Citicoline Treatment of Methamphetamine Dependence
Condition: Methamphetamine Dependence
Intervention: Citicoline; Placebo
Intervention description: Subjects will be given 1g citicoline twice daily for a total of 8-9 weeks.; 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.
Intervention MeSH terms: Choline; Cytidine Diphosphate Choline
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 104.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: methamphetamine; Citicoline; CDP-Choline; Neuroimaging; MRI; Brain; MRS; DTI

Summary:

      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.
    

Eligibility criteria:

        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.