The Brain Institute of the University of Utah
Salt Lake City, Utah, 84108, United States
NCT Number: NCT00950352
The purpose of the study is to determine if citicoline (a nutritional supplement) is effective in helping people reduce their dependence on methamphetamine. The investigators will use neuroimaging to look at the structure and chemical make up of the brain at the start of the study and after 8-9 weeks of treatment of citicoline or placebo.
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Notify Me18 year–45 year
All sexes
Interventional
Phase 3
Salt Lake City, Utah, 84108, United States
This is a prospective, randomized, double-blind, placebo-controlled study, in which we will systematically evaluate the therapeutic effects of citicoline, which may both increase dopamine and normalize cognitive and structural deficits in the brains of methamphetamine dependent subjects. Methamphetamine dependent subjects will undergo baseline and repeat cognitive assessments after 8-9 weeks of placebo or oral citicoline as a nutritional supplement. We will also evaluate the chemical and structural changes in brain regions identified by magnetic resonance spectroscopy (MRS), diffusion tension imaging (DTI) and cortical thickness, which in turn are expected to recover after 8-9 weeks of citicoline treatment. Specific brain regions of interest include the prefrontal cortices, temporal cortex, and the caudate/putamen all of which are known to be involved in the pathophysiology of methamphetamine dependence.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Methamphetamine Dependent Subject Eligibility:
Inclusion criteria
Exclusion criteria
Healthy Control Subject Eligibility:
Inclusion criteria
Exclusion criteria
Subjects will be given 1g citicoline twice daily for a total of 8-9 weeks.
Other names: CDP-Choline
Subjects will be given 1 capsule of placebo twice daily for 8-9 weeks. They will be taking the same quantity as the citicoline group.
Time frame: 8 weeks, assessed twice weekly starting week1
Total Amount of Methamphetamine consumed by the participants after 8-9 weeks of treatment. Methamphetamine was assessed twice weekly.
Time frame: Neuropsychological testing will occur at week 0 and week 8/9
Cognitive measurement tests will be employed.
Time frame: Neuroimaging will occur at week 0 and week 8/9
Phosphorus-31 ((31)P) magnetic resonance spectroscopy (MRS) was used to evaluate changes in mitochondrial high energy phosphates, including phosphocreatine (PCr) and β-nucleoside triphosphate (β-NTP, primarily ATP in brain) levels.
Time frame: Throughout the course of the study
Self report drug use and mood will be evaluated at each study visit throughout the course of the study. Also, urine samples will be collected twice a week for drugs of abuse testing.
Perry Renshaw
Other
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