Citicoline and Omega-3 Fatty Acid Effects in Veterans With Traumatic Brain Injury (TBI)

Study Overview
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Brief Summary
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This is a placebo-controlled study intended to examine the effects of the neutraceutical citicholine, together with omega-3 fatty acids, on a range of measures in individuals with concussive head injury, often referred to as traumatic brain injury, or TBI. The study will consist of three visits, during which participants will complete brain scans, a thorough testing battery and a clinical interview to assess mood and other diagnostic information relevant to the study.

Official Title
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Citicoline and Omega-3 Fatty Acid Effects in Veterans With TBI

Conditions
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Traumatic Brain Injury, Substance Abuse, Substance Dependence

Intervention / Treatment
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* Drug: Citicoline
* Drug: Omega-3
* Other: Rice bran oil
* Other: Microcrystalline Cellulose


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Veteran status Age 18 to 55 History of TBI DSM-IV-TR diagnosis of abuse or dependence disorder for either alcohol or drugs of abuse Multiple concussive head injuries that meet the following criteria for TBI: 1) normal structural imaging, 2) loss of consciousness (LOC) between 0-30 minutes, 3) alteration of consciousness or mental status for a moment up to 2 hours or 4) post-traumatic amnesia of 0-1 day Stable on current psychotropic medication regimen for ≥ 3 months Exclusion Criteria: Non Veteran Significant medical or neurological illness with the exception of TBI, which might affect cognitive function Significant medical illness which has the potential to be exacerbated by ingestion of citicoline/omega-3 fatty acids, including diabetes, congestive heart disorder, hyperlipidemia and severe coronary artery disease Age other than 18 to 55 years old History of ECT treatment Estimated IQ < 70 Past or present history of bipolar disorder, schizophrenia, delusional disorder or any other psychotic disorder Currently taking a prescribed blood thinner (i.e., Coumadin) Claustrophobia Metal implanted within the body Pregnancy or lactation Left-handedness Poor vision, as subjects must have normal or corrected-to-normal vision for viewing of cognitive challenge paradigms during fMRI protocols Non-native English speakers (for neurocognitive tasks)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Citicoline and Omega-3<br>At visit 1 and again at visit 2, participants assigned to the experimental arm will receive a 14-day supply of citicoline and omega-3 fatty acid, of which they will be instructed to take 1000 mg and 2000 mg daily, respectively. This will be done in a double-blind, randomized fashion. | Drug: Citicoline<br>* Participants randomly assigned to the experimental group, who, in addition to the research staff will be blind to such assignment, will be instructed to orally administer 1000 mg daily citicoline. These participants will receive a 14-day supply of citicoline at visit 1 and again at visit 2, making for a 28-day administration period.<br>* Other names: Cognizin Citicoline;Drug: Omega-3<br>* Participants randomly assigned to the experimental group, who, in addition to the research staff will be blind to such assignment, will be instructed to orally administer 2000 mg daily omega-3. These participants will receive a 14-day supply of omega-3 at visit 1 and again at visit 2, making for a 28-day administration period.<br>* Other names: Omegabrite;|
| Placebo Comparator: Placebo<br>At visit 1 and again at visit 2, participants assigned to the placebo group will be given 14-day supplies of placebo to be taken daily throughout the study period. This will be done in a double-blind, randomized fashion. | Other: Rice bran oil<br>* Rice bran oil will be one of two placebos administered to participants randomly assigned to the placebo arm. Rice bran oil will serve as the placebo for omega-3 fatty acids and will be orally administered daily in 500 mg doses.<br>Other: Microcrystalline Cellulose<br>* Microcrystalline Cellulose will be one of two placebos administered to participants randomly assigned to the placebo arm. Microcrystalline Cellulose will serve as the placebo for Citicoline and will be orally administered daily in 470 mg doses.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurocognitive performance | Using baseline assessment measures gathered at Visit 1, assessments collected at Visits 2 and 3 will be used to determine whether the combined administration of neutraceuticals citicoline and omega-3 fatty acids will improve neurocognitive performance in individuals with TBI and substance abuse/dependence. | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brain changes | Participants will undergo MRI scanning designed to assess white matter microstructure and focal brain activation at Visit 1 (Day 0) and again at Visit 3 (Day 28) in order to determine whether the combined administration of neutraceuticals citicoline and omega-3 fatty acids result in changes to these brain indices in participants with TBI and substance abuse/dependence. | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Veterans, Traumatic Brain Injury, TBI, Substance Abuse, Substance Dependence, Veterans with traumatic brain injury (TBI), Veterans with substance abuse or dependence