Clinical trial NCT01007539: Efficacy and Safety of CDP-choline in Patients With Methamphetamine Dependence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Methamphetamine Dependence
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2009-11-04
Enrollment: 31
Sex: ALL
Minimum age (years): 19
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Urinary drug screening test
timeFrame: 0-8 week visits
Secondary outcomes:
measure: Craving symptoms
timeFrame: 0-8 week visits
measure: Depressive symptoms
timeFrame: 0-8 week visits
measure: Anxiety symptoms
timeFrame: 0-8 week visits
measure: Side effect check
timeFrame: 1-8 week visits
measure: Neuropsychological test battery
timeFrame: 0, 8 week visits
measure: Clinical Global Impression
timeFrame: 0-8 week visits
measure: Alcohol and tobacco use
timeFrame: 0, 4, 8 week visits
measure: Addiction severity index
timeFrame: 0, 8 week visits
measure: Withdrawal symptoms
timeFrame: 0-8 week visits
measure: Magnetic Resonance Scan
timeFrame: 0, 8 week visits
measure: Self-reported drug diary
timeFrame: 0-8 week visits
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References: