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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Citicoline and Omega-3 | Experimental | 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. |
|
| Placebo | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Citicoline | Drug | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D003566 | Cytidine Diphosphate Choline |
| D004281 | Docosahexaenoic Acids |
| D000073879 | Rice Bran Oil |
| C109691 | microcrystalline cellulose |
| ID | Term |
|---|---|
| D002794 | Choline |
| D050337 | Trimethyl Ammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
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| Omega-3 | Drug | 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. |
|
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| Rice bran oil | Other | 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. |
|
| Microcrystalline Cellulose | Other | 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. |
|
| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D009930 |
| Organic Chemicals |
| D009861 | Onium Compounds |
| D003565 | Cytidine Diphosphate |
| D003597 | Cytosine Nucleotides |
| D011742 | Pyrimidine Nucleotides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012265 | Ribonucleotides |
| D015525 | Fatty Acids, Omega-3 |
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |
| D005224 | Fats, Unsaturated |
| D010938 | Plant Oils |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |