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

Not Applicable

Withdrawn

• Conditions: Traumatic Brain Injury; Substance Dependence; Substance Abuse
• Interventions: Other: Rice bran oil; Drug: Citicoline; Other: Microcrystalline Cellulose; Drug: Omega-3

• Registration Number: NCT01515917
• Lead Sponsor: Deborah Yurgelun-Todd

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-01-18
• Study First Submitted QC: 2012-01-23
• Study First Posted: 2012-01-24
• Study Start: 2013-11
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-15
• Last Update Posted: 2015-01-19
• Primary Completion: 2016-07
• Study Completion: 2017-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Rice bran oil	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.
Placebo	Microcrystalline Cellulose	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.
Citicoline and Omega-3	Citicoline	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.
Citicoline and Omega-3	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.

Primary Outcome Measures

Name	Time	Method
Neurocognitive performance	28 days	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

Name	Time	Method
Brain changes	28 days	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.