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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01007539
Other study ID # KC09MISI0166
Secondary ID
Status Completed
Phase Phase 3
First received November 3, 2009
Last updated August 29, 2012
Start date November 2009
Est. completion date January 2012

Study information

Verified date August 2012
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority South Korea: Korea Food and Drug Administration (KFDA)
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 31
Est. completion date January 2012
Est. primary completion date January 2012
Accepts healthy volunteers No
Gender Both
Age group 19 Years to 60 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
CDP-choline
The subjects will be given 1g citicoline twice daily for a total of 8 weeks.
Placebo (fructose)
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.

Locations

Country Name City State
Korea, Republic of Seoul National University Hospital Seoul
Korea, Republic of Seoul St. Mary's Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Urinary drug screening test 0-8 week visits No
Secondary Craving symptoms 0-8 week visits No
Secondary Depressive symptoms 0-8 week visits No
Secondary Anxiety symptoms 0-8 week visits No
Secondary Side effect check 1-8 week visits Yes
Secondary Neuropsychological test battery 0, 8 week visits No
Secondary Clinical Global Impression 0-8 week visits No
Secondary Alcohol and tobacco use 0, 4, 8 week visits No
Secondary Addiction severity index 0, 8 week visits No
Secondary Withdrawal symptoms 0-8 week visits No
Secondary Magnetic Resonance Scan 0, 8 week visits No
Secondary Self-reported drug diary 0-8 week visits No
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