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

Methamphetamine Dependence Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01007539
• Other study ID #: KC09MISI0166
• Status: Completed
• Phase: Phase 3
• First received: November 3, 2009
• Last updated: August 29, 2012
• Start date: November 2009
• Est. completion date: January 2012

Study information

• Verified date: August 2012
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 60 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Methamphetamine Dependence

Intervention

Dietary Supplement:
• CDP-choline
The subjects will be given 1g citicoline twice daily for a total of 8 weeks.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Seoul St. Mary's Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urinary drug screening test		0-8 week visits	No
Secondary	Craving symptoms		0-8 week visits	No
Secondary	Depressive symptoms		0-8 week visits	No
Secondary	Anxiety symptoms		0-8 week visits	No
Secondary	Side effect check		1-8 week visits	Yes
Secondary	Neuropsychological test battery		0, 8 week visits	No
Secondary	Clinical Global Impression		0-8 week visits	No
Secondary	Alcohol and tobacco use		0, 4, 8 week visits	No
Secondary	Addiction severity index		0, 8 week visits	No
Secondary	Withdrawal symptoms		0-8 week visits	No
Secondary	Magnetic Resonance Scan		0, 8 week visits	No
Secondary	Self-reported drug diary		0-8 week visits	No