Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2012 by University of Utah
Sponsor:
Information provided by (Responsible Party):
Deborah Yurgelun-Todd, University of Utah
ClinicalTrials.gov Identifier:
NCT01515917
First received: January 18, 2012
Last updated: February 5, 2013
Last verified: January 2012

January 18, 2012
February 5, 2013
November 2013
July 2016   (final data collection date for primary outcome measure)
Neurocognitive performance [ Time Frame: 28 days ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01515917 on ClinicalTrials.gov Archive Site
Brain changes [ Time Frame: 28 days ] [ Designated as safety issue: No ]
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.
Same as current
Not Provided
Not Provided
 
Citicoline and Omega-3 Fatty Acid Effects in Veterans With Traumatic Brain Injury (TBI)
Citicoline and Omega-3 Fatty Acid Effects in Veterans With TBI

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Traumatic Brain Injury
  • Substance Abuse
  • Substance Dependence
  • Drug: Citicoline
    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.
    Other Name: Cognizin Citicoline
  • Drug: Omega-3
    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.
    Other Name: Omegabrite
  • Other: Rice bran oil
    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.
  • Other: Microcrystalline Cellulose
    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.
  • Experimental: Citicoline and Omega-3
    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.
    Interventions:
    • Drug: Citicoline
    • Drug: Omega-3
  • Placebo Comparator: Placebo
    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.
    Interventions:
    • Other: Rice bran oil
    • Other: Microcrystalline Cellulose
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
100
July 2017
July 2016   (final data collection date for primary outcome measure)

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)
Both
18 Years to 55 Years
No
Not Provided
 
NCT01515917
IRB_53174
Yes
Deborah Yurgelun-Todd, University of Utah
Deborah Yurgelun-Todd
Not Provided
Not Provided
University of Utah
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP