrolled after a washout period of one month.
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 |
|---|---|---|
| naltrexoneRandomized controlled trial of naltrexone for Gulf War Illness. | Drug | Naltrexone Study Drug, Naltrexone placebo |
| DextromethorphanRandomized controlled trial of dextromethorphan for Gulf War Illness | Drug | dextromethoprhan placebo, dextromethrophan study drug |
Primary outcome
Symptoms Scores
Time frame: 28 weeks approximately
Symptoms of Gulf War Illness will be scored by participants using a ten center meter scale. Scores will be collected at the end of 12 weeks/16 weeks/28weeks
2 secondary outcomes
SF-36
Time frame: 28 weeks approximately
Connors Continuous Performance Test
Time frame: 28 weeks approximately
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 3 Mar 2016.
Related trials for Gulf War Illness
RecruitingObservational study
NIH Investigative Deep Phenotyping Study of Gulf War Veteran Health (Project NIH IN-DEPTH)
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Ca-Mg Butyrate in Gulf War Illness
Gulf War Illness, Chronic Fatigue
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Pycnogenol (French Maritime Pine Bark) for the Treatment of Gulf War Illness
Gulf War Syndrome
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Clinical Evaluation of Montelukast in Veterans With Gulf War Illness
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Recruiting
Mechanisms of Gulf War Illness
Gulf War Illness, Irritable Bowel Syndrome
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing naltrexone and Dextromethorphan in people with Gulf War Illness, run by East Carolina University 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 1 inclusion and 4 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 3 Mar 2016. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Symptoms Scores (time frame: 28 weeks approximately). 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 3 Mar 2016.