Alcoholism Clinical Trial
Official title:
A Double Blind Trial of Divalproex Sodium for Affective Lability and Alcohol Use Following Traumatic Brain Injury
Successful treatment of traumatic brain injury (TBI)-induced mood lability may reduce or
eliminate drinking behaviors in persons with alcohol abuse/dependence (AA/D) and affective
lability following TBI. Observed clinically, the symptoms of poorly regulated affective
expression of AA/D+TBI patients who reach alcohol abstinence do not appear to be those of an
idiopathic mood or anxiety disorder. These symptoms do not present the severity or the same
natural courses as do Major Depressive Disorder, Bipolar Illness, or Anxiety Disorder, for
example. Instead, both symptoms and course appear more characteristic of the sustained affect
lability often observed following TBI. This observation suggests that TBI survivors represent
a patient group for whom treatment of neuropsychiatric symptoms following TBI may alleviate
both TBI-related affect lability and also heavy ethanol use by treating the condition that is
contextually related to excessive alcohol use.
Based on this concept of consequently treating AA/D through the management of post-TBI
affective lability, this study was conducted observing the efficacy of divalproex sodium on
the severity of affective lability and AA/D in persons suffering from a moderate TBI.
Divalproex sodium has been shown to ameliorate mood disorders, even in those with substance
abuse problems. This drug has also shown positive results as an alternate medication to
benzodiazapines in the treatment of alcohol withdrawal, significantly reducing the
progression of withdrawal symptoms in patients.
Despite the body's natural healing during the first year after a head injury, many veterans
who have suffered even mild brain injuries find themselves easily upset or fearful as they go
about their daily lives. While these reactions to the world around them were easily managed
before the head injury, they now occur with little or no interruption and are exceedingly
difficult to manage. Such reactions include a sense of always being upset or fearful that
often makes it difficult to get along with family members, friends, coworkers, and employers.
This may lead to broken marriages, unemployment, and even homelessness.
Some people with head injuries try to manage their unmanageable moods by drinking alcohol
because it can create a sense of calm. However, alcohol's actions are short in duration. Most
find that they have to drink more and more for a similar calming effect, and they soon become
dependent on alcohol. This makes working and being part of their families even more
difficult.
To treat the unmanageable mood, we tried a medicine called valproate, one that eases mood
problems in people without head injury. We gave valproate to head injured persons with mood
problems in a "non-blinded" study where both the doctor and the patient knew that the
medicine was valproate and both were optimistic that it would work. In a small sample of
eighteen people, 85% found mood relief and most of those either stopped drinking alcohol or
drank much less than before. However, this might have been because both the doctor and
patient were hopeful that the medication would make the patient feel better or because the
medicine actually worked.
The only way to know for sure if the medicine works is to perform a study in which people
receive either valproate or a sugar pill while neither they nor their doctor know which one
they are taking. This is called a double blind study, as proposed here, and will involve
nearly three times as many head injured persons as the first study.
If it is successful, the new study will show that valproate treatment helps head injured
people manage their moods and allows them to return to families, friends, and work. It will
also show that they drink alcohol less or not at all, improving their health even further.
Then doctors will know that they can use this medicine for large numbers of people who suffer
from head injury and help them to lead normal lives. If the outcome of the study shows that
the medicine works well, doctors can then use this medicine to treat people with head injury
immediately after the study results are published.
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