Alcoholism Clinical Trial
Official title:
A Double Blind Trial of Divalproex Sodium for Affective Lability and Alcohol Use Following Traumatic Brain Injury
Verified date | January 2020 |
Source | University of Colorado, Denver |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 50 |
Est. completion date | June 2016 |
Est. primary completion date | August 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Veteran - history of closed-head traumatic brain injury (TBI) at least one year prior to enrollment - symptoms of affective lability such as mood swings, irritability, frustration and anxiety - currently using alcohol Exclusion Criteria: - history of Axis I bipolar disorder or anxiety disorder prior to the TBI - skull opened either surgically or traumatically - history of stroke - current diagnosis or past history of major psychosis as defined by Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) - active liver disease - evidence of the alcohol amnesic syndrome - history of seizure disorder other than those caused by ethanol withdrawal - any type of dementia - current suicidal/homicidal ideations - symptomatic thiamine, folate or Vitamin B-12 deficiency - HIV positive - any medical conditions that would constitute contraindications to treatment with divalproex sodium |
Country | Name | City | State |
---|---|---|---|
United States | Denver Veteran's Affairs Medical Center | Denver | Colorado |
Lead Sponsor | Collaborator |
---|---|
University of Colorado, Denver | United States Department of Defense |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Severity of Affective Lability Based on Shortened Agitated Behavior Scale | Severity of affective lability was measured using a shortened version of the Agitated Behavior Scale (ABS). The ABS is used to assess the nature and extent of present agitation. Eight items from the 14-item scale were used, which measured the presence and severity of various affective lability symptoms including: short attention span, impulsivity, uncooperative behavior, violent tendencies, restlessness, rapid or excessive talking, sudden changes in mood, and easily initiated or excessive crying and/or laughter. Each of the eight items was scored using a 1-4 Likert scale, where 1 stands for absence of symptom and 4 stands for presence to an extreme degree. The minimum possible score for this measure was 8, and the maximum possible score was 32. Due to the nature of the measure, a lower score indicated less severe affective lability, while conversely higher scores indicated more severe affective lability. The mean of scores for weeks 2 through 8 for each group were reported. | Weeks 2 through 8 | |
Secondary | Frequency of Alcohol Use | Frequencies of alcohol use/misuse will be measured weekly utilizing the Timeline Followback assessment. Participants will also be given an alcohol breath test at every clinic visit. | Weeks 1-10 |
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