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Completed

NCT Number: NCT01007539

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

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.

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Key information

Age range

19 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Seoul National University Hospital, Seoul, South Korea

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CDP-choline

Dietary Supplement

The subjects will be given 1g citicoline twice daily for a total of 8 weeks.

Placebo (fructose)

Dietary Supplement

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.

Primary outcomes

  1. Urinary drug screening test

    Time frame: 0-8 week visits

Secondary outcomes

  1. Craving symptoms

    Time frame: 0-8 week visits

  2. Depressive symptoms

    Time frame: 0-8 week visits

  3. Anxiety symptoms

    Time frame: 0-8 week visits

  4. Side effect check

    Time frame: 1-8 week visits

  5. Neuropsychological test battery

    Time frame: 0, 8 week visits

  6. Clinical Global Impression

    Time frame: 0-8 week visits

  7. Alcohol and tobacco use

    Time frame: 0, 4, 8 week visits

  8. Addiction severity index

    Time frame: 0, 8 week visits

  9. Withdrawal symptoms

    Time frame: 0-8 week visits

  10. Magnetic Resonance Scan

    Time frame: 0, 8 week visits

  11. Self-reported drug diary

    Time frame: 0-8 week visits

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Nov 4, 2009
Registry last updated
Aug 31, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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