Efficacy and Safety of CDP-choline in Patients With Methamphetamine Dependence
NCT ID: NCT01007539
Last Updated: 2012-08-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
31 participants
INTERVENTIONAL
2009-11-30
2012-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
CDP-choline
CDP-choline
The subjects will be given 1g citicoline twice daily for a total of 8 weeks.
Placebo (fructose)
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
19 Years
60 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Seoul National University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
In Kyoon Lyoo, MD, PhD, MMS
Professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Seoul St. Mary's Hospital
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
KC09MISI0166
Identifier Type: -
Identifier Source: org_study_id