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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01007539
Recruitment Status : Completed
First Posted : November 4, 2009
Last Update Posted : August 31, 2012
Information provided by (Responsible Party):
In Kyoon Lyoo, MD, PhD, MMS, Seoul National University Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Methamphetamine Dependence Dietary Supplement: CDP-choline Dietary Supplement: Placebo (fructose) Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : November 2009
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Methamphetamine
U.S. FDA Resources

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

Primary Outcome Measures :
  1. Urinary drug screening test [ Time Frame: 0-8 week visits ]

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01007539

Korea, Republic of
Seoul St. Mary's Hospital
Seoul, Korea, Republic of, 137-701
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital

Responsible Party: In Kyoon Lyoo, MD, PhD, MMS, Professor, Seoul National University Hospital Identifier: NCT01007539     History of Changes
Other Study ID Numbers: KC09MISI0166
First Posted: November 4, 2009    Key Record Dates
Last Update Posted: August 31, 2012
Last Verified: August 2012

Additional relevant MeSH terms:
Cytidine Diphosphate Choline
Lipotropic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Lipid Regulating Agents
Nootropic Agents