Efficacy and Safety of CDP-choline in Patients With Methamphetamine Dependence

Study Overview
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Brief Summary
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The purpose of the study is to determine if cytidine 5'diphosphocholine (CDP-choline, a naturally occurring chemical in your body) has efficacy in reducing the methamphetamine craving of the subjects with methamphetamine dependence craving and helping them maintain the abstinence. In addition, investigators will measure the brain N-acetyl aspartate (a biologic marker for neuronal viability) level of participants to determine if brain deficits induced by methamphetamine may recover by taking CDP-choline.

Conditions
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Methamphetamine Dependence

Intervention / Treatment
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* Dietary Supplement: CDP-choline
* Dietary Supplement: Placebo (fructose)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 19-60 year-old male or female Methamphetamine dependence diagnosed by DSM-IV Total cumulative dose for methamphetamine during the last two years: over 10 gram (over 200 shots of 0,05 mgram intravenous methamphetamine injection) Methamphetamine use in recent 4 weeks Subscale score of drug use in ASI: >2 Exclusion Criteria: Significant current or past medical, neurological, or psychiatric co-morbidity including cardiovascular, renal, and endocrine disorder, as identified by medical history Lifetime axis I psychiatric disorders of bipolar disorder, schizophrenia, identified by SCID-IV Socially dysfunctional antisocial personality disorder Current alcohol or nicotine dependence identified by SCID-IV Taking psychotropic medication in recent two months Head trauma history with loss of consciousness or seizure Intelligence quotient < 80 Pregnant subjects. 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. Any contraindication to an MR scan

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CDP-choline<br> | Dietary Supplement: CDP-choline<br>* The subjects will be given 1g citicoline twice daily for a total of 8 weeks.<br>|
| Placebo Comparator: Placebo (fructose)<br> | Dietary Supplement: Placebo (fructose)<br>* The Subjects will be given 2 tablets of placebo twice daily for 8 weeks. They will be taking the same quantity as the CDP-choline group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary drug screening test |  | 0-8 week visits | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Craving symptoms |  | 0-8 week visits | 
| Depressive symptoms |  | 0-8 week visits | 
| Anxiety symptoms |  | 0-8 week visits | 
| Side effect check |  | 1-8 week visits | 
| Neuropsychological test battery |  | 0, 8 week visits | 
| Clinical Global Impression |  | 0-8 week visits | 
| Alcohol and tobacco use |  | 0, 4, 8 week visits | 
| Addiction severity index |  | 0, 8 week visits | 
| Withdrawal symptoms |  | 0-8 week visits | 
| Magnetic Resonance Scan |  | 0, 8 week visits | 
| Self-reported drug diary |  | 0-8 week visits |