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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
In Kyoon Lyoo, MD, PhD, MMS, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01007539
First received: November 3, 2009
Last updated: August 29, 2012
Last verified: August 2012
  Purpose

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 Intervention Phase
Methamphetamine Dependence
Dietary Supplement: CDP-choline
Dietary Supplement: Placebo (fructose)
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Urinary drug screening test [ Time Frame: 0-8 week visits ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Craving symptoms [ Time Frame: 0-8 week visits ] [ Designated as safety issue: No ]
  • Depressive symptoms [ Time Frame: 0-8 week visits ] [ Designated as safety issue: No ]
  • Anxiety symptoms [ Time Frame: 0-8 week visits ] [ Designated as safety issue: No ]
  • Side effect check [ Time Frame: 1-8 week visits ] [ Designated as safety issue: Yes ]
  • Neuropsychological test battery [ Time Frame: 0, 8 week visits ] [ Designated as safety issue: No ]
  • Clinical Global Impression [ Time Frame: 0-8 week visits ] [ Designated as safety issue: No ]
  • Alcohol and tobacco use [ Time Frame: 0, 4, 8 week visits ] [ Designated as safety issue: No ]
  • Addiction severity index [ Time Frame: 0, 8 week visits ] [ Designated as safety issue: No ]
  • Withdrawal symptoms [ Time Frame: 0-8 week visits ] [ Designated as safety issue: No ]
  • Magnetic Resonance Scan [ Time Frame: 0, 8 week visits ] [ Designated as safety issue: No ]
  • Self-reported drug diary [ Time Frame: 0-8 week visits ] [ Designated as safety issue: No ]

Enrollment: 31
Study Start Date: November 2009
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   19 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01007539

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

No publications provided

Responsible Party: In Kyoon Lyoo, MD, PhD, MMS, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01007539     History of Changes
Other Study ID Numbers: KC09MISI0166
Study First Received: November 3, 2009
Last Updated: August 29, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:
Choline
Cytidine Diphosphate Choline
Lipotropic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Gastrointestinal Agents
Therapeutic Uses
Lipid Regulating Agents
Nootropic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 22, 2014