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

Sponsor
Seoul National University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01007539
Collaborator
(none)
31
Enrollment
2
Locations
2
Arms
26
Duration (Months)
15.5
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

Study Description

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
  • Dietary Supplement: CDP-choline
  • Dietary Supplement: Placebo (fructose)
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
31 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Study Start Date :
Nov 1, 2009
Actual Primary Completion Date :
Jan 1, 2012
Actual Study Completion Date :
Jan 1, 2012

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Urinary drug screening test [0-8 week visits]

Secondary Outcome Measures

  1. Craving symptoms [0-8 week visits]

  2. Depressive symptoms [0-8 week visits]

  3. Anxiety symptoms [0-8 week visits]

  4. Side effect check [1-8 week visits]

  5. Neuropsychological test battery [0, 8 week visits]

  6. Clinical Global Impression [0-8 week visits]

  7. Alcohol and tobacco use [0, 4, 8 week visits]

  8. Addiction severity index [0, 8 week visits]

  9. Withdrawal symptoms [0-8 week visits]

  10. Magnetic Resonance Scan [0, 8 week visits]

  11. Self-reported drug diary [0-8 week visits]

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years to 60 Years
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Seoul St. Mary's Hospital Seoul Korea, Republic of 137-701
2 Seoul National University Hospital Seoul Korea, Republic of

Sponsors and Collaborators

  • Seoul National University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
In Kyoon Lyoo, MD, PhD, MMS, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01007539
Other Study ID Numbers:
  • KC09MISI0166
First Posted:
Nov 4, 2009
Last Update Posted:
Aug 31, 2012
Last Verified:
Aug 1, 2012
Additional relevant MeSH terms:
Choline
Cytidine Diphosphate Choline

Study Results

No Results Posted as of Aug 31, 2012