D-cycloserine: A Novel Treatment for Gulf War Illness (GWDCS)
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 43 - 85 |
| Updated: | 1/17/2019 |
| Start Date: | October 2015 |
| End Date: | September 2019 |
| Contact: | Allison Coyne, B.S. |
| Email: | afcoyne@bu.edu |
| Phone: | 617-358-3048 |
D-cycloserine: A Novel Treatment for Gulf War Illness
The purpose of this study is to investigate the efficacy of d-cycloserine (DCS) treatment for
Gulf War Illness (GWI). Gulf War veterans with Gulf War Illness experience numerous chronic
health symptoms, including cognition and fatigue, which reduces their quality of life. Gulf
War veterans are in urgent need of novel treatment plans to tackle elusive symptomatology of
Gulf War Illness. By using the literature of previous studies, the investigators have chosen
to investigate d-cycloserine as a possible candidate for treating GWI, specifically cognitive
symptoms. DCS has been shown to reduce neuroinflammation, regulate glutamate levels, and
improve synaptic functioning in key areas of the brain.
Gulf War Illness (GWI). Gulf War veterans with Gulf War Illness experience numerous chronic
health symptoms, including cognition and fatigue, which reduces their quality of life. Gulf
War veterans are in urgent need of novel treatment plans to tackle elusive symptomatology of
Gulf War Illness. By using the literature of previous studies, the investigators have chosen
to investigate d-cycloserine as a possible candidate for treating GWI, specifically cognitive
symptoms. DCS has been shown to reduce neuroinflammation, regulate glutamate levels, and
improve synaptic functioning in key areas of the brain.
Our study is a pilot study for the novel treatment of d-cycloserine to treat GWI. Our study
will consist of two experimental groups of equal size (n=28): DCS treatment group and a
placebo group. Participants will be randomized into either group; with a double blind study
design. Participants will be instructed to self-administer their treatment pills once per day
for 28 days. There will be a total of 6 study visits that will include medical and
neuropsychological assessment. The first visit will be for establishing eligibility and
baseline functioning. Three visits (visits 2-4) will occur during the medication trial (day
1, day 2 and two weeks into medication/placebo). Visit 5 will occur around the time
medication/placebo is finished. Visit 6 (follow up) will occur one month after
medication/placebo is complete.
will consist of two experimental groups of equal size (n=28): DCS treatment group and a
placebo group. Participants will be randomized into either group; with a double blind study
design. Participants will be instructed to self-administer their treatment pills once per day
for 28 days. There will be a total of 6 study visits that will include medical and
neuropsychological assessment. The first visit will be for establishing eligibility and
baseline functioning. Three visits (visits 2-4) will occur during the medication trial (day
1, day 2 and two weeks into medication/placebo). Visit 5 will occur around the time
medication/placebo is finished. Visit 6 (follow up) will occur one month after
medication/placebo is complete.
Inclusion Criteria:
- Veterans of the 1991 Gulf War, male or female
- Physical examination and laboratory findings within normal limits
- Willingness and ability to participate in the informed consent process and comply with
study protocols
- Symptom criteria: Meets Gulf War Illness criteria with the cognitive symptom domain
being present. Veteran does not have medical exclusions for Gulf War Illness
Exclusion Criteria:
- Veteran lacks the capacity to provide consent during the informed consent process
- Veteran has the one of the following medical exclusion conditions and/or has been
active or received treatment within the past 5 years: Cancer (except nonmelanoma skin
cancer), diabetes (not well managed), seizure disorder, heart disease (except
hypertension), liver disease, kidney disease, Lupus, multiple sclerosis, stroke,
chronic infectious disease, immune disorder/immunosuppression
- Veteran has a history of a major psychiatric or central nervous system disorder that
can affect cognitive function (ie. epilepsy, brain tumor, Parkinson's Disease)
- Veteran has been hospitalized in the past 5 years for depression, PTSD, alcohol or
drug dependence
- Veteran has current suicidal ideation or current alcohol or drug dependence
- Pregnant women, lactating women, women who are breastfeeding, or women of childbearing
potential who are not using medically accepted forms of contraception
- Veteran is active duty personnel
We found this trial at
1
site
Boston University Boston University is no small operation . With over 33,000 undergraduate and graduate...
Click here to add this to my saved trials
