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.

Study Overview

• Status: Completed
• Conditions: Methamphetamine Dependence
• Intervention / Treatment: Dietary supplement: CDP-choline; Dietary supplement: Placebo (fructose)

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 137-701
    • Seoul st. mary's hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Urinary drug screening test	0-8 week visits

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Clinical Global Impression	0-8 week visits
Alcohol and tobacco use	0, 4, 8 week visits
Addiction severity index	0, 8 week visits
Withdrawal symptoms	0-8 week visits
Magnetic Resonance Scan	0, 8 week visits
Self-reported drug diary	0-8 week visits

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: November 3, 2009
• First Submitted That Met QC Criteria: November 3, 2009
• First Posted (Estimate): November 4, 2009

Study Record Updates

• Last Update Posted (Estimate): August 31, 2012
• Last Update Submitted That Met QC Criteria: August 29, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Antimetabolites; Gastrointestinal Agents; Hypolipidemic Agents; Lipid Regulating Agents; Nootropic Agents; Lipotropic Agents; Choline; Cytidine Diphosphate Choline
• Other Study ID Numbers: KC09MISI0166

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No