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

Primary Purpose

Traumatic Brain Injury, Substance Abuse, Substance Dependence

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Citicoline
Omega-3
Rice bran oil
Microcrystalline Cellulose
Sponsored by
Deborah Yurgelun-Todd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Brain Injury focused on measuring Veterans, Traumatic Brain Injury, TBI, Substance Abuse, Substance Dependence, Veterans with traumatic brain injury (TBI), Veterans with substance abuse or dependence

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Citicoline and Omega-3

    Placebo

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    January 18, 2012
    Last Updated
    January 15, 2015
    Sponsor
    Deborah Yurgelun-Todd
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01515917
    Brief Title
    Citicoline and Omega-3 Fatty Acid Effects in Veterans With Traumatic Brain Injury (TBI)
    Official Title
    Citicoline and Omega-3 Fatty Acid Effects in Veterans With TBI
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2015
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    November 2013 (undefined)
    Primary Completion Date
    July 2016 (Anticipated)
    Study Completion Date
    July 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Deborah Yurgelun-Todd

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Traumatic Brain Injury, Substance Abuse, Substance Dependence
    Keywords
    Veterans, Traumatic Brain Injury, TBI, Substance Abuse, Substance Dependence, Veterans with traumatic brain injury (TBI), Veterans with substance abuse or dependence

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Citicoline and Omega-3
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Citicoline
    Other Intervention Name(s)
    Cognizin Citicoline
    Intervention Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Omega-3
    Other Intervention Name(s)
    Omegabrite
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Rice bran oil
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Microcrystalline Cellulose
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Neurocognitive performance
    Description
    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.
    Time Frame
    28 days
    Secondary Outcome Measure Information:
    Title
    Brain changes
    Description
    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.
    Time Frame
    28 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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)

    12. IPD Sharing Statement

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

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