NCT01007539

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2009

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

November 3, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 2009

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

August 31, 2012

Status Verified

August 1, 2012

Enrollment Period

2.2 years

First QC Date

November 3, 2009

Last Update Submit

August 29, 2012

Conditions

Methamphetamine Dependence

Outcome Measures

Primary Outcomes (1)

  • Urinary drug screening test

    0-8 week visits

Secondary Outcomes (11)

  • 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

  • +6 more secondary outcomes

Study Arms (2)

CDP-choline

EXPERIMENTAL
Dietary Supplement: CDP-choline

Placebo (fructose)

PLACEBO COMPARATOR
Dietary Supplement: Placebo (fructose)

Interventions

CDP-cholineDIETARY_SUPPLEMENT

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

CDP-choline
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.

Placebo (fructose)

Eligibility Criteria

Age19 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Seoul St. Mary's Hospital

Seoul, 137-701, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Interventions

Cytidine Diphosphate CholineFructose

Intervention Hierarchy (Ancestors)

CholineTrimethyl Ammonium CompoundsQuaternary Ammonium CompoundsAminesOrganic ChemicalsOnium CompoundsCytidine DiphosphateCytosine NucleotidesPyrimidine NucleotidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleotidesNucleic Acids, Nucleotides, and NucleosidesRibonucleotidesHexosesMonosaccharidesSugarsCarbohydratesKetoses

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 3, 2009

First Posted

November 4, 2009

Study Start

November 1, 2009

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

August 31, 2012

Record last verified: 2012-08

Locations

KR(2)