Citicoline Treatment of Methamphetamine Dependence



Status:Completed
Conditions:Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:Any
Updated:11/18/2012
Start Date:January 2010
End Date:August 2014
Contact:Tracy Hellem, RN, BSN
Email:tracy.hellem@hsc.utah.edu
Phone:801-587-1546

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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.


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.

Methamphetamine Dependent Subject Eligibility:

Inclusion Criteria:

- Subjects who use methamphetamine as their preferred drug of abuse.

- Subjects must be between the ages of 18 and 45 years.

- Subjects must have recent methamphetamine use (within 6 months of screening).

- Subjects must have an established residence and phone.

- Subjects must be able to give informed consent.

Exclusion Criteria:

- Significant current or past medical, neurological, or psychiatric co-morbidity
including cardiovascular, renal, and endocrine disorder, as identified by medical
history.

- Pregnant subjects - due to the unknown effects of MRI on a fetus. In addition, women
of childbearing potential who will not practice a medically accepted method of
contraception will be excluded. Female subjects who are of child-bearing potential
will have to pass a urine pregnancy test before each visit.

- Subjects who, in the investigator's judgment, pose a current serious homicidal or
suicidal risk.

- Subjects who will not likely be able to comply with the study protocol.

- Subjects who have any contraindication to an MR scan.

- Hypersensitivity to any of the study drugs or excipients

- Subjects with current DSM-IV diagnosis of a major mental illness. Major illness will
be defined as Major Depression, Manic Depression, Schizophrenia, Dissociative
Disorder, other psychotic illnesses, Attention-Deficit Hyperactivity Disorder, Post
Traumatic Stress Disorder, Borderline Personality Disorder, Reactive Attachment
Disorder, and Panic Disorder.

- Predominant alcohol or other substance dependence as preferred drug of abuse.

- Positive HIV test result.

- An individual having any pending legal or criminal charge or action, or who has
pending or a reasonable potential for court involvement, or a person who is
incarcerated or is in detention, or who is pending or having completed a competency
evaluation or commitment procedure.

Healthy Control Subject Eligibility:

Inclusion Criteria:

- Subjects must be between the ages of 18 and 45 years.

- Subjects must be able to give informed consent.

- To have an established residence and phone.

Exclusion Criteria:

- Significant medical, neurological, or psychiatric disorders

- Pregnant subjects - due to the unknown effects of MRI on a fetus. In addition, women
of childbearing potential who will not practice a medically accepted method of
contraception will be excluded. Female subjects who are of child-bearing potential
will have to pass a urine pregnancy test before each visit.

- Subjects who have any contraindication to an MR scan.

- Subjects unable to comply with protocol.

- Positive HIV test result.

- Positive urine drug screen.
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